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The subject devices are single use components, intended for cemented use only. They are intended for use in conjunction with associated Duracon femoral components as part of cemented total knee replacement surgery. Indications for use, in keeping with those of other commercially-available, Class II total knee devices, are as follows:

• . Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis.
• Rheumatoid arthritis. .
• . Correction of functional deformity.
• . Revision procedures where other treatments have failed.
• . Post-traumatic loss of knee joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy.
• . Irreparable fracture of the knee.

The subject 25mm Duracon Inset Patellar Component is identical to the commercially-available Duracon Inset Patellar Components (available in sizes 27, 29, 31, and 33mm), except for its smaller diameter.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML medical devices. The document describes a 510(k) submission for an additional size of an existing patellar component (Duracon Inset Patellar Component, 25mm).

Here's an analysis based on the information provided, highlighting why it doesn't fit the requested format for AI/ML device evaluation:

1. Acceptance Criteria and Reported Device Performance: This information is not present. The submission focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific quantitative performance metrics as an AI/ML system would. The "Performance Data" section briefly mentions "Comparative testing (simulated chair rising and stair climbing) confirmed that the wear resistance of the modified component is not significantly different from that of existing product," but no specific numerical acceptance criteria or detailed results are given.

2. Sample Size for Test Set and Data Provenance: Not applicable. This is a physical medical device (knee implant), not an AI/ML algorithm evaluated on a dataset. The "comparative testing" likely refers to mechanical stress tests on the physical component.

3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant here.

4. Adjudication Method: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. There is no AI assistance involved with human readers for this physical implant.

6. Standalone Performance: Not applicable. This is a physical implant; its "performance" would be related to its mechanical properties and biocompatibility, not an algorithm's standalone output.

7. Type of Ground Truth Used: Not applicable in the context of AI/ML evaluation. The "ground truth" for a physical implant's safety and effectiveness relies on established engineering principles, material science, and clinical outcomes data from similar devices. The comparative testing mentioned focuses on wear resistance, which would be measured directly from mechanical tests, not an "expert consensus" on data labels.

8. Sample Size for Training Set: Not applicable. There is no AI/ML model being trained.

9. How Ground Truth for Training Set was Established: Not applicable.

Summary based on the provided text:

The submission is for a physical medical device (knee implant), specifically an additional size (25mm) of an already cleared patellar component. The 510(k) process for such devices relies on demonstrating substantial equivalence to a predicate device.

The key points from the provided text are:

• Device: Duracon Inset Patellar Component, additional 25mm size.
• Predicate Device: Existing Duracon Inset Patellar Components (27, 29, 31, 33mm sizes) cleared via K961482 and K965173.
• Basis for Substantial Equivalence:
  • Identical intended use and indications for use.
  • Identical materials.
  • Identical design, except for the smaller diameter.
• Performance Data (limited details): "Comparative testing (simulated chair rising and stair climbing) confirmed that the wear resistance of the modified component is not significantly different from that of existing product." This suggests that the wear performance of the new 25mm size was found to be comparable to the existing, cleared sizes.

Therefore, the requested information about acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods (which are typical for AI/ML device evaluations) are not applicable to this 510(k) submission for a physical knee implant component.

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The PCA® Primary Inserts for Duracon® Baseplates (K936008), PCA® Modular Inserts for Duracon® Baseplates (K940861), PCA® Modular Primary/Revision Patella (K940713), Duracon® Recessed Patella (K951655), Duracon® Inset Patella with Central Peg (K961482), Duracon® All Poly Patella II (K961483), Duracon® Extra Small Tibial Stabilizer Insert (K970758), Kinematic® All Poly Patella with Three Pegs (K971550), and the Kinematic® II Replacement Tibial Inserts (K960976) are intended was a to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.

This submission describes additional UHMWPE Knee components that have been previously cleared for sterilization by the Duration® Stabilized process and are to be added to the list of devices cleared for the corresponding wear claims in submission K965173. The additional products are described below, as are the wear claims from K965173.

The products that have been added to the list of devices cleared for the wear claims are: The PCA® Primary Inserts for Duracon® Baseplates (K936008), PCA® Modular Inserts for Duracon® Baseplates (K940861), PCA® Modular Primary/Revision Patella (K940713), Duracon® Recessed Patella (K951655), Duracon® Inset Patella with Central Peg (K961482), Duracon® All Poly Patella II (K961483), Duracon® Extra Small Tibial Stabilizer Insert (K970758), Kinematic® All Poly Patella with Three Pegs (K971550), and the Kinematic® II Replacement Tibial Inserts (K960976). These components are intended to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.

The provided text describes wear claims for Howmedica's Duration® Stabilized UHMWPE Knee Components based on in vitro laboratory tests. The document repeatedly states that "The results of in vitro tests have not been shown to correlate with clinical wear mechanisms," which is a crucial disclaimer when interpreting the data.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not directly available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in the traditional sense of a predetermined threshold that the device must meet to be considered effective. Instead, it presents wear claims as observed reductions in volumetric wear compared to a conventional material. The "acceptance criteria" are implied by the reported reductions themselves, showcasing the improved performance of the stabilized UHMWPE.

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

The document describes the test samples rather than a "test set" in the context of a statistical study with a specific sample size (N). The tests involved specific physical samples:

• Reciprocating ring-on-block test: "A block of Howmedica's Duration® Stabilized UHMWPE" and "the same block of Howmedica's conventionally gamma sterilized UHMWPE." This implies a comparison between two samples (one stabilized, one conventional).
• Independent pin-on-disk tests: "a 9mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE" and "the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE" (for both the unaged and aged comparisons). This also implies a comparison between two samples for each test.

Sample Sizes: For each test described, the comparison appears to be one-to-one, comparing a stabilized sample directly against a conventional sample. The total number of individual samples tested across all three scenarios would be small (e.g., 2 blocks, 4 disks).

Data Provenance: The data is generated from in vitro laboratory tests.

• The first test (ring-on-block) is described as being performed internally ("Howmedica's Duration® Stabilized UHMWPE").
• The second and third tests (pin-on-disk) are explicitly stated as being performed in "an independent laboratory test."

The country of origin is not specified, but Howmedica Inc. is based in Rutherford, New Jersey, USA. The data is retrospective in the sense that the tests were conducted prior to this 510(k) submission, but it's not "retrospective clinical data."

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

N/A. This is a technical performance study of materials (wear testing) and does not involve human interpretation or subjective assessment of physiological conditions. Therefore, there is no "ground truth" established by experts in the medical diagnostic sense. The ground truth for volumetric wear is established by the physical measurement methods used in the laboratory tests.

4. Adjudication Method for the Test Set

N/A. As this is a physical wear testing study, there is no team of human adjudicators reviewing output. The "adjudication" is inherent in the standardized measurement protocols of the wear tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document describes in vitro wear testing of materials, not a clinical study involving human readers or cases. Therefore, an MRMC comparative effectiveness study was not performed, and there is no effect size related to human reader improvement with AI.

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

N/A. This is not an AI/algorithm-based device. It is a physical medical device (UHMWPE knee components) whose performance is evaluated through mechanical in vitro tests.

7. The Type of Ground Truth Used

The ground truth used is physical measurement of volumetric wear. This is determined by the methodologies of the reciprocating ring-on-block and pin-on-disk wear tests, which are standardized engineering and materials science techniques.

8. The Sample Size for the Training Set

N/A. This is not an AI/machine learning device; therefore, there is no concept of a "training set" in the context of an algorithm. The UHMWPE material itself is a product of manufacturing processes, and its inherent properties (including resistance to wear) are determined by its formulation and stabilization process.

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

N/A. As there is no training set for an algorithm, there is no ground truth established for it.

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The Continuum Patellar is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, and 5) treatment of fractures that are unmanageable using other techniques. This device is intended for use with bone cement.

The Continuum Patellar is fabricated from Hedrocel® and UHMWPE. The UHMWPE is direct compression molded into the Hedrocel®, thereby creating the articulation surface. The Continuum Patellar is intended for use with bone cement when performing total knee arthroplasty or revisions with legally marketed Implex Continuum Femoral and Tibial components.

The Implex Continuum Patellar is a knee joint patellofemorotibial prosthesis. The 510(k) summary states that "Performance testing of the Continuum Patellar demonstrates its equivalence to the claimed predicate devices." This implies that the acceptance criteria for the device are met if its performance is comparable or non-inferior to the predicate devices.

However, the provided text does not explicitly define specific "acceptance criteria" in terms of quantitative metrics or performance thresholds. Instead, it relies on the concept of "substantial equivalence" to predicate devices.

Here's an analysis of the information requested, based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

The document mentions "Performance testing of the Continuum Patellar demonstrates its equivalence to the claimed predicate devices," but it does not provide details about a specific study in the format of a clinical trial or a detailed bench testing report. It's a summary statement rather than a detailed study description.

Based on the provided text, the following information is not available or implicitly handled by the substantial equivalence argument:

1. Sample size used for the test set and the data provenance: Not specified. The "performance testing" is not detailed.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified. This typically applies to image-based diagnostic devices. For a prosthetic device, "ground truth" would likely refer to engineering specifications, material properties, and clinical outcomes, which are not outlined in a study format here.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified.
4. 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 prosthetic device, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a prosthetic device, "ground truth" would generally involve meeting engineering specifications, material tests, and potentially biomechanical evaluations, comparing them to established predicate devices. The document only states "Performance testing" without detailing methodology.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided K971789 document details a 510(k) submission where "substantial equivalence" to predicate devices is the primary means of demonstrating safety and effectiveness. It does not contain detailed information about a specific quantitative study with predefined acceptance criteria, sample sizes, and expert panel ground truth verification as typically seen for diagnostic devices or more complex clinical trials. The "performance testing" mentioned is general and not elaborated upon in this summary document. The FDA's decision emphasizes the "cemented use only" limitation as a critical aspect of its substantial equivalence finding.

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