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The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of: Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis; Correction of functional deformities: Revision of previous unsuccessful unicompartmental knee replacement or other procedure; As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. These components are single use only and are intended for implantation with bone cement.

The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and tibial tray and a polyethylene tibial insert.

This document describes a Special 510(k) submission for a line extension to the ACCIN UNI-Knee System. The modification is the addition of new tibial bearing components with thicknesses of 11mm, 13mm, and 14mm, expanding the thickness range from 8mm-10mm to 8mm-14mm. No other changes were made.

The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Accin UNI-Knee System - K060670 and Zimmer Unicompartmental Knee System - K033363) rather than proving general safety and effectiveness through extensive clinical trials. Therefore, the information provided does not align with a typical AI/software device evaluation.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For a device modification of this nature (a line extension adding different sizes), the "acceptance criteria" are implied to be that the new components perform equivalently to the existing ones and the predicate device in terms of mechanical properties, biocompatibility, and manufacturing quality, and that the new sizes do not introduce new safety or effectiveness concerns. The "study" proving this is often through bench testing, material characterization, and comparison to design specifications and predicate devices, demonstrating that the change in thickness does not alter the fundamental safety and effectiveness. The FDA's substantial equivalence determination confirms that these criteria were met to their satisfaction for market clearance.

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. For mechanical testing or design verification in medical devices, the sample size would refer to the number of components tested to ensure their performance meets specifications. This information is not detailed in the provided summary.
• Data Provenance: Not applicable in the context of clinical "data provenance" as this is not a study relying on patient data. The provenance for the device modification would be the manufacturing process and design documentation for the new components.

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

• Experts and Qualifications: Not applicable. This submission is for a device modification (size extension) rather than a diagnostic or AI device requiring expert consensus for ground truth on patient data. The "ground truth" here is based on engineering specifications, material science, and manufacturing standards for the knee implant components. The FDA reviewers and the manufacturer's internal team would be the "experts" assessing this.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" in the context of diagnostic performance or clinical outcomes that would require adjudication by multiple experts. The approval process is regulatory in nature.

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

• MRMC Study: No. This is not an AI or diagnostic imaging device; it is a physical implant. Therefore, an MRMC study is not relevant or performed for this type of device modification.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Ground Truth: For this device modification, the "ground truth" would be established by:
  • Engineering Specifications: Mechanical properties (e.g., strength, wear resistance, fatigue life) designed for the new components.
  • Material Standards: Conformance to established standards for cobalt chrome and polyethylene used in implantable devices.
  • Bench Testing: Results from laboratory tests demonstrating the physical performance of the new components meet established safety and effectiveness benchmarks, often comparing them directly to the predicate devices.
  • Design Rationale: Justification that the increased thickness does not negatively impact performance or safety, based on biomechanical principles.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. There is no AI algorithm being "trained" in this context.

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

• Ground Truth for Training Set Establishment: Not applicable. There is no training set for an AI algorithm.

In summary: The provided document is a regulatory submission for a medical device line extension, not an AI or diagnostic performance study. The "acceptance criteria" and "study" refer to the demonstration of substantial equivalence to predicate devices through engineering, material, and manufacturing standards, as reviewed and approved by the FDA. The questions posed are primarily relevant to AI/diagnostic device evaluations and are mostly not applicable to this type of medical implant modification.

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The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of:

• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
  These components are single use only and are intended for implantation with bone cement.

The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and tibial tray and a polyethylene tibial insert.

Here's a breakdown of the acceptance criteria and the study details for the ACCIN UNI-Knee System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided summary does not explicitly state the sample size used for the comparative testing between the ACCIN UNI-Knee System and the Stelkast Unicondylar Knee System.

Furthermore, the data provenance (e.g., country of origin, retrospective or prospective) is not mentioned in the provided text. The testing appears to be primarily in vitro or mechanical rather than human clinical data based on the nature of the device and the guidance document referenced.

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

This information is not applicable and therefore not provided in the document. The study described is a comparison of a medical device (a knee prosthesis) to a predicate device, focusing on mechanical and material equivalence rather than interpretation of medical images or diagnoses requiring expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. As noted above, the study is not clinical in nature requiring adjudication of medical findings.

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

An MRMC study was not performed. This type of study is relevant for AI-assisted diagnostic devices and is not pertinent to the mechanical and material equivalence testing of a knee prosthesis.

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

A standalone performance study as typically understood for AI algorithms was not performed. The device is a physical knee prosthesis, not an algorithm. The testing described is intrinsic to the device itself (e.g., mechanical properties) in comparison to another physical device.

7. The Type of Ground Truth Used

The "ground truth" for this study is established by engineering and mechanical testing standards and the performance characteristics of the predicate device (Stelkast Unicondylar Knee System). The reference to the "Class II Special Controls Guidance Document" indicates that the tests performed and the criteria for success are based on established regulatory guidance for such devices. Therefore, the ground truth is derived from device performance specifications and comparison to a legally marketed equivalent.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. The study is not an AI/machine learning study that would involve a training set.

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

This information is not applicable and therefore not provided in the document, as there is no training set for this type of device submission.

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