(316 days)
The Arthrex Univers Revers CA Heads and Adapters are indicated for
- . salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or
- . conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device
The Arthrex Univers Revers CA Heads and Adapters consist of a line of CA Heads and Adapters which are designed to be used with the existing well-fixated Revers stem of the Univers Revers Shoulder Prosthesis System (K130129 and K142863). The Arthrex Univers Revers CA Heads and Adapters will convert existing reversed shoulder prosthesis to a hemi anatomic configuration. The cobalt chrome CA Head were designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency, similar to the Univers II The proposed Arthrex Univers Revers CA Heads have a CA Heads (K130675). similar spherical articulating surface as that of the previously cleared heads and are available in 14 nominal sizes. The Adapters are manufactured from Titanium and UHMWPE and are available in 3 nominal sizes.
The provided text describes a 510(k) premarket notification for a medical device called "Arthrex Univers Revers CA Heads and Adapters." This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness criteria. Therefore, the document does not contain information about acceptance criteria and a study to prove the device meets specific performance metrics in the way your request outlines for AI/software-based devices.
The information provided only discusses the substantial equivalence summary based on bench testing. Here's a breakdown of what is available and what is not in relation to your request:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for clinical performance in a typical sense for AI, but rather a demonstration of equivalence to predicates. The acceptance for this 510(k) submission is that the device's design, materials, and mechanical performance are comparable to cleared predicate devices and do not raise new questions of safety or effectiveness.
- Reported Device Performance: The document states that in-vitro testing (static loading, endurance, fretting corrosion, disengagement, torque out) was performed and demonstrated that the performance of the proposed devices is "substantially equivalent to that of the predicate devices." No specific numerical performance metrics from these tests are provided, nor are the acceptance criteria for these mechanical tests detailed.
Table (based on available information, highly summarized):
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance |
|---|---|
| Mechanical performance not inferior to predicate devices. | In-vitro static loading, endurance, fretting corrosion, disengagement, torque-out tests demonstrated performance "substantially equivalent" to predicate devices. |
| Design, size range, and material consistent with intended use and predicates. | Device design, size range, and materials are comparable to predicates. |
2. Sample size used for the test set and the data provenance:
- Test Set (for in-vitro mechanical testing): Not specified in this document. Since it's mechanical testing, the "sample size" would refer to the number of devices tested for each mechanical property.
- Data Provenance: The nature of in-vitro testing suggests it's likely conducted in a lab setting, presumably by the manufacturer (Arthrex, Inc.). No country of origin is mentioned for the test data itself, but the manufacturer is based in Naples, Florida, USA. The testing is prospective in the sense that it's performed to support the 510(k) submission for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes mechanical testing of a physical implant, not clinical performance based on expert review or ground truth labeling like in an AI study.
4. Adjudication method for the test set:
- Not applicable. This relates to clinical or interpretative studies, not mechanical bench testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study applies to diagnostic imaging or interpretation devices, typically AI-powered. The device in question is a physical orthopedic implant. The document explicitly states: "Clinical data and conclusions are not needed for this device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used:
- Not applicable. For mechanical testing, the "ground truth" would be the measured physical properties against established engineering standards or predicate device performance.
8. The sample size for the training set:
- Not applicable. This device is a passive implant; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. Again, no training set for a physical implant.
In summary: The provided document is a 510(k) clearance letter for a physical orthopedic implant, focusing on its substantial equivalence to previously cleared predicates through in-vitro mechanical testing. It does not contain the detailed performance criteria, clinical study designs, or AI-specific information requested.
§ 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.