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510(k) Data Aggregation
(61 days)
The Total Knee Femoral Components are indicated for rheumatoid arthritis; posttraumatic arthritis; degenerative arthritis; failed osteotomies; hemiarthroplasties, unicompartmental replacement; or total knee arthroplasties. The Total Knee Femoral Components are single use only and are intended for implantation with bone cement.
The Total Knee Femoral Components are designed for use with tibial and patellar components of the Genesis II or Profix Total Knee Systems. The Total Knee Femoral Components are metal alloy devices processed via a proprietary oxidation process.
The provided document, K022010, describes the Total Knee Femoral Components from Smith & Nephew, Inc. However, it does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based device.
Instead, this document is a 510(k) premarket notification for a traditional medical device (a knee implant) and focuses on demonstrating substantial equivalence to a legally marketed predicate device. The information provided is related to:
- Mechanical and Clinical Data: A general statement about mechanical testing indicating equivalence to existing devices and ability to withstand in vivo loading.
- Wear Claims: A specific marketing claim about wear reduction based on in-vitro simulator testing, but it explicitly states "The results of in-vitro tests have not been shown to correlate with clinical wear mechanisms." This wear test has its own methodology, but it's not framed as "acceptance criteria" for a primary performance standard in the way an AI device would be evaluated.
- Substantial Equivalence: The primary method for gaining market clearance through comparison to existing, legally marketed devices.
Therefore, many of the requested categories for an AI-based device's acceptance criteria and study cannot be directly addressed from this document because it's not evaluating an AI device in that manner.
However, I can extract the closest analogous information where possible and explicitly state when the requested information is not available or not applicable based on the document's content.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (or Analogous Performance Claim) | Reported Device Performance (from In-Vitro Wear Test) |
|---|---|
| 85% reduction in aggregate wear rate compared to CoCr femoral components | Total Knee Femoral Components: 0.69 ± 0.52 mm³/million cycles |
| Cobalt Chrome (CoCr) Femoral Components: 4.68 ± 2.30 mm³/million cycles | |
| Capable of withstanding expected in vivo loading without failure | "The Total Knee Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure." (General statement, no specific metric provided.) |
| Substantial Equivalence to predicate devices | Similarities in design features, overall indications, and material composition to existing Genesis II and Profix Total Knee Systems. |
2. Sample Size Used for the Test Set and Data Provenance
This information is primarily available for the in-vitro wear test:
- Sample Size for Wear Test: n=3 per test condition (for the aggregate wear rates computed).
- Data Provenance: In-vitro testing in a multi-axial knee joint simulator using specific device components and bovine calf serum. This is a controlled laboratory environment, not human data.
- Country of Origin: Not specified for the in-vitro lab where testing was performed, but the manufacturer is based in Memphis, TN, USA.
- Retrospective or Prospective: Not applicable for in-vitro simulator testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: For the mechanical and wear testing of this traditional device, "ground truth" as established by human experts for an AI system is not relevant. The wear rates are derived from direct physical measurements in a simulator.
4. Adjudication Method for the Test Set
- Not Applicable: No human adjudication is described for the in-vitro wear test. The measurements are taken directly from the simulator outputs.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No: This is not an AI device, so an MRMC study comparing human readers with and without AI assistance was not performed or described.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is not an AI algorithm; therefore, a standalone performance assessment of an algorithm was not done. The "standalone" performance here refers to the device's inherent mechanical properties and wear characteristics.
7. The Type of Ground Truth Used
- For Wear Claims: Direct physical measurement of material loss (wear debris) from in-vitro simulator testing.
- For Mechanical Equivalence: Mechanical test data (details not provided beyond a general statement).
- For Substantial Equivalence: Comparison of device design features, indications, and material composition to predicate devices. This relies on engineering specifications and regulatory definitions rather than expert consensus, pathology, or outcomes data in the AI sense.
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" in the context of an AI algorithm for this traditional medical device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set, this question is not applicable.
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