(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.
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SEP 2 4 2003
510(k) Summary
2
P. I
| Name of Sponsor: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910 |
|---|---|
| 510(k) Contact Person: | Tiffani RogersClinical Research Specialist, Product DevelopmentPhone: (574) 371-4927FAX: (574) 371-4987 |
| Trade Name: | Global CAP Resurfacing Replacement Shoulder |
| Common Name: | Resurfacing shoulder |
| Classification: | Class II Device per 21 CFR 888.3690:Shoulder joint, humeral (hemi-shoulder), metallicuncemented prosthesis. |
| Device Product Code: | HSD |
| Panel: | Orthopaedic |
| Performance Standards: | No performance standards have been establishedunder Section 514 of the Federal Food, Drug, andCosmetic Act for humeral shoulder prosthesis. |
| Substantially Equivalent Devices: | Copeland Shoulder MB/HA Resurfacing HeadK010827DePuy Global Advantage ShoulderK911686(Formerly the Global Total Shoulder) |
| Device Description: | The Global CAP Resurfacing Shoulder is acementless humeral head to be used for thetreatment of shoulder joints:• The humeral head is made of ASTM F-75Cobalt Chrome Molybdenum alloy with aporocoat application on the non-articulatingsurface and the proximal stem. Curvature sizesare available in 40mm to 56mm (in 4mmincrements) with head sizes of 15mm, 18mm |
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510(k) Summary (continued)
The DcPuy Global CAP Resurfacing Shoulder is Indications for use: 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 will increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation. The DePuy Global CAP Resurfacing 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 Shoulder is intended for cementless use only. Substantial equivalence: The DePuy Global CAP Resurfacing Shoulder is manufactured from the same material, sterilized and packaged in the same fashion and has the same intended use and design features as the predicate devices and is therefore substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2003
Ms. Tiffani Rogers Clinical Research Specialist, Product Development DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K031971
Trade/Device Name: Global CAP Resurfacing Replacement Shoulder Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: June 24, 2003 Received: June 26, 2003
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Tiffani Rogers
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. Mark N. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K03197 510(k) Number (if known):
Device Name: Global CAP Resurfacing Replacement Shoulder
Indications for Use:
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.
Mark N. Milkena
(Division Sign-Off) Division of General. Restorative and Neurological Devices
K031971 510(k) Number
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
§ 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.