(77 days)
The Endurance Calcar Hip Prosthesis is indicated for cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty. The stem is especially suited to primary or revision cases where the calcar of the femur may be deficient and for cases of intertrochanteric fracture.
The Endurance Calcar Hip Prosthesis is a forged Co-Cr-Mo stem, available in one size and two stem lengths. The design of the stem is similar to the design of the size 3 DePuy Cemented Hip Stem (now called the Endurance hip stem) except that the Endurance Calcar has an offset that is midway between the standard and high offset Endurance stems, does not have a collar and does have a 2.25cm calcar platform which is used to seat the implant.
Based on the provided text, a conventional medical device (hip prosthesis) is being described, not a device that relies on algorithms, AI, or image analysis for its primary function. Therefore, most of the requested information regarding acceptance criteria for AI/algorithmic performance, sample sizes for AI training/testing, ground truth establishment, expert review, MRMC studies, and standalone performance is not applicable to this document.
The document describes a 510(k) submission for a hip prosthesis, which focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use as per traditional medical device regulations.
Here's an attempt to address the applicable parts of your request based on the provided text, while clearly stating where the information is not relevant:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain specific quantitative acceptance criteria or detailed performance data (e.g., success rates, complication rates, longevity data) for the Endurance Calcar Hip Prosthesis in the way one would assess an AI/algorithmic device. The "performance" described is in terms of its design similarity and intended use compared to predicate devices, which is the basis for its 510(k) clearance.
| Acceptance Criteria (Implied for 510(k) Clearance) | Reported Device "Performance" (as per document) |
|---|---|
| Design Similarity to Predicates: | Same basic design as Endurance Hip Stem. |
| - Basic design | |
| - Material composition | Manufactured from the same Co-Cr-Mo material as predicate. |
| - Offset characteristics | Offset midway between standard and high offset Endurance stems. |
| - Collar presence | Does not have a collar (distinguishes from some predicates). |
| - Calcar platform presence | Has a 2.25cm calcar platform. |
| Intended Use Equivalence: | Indicated for cemented use in total hip arthroplasty (THA). |
| - Patient population | Patients with damaged hip joints due to inflammatory/non-inflammatory degenerative joint disease, fracture, or failed arthroplasty. |
| - Specific applications | Especially suited for primary/revision cases where calcar of the femur may be deficient, and intertrochanteric fracture cases. |
| - Surgical procedure | Cemented femoral component in THA. |
| Material Safety & Biocompatibility: | Forged Co-Cr-Mo stem (standard implant material). Implied to meet safety standards given 510(k) context. |
| Manufacturing Process: | Implied to meet quality standards. |
2. Sample sizes used for the test set and the data provenance
- Not Applicable: This device is a physical implant. The concept of a "test set" with "data provenance" (country of origin, retrospective/prospective) is typically relevant for AI/algorithmic systems that process data (e.g., images, clinical records). For a hip prosthesis, clinical trials or post-market surveillance would involve patient cohorts, but these details are not provided in this 510(k) summary. The 510(k) focuses on demonstrating substantial equivalence based on design and materials, not extensive new clinical outcome data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: "Ground truth" and "expert review" in this context refer to the assessment of an algorithm's output. For a physical hip prosthesis, the "truth" is established through engineering specifications, material properties, biomechanical testing (not detailed here), and ultimately, clinical outcomes in patients. This document does not describe such an expert review process for a "test set."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used in AI/algorithmic studies to resolve disagreements among human reviewers (experts) establishing ground truth for the algorithm's performance evaluation. This is not relevant for the submission of a hip prosthesis.
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
- Not Applicable: This is entirely irrelevant. MRMC studies are specific to evaluating the impact of AI assistance on human reader performance, typically in diagnostic imaging. This device is a surgical implant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device does not have an "algorithm" component. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the AI/Algorithmic sense: For a hip prosthesis, the "truth" about its performance would be derived from:
- Engineering specifications and material properties: Conformance to design drawings, material standards (e.g., ASTM for Co-Cr-Mo).
- Pre-clinical mechanical testing: Fatigue, wear, and strength testing (though not detailed in this summary).
- Clinical outcomes data: Long-term patient data on pain relief, function, revision rates, and complications (collected during clinical trials or post-market, but not the focus of a 510(k) summary based on substantial equivalence).
- The 510(k) itself relies on the "ground truth" that predicate devices with similar designs and materials have a known safety and efficacy profile.
8. The sample size for the training set
- Not Applicable: There is no "training set" for a physical hip prosthesis. This concept applies to machine learning algorithms.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, there is no establishment of ground truth for it.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.