(80 days)
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.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.