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Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease including
  • osteoarthritis
  • traumatic arthritis, and
  • avascular necrosis (not applicable to Physica TT Tibial Plate);
• Inflammatory degenerative joint disease including rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and
• Treatment of fractures that are unmanageable using other techniques.

Additional indications for Physica LMC component are:

• Moderate varus, valgus, or flexion deformities.

In patients with preserved and well functioning collateral ligaments, Physica PS, PS Pro and HPS components are also indicated for:

• Absent or not-functioning posterior cruciate ligament;
• Severe antero-posterior instability of the knee joint.

Additional indications for Physica HPS component are:

• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate varus, valgus, or flexion deformities.

Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use.

Tibial liners can be used with cemented or uncemented tibial or femoral components.

This 510(k) submission aims at introducing the Physica CR Porous Femoral components as part of the subject Physica system. The subject device components are intended to be used without cement, articulating with other components of the cleared Physica system. The Physica system (including subject Physica CR Porous Femoral components) is intended for a total knee replacement.

Physica CR Porous Femoral components are designed based on the cemented Physica CR Femoral components already cleared (K151266). They are made of CoCrMo (ISO 5832-4 / ASTM F75) and are intended to replace the condyles of the distal femur. The femoral components are available in ten sizes (left and right) and are intended to replace the condyles of the distal femur. The femoral components are available in left and right versions and have an asymmetric anterior flange (to adapt left and right knees) with symmetric condyles for the articulation with the tibial liner.

This FDA 510(k) clearance letter pertains to a medical device, specifically the Physica CR Porous Femoral components for total knee replacement, not an AI/Software as a Medical Device (SaMD).

Therefore, the requested information (acceptance criteria and study that proves the device meets the acceptance criteria), which is typically associated with the validation of AI/SaMD, is not directly applicable to this document. The document describes the device, its intended use, and indicates that substantial equivalence to predicate devices was demonstrated through non-clinical mechanical testing and comparisons.

Here's how I can describe the information requested if this were an AI/SaMD, and then explain what the provided document does say in terms of device performance:

As this document describes a physical medical device (knee implant) and not an AI/SaMD, the requested information regarding acceptance criteria and studies for AI/SaMD performance validation (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, training set details) is not present in the provided text.

However, I can interpret your request in the context of the provided document by outlining the performance evaluation conducted for this physical device as presented in the 510(k) summary.

Acceptance Criteria and Study for Physica CR Porous Femoral Components (Non-AI/SaMD Context)

The primary method to demonstrate "acceptance criteria" and "device performance" for this type of medical device in a 510(k) submission is through substantial equivalence to legally marketed predicate devices, supported by non-clinical (mechanical) testing and material characterization.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document mentions "worst case components or constructs" were used for mechanical testing. It does not specify a numerical sample size for these tests.
• Data Provenance: The data comes from non-clinical mechanical testing conducted on physical components of the device, likely performed in a laboratory setting by the manufacturer (Limacorporate S.p.A. in Italy). It is not retrospective or prospective patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This question is not applicable as the ground truth for a physical medical device like a knee implant is established through objective engineering standards and mechanical test results, not through expert consensus on diagnostic images or clinical outcomes in the same way as an AI/SaMD. The "experts" involved would be engineering and material science professionals conducting and interpreting the tests.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in evaluating subjective assessments (e.g., image interpretation). Mechanical testing results are objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is a physical knee implant, not an AI or a system that assists human readers. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical knee implant, not an algorithm.

7. The Type of Ground Truth Used

• For mechanical performance: The ground truth is defined by established engineering standards (e.g., ASTM F3210-22e1 for fatigue testing) and material specifications (e.g., ISO 5832-4 / ASTM F75 for CoCrMo, FDA Guidelines for PoroTi coating). The "ground truth" is that the device must meet these predetermined, objectively measurable criteria.
• For substantial equivalence: The ground truth is the performance and characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI. Its design is based on established engineering principles and prior device designs.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8. The design and development process for a physical implant involves engineering principles, CAD, materials science, and testing against known biomechanical principles, rather than AI training data.

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The MedalOne Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;

• 2. inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. correction of functional deformity:

revision procedures where other treatments or devices have failed: and treatment of fractures 4) that are unmanageable using other techniques.

The MedalOne Total Knee System is for cemented use only.

The subject device, MedalOne Total Knee System, is intended for reduction or relief of pain and/or improved knee function. The subject device is a total knee replacement system composed of four different component types: MedalOne Femoral Component, MedalOne CS Tibial Insert, MedalOne Tibial Base and SoSuperior Patella.

The subject system is based on, and substantially equivalent to, the predicate EVOLUTION® MP Total Knee System in terms of size availability, geometry, nominal dimensions, manufacturing tolerances, overall device processing steps, and materials of construction. The articulation adheres to the same "Medial-Pivot" philosophy as the predicate device. The femoral components are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are offered in sizes 1-8 in left and right variants. The tibial inserts are made from standard UHMWPE conforming to ISO 5834-2 and are available in sizes 1-8 in standard and "extended" versions with thickness options of 10, 12, 14, 17, 20, and 24mm. The tibial bases are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are available in 8 standard sizes and 3 plus sizes to permit 1-up/1-down size interchangeability. The patellas are made from UHMWPE conforming to ISO 5834-2 and are offered in a tri-peg design in 4 sizes: 26, 29, 32, and 35mm. The system is intended to be used with bone cement for fixation.

The system also includes device-specific instrumentation to facilitate implantation of the subject devices. The instrument system includes new MedalOne instrumentation and is fully compatible with the predicate Evolution instrumentation.

This FDA 510(k) summary describes a new knee replacement system, the MedalOne Total Knee System, and compares it to a legally marketed predicate device. The document focuses on demonstrating substantial equivalence rather than presenting an acceptance criteria table with reported device performance against specific targets for a new AI/software device.

Here's an analysis based on the provided text, addressing your points where information is available:

1. A table of acceptance criteria and the reported device performance

The provided text does not contain a typical acceptance criteria table with specific performance metrics and reported values. This document is a 510(k) submission summary for a medical device (a knee replacement system), not an AI/software performance study. The "acceptance criteria" here are implicitly related to demonstrating "substantial equivalence" to a predicate device through various non-clinical tests.

Instead of a table of acceptance criteria and reported device performance in the context of an AI/software driven diagnostic, the document outlines the types of non-clinical tests performed to support the safety and effectiveness of the MedalOne Total Knee System. The "performance" is demonstrated by showing that these tests align with established standards (e.g., ISO, ASTM) and that the results are comparable to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable in the context of this document. The submission pertains to a physical knee implant, not a software or AI device that processes data. The "tests" mentioned are mechanical, materials, and biocompatibility evaluations of the physical components, not studies on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth establishment by experts (like radiologists) is relevant for diagnostic AI/software, not for the physical and material testing of a knee implant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth for diagnostic AI, neither of which is present in the context of this physical device's 510(k) summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human diagnostic performance. The document describes a physical knee implant, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This question assesses the standalone performance of an algorithm. The document is about a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable in the sense of ground truth for a diagnostic AI system. For the physical device, "ground truth" implicitly refers to established biomechanical principles, material science standards (e.g., ISO 5832-4 for Cobalt Chrome alloy, ISO 5834-2 for UHMWPE), and biocompatibility guidelines (ISO 10993 series). The device's performance is compared against these engineering and biological standards and the performance of the predicate device.

8. The sample size for the training set

This information is not applicable. A training set is used for machine learning models. This document is for a physical medical implant.

9. How the ground truth for the training set was established

This information is not applicable. As above, there is no training set mentioned or implied as this is not an AI/ML device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document's context):

The "study" in this context refers to the non-clinical testing performed and leveraged analyses to demonstrate substantial equivalence to the predicate device, the EVOLUTION® MP Total Knee System (K093552), and other reference devices.

• Acceptance Criteria (Implicit): The implicit acceptance criteria are that the MedalOne Total Knee System must perform as safely and effectively as the predicate device(s) and conform to relevant international standards for materials, biomechanics, and biocompatibility. The differences in technological characteristics should not raise new questions of safety and effectiveness.

• Reported Device Performance (Implicit): The non-clinical performance testing results demonstrate that the device is "as safe and effective and performs as well or better than the legally marketed predicate and reference devices." Specific numerical performance values are not given in this summary, but the types of tests performed are listed.

• Non-Clinical Tests Performed:

  • Tibial baseplate fatigue strength evaluation per ISO 14789-1:2000
  • MRI safety evaluation per ASTM F2182-19 and FDA guidance (including other ASTM standards like F2182-11a, F2181-11, F2052-15, F2213-17, F2119-07)
  • Biocompatibility testing per ISO 10993-1 (2018), ISO 10993-5 (2009), ISO 10993-10 (2014), ISO 10993-11 (2017), ISO/TS 21726 (2019), and FDA Guidance.
  • Endotoxin Testing

• Analyses Leveraged from Predicate Device (due to substantial equivalence):

  • Range of motion evaluation
  • Femorotibial and patellofemoral contact area and stability evaluation
  • Component lock detail evaluation
  • UHMWPE Material Property Characterization
  • Durability of the Patellofemoral Joint
  • UHMWPE Tibial Insert Endurance and Deformation Under High Flexion
  • Fatigue Strength of Knee Femoral Components

• Justification for Omissions: Justification was provided for not completing wear testing of the tibial bearing components.

• Clinical Data: No clinical data were provided, and the submitter stated they were "not necessary to support the substantial equivalence."

In essence, the "study" for this device involved a battery of engineering, materials, and biological tests to demonstrate that its physical properties and intended function are within acceptable limits defined by established standards and are equivalent to a device already cleared for market.

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General Total Knee Arthroplasty (TKR) Indications:
• Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.

• Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques.
  The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use. The Triathlon® Total Knee System beaded with Peri-Apatite components are intended for uncemented use only.
  The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
  Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
  · Severe anteroposterior instability of the knee joint.
  Additional Indications for Total Stabilizer (TS) Components:
  · Severe instability of the knee secondary to compromised collateral ligament integrity or function.
  Indications for Bone Augments:
  · Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatic arthritis, complicated by the presence of bone loss.
  · Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
  Additional Indications for Cone Augments:
• · Severe degeneration or trauma requiring extensive resection and replacement
• · Femoral and Tibial bone voids
• Metaphyseal reconstruction
  The Triathlon TS Cone Augment components are intended for cemented or cementless use.

Triathlon Pro Posterior Stabilized Femoral Components Indications for Use:
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Post-traumatic loss of knee joint configuration and function.
  · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
  · Revision of previous unsuccessful knee replacement or other procedure.
  · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques. Additional Indications for Posterior Stabilized (PS) components:
• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
• · Severe anteroposterior instability of the knee joint.
  The Triathlon® Pro PS Femoral Components are intended for cemented use only.

Triathlon Tritanium Tibial Baseplate Indications for Use:
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis

• · Post-traumatic loss of knee joint configuration and function
• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
• · Revision of previous unsuccessful knee replacement or other procedure
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques
  Additional General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:
• · Ligamentous instability requiring implant bearing surface geometries with increased constraint
• Absent or non-functioning posterior cruciate ligament
• · Severe anteroposterior instability of the knee joint
  The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.

Triathlon Low Profile Tibial Tray Indications for Use:
The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below:
Indications for Use:
· Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

Triathlon Metal Backed Patella Indications for Use:

• · Noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis;
• Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed;
• · Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
• · Irreparable fracture of the knee.
  These products are intended to achieve fixation without the use of bone cement.

Triathlon Partial Knee System Indications for Use:
Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.

Avon Patello-femoral Joint Prosthesis Indications for Use:
The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity, or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

Restoris Multi-Compartmental Knee System Indications for Use:
Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis of the tibiofemoral and/or patellofemoral articular surfaces.
The specific knee replacement configurations include:

• Medial unicondylar
• Lateral unicondylar
• Patellofemoral
• · Medial bi-compartmental (medial unicondylar and patellofemoral)
  Restoris Multi Compartmental Knee is for single use only and is intended for implantation with bone cement.

All of the subject devices have been found substantially equivalent in previous 510(k)s. All the subject devices have been cleared for MR conditional labeling in previous 510(k)s. The purpose of this submission is to modify the MR conditional information in the instructions for use to update the parameters in which a patient who has the device can be safely scanned, per testing conducted accordance to updated FDA guidance. There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified.
An additional contraindication is being added to the components of the Triathlon Total Knee System. This contraindication regarding material sensitivity to implant materials is being added.

This document is a 510(k) premarket notification for knee arthroplasty devices, specifically for the Triathlon Knee System and related components. It is important to note that this document does NOT describe a study evaluating the performance of a device driven by an AI algorithm or software.

Instead, this submission is for physical medical devices (knee implants) and their associated labeling. The core purpose of this 510(k) submission is to modify the MR conditional information in the instructions for use for these existing, previously cleared devices due to updated FDA guidance on MR safety testing. The document explicitly states:

• "There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified." (Page 16)
• "There have been no changes requiring 510(k) clearance to the technological characteristics of the Stryker Knee systems as a result of the revision to the labeling." (Page 19)
• "Clinical testing was not required as a basis for substantial equivalence." (Page 20)

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-driven device's performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop studies) cannot be extracted from this document, as it pertains to entirely different types of evaluation (mechanical performance, biocompatibility, and in this specific case, MR safety of physical implants, not AI algorithm performance).

To explicitly answer your questions based on the provided document, even if they don't fully apply to the nature of this submission:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implicit for this submission): The new MR safety testing results must demonstrate that the device is safe for use in an MR environment under the updated parameters to justify the labeling changes, and that the device remains substantially equivalent to its predicates.
   • Reported Device Performance: The document states: "New testing was performed to comprehensively assess the RF-related heating effects induced by the subject devices when implanted into bone, following the FDA guidance document, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," dated May 20, 2021." (Page 19). While the specific quantitative results of this testing are not provided in this summary document, the FDA's clearance (the letter at the beginning) implies the acceptance criteria for MR safety were met.

2. Sample sized used for the test set and the data provenance:

   • This document describes non-clinical (laboratory) testing for MR safety. It does not involve "test sets" in the sense of patient data for AI evaluation. The "sample size" would refer to the number of physical implants tested for MR compatibility. This specific number is not provided in the summary.
   • Data Provenance: N/A for clinical data; the testing was performed per FDA guidance, implying controlled laboratory conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. This is not a study requiring expert readers or ground truth establishment in the context of AI performance. The "ground truth" for MR safety is established by quantitative measurements in a laboratory setting based on physics principles and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. Not a clinical study requiring human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This document does not pertain to AI or human reader performance.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

   • No. This document does not describe an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • N/A for artificial intelligence context. The ground truth for this submission relates to physical properties and safety in an MR environment, established through standardized physical testing and engineering measurements.

8. The sample size for the training set:

   • N/A. There is no training set mentioned or implied for an AI algorithm in this submission.

9. How the ground truth for the training set was established:

   • N/A. There is no training set mentioned or implied.

In summary, this 510(k) notification is for knee replacement components and deals with updating their MR conditional labeling based on physical testing, not with the performance evaluation of an AI-powered device.

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ATTUNE™ Total Knee System Indications for Use
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

ATTUNE™ Cementless Knee System Indications for Use
The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ Total Knee Replacement System.
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).

LPS TM Limb Preservation System Indications for Use
The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

• · malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
• · patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
• · revision cases for a failed previous prosthesis requiring extensive resection and replacement;
• · severe trauma requiring extensive resection and replacement.
  The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
  The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
  The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

Sigma™ High Performance (HP) Partial Knee System Indications for Use
The SIGMA™ High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.

ATTUNE™ Total Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

ATTUNE™ Cementless Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

LPS - Limb Preservation System: The DePuy LPSTM Limb Preservation System is designed for the replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The DePuy LPS system offers a variety of component options (including, but not limited to, proximal femoral bodies, segmental components, distal femoral components, femoral stems, tibial stems, proximal tibial components, hinged tibial insert bearings, metaphyseal sleeves, and adapters). The components, which can be used in conjunction with certain components from other systems, are for treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty. A total femoral replacement is possible in those cases where no part of the femur can be salvaged.

Sigma High Performance (HP) Partial Knee System: The DePuy SIGMATM High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral, and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint. The unicompartmental femoral components are Co-Cr-Mo metal implants. The metal backed tibial components are Co-Cr-Mo with polyethylene inserts. The all-polyethylene unicompartmental tibial component are manufactured from polyethylene. The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).

This document (K233980) is a 510(k) premarket notification for several DePuy knee systems. It primarily focuses on adding updated MRI compatibility information and standardizing language in the Instructions for Use (IFU) and labels. The core claim for substantial equivalence relies on non-clinical performance data related to MRI safety and bacterial endotoxin testing, rather than a clinical study of device performance in a human-in-the-loop or standalone AI context.

Therefore, the requested information regarding acceptance criteria, study design for device performance, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from this document as it pertains to a different type of device (knee implants) and regulatory submission (510(k) for labeling changes related to MRI safety, not an AI/software as a medical device performance study).

However, I can extract the acceptance criteria for the non-clinical performance tests that were conducted, and the reported performance as implied by the conclusion of substantial equivalence.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

For MRI safety, the acceptance criteria are implicit in meeting the standards listed. The reported "performance" is that the devices meet these standards, thus proving MRI safety.

2. Sample sizes used for the test set and the data provenance

• Sample Size: Not applicable in the context of clinical or AI performance. The "test set" here would refer to the physical devices tested for MRI compatibility and bacterial endotoxin. The document does not specify the number of individual devices subjected to these non-clinical tests.
• Data Provenance: Not applicable for a typical AI/software study. The "data" here are the results from physical and chemical testing of the devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as there is no "ground truth" established by experts in the context of an AI or diagnostic device study. The ground truth for these tests is defined by the physical properties measured according to established ASTM and ANSI standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This is not applicable as this is not an image-based or diagnostic AI study requiring human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." (pages 6, 9, 12, 15)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable as the device is a knee implant, not an algorithm or software. The "performance" assessment is of the physical and material properties of the implant itself in relation to MRI safety.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the non-clinical tests is established by the physical and chemical properties measured according to the specified ASTM and ANSI international standards for MRI compatibility and bacterial endotoxin levels.

8. The sample size for the training set

• Not applicable. There is no AI model or training set involved in this regulatory submission.

9. How the ground truth for the training set was established

• Not applicable. There is no AI model or training set involved in this regulatory submission.

In summary: This FDA 510(k) submission for DePuy knee systems is related to changes in labeling for MRI compatibility, not an AI/software/diagnostic device. The "study" described focuses on non-clinical bench testing to demonstrate MRI safety and bacterial endotoxin compliance, adhering to recognized industry standards, rather than clinical performance or AI algorithm validation.

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The Modular Rotating Hinge Knee System is intended to be implanted with bone cement for the following conditions:

• · There is destruction of the joint surfaces, with or without significant bone deformity
• · The cruciate and/or collateral ligaments do not stabilize the knee joint
• · The ligaments are inadequate and/or the musculature is weak and/or
  · Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue

Indication for Use for Duracon Components (Cobalt Chrome & Titanium Stems, and Tibial Wedges) and Stryker Stem Components:
Indications for use of total knee replacement prostheses include:

• · noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis;
• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed;
• · post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and
• · irreparable fracture of the knee.

Indications for US and Rest of World for Total Stabilizer Offset Adapter:
Indications for use of total knee replacement prostheses include:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;

• 2. Rheumatoid arthritis;

3. Correction of functional deformity:
4. Revision procedures where other treatments or devices have failed;
5. Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and.
6. Irreparable fracture of the knee
   When the Total Knee Replacement Prosthesis is used with the components of the Modular Rotating Hinge Knee System, the indication for the Modular Rotating Hinge Knee with Offset Adapters is as follows:
   The Rotating Hinge Knee Systems are intended to be implanted with bone cement for the following condition(s):
7. There is destruction of the joint surfaces, with or without significant bone deformity.
8. The cruciate and/or collateral ligaments do not stabilize the knee joint.
9. The ligaments are inadequate and/or the musculature is weak and/or,
10. Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

GMRS Pediatric Tibial Bearing Component:
Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement.

MRS Pediatric All Poly Tibial Component:
MRS Pediatric All Polyethylene Tibial Component is intended to be used in oncology patients where radical resection of the distal femur/proximal tibia is required. Additional indications include limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage includes surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.

The Modular Rotating Hinge (MRH) Knee System is a tri-compartmental knee system that consists of a stemmed femoral component and a stemmed tibial rotation component, connected by a set of bushings and an axle. A bumper locks this assembly. This assembly provides motion through the axle/bushing combinations in the flexion/extension plane. The articulation between the cylindrical bearing surfaces on the underside of the tibial rotating component and a tibial insert provide motion in the rotation plane. The tibial insert is assembled to a tibial stemmed tray which incorporates a longitudinal bore to accept a tibial sleeve.
The Modular Rotating Hinge Knee System is designed to provide varus/valgus stability throughout the range of motion, internal/external rotation about the tibial axis, constrained by the bearing surface radius on the tibial rotating component, and an extensive range of size, modularity and resection options. The implant system consists of a femoral component in five sizes, a tibial rotating component in five sizes, tibial crossover bearing components in various sizes, bumper inserts, tibial and femoral augmentation components and a tibial sleeve. The MRH Knee System is compatible with components of the Kinemax/Kinematic Knee System, Duracon Knee System, Howmedica Total Stabilizer Knee System, and the GMRS/MRS System.

This document is a 510(k) premarket notification for several knee joint prostheses and related components. The submission's purpose is to modify the labeling of these devices to include "MR Conditional" information. Therefore, the "device" in question for this prompt is the MR Conditional labeling for the existing knee implant systems, not a new or modified implant design itself. The study discussed relates to the safety of these existing implants in an MRI environment.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in terms of number of physical devices tested or a number of patients or images. The testing described is non-clinical testing (phantom/bench testing) performed on the device components themselves to evaluate their interaction with MRI fields.

• Sample Size: Not specified as typically understood for clinical studies (e.g., number of patients/images). This refers to physical samples of the device components or simulated constructs used in bench testing.
• Data Provenance: This is non-clinical/bench testing data, likely generated in a laboratory setting by the manufacturer or a contract testing facility. "Country of origin" for non-clinical testing is not specified, but the applicant is based in Mahwah, New Jersey, USA. The testing is retrospective in the sense that it's performed on manufactured devices, but it's a prospective evaluation of their MRI safety characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For this type of non-clinical, MRI safety testing, "ground truth" is not established by human experts in the same way it would be for diagnostic image interpretation. The "ground truth" is determined by the physical measurements against established safety standards (e.g., ASTM standards for magnetic force, torque, heating, and artifact). The "experts" involved would be technicians and engineers skilled in conducting these specific non-clinical tests and interpreting their results against the predefined standard limits. Their qualifications would involve expertise in materials science, biomechanics, and MRI physics, along with knowledge of the relevant ASTM standards and FDA guidance documents. The document does not specify the number or specific qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for clinical studies where human reviewers assess data. For non-clinical, objective measurements against established standards, the test results themselves, when within the specified limits of the standards, serve as the "adjudication."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence." This is a non-clinical evaluation of device safety with MRI, not a comparative study of diagnostic performance or human reader improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical knee implant component, not an algorithm or AI software. The testing evaluated the physical device's interaction with MRI machines.

7. Type of Ground Truth Used

The ground truth used in this submission is based on established engineering and medical device safety standards (specifically ASTM standards F2052-15, F2213-17, F2119-07, F2182-19e1) and FDA guidance documents (e.g., "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment..." and the May 2021 guidance document for heating in tissue). The "truth" is whether the measured physical properties (displacement, torque, artifact, heating) fall within the acceptable limits defined by these recognized standards and guidance.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The testing performed is non-clinical for MRI safety.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

• · Medial unicondylar
• · Lateral unicondylar
• · Patellofemoral
• · Medial bi-compartmental (medial unicondylar and patellofemoral)

RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

The purpose of this Changes Being Effected premarket notification is to add a contraindication for the Restoris Multicompartmental Knee (MCK) System. Additionally, minor modifications are being made to the contraindications for clarity. There is no change to the intended use, indications, design, technological characteristics or operational principles for the devices. The subject implant components are identical to the predicate components. The Restoris MCK system was most recently cleared in K180612, and has also been cleared previously in K172326, K150307, K090763, K082172, K082088, K082081, and K080368.

This FDA 510(k) submission [K220930] for the Restoris Multi-Compartmental Knee System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document explicitly states:

• "The purpose of this Changes Being Effected premarket notification is to add a contraindication for the Restoris Multicompartmental Knee (MCK) System. Additionally, minor modifications are being made to the contraindications for clarity." (Page 4)
• "There is no change to the intended use, indications, design, technological characteristics or operational principles for the devices." (Page 4)
• "No additional testing was performed as part of this submission, as the only changes being made are to the labeling for the devices. There is no impact to the device design or the physical characteristics of the devices. Testing submitted as part of previously cleared premarket notifications is applicable to this submission." (Page 5)

Therefore, based on the provided text, I cannot fill in the requested information about acceptance criteria and study results because this particular 510(k) submission is for a labeling change and explicitly states that no new testing was performed. The performance data and acceptance criteria would have been part of previous 510(k) submissions (e.g., K180612, K172326, etc.) referenced in this document.

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Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• · Non-inflammatory degenerative joint disease including
  • o osteoarthritis
  • o traumatic arthritis, and
  • avascular necrosis (not applicable to Physica TT Tibial Plate);
• Inflammatory degenerative joint disease including rheumatoid arthritis;
• · Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and
• · Treatment of fractures that are unmanageable using other techniques.

Additional indications for Physica LMC component are:

• Moderate varus, valgus, or flexion deformities.
  In patients with preserved and well functioning collateral ligaments, PS Pro and HPS components are also indicated for:
• Absent or not-functioning posterior cruciate ligament;
• · Severe antero-posterior instability of the knee joint.

Additional indications for Physica HPS component are:

• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
• · Collagen disorders, and/or avascular necrosis of the femoral condyle.
• · Moderate varus, valgus, or flexion deformities.

AMF Revision TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon.

Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Tibial liners can be used with cemented or uncemented tibial or femoral components.

The Physica system is a total knee replacement system consisting of a Femoral component, a Tibial plate, a Tibial liner, a Tibial stem and a Patella component; the Tibial stem and the Patellar component are optional to be used as required for each individual patient and as allowed in the Instructions for Use.

The Physica PS PRO Femoral component is made of CoCrMo alloy; Physica PS, PS PRO and HPS Tibial liners are made of cross-linked UHMWPE with Vitamin E.

The PS PRO Femoral component is intended to be used with bone cement.

The addition of the High Posterior Stabilized (HPS) LimaVit articular surface will provide the surgeon with a more constrained option in obtaining moderate varus/valgus and/or internal/external rotation constraint compared to Physica system posterior stabilized articular surfaces.

This document is an FDA 510(k) clearance letter for the Physica system, a knee replacement device. It primarily focuses on the device's substantial equivalence to previously cleared predicate devices through mechanical testing and a comparison of materials and intended use.

Therefore, the input does not contain information related to a study that proves a device meets acceptance criteria, especially not for an AI/software device. It lacks details regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance (e.g., country, retrospective/prospective).
• Number of experts, their qualifications, and adjudication methods for ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone AI performance.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• Training set sample sizes or how their ground truth was established.

In summary, this document is a 510(k) clearance for a physical medical device (knee prosthesis), not an AI/software device. It relies on non-clinical mechanical testing and comparison to predicates, not clinical studies or performance metrics typically seen with AI/ML device clearances.

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Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• · Non-inflammatory degenerative joint disease including
  • o osteoarthritis
  • o traumatic arthritis, and
  • o avascular necrosis (not applicable to Physica TT Tibial Plate);
• · Inflammatory degenerative joint disease including rheumatoid arthritis;
• · Correction of functional deformity:
• Revision procedures where other treatments or devices have failed; and
• · Treatment of fractures that are unmanageable using other techniques.

Additional indications for Physica LMC component are:

• . Moderate varus, valgus, or flexion deformities.
  In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated for:

• · Absent or not-functioning posterior cruciate ligament;

• · Severe antero-posterior instability of the knee joint.

AMF Revision TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon.

Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Tibial liners can be used with cemented or uncemented tibial or femoral components.

Physica LMC Knee System is a modular knee system which consists of Physica LMC tibial liner, made of UHMWPE or LimaVit, used in combination with a Physica CR femoral component, Physica tibial plate, cemented or uncemented versions, Physica patellar component, made of standard UHMWPE or LimaVit and Physica tibial stem, that were cleared as part of the Physica Knee System in K141934, K151266 and K201084.

The Physica LMC knee system is intended to be used in patients with or without a functioning posterior cruciate ligament.

This document is a 510(k) premarket notification decision letter from the FDA regarding the Physica LMC Knee System. It is a regulatory approval document and does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication), or clinical/non-clinical testing data to prove the device meets acceptance criteria.

The document explicitly states:

• "Non-Clinical testing was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices."
• "Clinical testing was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices."

Therefore, I cannot provide the requested information. The 510(k) summary only discusses changes to the indications for use and surgical technique, asserting substantial equivalence based on these changes to already cleared predicate devices, rather than presenting new performance data.

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General: The LinkSymphoKnee System is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: Primary degenerative arthritis / osteoarthritis Secondary arthritis resulting from rheumatoid arthritis Fracture

The LinkSymphoKnee System is available in multiple versions with different applications, characteristics, and materials. The LinkSymphoKnee Cruciate Retaining (CR) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for crucial retaining applications made from CoCrMo, a cemented tibial component for fixed bearing (FB) applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for crucial retaining and fixed bearing applications made from cPE or X-LINKed Vit-E PE (E-Dur). The LinkSymphoKnee Posterior Stabilized (PS) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for posterior stabilized applications made from CoCrMo, a cemented tibial component for fixed bearing applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for posterior stabilized and fixed bearing applications made from cPE or X-LINKed Vit-E PE (E-Dur). Additonally, the tibial components can also be replaced by an All-Poly tibial component made from cPE. The LinkSymphoKnee Posterior Stabilized Plus (PS+) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for posterior stabilized applications made from CoCrMo, a cemented tibial component for fixed bearing applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for posterior stabilized plus and fixed bearing applications that provides more stability than the standard PS. The articulating surface PS+ provides a constraint from 0 to 3 degrees of varus/valgus and from 0 to 3 degrees of internal/external rotation and is made from cPE or X-LINKed Vit-E PE (E-Dur). The LinkSymphoKnee Condylar Constrained (CCK) Fixed Bearing (FB) consists of a cemented femoral component for condylar constrained applications made from CoCrMo with a cemented modular stem made from CoCrMo or with a cementless modular stem made from TiAl6V4 (Tilastan), a cemented modular tibial component for fixed bearing applications made from CoCrMo with a cemented modular stem (CoCrMo with or without LINK PorEx (TiNbN) modification) or with a cementless modular stem made from TiAl6V4 (Tilastan), and an articulating surface for condylar constrained (CCK) and fixed bearing (FB) applications made from cPE or X-LINKed Vit-E PE (E-Dur). The femoral components can be used with distal, posterior, and L-shaped femoral augments made from TiAl6V4 (Tilastan). The modular tibial components can be used with tibial augments made from TiAl6V4 (Tilastan). The femoral and tibial components are also available in LINK PorEx (TiNbN) coated version. Additionally a 3-peg patella can be used with the LinkSymphoKnee System. It is made from cPE or X-LINKed Vit-E PE (E-Dur). The LinkSymphoKnee System is compatible with previously cleared Tibial and Femoral Cones of Waldemar Link GmbH & Co. KG (K200113 and K201364).

The provided text describes a medical device, the LinkSymphoKnee System, and its clearance process with the FDA. However, it does not include information about performance criteria or a study that evaluates a device's performance against such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study data against acceptance criteria. The "Performance Testing" section explicitly states that "Non-clinical performance testing and analysis were provided" and lists various mechanical tests (e.g., Range of Motion, Wear analysis, Fatigue testing). It concludes that "The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and substantially equivalent to the predicates." Importantly, it also explicitly states, "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

Therefore, based only on the provided text, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or quantitative performance results related to a study are provided. The document generally states suitability and substantial equivalence.
2. Sample size used for the test set and the data provenance: No test set or data provenance mentioned for a performance study. Only mentions "non-clinical performance testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a knee replacement system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document mainly focuses on providing information about the device, its indications for use, comparison to predicate devices, and the types of non-clinical tests performed to demonstrate substantial equivalence (e.g., mechanical testing, wear analysis). It does not provide the detailed performance study information typically associated with AI/software devices or clinical performance criteria.

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Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• · Non-inflammatory degenerative joint disease including
  • o osteoarthritis
  • traumatic arthritis, and o
  • avascular necrosis (not applicable to Physica TT Tibial Plate); o
• · Inflammatory degenerative joint disease including rheumatoid arthritis;
• · Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and
• · Treatment of fractures that are unmanageable using other techniques.

Additional indications for Physica LMC component are:

• . Moderate varus, valgus, or flexion deformities.
  In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated for:
• · Absent or not-functioning posterior cruciate ligament;
• · Severe antero-posterior instability of the knee joint.

AMF Revision TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the surgeon.

Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the fixed to the femoral and tibial implants using bone cement. Tibial liners can be used with cemented or uncemented tibial or femoral components.

The Physica system is a total knee replacement system consisting of a Femoral component, a Tibial plate, a Tibial liner, a Tibial stem and a Patella component; the Tibial stem and the Patella component are optional to be used as required for each individual patient and as allowed in the Instructions for Use.

The Physica Porous Femoral components are made of CoCrMo alloy and the internal surface is PoroTi coated; they are intended to be used without bone cement; the components to be used in combination with (Tibial plate, TT Tibial plate, Tibial liner, Tibial stem, Patella) were previously cleared (K141934, K152008, K190911, K201084).

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Physica system," a knee replacement system. This document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML powered device, which typically involves performance metrics like sensitivity, specificity, accuracy, or other relevant statistically derived performance measures against a defined ground truth.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, as required for a 510(k) submission.

Here's why the requested information cannot be extracted:

• No AI/ML Component: The "Physica system" is a physical knee replacement prosthesis, not an AI or software-as-a-medical-device (SaMD). Therefore, the concept of "device performance" in this context refers to biomechanical properties, material compatibility, and overall safety and efficacy in a surgical setting, not diagnostic or predictive performance.
• No "Acceptance Criteria" for AI Performance: The document discusses conformity to FDA guidelines and referenced standards for mechanical safety and materials, which are the "acceptance criteria" for a physical implant. It does not define statistical performance thresholds for an AI algorithm.
• No "Study Proving Device Meets Acceptance Criteria" for AI: The "non-clinical testing" mentioned primarily involves mechanical comparisons and material testing, not studies comparing algorithmic output to ground truth. The document explicitly states "Clinical testing was not necessary to demonstrate substantial equivalence."
• No Ground Truth for AI: Since there's no AI component, there's no need for an "expert consensus," "pathology," or "outcomes data" to establish ground truth for algorithm training or testing.
• No Training or Test Set: Again, as there's no AI, there are no training or test datasets in the traditional sense.

Therefore, it is not possible to provide the requested table and information based on the provided PDF content.

The document's conclusion of "substantial equivalence" is based on:

• Comparison of intended use.
• Comparison of materials.
• Summary of technological characteristics.
• Preclinical (non-clinical) testing which primarily involved mechanical safety confirmation and material conformity.

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