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U2 Total Knee System - PF+ is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Femoral Component, PF+, Tibial Baseplate, PF+, Tibial Extension Stem, Patella, Onset, E-XPE, PF+, and Patella, Asymmetric Onset, E-XPE, PF+ are indicated for both cemented and cementless use.

USTAR II Total Knee System

1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
5. Joint instability resulting from excessive bone resection.

For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.

For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and intended for cementless use only.

The subject PF+ Patella is a line extension of the U2 Total Knee System, and is compatible to the USTAR II System. The subject device, U2 Total Knee System–PF+ Patella; USTAR II System - PF+ Patella, is a Metal-Backed Patella, indicated for both cemented or cementless application. There are two variations available: (1) Patella, Onset, E-XPE, PF+, and (2) Patella, Asymmetric Onset, E-XPE, PF+. Patella, Onset, E-XPE, PF+ is a symmetric, dome-type metal-backed patella, and Patella, Asymmetric Onset, E-XPE, PF+ is an asymmetric, anatomic-type patella. Each type is available in five sizes. The body of PF+ patella is manufactured from Vitamin E blended highly cross-linked UHMWPE (ASTM F2695, ASTM F648/ISO5834-1), while the part of the metal back and the three pegs are produced by additive manufacturing according to the FDA guidance "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff", "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", and "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post market Surveillance Requirements." The metal back is made of Ti-6Al-4V alloy (ASTM 2924) and has a porous Ti structure on the bone side, peg side, and poly side. All types of PF+ Patella are compatibility with "United" U2 Total Knee System-Femoral components (K051640, K120507, K140073, K140075, K150829, and K150832), Femoral component, PSA (K082424), Femoral components, PF+ (K221705), and USTAR II System-Femoral components (K190100).

The provided text is a 510(k) Clearance Letter from the FDA for a total knee system. It details the device's name, regulation, a summary of its description, intended use, and a comparison to predicate devices, along with a list of non-clinical tests conducted.

However, the document specifically states "No clinical data is necessary." This means that the clearance was not based on a clinical study demonstrating the device's performance against detailed acceptance criteria in human patients with the format typically requested in your prompt (e.g., sensitivity, specificity, human-in-the-loop performance, ground truth establishment by experts, etc.).

Instead, the clearance is based on the substantial equivalence of the new device to existing legally marketed predicate devices, primarily through non-clinical testing and technological comparison.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from a clinical study, as no such study was presented or required for this 510(k) clearance.

The "acceptance criteria" for this device, as implied by the FDA clearance, revolve around demonstrating that its technological characteristics and non-clinical performance are substantially equivalent to already cleared devices.

Here's what I can extract from the document regarding the non-clinical tests that functionally served as part of the "proof" that the device meets some form of performance criteria:

Summary of Non-Clinical Tests (Implicit Acceptance Criteria & Performance):

Since no clinical study was conducted or referenced in this 510(k) clearance documentation, the following points of your request cannot be addressed from the provided text:

• Sample size used for the test set and data provenance: Not applicable, as no clinical test set was used. The non-clinical tests were performed on device prototypes or samples.
• Number of experts used to establish the ground truth... / qualifications of those experts: Not applicable. Ground truth for clinical performance was not established.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: For the non-clinical tests, the "ground truth" is defined by established engineering and material science standards and methodologies (e.g., ASTM standards for material properties, mechanical testing protocols).
• The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

In essence, this 510(k) clearance is a regulatory determination of substantial equivalence based on non-clinical performance data and technological comparisons to predicate devices, not on a clinical trial demonstrating performance against specific diagnostic or treatment outcome acceptance criteria in humans.

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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 iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatic arthritis or osteonecrosis of the knee.

· Post traumatic loss of joint function.

· Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.

· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans

This implant intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.

The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.

The iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is a tricompartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component. The product design incorporates a bone preserving approach for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. The joint restoring design provides for more natural kinematics by maintaining the patient specific femoral sagittal curves, preserving the patient specific femoral offset, preserving the medial and lateral joint lines and having a patient specific fit. It is intended for use in those patients whose condition cannot be appropriately or effectively addressed using a device that treats only one or two compartments of the knee (i.e. a unicompartmental, bicompartmental, or patellofemoral prosthesis).

Using patient imaging (CT scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of an uncemented metallic device designed from the patient's natural bone geometry. The femoral component is additively manufactured from a cobalt chromium molybdenum ("CoCrMo") alloy. The tibial tray is additively manufactured from titanium ("Ti-6Al-4V") alloy. The tibial inserts are manufactured and offered in either ultra-high molecular weight polyethylene (iPoly®) or highly crosslinked ultra-high molecular weight Vitamin-E enriched polyethylene (iPoly® XE). The patellar component is manufactured and offered in ultra-high molecular weight polyethylene (iPoly®) with a porous Ti6Al4V metal backing. The femoral, tibial, and patellar implants are additively manufactured using proprietary TIDAL Technology™ which allows biological fixation without the need for bone cement. The iTotal® ldentity™ CR 3DP Porous KRS is designed for press-fit use without cement, but may be used with a cemented technique if desired.

The iTotal® Identity™ CR 3DP Porous KRS is supplied with disposable, patient-specific instrumentation (ilig®) designed for use with the system. These patient-specific guides are pre-navigated to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. Each set of instruments is designed for one-time use, specifically for one patient. The iJig® instrument set is manufactured from biocompatible nylon material and supplied sterile along with the implants.

The provided text describes a medical device, the "iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System," and its submission for FDA 510(k) clearance. However, it explicitly states that "No clinical testing was warranted for the subject device."

This means that the information you requested regarding acceptance criteria and the study that proves the device meets those criteria cannot be found in this document because a clinical study was not conducted or submitted for this particular clearance.

Therefore, I cannot provide the following information:

1. A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
2. Sample size used for the test set and the data provenance: No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No clinical test set.
4. Adjudication method for the test set: No clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable as no clinical study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical implant, not a software algorithm.
7. The type of ground truth used: No clinical ground truth established.
8. The sample size for the training set: No clinical training set.
9. How the ground truth for the training set was established: No clinical training set.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance evaluation, which includes various biomechanical and material tests. These non-clinical tests are listed, but their specific acceptance criteria and detailed results are not provided in this summary.

Non-Clinical Performance Evaluation (as listed in the document):

• Patella static tensile test
• Patella static shear test
• Patella shear fatigue test
• Tibial tray fatigue test
• Femoral fatigue test
• Tibial micromotion
• Tibiofemoral constraint test
• Tibiofemoral contact area, stress and wear test
• Tibial interlock test
• Patellofemoral subluxation, contact area and stress test
• Particle characterization
• Porous coating testing per FDA guidance on modified metallic surfaces
• Biocompatibility assessment

Conclusion from the document: "The results of the testing demonstrate that the subject device iTotal® Identity™ CR 3DP Porous KRS is as safe and effective and is substantially equivalent to the cleared predicates... and the differences between the subject and predicates do not raise different questions of safety or effectiveness."

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The Freedom® Total Knee System is indicated for the following:
• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components and Primary PCK Components only).
The Freedom® Porous Tibial Base Plate and Cementless Femoral Components are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.

The Freedom® Porous Tibial Base Plate is a line extension of the Freedom® Total Knee System comprising of tibial base plate components for cemented or uncemented use in total knee arthroplasty. Freedom® Porous Tibial Base Plates are intended for use with existing, compatible Freedom® femoral and tibial liner components. Freedom® Porous Tibial Base Plates are additively manufactured from Ti-6Al-4V ELI Grade 23 and include a porous lattice structure on the distal face. Freedom® Porous Tibial Base Plates are available in eight asymmetric design offerings (Sizes 1 – 8, Left / Right configurations), based on anterior / posterior (A/P) and medial / lateral (M/L) dimensions.

The provided document is a 510(k) premarket notification for a medical device, specifically the Freedom® Total Knee System - Porous Tibial Base Plate. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with strict acceptance criteria and performance analysis. Therefore, the information requested about acceptance criteria and a study proving the device meets them, typically found in a clinical trial report or a performance study for novel devices or software, is not directly applicable in the same way.

However, I can extract the information related to the non-clinical performance testing conducted to support the substantial equivalence claim. This testing serves as the "study" demonstrating that the device performs as intended and is similar to the predicate.

Here's an interpretation based on the provided text:

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

The document does not explicitly state numerical "acceptance criteria" for each test in the way a clinical trial might. Instead, the "acceptance" is implicitly defined by demonstrating that the subject device's performance is substantially equivalent to established performance standards or the predicate/reference devices. The "reported device performance" is summarized as the satisfactory completion of these tests.

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

• Sample Size: The document does not specify the exact number of implants or test coupons used for each non-clinical test (e.g., how many tibial trays were fatigue tested). It mentions that "All testing was performed on worst case implants or test coupons as dictated by the relevant performance standards."
• Data Provenance: The tests are non-clinical (laboratory/mechanical testing), not human clinical data. Thus, terms like "country of origin" or "retrospective/prospective" are not applicable. The data originates from laboratory testing conducted by or for the manufacturer (Maxx Orthopedics, Inc.).

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

This information is not applicable. The "test set" here refers to physical specimens (implants/coupons) for non-clinical testing, not patient data requiring expert interpretation or ground truth establishment. The "ground truth" for these tests is defined by the technical specifications and requirements of the referenced ASTM and ISO standards.

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

This is not applicable as the tests are non-clinical, mechanical, and material evaluations performed against established standards, not clinical data requiring adjudication by experts.

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 is not applicable. The device is a physical knee implant, not an AI software or diagnostic tool used by human readers.

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

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

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

For the non-clinical performance tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced ASTM and ISO standards. For example, the acceptable number of cycles for fatigue testing is defined by ASTM F1800. For residual particles, the "ground truth" is the acceptable range established in the literature for the reference device, as evaluated against ASTM F1877.

8. The sample size for the training set

This is not applicable. The device is a physical knee implant. There is no "training set" in the context of machine learning or AI. The manufacturing process is validated, and the device's design is based on engineering principles and existing predicate designs, not a data-driven training set.

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

This is not applicable for the reasons stated above.

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When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• 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.
  When a personalized alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:
• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate valgus, varus, or flexion deformities.

The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones.
The purpose of this submission is to add compatibility for cemented nonporous Persona tibial components with a stem extension to the current Personalized Alignment (PA) surgical technique option. In addition to the modifications regarding personalized alignment, this submission also discusses the updated geometric evaluations for the Persona Personalized Knee System as well as the shelf-life extension (5 years to 10 years) of its Vivacit-E VEXLPE implant components.

I'm sorry, but based on the provided text, I cannot describe the acceptance criteria and a study that proves the device meets those criteria, as the document does not contain this information. The text is a 510(k) premarket notification letter from the FDA to Zimmer Biomet regarding the Zimmer® Persona® Personalized Knee System, confirming its substantial equivalence to previously marketed devices.

The document focuses on:

• The FDA's determination of substantial equivalence (K243293).
• Regulatory information and requirements for medical devices.
• Indications for use of the Zimmer® Persona® Personalized Knee System.
• Identification of predicate devices (K240299, K222566).
• A brief description of the device and the purpose of the submission (adding compatibility for cemented nonporous Persona tibial components with a stem extension to the Personalized Alignment surgical technique; updated geometric evaluations; shelf-life extension for specific components).
• A summary of technological characteristics comparing the subject device to the predicate device, emphasizing their similarities regarding intended use, indications for use, variants/sizes, design features, material, and sterility, and noting a similar shelf life with an extension for Vivacit-E VEXLPE components.
• A general statement about performance data indicating the proposed devices meet established acceptance criteria and are as safe and effective as predicate devices.

However, the document does NOT include:

• A table of specific acceptance criteria and detailed reported device performance against those criteria.
• Information about sample sizes for test sets, data provenance, or the nature of prospective/retrospective studies.
• Details on the number or qualifications of experts used for ground truth establishment.
• Adjudication methods.
• Statements about multi-reader, multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance.
• Information on standalone algorithm performance.
• The specific type of ground truth used (e.g., pathology, outcomes data).
• Sample sizes for training sets or how ground truth for training sets was established.

The text primarily attests to substantial equivalence based on the similarity of the device to existing predicates and a general statement about meeting performance criteria, but it does not elaborate on the specific studies or data that would fulfill your request for detailed acceptance criteria and proof of adherence.

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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, valqus, 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.

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 Porous Femoral Components have been cleared via K210554 with a Porous coating performed by a supplier. With this 510(k) submission, Limacorporate intends to add an additional coating vendor for these components. No other change is introduced on the Physica Porous Femoral Components: Intended use, design, material, sterilization, packaging and principle of operation are unchanged compared to the information approved in K210554.

The provided text is a 510(k) premarket notification for a medical device called "Physica Porous Femoral Components." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific performance acceptance criteria via a clinical study with a detailed test set, ground truth, or expert review.

Therefore, the document does not contain the information requested regarding acceptance criteria met by a study that proves the device meets them. Specifically:

• No table of acceptance criteria and reported device performance: The document does not define specific performance metrics or acceptance thresholds that the device was tested against in a clinical setting.
• No sample size used for the test set or data provenance: There is no clinical test set described.
• No number of experts or their qualifications for ground truth: Since no clinical test set is described, there's no mention of experts establishing ground truth for it.
• No adjudication method for the test set: Not applicable as there's no clinical test set.
• No multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical testing was not necessary to demonstrate substantial equivalence of the new Physica Porous Femoral components to the predicate devices." This means no human-in-the-loop study was conducted.
• No standalone (algorithm only) performance study: This is not an AI/algorithm-based device; it's a knee prosthesis component.
• No type of ground truth used: Not applicable as there's no clinical test.
• No sample size for the training set: Not applicable as this is a physical device and not an AI/ML model.
• No description of how ground truth for the training set was established: Not applicable.

What the document does state regarding demonstrating equivalence:

The submission for the Physica Porous Femoral Components focuses on demonstrating substantial equivalence primarily through non-clinical testing and comparison of technological characteristics.

• Non-clinical testing: "Mechanical and morphological characteristics of the coating of the subject cementless Physica Porous Femoral components were confirmed through a comparison with previously cleared (K210554) cementless Physica Porous Femoral components. The PoroTi coating of subject Porous Femoral components fulfills the conformity to the FDA guidelines and referenced standards and the analysis was performed on worst case components or constructs."
• Comparison of technological characteristics: The document asserts that "The intended use, design, and materials of the subject Physica Porous Femoral components (part of Physica system) are substantially equivalent to those of the predicate devices."

In essence, the "study" proving the device meets requirements for market clearance in this case is a non-clinical bench testing and design control process to ensure the new manufacturing of the porous coating is equivalent to a previously cleared version, which itself would have established safety and effectiveness through its own predicate or data. No new clinical or human performance data was required for this specific 510(k) submission.

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When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

• Collagen disorders, and/or avascular necrosis of the femoral condyle.

• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

• Moderate valgus, varus, or flexion deformities.

• 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.

When a Personalized Alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

• Collagen disorders, and/or avascular necrosis of the femoral condyle.

• Moderate valgus, varus, or flexion deformities.

The Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.

Porous coated components may be used cemented (biological fixation), except for the Persona OsseoTi Keel Tibia and the Persona OsseoTi 3-Peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

The purpose of this submission is to add a new component to the Personalized Knee System, the component is the Persona Ti-Nidium PPS Femurs. The addition of these components do not change the intended use or fundamental scientific technology of the device system.

The Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones. With this submission a new porous coated Ti-6Al-4V femoral component will be added to the system. These femoral components articular surface of the tibial component, as well as, a patellar component, as part of a total knee system. The new femoral come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.

The provided text describes the regulatory clearance for the Persona Ti-Nidium PPS Femurs, a component of the Personalized Knee System, but it does not contain the specific details required to answer your questions about acceptance criteria and study design.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance validation studies with acceptance criteria in the way you've outlined for software or AI-driven medical devices.

Here's why the information you're asking for is not in the text:

• Device Type: This submission is for an orthopedic implant (knee prosthesis components), not a diagnostic software or AI device. The regulatory pathway and what's typically reported in these summaries are different. Performance for orthopedic implants is usually evaluated through biomechanical testing, material characterization, and sometimes clinical follow-up for the overall system, rather than metrics like sensitivity, specificity, or AUC based on expert reads of images.
• Focus of the Document: The document is primarily an FDA clearance letter and a 510(k) summary. It confirms the device's substantial equivalence to previously cleared predicate devices. It lists the types of non-clinical tests performed (e.g., fatigue, wear evaluation, material characterization) but does not provide the acceptance criteria for these tests or detailed results against those criteria. It states that "Clinical Testing Not Applicable," indicating that a clinical study with human subjects for efficacy was not required for this 510(k) clearance.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance (in the context of AI/software metrics).
2. Sample size used for a "test set" (as in expert-labeled data) or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Indications:

Indications for Total Knee Replacement:

• 1. Rheumatoid arthritis,
• 2. Correction of functional deformity.
• 3. Osteoarthritis.

4. Degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result.

5. Failed osteotomies, unicompartmental replacement, or total knee replacement.

The femoral component and tibial tray are for cemented use (biological fixation).

The patellar component and metaphyseal stem (K080199) are for cemented use only.

Indications for Posterior Stabilized Knee Replacement:

Posterior stabilized knee systems with a deep articular surface are designed for use in patients in primary and revision surgery, where the anterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Total Knee indications still apply.

Indications for Constrained Knee Replacement:

Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/ or lateral collateral ligament) are absent or incompetent. Total Knee indications still apply.

The Agility Symmetric™ Total Knee System is intended for the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem previously cleared in K080199) and a potellar component (also cleared in K080199).

The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/ molybdenum (CoCrMo). The femoral component is available in five sizes (3-7) and will have two condylar pegs to aid in rotational stability. It is mesh coated with ASTM F67 titanium.

The TIBIAL TRAY is a symmetric designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti6Al4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside providing rotational stabilization and increased tray strew holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting an ultra-high polyethylene (UHMWPE) tibial insert to be snapped into place. The tibial tray has 5 sizes (3-7) and is mesh coated with ASTM F67 titanium.

Mating geometries for the previously cleared (K080199) TIBIAL INSERT, METAPHYSEAL STEM, REVISION STEM, and PATELLAR COMPONENT have not changed from the predicate devices.

The prompt asks to describe the acceptance criteria and the study proving a device meets them, but the provided text is a 510(k) clearance letter for a total knee replacement system (Agility Symmetric Total Knee System). This document does not describe acceptance criteria for an AI/ML medical device, nor does it detail a clinical study with human readers or AI assistance.

Instead, it's a premarket notification for a medical implant and focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot fulfill the request as it pertains to an AI/ML medical device's acceptance criteria and study, based on the provided text. The text outlines:

• Device Name: Agility Symmetric™ Total Knee System
• Regulation Number/Name: 21 CFR 888.3565 / Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
• Product Codes: MBH, JWH
• Indications for Use: Total Knee Replacement, Posterior Stabilized Knee Replacement, Constrained Knee Replacement (details specific conditions like rheumatoid arthritis, osteoarthritis, failed osteotomies, ligament integrity, etc.).
• Predicate Devices: K080199 (Symmetric™ Total Knee System - primary), K141635 (Arthrex iBalance® TKA System - secondary)
• Device Description: Components (femoral, tibial tray, patellar, metaphyseal stem), materials (CoCrMo, Ti6Al4V), and coating (ASTM F67 titanium mesh).
• Technological Comparison: Differences from predicates in coating material and bone interface features (e.g., removal of central post/gussets, addition of condylar pegs), but deemed to not raise new questions of safety and effectiveness.
• Non-Clinical Tests Summary & Conclusions:
  • Fatigue testing per ASTM F3210 (femoral knee) and ASTM F1800 (tibial tray, tibial tray and modular stem).
  • Wear testing per ISO 14243-1.
  • Particle characterization per ASTM F1877-16.
  • Shear-off testing for tibial locking mechanism per ASTM 1814.
  • Cleaning validation per ISO 19227.
  • Biocompatibility assessment per ISO 10993-1.
  • Sterilization assessment per ISO 11135 and AAMI TIR28.
  • Uncemented design validation per ISO 21536.
  • Morse taper modular connection assessment per ISO 21536 and ASTM F1814.
  • Constraint and contact area assessment per ASTM F1223 and ISO 21536.
• Clinical Testing: Not Applicable. This further confirms that no human-in-the-loop or standalone AI/ML performance study was conducted.

In summary, the provided document does not contain the information required to answer the prompt regarding acceptance criteria and study data for an AI/ML medical device.

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When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:
-Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• 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.

When a Personalized Alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate valgus, varus, or flexion deformities.

The Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.

Porous coated components may be used cemented (biological fixation), except for the Persona Osseo Ti Keel Tibia and the Persona OsseoTi 3-peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

The purpose of this submission is to add compatibility of the Persona OsseoTi 3-Peg Patella to the Persona® the Personalized Knee System Posterior Stabilized (PS) femoral components. The addition of this compatibility does not change the intended use or fundamental scientific technology of the device system.

The Persona® the Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patella bones. With this submission compatibility of the Persona OsseoTi 3-Peg patella components will be added to the Persona PS femoral components of the knee system. These patella components articulate against femoral component as part of a total knee system. These patellar components come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.

The provided text is a 510(k) summary for the "Persona the Personalized Knee System." It details the device's indications for use, technological characteristics, and comparison to predicate devices, focusing on the added compatibility of the Persona OsseoTi 3-Peg Patella with Posterior Stabilized (PS) femoral components.

However, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an algorithm or AI performance. The tests mentioned are non-clinical durability tests for mechanical components of a knee prosthesis, performed according to ISO standards. These are physical tests, not studies evaluating software or algorithm performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as it is not relevant to the type of device being described.

Here's what can be extracted based on the provided text, while acknowledging that the primary request is not fully addressable due to the nature of the device:

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

Since the device is a knee prosthesis and not an AI/software device, the "acceptance criteria" and "reported device performance" are related to mechanical durability rather than algorithmic accuracy. The document states that durability testing was performed "per ISO 14243-5." This ISO standard would inherently define the acceptance criteria (e.g., number of cycles without failure, wear rates within limits). However, the specific quantitative acceptance criteria and the detailed qualitative or quantitative performance results (e.g., actual wear rates, exact number of cycles completed by the device in the test without failure) are not reported in this summary. It only states that the tests were done.

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

• Sample Size for Test Set: Not applicable in the context of an AI/software test set. For the mechanical durability tests, the "sample size" would refer to the number of prostheses tested. This is not explicitly stated in the provided text.
• Data Provenance: Not applicable in the context of clinical data for AI. These are non-clinical mechanical tests, likely performed in a lab setting by the manufacturer (Zimmer, Inc., based in Warsaw, Indiana, USA).

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):

Not applicable. Ground truth, in the context of experts interpreting data, is relevant for AI/software evaluations. For mechanical durability testing, the "ground truth" is determined by the physical outcome of the test (e.g., whether a component fractured, or wear measurements). This doesn't involve human experts establishing a ground truth in the interpretative sense.

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

Not applicable. Adjudication methods are used to resolve disagreements among multiple human readers/experts in AI/software evaluations. This is a non-clinical mechanical test.

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 mention any MRMC study. The device is a physical knee prosthesis, not an AI or software product intended to assist human readers.

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

No. This is not an algorithm.

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

Not applicable in the AI/software sense. For mechanical tests, the "ground truth" is the physical measurement or observation of the component's state after rigorous testing (e.g., did it fail, what was the wear rate).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, no training set for an algorithm is involved.

In summary, the provided document describes a premarket notification for a physical medical device (knee prosthesis) and its mechanical testing. It does not pertain to an AI/software device, therefore, almost all the specific questions about acceptance criteria and studies for AI performance cannot be answered from this text.

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The Exactech® TRULIANT® Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The TRULIANT Cemented Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only. The TRULIANT Porous Femoral Components are indicated for cemented or cementless use. The TRULIANT Porous Tibial Trays are indicated for cemented or cementless use.

The Exactech® Truliant® Knee System is a total knee replacement system comprised of femoral, tibial, and patellar implants. The proposed Porous Tibias are additional tibial tray implant variants intended for use with the Truliant Knee System. This submission proposes Truliant Porous Tibial Trays made from titanium alloy consolidated via direct metal laser sintering (DMLS). This submission additionally proposes a Porous Tibial Tray variant without screw holes, additional intermediate tray sizes, and minor geometric change(s) to the predicate Porous Tibial Tray design.

This document is a 510(k) Premarket Notification from the FDA regarding the Exactech® TRULIANT® Knee System. It does not describe an AI/ML device and therefore does not contain the specific information requested in the prompt about acceptance criteria for an AI model, such as performance metrics like sensitivity/specificity, AI model training/test sets, expert adjudication, or MRMC studies.

The document discusses the substantial equivalence of a medical device (a knee replacement system) to a legally marketed predicate device. The performance data presented relates to engineering and biocompatibility testing for a physical implant, not an AI algorithm.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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