(90 days)
The DePuy Global CAP Resurfacing Replacement Shoulder is intended as a hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation.
The DePuy Global CAP Resurfacing Replacement Shoulder is indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, noninflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis.
CAUTION: The DePuy Global CAP Resurfacing Replacement Shoulder is intended for cementless use only.
The Global CAP Resurfacing Shoulder is a cementless humeral head to be used for the treatment of shoulder joints: • The humeral head is made of ASTM F-75 Cobalt Chrome Molybdenum alloy with a porocoat application on the non-articulating surface and the proximal stem. Curvature sizes are available in 40mm to 56mm (in 4mm increments) with head sizes of 15mm, 18mm
Here's an analysis of the provided text regarding the acceptance criteria and study for the Global CAP Resurfacing Replacement Shoulder:
Important Note: The provided text is a 510(k) summary and the FDA's clearance letter for a medical device (a shoulder implant). It is crucial to understand that 510(k) submissions typically do not involve AI algorithms, standalone studies, or human reader performance comparisons. This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through material, design, sterilization, and intended use comparisons. Therefore, most of the requested fields about AI-specific criteria will likely be absent.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 510(k) context) | Reported Device Performance (from 510(k) context) |
|---|---|
| Manufactured from the same material as predicate devices. | The DePuy Global CAP Resurfacing Shoulder is manufactured from ASTM F-75 Cobalt Chrome Molybdenum alloy, which is comparable to predicate devices. |
| Sterilized and packaged in the same fashion as predicate devices. | The device is sterilized and packaged in the same fashion as predicate devices. (Specifics not detailed, but implied to be equivalent). |
| Same intended use as predicate devices. | Intended for hemi or total shoulder replacement in patients with sufficient humeral head/neck bone stock and intact/reconstructable rotator cuff, to reduce pain, restore alignment/movement, and resist dislocation. Indicated for conditions like rheumatoid arthritis, osteoarthritis, avascular necrosis, deformity, limited motion, humeral head fractures, and traumatic arthritis. This aligns with predicate device indications. |
| Similar design features to predicate devices. | The device has similar design features to predicate devices. (Specifics not detailed, but implied by substantial equivalence claim). |
| Cementless use only. | The device is explicitly intended for cementless use only, aligning with its design and potentially predicate devices. |
Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, "acceptance criteria" generally refers to the benchmarks used by the manufacturer to demonstrate that their new device is "substantially equivalent" to legally marketed predicate devices. This is not about achieving specific performance metrics in an independent study (like an AI algorithm's accuracy), but rather showing that the new device is as safe and effective as existing ones.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. Given that this is a pre-2003 submission for a physical orthopedic implant seeking substantial equivalence, it's highly unlikely that a "test set" in the context of data analysis (as would be used for an AI algorithm) was part of the submission. The "testing" would have involved mechanical, material, and biocompatibility testing, but not a clinical "test set" for performance metrics like sensitivity/specificity of an AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not provided. As explained above, this submission is for a physical implant and does not involve AI or diagnostic interpretation requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. This is relevant for AI or diagnostic imaging studies, not for a physical implant's 510(k) submission.
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/Not provided. MRMC studies are used to evaluate diagnostic performance, often comparing human readers with and without AI assistance. This device is a physical implant, not a diagnostic tool or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided in the AI/diagnostic sense. For this 510(k), the "ground truth" for showing substantial equivalence would have been established through:
- Material specifications: Conformance to ASTM F-75 Cobalt Chrome Molybdenum alloy.
- Design comparisons: Engineering drawings and specifications showing similarity to predicate devices.
- Biocompatibility testing: Standardized tests demonstrating the material's safety in biological environments.
- Mechanical testing: Bench testing for strength, fatigue, and wear, ensuring the device meets engineering standards comparable to predicate devices.
- Clinical history of predicate devices: Relying on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable/Not provided. This is for AI algorithms, not a physical implant.
9. How the ground truth for the training set was established
Not applicable/Not provided. This is for AI algorithms, not a physical implant.
Summary of the Study (as presented in the 510(k) summary):
The "study" presented here is a demonstration of substantial equivalence rather than a traditional clinical trial or performance study (especially not for AI). The core argument is:
- Comparison to Predicate Devices: The DePuy Global CAP Resurfacing Shoulder is compared to the Copeland Shoulder MB/HA Resurfacing Head (K010827) and the DePuy Global Advantage Shoulder (K911686).
- Basis for Equivalence: The manufacturer asserts substantial equivalence based on the device being manufactured from the same material (ASTM F-75 Cobalt Chrome Molybdenum alloy), sterilized and packaged in the same fashion, having the same intended use, and possessing similar design features as the predicate devices.
- Indications for Use: The indications for the new device align with those of the predicate devices, covering conditions like rheumatoid arthritis, osteoarthritis, avascular necrosis, deformity, limited motion, and fractures of the humeral head, for both hemi or total shoulder replacement.
- Safety and Performance: By demonstrating these similarities, the manufacturer implicitly argues that the new device will be as safe and effective as the predicate devices, which have already been cleared for market.
Conclusion regarding the "study that proves the device meets the acceptance criteria":
The "study" is a regulatory submission arguing for substantial equivalence. It does not involve a traditional "study" generating new performance data in the AI sense, but rather a detailed comparison to already approved products. The "acceptance criteria" are met by systematically demonstrating that the new device does not raise new questions of safety or effectiveness compared to its predicate devices across material, manufacturing, intended use, and design.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.