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The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.

The UNIVATION® Unicompartmental Knee System is a prosthesis that replaces only one compartment of the knee condyle which consists of a femoral, tibial and meniscal components that are available in a wide range of sizes. The UNIVATION® Unicompartmental Knee System components are medial unicondylar knee replacements for either the right or left knee. The femoral and tibial components are manufactured from CoCrMo, the meniscal components are manufactured from UHMWPE. The femoral and tibial components are available with either a PMMA (polymethylmethacrylate) or ZrN (Zirconium nitride) coating. All components are sterile and for single use only.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided document describes a UNIVATION® Unicompartmental Knee System, which is a medical device, and the information is from a 510(k) summary, likely for FDA clearance. This type of document focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving efficacy or diagnostic accuracy through clinical studies in the way an AI or diagnostic device would.

Therefore, many of the requested categories for acceptance criteria and study details (especially those related to AI, human readers, ground truth establishment, training sets, etc.) are not applicable to this type of device and its submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable/Specified. For this type of orthopedic implant, "test set" typically refers to the physical samples of the modified components used in the mechanical/endurance testing, not a dataset of patient images or clinical outcomes. The document states "customized endurance testing" was used, implying a certain number of physical components were tested, but the exact count is not provided.
• Data Provenance: Not applicable in the context of clinical/patient data. The "data" here comes from mechanical/endurance laboratory testing of the device components.

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

• Not applicable. "Ground truth" in this context is established by the physical properties and performance metrics defined by the ISO and ASTM standards (e.g., deflection, fatigue life, failure modes). Experts (engineers, materials scientists) are involved in designing and conducting the tests, but it's not a "consensus-based ground truth" on clinical observations.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of clinical data (e.g., radiology images). This submission relies on objective mechanical engineering performance testing against established standards.

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

• No, not applicable. MRMC studies are used for diagnostic imaging devices to assess how AI affects human reader performance. This device is an orthopedic implant.

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

• No, not applicable. This device is an implant, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance Standards. The "ground truth" for the performance of the modified components is their ability to withstand defined stress/load cycles (5 million cycles for femur, 10 million cycles for tibia) without failure or exhibiting similar performance characteristics to the predicate device, as specified by ISO 14879-1:2000 and ASTM F1800-07 standards.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI algorithm for this device submission.

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

• Not applicable. (See #8)

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study conducted was a mechanical/endurance testing program focused on the design modifications made to the femur and tibia components of the UNIVATION® Unicompartmental Knee System.

• Purpose: To evaluate the bone interface geometry of the modified components and demonstrate that their performance characteristics are similar to the previously cleared predicate device (K081293). This was done to address potential risks identified in a risk analysis of the design changes.
• Methodology:
  • Femur Component: Customized endurance testing based on ISO 14879-1:2000.
  • Tibia Component: Customized endurance testing based on ASTM F1800-07.
• Test Duration/Cycles:
  • Femur: 5 million load cycles.
  • Tibia: 10 million load cycles.
• Results: "The results were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System." This indicates that the modified components performed equivalently to the predicate under the specified mechanical stress tests, thus meeting the key acceptance criteria for demonstrating substantial equivalence for the design changes.

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The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis. traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.

The Univation® Unicompartmental Knee System is a prosthesis that replaces only one compartment of the knee condyle which consists of a femoral, tibial and meniscal components that are available in a wide range of sizes. The Univation® Unicompartmental Knee System components are medial unicondylar knee replacements for either the right or left knee. The femoral and tibial components are manufactured from CoCrMo, the meniscal components are manufactured from UHMWPE. The femoral and tibial components are available with either a PMMA (polymethylmethacrylate) or ZrN (zirconium nitride) coating. All components are sterile and for single use only.

The provided document is a 510(k) summary for the UNIVATION® Unicompartmental Knee System, which is a medical device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the detailed information necessary to answer all sections of the request regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm-driven device.

Specifically, it describes performance data from physical testing based on general guidance documents for orthopedic devices, not from a study involving an algorithm or AI.

Therefore, I can only provide information where it aligns with the data found in the document.

Based on the provided text, here is what can be extracted and what cannot:

Acceptance Criteria and Study for UNIVATION® Unicompartmental Knee System

The UNIVATION® Unicompartmental Knee System is a mechanical prosthetic device, not an AI or algorithm-driven device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical performance and safety evaluations as per FDA guidance for orthopedic implants, rather than performance metrics for an algorithm.

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

The document does not present a table of specific acceptance criteria with corresponding reported device performance results in numerical form. Instead, it states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable." It also references specific guidance documents for cemented total knee prostheses, PMMA bone cement, and porous-coated uncemented prostheses.

This implies that the acceptance criteria are adherence to the mechanical, material, and biocompatibility standards outlined in these FDA guidance documents. The "reported device performance" is implicitly that the device met all these required tests, which allowed it to receive 510(k) clearance based on substantial equivalence.

Summary of "Performance Data" from the document:

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

This information is not provided in the 510(k) summary. For mechanical devices, testing typically involves a specific number of samples (e.g., components) subjected to various mechanical load tests (fatigue, wear, static strength) in a laboratory setting, rather than a clinical "test set" as understood for AI/diagnostic algorithms. The provenance of such mechanical test data would be the testing laboratory.

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

This concept of "experts establishing ground truth for a test set" is not applicable to the mechanical testing required for this type of medical device clearance. Ground truth in this context refers to established engineering standards and material properties, validated through laboratory tests.

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

This is not applicable to the mechanical performance testing of an orthopedic implant.

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 as the UNIVATION® Unicompartmental Knee System is a physical orthopedic implant, not an AI or algorithm for diagnostic interpretation or human reader assistance.

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

This is not applicable as the UNIVATION® Unicompartmental Knee System is a physical orthopedic implant, not a standalone algorithm.

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

For this device, the "ground truth" for its performance is established through adherence to recognized industry standards (e.g., ISO, ASTM) and FDA guidance documents for mechanical and material properties (e.g., fatigue strength, wear resistance of materials, bone cement interface strength). This is typically determined through laboratory testing and material characterization, not clinical expert consensus, pathology, or outcomes data at the premarket application stage (though post-market surveillance would gather outcomes data).

8. The sample size for the training set

This is not applicable, as there is no "training set" for a mechanical device in the way there is for an AI algorithm.

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

This is not applicable, as there is no "training set."

In summary: The provided document is a regulatory submission for a physical medical device. The questions posed are primarily structured for evaluating an AI/algorithm-driven device. Therefore, most of the specific details requested regarding "acceptance criteria" and "study" are not present in the document because they pertain to a different type of medical technology. The "studies" for this device were mechanical and material tests conducted according to established engineering standards and FDA guidance, demonstrating substantial equivalence to predicate devices, rather than clinical studies with human readers or AI performance metrics.

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