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510(k) Data Aggregation
(80 days)
KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY
The Klassic HD™ Acetabular Insert with E-Link™ Poly, for use within the Klassic HD™ Hip System, is intended for prosthetic replacement without bone cement in treatment of the following:
- . Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. ●
- . Those patients with failed previous surgery where pain, deformity or dysfunction persists.
- Revision of a previously failed hip arthroplasty. ●
- o Patients who require a total hip replacement.
The Total Joint Orthopedics Klassic HD™ Acetabular Insert with E-Link™ Poly ("Insert with E-Link'') is a permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The Insert with E-Link is fully compatible for use with the previously cleared Klassic HD™ Hip System and is manufactured from Vitamin E blended UHMWPE crosslinked by gamma irradiation. The Insert with E-Link is sterilized by ethylene oxide gas and intended for single-use only.
The provided FDA 510(k) summary for the "Klassic HD™ Acetabular Insert with E-Link™ Poly" does not contain the type of acceptance criteria and study details commonly associated with AI/ML medical devices. This document describes a traditional medical device (an acetabular insert for hip replacement) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing.
Therefore, many of the requested items related to AI/ML device performance (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.
However, I can extract the information that is present and indicate where information is not provided.
Here's the analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured / intended outcome) | Reported Device Performance (Results) |
|---|---|
| Material Characterization (before/after accelerated aging) | Met established specifications; demonstrated substantial equivalence to predicate device materials. (Implicitly, the material properties were within expected ranges for safety and efficacy, or comparable to the predicate). |
| Abrasive Wear Testing | Met established specifications; demonstrated substantial equivalence to predicate devices. (Implicitly, wear rates were acceptable or comparable to the predicate). |
| Biocompatibility | Met established specifications; demonstrated substantial equivalence to predicate devices. (Results indicated it is biologically compatible for implantation). |
| Sterility Validation | Met established specifications; demonstrated substantial equivalence to predicate devices. (The sterilization method was effective and validated). |
| Mechanical Performance Testing (with Klassic HD acetabular liner, femoral stem, and femoral head) | Met established specifications necessary for consistent performance during its intended use; demonstrated substantial equivalence to predicate devices. (Implicitly, the device components performed as expected under mechanical stress, ensuring proper function in the hip system). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document states "Non-clinical bench testing was conducted," implying physical samples of the device were tested, but the number of samples for each test type is not detailed.
- Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). This refers to bench testing performed on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth for non-clinical bench testing is established by recognized standards (ASTM, ISO) and laboratory measurements of physical properties, not by human expert interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Bench testing results are typically evaluated against pre-defined specifications or predicate device performance, not adjudicated by a panel of human reviewers.
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
- MRMC Study: No. This is a traditional medical device, not an AI/ML device, so MRMC studies are not relevant.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This is not an AI/ML algorithm.
7. The type of ground truth used
- Type of Ground Truth: For the non-clinical testing, the "ground truth" (or reference against which performance was assessed) was established by:
- Recognized Standards: When available (e.g., ASTM, ISO standards for material properties, sterility, mechanical strength).
- "Non-recognized standards from ASTM and ISO" used as a guide: For tests where no directly recognized standard existed.
- Established Specifications: The document states that the device "meets the established specifications necessary for consistent performance during its intended use."
- Predicate Device Performance: Comparison of technological characteristics and performance to legally marketed predicate devices to demonstrate substantial equivalence.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable. This is not an AI/ML device.
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