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1. Painful and disabled knee joint resulting from osteoarthritis, or traumatic arthritis, or traumatic arthritis where one or more compartments are involved.

2. Correction of varus, valgus, or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.

Femoral components and tibial tray components with porous coatings are indicated for cemented biological fixation application. Non-coated (Interlok) femoral components and all polyethylene patellar components are indicated for cemented application only.

The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of cobalt-chromium-molybdenum (Co-Cr-Mo), two styles of tibial trays manufactured out of Co-Cr-Mo (with locking bar), and dual bearings machined of Vivacit-E Vitamin-E Highly Crosslinked Polyethylene (VEHXPE). Biomet patellae can be used with the Vanguard XP Knee System. The subject Vanguard XP tibial components are available with a porous plasma spray (PPS®) of titanium alloy powder for uncemented or cemented fixation or with Biomet's Interlok coarse blasted finish for cemented fixation only. The Vanguard XP Knee System offers the flexibility to retain the ACL and PCL ligaments, retain just the PCL ligament and accommodate an intact, partially functioning PCL within a single system.

The provided document, a 510(k) premarket notification for the Vanguard XP Knee System, primarily focuses on demonstrating substantial equivalence to predicate devices for a knee implant, specifically a modification to the tibial bearings. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.

The document discusses:

• Device Identity: Vanguard XP Knee System, a total knee replacement system.
• Modification: A modification to the tibial bearings within the system.
• Purpose of Submission: To demonstrate that this modification does not adversely affect safety and efficacy and that the modified device remains substantially equivalent to predicate devices.
• Testing: Engineering analysis and non-clinical tests (e.g., material characteristics, stress analysis, MRI compatibility, non-pyrogenicity).
• Clinical Data: Explicitly states, "Clinical data was not deemed necessary for the subject device." This indicates that no human clinical study was conducted for this specific 510(k) submission, and certainly not a study related to AI/ML performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI/ML device meets them based on the provided text. The document pertains to a traditional orthopedic implant, not an AI/ML medical device.

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The b-ONE MOBIO Total Knee System is intended for total knee arthroplasty due to the following conditions:

· 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 stabilized by standard fracture- management techniques.

Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components:

· Ligamentous instability requiring implant bearing surface geometries with increased constraint.

• · Absent or nonfunctioning posterior cruciate ligament.
  · Severe anteroposterior instability of the knee joint.

The b-ONE MOBIO Total Knee System is intended for implantation with bone cement only. b-ONE MOBIO Total Knee System components are not intended for use with other knee systems.

The b-ONE™ MOBIO™ Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.

The purpose of this submission is to add a line extension to the existing system to offer the Tibial Inserts and Patella components in UHMWPE Crosslinked with 0.1% tocopherol.

All system components are supplied sterile and are single use devices.

This is a 510(k) Premarket Notification for a medical device (a total knee replacement system), not for a diagnostic AI/ML device. Therefore, the provided text does not contain the information requested regarding acceptance criteria, study design for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, or ground truth establishment for an AI/ML algorithm.

The document discusses a traditional 510(k) submission for a physical medical device (knee implant), focusing on its materials, design features, and manufacturing processes, and demonstrating substantial equivalence to a predicate device. The "Performance Data" section refers to non-clinical studies (material characterization, wear testing, biocompatibility) for the physical implant material, not the performance of an AI/ML algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI device meets the acceptance criteria from this document.

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The b-ONE Total Knee System is intended for total knee arthroplasty due to the following conditions:

· 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) and Posterior Stabilized Plus (PS+) components:

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.

• · Absent or nonfunctioning posterior cruciate ligament.

• · Severe anteroposterior instability of the knee joint.

The b-ONE Total Knee System is intended for implantation with bone cement only. b-ONE Total Knee System components are not intended for use with other knee systems.

The b-ONE Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device type and includes two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.

The System includes left and right femoral components manufactured from cast cobalt chrome. The system includes 30 sizes. Sizes 1-10 are provided in right and left versions. Sizes 3-7 are provided in both standard and narrow configurations, with the narrow sizes having a relatively smaller aspect ratio of the medial-lateral to anterior-posterior widths when compared to the standard sizes. Optional modular distal pegs are included in the system.

The system includes a Patella Component offered in seven sizes of variable diameter and thicknesses. The bone fixation surface incorporates three fixation pegs. The Patella Components are made from Conventional UHMWPE.

The system includes Tibial Inserts which are offered in 40 sizes, size A/1-4 through HJ/7-10 with 8 thicknesses and 48 sizes for PS+ inserts, size A1-2+ through HJ/7-10+ with 8 thicknesses. The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.

The system includes Tibial Baseplates offered in 9 sizes ranging from A-J. Tibial Baseplates are manufactured from forged titanium alloy.

All system components are supplied sterile and are single use devices.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the b-ONE Total Knee System. This type of document is used to demonstrate that a new device is "substantially equivalent" to an existing, legally marketed device (predicate device) and therefore does not require a full Pre-Market Approval (PMA).

It is important to understand that a 510(k) summary for a prosthetic joint like a knee replacement does NOT involve clinical studies or "acceptance criteria" related to diagnostic performance as would be found in AI/ML medical devices.

Instead, the "acceptance criteria" for a knee replacement relate to the performance of the physical components (e.g., strength, fatigue life) and their biocompatibility, demonstrating that the new device functions as safely and effectively as the predicate devices. The "study that proves the device meets the acceptance criteria" refers to non-clinical (bench) tests of the device's materials, design, and mechanical properties.

Therefore, the requested information elements related to AI/ML device evaluations (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

Here's a breakdown of the applicable information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Not Applicable. This is a physical medical device (knee implant), not a diagnostic algorithm. The "test sets" refer to individual device components or representative samples subjected to specific engineering tests, not patient data sets. The data provenance would be laboratory testing results.

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 this context refers to established engineering standards, material specifications, and mechanical performance criteria, not expert consensus on medical images or diagnoses. These tests are conducted by engineers and technicians.

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

• Not Applicable. Adjudication methods are relevant for subjective interpretations of data, typically in clinical evaluations or AI/ML ground truth establishment. These are objective engineering tests.

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 is a physical knee implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant.

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

• No. This is a physical knee implant, not an AI/ML algorithm.

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

• The "ground truth" for the non-clinical tests is based on established engineering standards, material specifications, mechanical performance criteria, and comparison to the predicate devices' known performance and specifications.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing processes are developed through engineering and materials science principles.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" for the device's design and manufacturing is established through adherence to recognized industry standards, regulatory requirements, and engineering principles.

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Indications for Persona Partial Knee System:

The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:

• Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;

• traumatic arthritis;

• previous tibial condyle or plateau fractures with loss of anatomy or function;

• varus deformities; and

• revision of the articular surface of a previously implanted Persona Partial Knee Systemknee surgeries providing that the tibial plate locking mechanism is not compromised and tibial plate components remain well fixed and undamaged.

The Persona Partial Knee System is a single use implantation with bone cement.

Indications for combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ):

• Osteoarthritis, traumatic arthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

• The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).

• History of patellar dislocation or patella fracture.

• Dysplasia-induced degeneration.

These indications will be used for the combined medial unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions.

Combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ) implants are intended for implantation with bone cement.

The Persona Partial Knee (PPK) System is a partial knee replacement for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).

The Persona Partial Knee System is compatible with the following devices:

• Zimmer Patellofemoral Joint Prosthesis (K070695)

The provided text is a 510(k) Summary for the Persona Partial Knee System, a medical device. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria and proving performance through a standalone study in the way a de novo or PMA submission might.

Therefore, the typical acceptance criteria and study design for validating an AI/ML device's performance are not applicable here. The device is a physical knee implant, not a software algorithm, and the submission does not describe a clinical study in the traditional sense, but rather non-clinical mechanical testing and engineering analyses.

Here's an breakdown based on the information provided, highlighting why many requested points are not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in a table format and does not represent clinical "performance" in the sense of accuracy, sensitivity, or specificity as would be expected for an AI/ML device. Instead, it lists mechanical tests and analyses performed to demonstrate the physical device's safety and effectiveness compared to predicates.

Acceptance Criteria: The document states that "Results from mechanical tests and engineering analyses demonstrate the proposed PPK components are substantially equivalent to the predicate devices." While specific numerical acceptance criteria (e.g., maximum deflection, minimum fatigue cycles) are implied by performing these tests to a standard or internal method and achieving "substantial equivalence," they are not explicitly listed in this summary. The general acceptance is that the device performs comparably or better than the predicate devices under these conditions.

Regarding other requested information points:

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

• Not applicable. This submission focuses on non-clinical mechanical testing and engineering analyses, not human clinical data or AI/ML model performance on a test set. There isn't a "test set" of patient data in this context.

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. This submission relies on engineering and material science principles, not expert consensus on medical images or diagnoses.

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

• Not applicable. No adjudication process is described as there is no clinical test set involved.

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 is a physical implant, not an AI/ML diagnostic or assistive device. No MRMC study was performed. The document explicitly states: "No animal or clinical testing was required to support substantial equivalence."

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

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

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

• Not applicable / Implied: For the mechanical tests, the "ground truth" would be established engineering standards (like ASTM F2083, ASTM F1223) or validated internal test methods, and the performance of the predicate devices. The aim is to show the new device meets these engineering benchmarks or performs comparably to the predicates.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" for this device.

Conclusion from document:

The Persona Partial Knee System gained 510(k) clearance (K161592) based on demonstrating substantial equivalence to existing legally marketed predicate devices. This was achieved through:

• Similar intended use (limited to medial tibiofemoral compartment, cemented use).
• Use of similar materials (Co-Cr-Mo alloy for femoral, Ti-6Al-4V alloy for tibial, Vivacit-E Vitamin E Highly Crosslinked Polyethylene for articular surfaces), which are already used in predicate/reference devices.
• Similar design features.
• Similar sterilization methods.
• Non-clinical mechanical tests and engineering analyses that showed the device performed comparably or acceptably against established engineering standards and predicate device performance. The specific quantitative acceptance criteria for each test are not detailed in this summary document but would have been part of the full 510(k) submission.

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The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for:
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;
Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
Ligamentous instability requiring implant bearing surfaces with increased constraint;
Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement, with the exception of porous coated femoral components which can be used cemented or uncemented (biological fixation).

The Arthrex iBalance® TKA System consists of femoral components, tibial tray, tibial bearing components and patellar components. All components are available in a range of sizes to fit varying anatomical requirements. Femoral components and tibial bearing components are available in both posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral components are available in left and right versions and are designed to work with the Arthrex dome patella components. Femoral and tibial tray components are manufactured from Cobalt-Chromium Alloy conforming to ASTM F-75. Tibial bearing and patellar components are manufactured from UHMWPE conforming to ASTM F-648.
The Arthrex iBalance® BioSync™ Femoral Components line offers the option of affixing the system's femoral components without cement through the use of a titanium scaffold porous coating (biological fixation).

The provided document is a 510(k) premarket notification for a medical device, the Arthrex iBalance® TKA System. It does not describe an AI/ML powered device, therefore, the requested information about acceptance criteria and the study proving the device meets those criteria, particularly as it relates to AI/ML performance metrics, is not present.

The document discusses the substantial equivalence of the Arthrex iBalance® TKA System to legally marketed predicate devices, focusing on design features, intended uses, materials, and mechanical testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving performance for an AI-powered device, as this document pertains to a traditional orthopedic implant.

The document details the following for the Arthrex iBalance® TKA System:

• Device Description: A total knee arthroplasty system consisting of femoral components, tibial tray, tibial bearing components, and patellar components. The BioSync™ Femoral Components line extension offers the option of uncemented fixation through a titanium scaffold porous coating.
• Intended Use/Indications for Use: For individuals undergoing surgery for painful, disabling joint disease of the knee (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of knee joint configuration and function, moderate varus, valgus, or flexion deformity, and revisions of previous unsuccessful knee replacement. Additional indications for posteriorly stabilized components include ligamentous instability and absent or non-functioning posterior cruciate ligament.
• Substantial Equivalence Summary: The device is considered substantially equivalent to the predicate device (K081127: Accin™ Total Knee System and K121771: Zimmer® Persona™ Personalized Knee System). Differences are considered minor and don't raise questions concerning safety and effectiveness.
• Testing Information: Fatigue, biocompatibility, metallurgical, corrosion, microstructure, strength, bonding, abrasion, and ingrowth testing information was submitted to demonstrate consistency with FDA Guidance for porous-coated orthopedic implants.

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Total Knee Replacement

The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer® Patient Specific Instruments System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persono™ PS fixed bearing and Zimmer Persona™ Trabecular Metal™ prostheses families only.

Unicompartmental Knee Replacement

The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer® Patient Specific Instruments System is to be used with Zimmer Unicompartmental High Flex Knee System prostheses families only.

The Zimmer® Patient Specific Instruments are intended for single use only.

The subject device Zimmer® Patient Specific Instruments System 6.0 is a modification to the predicate device Zimmer® Patient Specific Instruments System 4.0 (K113829) to accommodate the new compatible implant system Zimmer® Persona'''' components, cleared via 510(k)s K113369, K122745 and K121771. A similar change was done for Zimmer® Patient Specific Instruments System 5.0 (K121640) where the Zimmer® Personal™ components, cleared via 510(k) K113369, were added to MRI image based system. Zimmer® Patient Specific Instruments System 6.0 is designed to assist a surgeon in the placement of total knee replacement components for Zimmer® Persona'" components. The system consists of a software device, branded as Zimmer® Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer® Patient Specific Instruments (ZPSI).

The provided text is a 510(k) Premarket Notification for the Zimmer Patient Specific Instruments System 6.0. It describes the device, its intended use, and its technological characteristics as compared to predicate devices. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or detailed performance studies.

Instead, the document states: "Results of software verification and validation testing demonstrated the device's safety and effectiveness is substantially equivalent to the predicate device." This indicates that the device's performance was evaluated against the predicate device, Zimmer Patient Specific Instruments System 4.0 (K113829) and 5.0 (K121640), rather than against pre-defined, quantitative acceptance criteria for new performance claims.

Therefore, I cannot provide the requested information for the following points:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to previously cleared devices through technological similarity and general software verification and validation, rather than presenting a standalone performance study with specific acceptance criteria.

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Total Knee Replacement

The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer® Patient Specific Instruments System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural – Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persono™ PS fixed bearing and Zimmer Persona™ Trabecular Metal™ prostheses families only.

Unicompartmental Knee Replacement

The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer® Patient Specific Instruments System is to be used with Zimmer Unicompartmental High Flex Knee System prostheses families only.

The Zimmer® Patient Specific Instruments are intended for single use only.

The subject 'device Zimmer® Patient Specific Instruments System 5.4 is a modification to the predicate device Zimmer® Patient Specific Instruments System 5.0 (K121640) to accommodate the new compatible implant system Zimmer® Personalized Knee System Trabecular Metal™ components cleared via 510(k) K122745 and K121771. It is designed to assist a surgeon in the placement of total knee replacement components for Zimmer® Persono™ Trabecular Metal™ components. The system consists of a software device, branded as Zimmer® Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer® Patient Specific Instruments (ZPSI).

Here's an analysis of the provided text regarding the Zimmer Patient Specific Instruments System 5.4, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria in a quantitative manner (e.g., target accuracy percentages, deviation limits). Instead, it relies on the concept of "substantial equivalence" to a predicate device.

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

The document mentions "Non-clinical tests using saw bones" for performance evaluation.

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: The tests were "Non-clinical" and used "saw bones." This implies an in vitro or laboratory setting, not patient data. No country of origin is mentioned for this testing. It is a retrospective analysis of the device's performance under controlled conditions, not utilizing patient data.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth specific to the saw bone testing. Since it's saw bone testing, the "ground truth" would likely be established by precise measurements or engineering specifications rather than expert medical interpretation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Given the nature of saw bone testing, where physical measurements confirm accuracy, expert adjudication in the typical clinical sense would not be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case comparative effectiveness study was not mentioned. The evaluation primarily focuses on the device's standalone performance in a non-clinical setting and its substantial equivalence to a predicate, not on how it improves human reader performance.

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

Yes, a standalone performance evaluation was done. The "Non-clinical tests using saw bones" without mention of human interaction suggests a standalone evaluation of the device's accuracy and performance. The software device, Zimmer Patient Specific Instruments Planner (ZPSIP), generates a pre-surgical plan, and the hardware (ZPSI) transfers this plan. The testing verifies the system's ability to "perform as intended" in this capacity, i.e., accurate planning and guidance.

7. Type of Ground Truth Used

The ground truth for the saw bone testing would be based on physical measurements and engineering specifications against the planned surgical cuts/positions. For example, if the device is intended to guide a cut at a specific angle, the ground truth would be the actual measured angle of the cut made on the saw bone. It is not expert consensus, pathology, or outcomes data, as these are typically associated with human patient clinical data.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set. This is a medical device clearance based on substantial equivalence, and typical AI/ML "training sets" are not explicitly mentioned as part of the evaluation. The software component, ZPSIP, implies some form of algorithmic processing, but the development and training details are not disclosed in this summary.

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

As no training set is described, there is no information on how its ground truth was established.

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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.
  Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

The Zimmer Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces. The addition of the Constrained Posterior Stabilized (CPS) Vivacit-E® articular surface components will provide surgeons with the ability to obtain moderate varus/valgus and/or internal/external rotation constraint compared to the existing Persona PS articular surfaces. CPS articular surfaces are for use with cemented nonporous tibial and femoral components only.

The Zimmer Persona Personalized Knee System is a medical device. Clinical data and conclusions were explicitly stated as NOT needed for this device. Therefore, the information provided focuses on non-clinical performance (bench testing).

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated in the provided text for individual bench tests. The description refers to "testing" which implies a sample size appropriate for engineering validation (e.g., usually 3-6 samples per test).
• Data Provenance: The data is from "bench testing" conducted by Zimmer, Inc. This is non-clinical, laboratory-based data. No information about country of origin for data or retrospective/prospective nature is applicable as it's not human or animal study data.

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

• Not applicable. The ground truth for this device is based on engineering specifications and validated bench test methodologies, not expert interpretation of clinical data.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or imaging data. For bench testing, results are typically analyzed against predefined engineering specifications or industry standards.

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 prosthesis, not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study involving human readers and AI assistance was conducted.

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

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

7. The type of ground truth used:

• The ground truth for this device's performance is based on engineering specifications, established industry standards for orthopaedic implants, and the performance characteristics of predicate devices. Bench tests are designed to simulate in-vivo conditions and measure physical properties against these predetermined criteria.

8. The sample size for the training set:

• Not applicable. This device is a knee prosthesis, not a machine learning model. There is no "training set" in the context of an algorithm.

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

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

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