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The Kinemax® Superstabilizer (K904208), Kinematic® II Modular Condylar and Stabilizer Inserts (K871349), PCA® Modular Inserts (K894403), Kinematio® Rotating Hinge Knee (K792089), Duracon® Unicompartmental Knee (K 926231), and the Modular Replacement Metal Encapsulated Components (K952970) 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.

This submission describes additional UHMWPE Knee components that can be sterilized by the Duration® Stabilized process previously cleared in submission K936292, as an alternate to standard air irradiated gamma sterilization. Corresponding wear claims, previously cleared in submission K 965173 and listed below, are also applicable to these additional components. This submission includes the Kinemax® Superstabilizer (K904208), the Kinematic® II Modular Condylar and Stabilizer Inserts (K871349), the PCA Modular Inserts(K894403), the Kinematic® Rotating Hinge Knee (K792089), the Duracon® Unicompartmental Knee (K926231), and the Modular Replacement Metal Encapsulated Components (K952970). 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.

This 510(k) summary describes the Duraction® Stabilized UHMWPE Knee Components and their wear claims. The submission details three in vitro wear tests comparing the Duraction® Stabilized UHMWPE with conventionally gamma sterilized UHMWPE.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" but rather presents the results as "wear claims" based on the performed in vitro tests. The implied acceptance criterion for each test is a demonstrated reduction in volumetric wear compared to the conventionally gamma sterilized UHMWPE.

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

The document describes material-level testing rather than patient or imaging data.

• Sample Size:
  • Ring-on-Block Test: "A block of Howmedica's Duration® Stabilized UHMWPE" and "the same block of Howmedica's conventionally gamma sterilized UHMWPE." (Implies n=1 for each material type for the block test, though likely multiple replicates were used within the block).
  • Pin-on-Disk Tests (both non-aged and aged): "A 9mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE" and "the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE." (Implies n=1 for each material type for the disk test, though likely multiple replicates were used).
• Data Provenance: The tests are described as "in vitro tests" and "independent laboratory test(s)." The country of origin of the data is not specified, but the manufacturer is Howmedica Inc. in the USA. The data is prospective for these specific tests as they were conducted to support the submission.

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

Not applicable. This is a materials science engineering test, not a medical device performance assessment based on expert interpretation (e.g., radiology reads). The "ground truth" is measured volumetric wear.

4. Adjudication Method for the Test Set

Not applicable. This is a direct measurement of material wear, not a consensus-based assessment.

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 an in vitro materials test, not a clinical study involving human readers or AI.

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

Not applicable. This refers to the performance of the UHMWPE material itself, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is measured volumetric wear of the material samples under controlled in vitro laboratory conditions.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context would refer to the development and optimization of the UHMWPE material and sterilization process, which is not detailed in terms of sample sizes for individual material property tests.

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

Not applicable. (See point 8). The "ground truth" for material development would involve various material characterization techniques and performance testing during the R&D phase, but this specific 510(k) focuses on the final wear claims derived from the described in vitro tests.

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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 Exeter All Plastic Acetabular Component (previously cleared in K936132) is intended to be used for primary and secondary reconstruction of the bearing surface of the acetabulum as a result of painful and/or severly disabled hip joints due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or revision of a failed acetabular component.

The Howmedica® Bipolar Prosthesis, Centrax® (previously cleared in K855231) is intended to be used in conjunction with a femoral stem component for the reconstruction of a femoral head damaged by fresh fracture, non-union, aseptic necrosis of the head and neck, or by osteoarthritis or post-traumatic arthritis.

This submission describes additional UHMWPE acetabular components that can be sterilized by the Duration® Stabilized process previously cleared in submission K934060, as an alternate to standard air irradiated gamma sterilization. The additional components are the Exeter All Plastic Acetabular Component (K936132) and the Howmedica® Bipolar Prosthesis, Centrax® (K855231). Corresponding wear claims, previously cleared in submission K 963612 and listed below, are also applicable to these additional components.

The provided document describes wear claims for Duration® Stabilized UHMWPE Acetabular Components through in vitro testing. It does not detail specific acceptance criteria in a quantitative manner (e.g., "device must achieve X performance in Y metric"). Instead, the performance is presented as a reduction in volumetric wear compared to a conventionally sterilized equivalent. This suggests the acceptance criterion was "demonstrate a reduction in volumetric wear" and the studies performed to meet this criterion successfully showed such a reduction.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document presents the results as statements of fact rather than explicit "criteria." The FDA's 510(k) clearance process relies on demonstrating "substantial equivalence" to a predicate device. For material claims like reduced wear, demonstrating a quantitatively superior or equivalent performance to a legally marketed predicate (or baseline, in this case, conventionally sterilized UHMWPE) serves as the basis for clearance. The "acceptance" is implicitly tied to these demonstrated reductions.

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

• Sample Size: The document does not explicitly state a "sample size" in terms of number of individual components tested in each condition. It refers to single tests or sets of tests (e.g., "System 12®, size P4, neutral acetabular inserts," "a hemispherical cup of generic design"). Typically, such in vitro wear testing involves a small number of samples (often n=3 or n=5) for each condition, but this detail is not provided.
• Data Provenance: The data is generated from in vitro laboratory testing using multiaxial hip joint simulators. The studies were conducted by Howmedica Inc. and an "independent laboratory" for one of the tests. The document explicitly states: "The results of in vitro tests have not been shown to correlate with clinical wear mechanisms."

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

Not applicable. This is an in vitro mechanical wear test of a medical device, not a diagnostic or clinical study requiring human experts for ground truth establishment. The "ground truth" here is the measured volumetric wear in a controlled laboratory environment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an in vitro mechanical test, so there is no expert adjudication process. The measurements of volumetric wear are objective and quantifiable by laboratory equipment.

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 not an AI/human-in-the-loop study. It's an in vitro material performance study.

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

Not applicable. This is explicitly an in vitro mechanical wear test of a physical medical device (UHMWPE acetabular components). It is not an algorithm, AI, or software device.

7. The Type of Ground Truth Used

The ground truth used is objective, quantitatively measured volumetric wear determined by laboratory testing in a hip joint simulator. This is a direct physical measurement, not based on expert consensus, pathology, or outcomes data, as explicitly warned by the statement: "The results of in vitro tests have not been shown to correlate with clinical wear mechanisms."

8. The Sample Size for the Training Set

Not applicable. This is an in vitro performance study for a physical device, not an AI or machine learning model. Therefore, there is no "training set."

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

Not applicable, as there is no training set.

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The P.C.A.® System Inserts (previously cleared in K921384) are intended to be used with P.C.A.® Acetabular Shells, and Howmedica femoral stems and heads in cementless primary or cemented primary/revision total hip arthroplasty.

The Premise® Hip Acetabular Components (previously cleared in K912426) are intended to be used with Howmedica femoral stems and heads in comented primary or revision total hip arthroplasty.

The Osteolock™ Inserts (previously cleared in K903362), and the System 12® inserts (previously cleared in K951114 and K951115), when used with the Osteolock™ and Vitalock® Shells, are intended to be used with Howmedica femoral stems and heads in cemented primary of revision total hip arthroplasty.

SEE ADDITIONAL PAGE LABELED DURATION WEAR CLAIMS

Duration™ Stabilized UHMWPE - Hip Components

The provided document describes wear claims for Howmedica's Duration™ Stabilized UHMWPE hip components and does not present acceptance criteria or a study design in the typical format for medical device performance evaluation against specific metrics like sensitivity, specificity, or accuracy. Instead, it describes a series of in vitro wear simulation tests demonstrating a reduction in volumetric wear compared to conventionally gamma-sterilized components.

Therefore, the requested information cannot be fully provided as it pertains to a different type of performance evaluation (e.g., diagnostic accuracy of an AI device vs. material wear properties of an implant). However, I can extract and structure the information presented regarding the wear tests.

Here's an attempt to structure the available information, noting where specific requested fields are not applicable or estimable from the provided text:

Acceptance Criteria and Device Performance (Wear Claims)

Given the nature of the document detailing material wear claims, the "acceptance criteria" are implicitly a demonstrable reduction in volumetric wear compared to the conventionally sterilized counterpart. The reported device performance is the percentage reduction in volumetric wear.

Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "The results of in vitro tests have not been shown to correlate with clinical wear mechanisms." This is a crucial disclaimer for interpreting these results.

Study Details (as inferrable from the provided text):

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify the exact number of hip components (samples) used in each test (e.g., N=3 per group). It refers to "a hemispherical cup" or "neutral acetabular inserts," implying at least one test article for each condition, but standard practice usually involves multiple samples for statistical validity.
   • Data Provenance: The data is from in vitro laboratory tests. The document mentions "Howmedica's" tests and an "independent laboratory test." This indicates the data is from manufacturer-sponsored and potentially third-party laboratory experiments, not from human patients or clinical trials.
   • Retrospective or Prospective: These are prospective laboratory experiments designed to assess wear characteristics under controlled conditions.

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

   • Not Applicable. For material wear testing, "ground truth" is typically established by direct measurement of material loss (e.g., gravimetric or profilometric methods) in a controlled laboratory setting, not by expert consensus or interpretation in the way one would assess clinical images or outcomes. The "ground truth" here is the measured volumetric wear.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods (like 2+1) are used for resolving disagreements among human readers or experts, which is not relevant to automated laboratory measurements of material wear.

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 document describes in vitro mechanical testing of a medical implant material, not a study involving human readers or AI assistance.

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

   • Not Applicable. This is not an algorithm-based device. It's a physical implant, and the assessment is of its material properties in a simulator.

6. The type of ground truth used:

   • The "ground truth" for these tests is the direct, quantifiable measurement of volumetric wear of the UHMWPE components under simulated physiological loading conditions. This is obtained through laboratory techniques (e.g., gravimetric analysis and density measurements to calculate volume loss).

7. The sample size for the training set:

   • Not Applicable. This is not a machine learning or AI context where "training sets" are used. The material properties are inherent to the manufactured product, and performance is tested directly.

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

   • Not Applicable. See point 7.

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The Duracon®, P.C.A.® and Kinemax® Plus Tibial Inserts, All Plastic Tibial Components and Patellar Components (proviously cleared in K915512, K923573, K910235, K922048, K932070, K913188, K872735, K871772 and K921640) are intended to be used with Duracon®, P.C.A.® or Kinemax® femoral components, tibial baseplates and patellar components in primary or revision cemented total knee arthroplasty.

This submission includes wear testing data on UHMWPE Knee Components sterilized by the method previously cleared in 510(k) submission K936292. This data is provided to substantiate claims of improved wear due to the processing of the devices. The submission includes Duracon®, P.C.A.® and Kinemax® Plus Tibial Inserts, All Plastic Tibial Components and Patellar Components which are intended to be used with Duracon®, P.C.A.® or Kinemax® Plus femoral components, tibial baseplates and patellar components in primary or revision cemented total knee arthroplasty.

This submission details the wear testing of Howmedica's Duration™ Stabilized UHMWPE Knee Components to substantiate claims of improved wear. The study compares the wear performance of the stabilized UHMWPE against conventionally gamma sterilized UHMWPE in various in vitro wear tests.

Here is an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The submission does not explicitly state pre-defined acceptance criteria in numerical terms (e.g., "must show at least X% reduction"). Instead, the reported device performance is the claim being substantiated, implying that any measured reduction in wear would be considered a positive outcome. The FDA's substantial equivalence determination suggests acceptance of these claims.

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

• Sample Size: The document refers to "a block" and "a 9mm thick circular disk" for the unaged tests, and "a 9 mm thick circular disk" for the aged test, both for the Duration™ Stabilized UHMWPE and the conventionally gamma sterilized UHMWPE for comparison. This phrasing suggests a sample size of one test article for each condition (stabilized vs. conventional, unaged vs. aged) for each type of test. However, wear testing typically involves multiple samples to ensure reproducibility and statistical significance. The limited detail provided here implies either a single sample per comparison or a simplified reporting of the outcome from multiple samples.
• Data Provenance: The tests were conducted as "in vitro tests" in an "independent laboratory test." The country of origin is not specified but is presumably the USA, given the FDA 510(k) submission. The data is prospective in the sense that these were controlled experiments specifically designed to test the wear properties.

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

Not applicable. This study involves in vitro mechanical wear testing, not a clinical study or diagnostic device assessment where expert opinion would establish ground truth. The "ground truth" for wear is established by the measured weight loss or volume displacement during the mechanical tests.

4. Adjudication Method for the Test Set

Not applicable. This is an in vitro mechanical test, not a clinical review requiring adjudication. The measurements of wear are objective.

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

No, an MRMC comparative effectiveness study was not done. This study is an in vitro mechanical wear test of materials, not a diagnostic imaging study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, in a way. The tests performed are standalone in the sense that they are material property tests performed in a lab setting, independent of human interaction once initiated. There is no "algorithm" in the context of AI, but the measurements of wear are objective outcomes of the material's performance under simulated conditions.

7. The Type of Ground Truth Used

The ground truth used is measured volumetric wear. This is an objective measurement obtained through laboratory testing (reciprocating ring-on-block wear test and reciprocating pin-on-disk wear evaluations) using established scientific methods (weight loss to calculate volume change, or direct volume measurement if applicable).

8. The Sample Size for the Training Set

Not applicable. This study does not involve a "training set" in the context of machine learning or AI algorithms. It is an in vitro study of material properties.

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

Not applicable, as there is no training set for an AI algorithm in this context.

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