(145 days)
The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. 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 Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to rotator cuff deficiency.
(Humeral) Stems are intended for cemented or cementless applications for use with Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
The Arthrex Univers Revers Humeral Stems and Suture Cups is a line extension to the Arthrex Univers Revers Shoulder Prosthesis System. The proposed humeral stems, sizes 6 thru 15, are modified versions of the humeral stems cleared under K130129/K142863 and are designed to be shorter in medial to lateral width. The line extension also introduces a size 5 modular stem as well as modified versions of the Humeral Suture Cups.
The provided text is a 510(k) premarket notification for a medical device, specifically the "Arthrex Univers Revers Shoulder Prosthesis System." It details the device's indications for use, its substantial equivalence to a predicate device, and some testing performed. However, it does not describe an acceptance criterion in the context of device performance metrics or any study that proves the device meets such criteria in terms of clinical outcomes or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a previously cleared device.
Therefore, I cannot provide the detailed information requested in the format of acceptance criteria and a study demonstrating device performance. This document pertains to regulatory clearance based on substantial equivalence to a predicate device, not a performance study against specific acceptance criteria for diagnostic accuracy or clinical efficacy in the way the request implies (e.g., sensitivity, specificity, or improvement with AI assistance).
Here's a breakdown of why and what information can be extracted:
Why the request cannot be fully fulfilled from the provided text:
- Acceptance Criteria & Reported Device Performance (Table): The document doesn't define quantitative acceptance criteria for clinical performance (e.g., success rates, pain reduction scores, range of motion improvement) for the new device. It states the device's intended use and then relies on demonstrating equivalency to a predicate device through non-clinical testing (fatigue and abrasion).
- Sample Size & Data Provenance (for test set): There is no test set described in terms of patients or images for clinical performance. The "test set" for the mechanical tests (fatigue and abrasion) would be the physical implants themselves, not a clinical data set.
- Number of Experts & Qualifications / Adjudication Method: These points are relevant to studies involving human interpretation or clinical endpoints, which are not described here.
- Multi-Reader Multi-Case (MRMC) Study / Effect Size: This is specific to diagnostic or AI-assisted devices and is not applicable here as the device is a prostheses system.
- Standalone Performance: This would be for a diagnostic algorithm, not a physical implant.
- Type of Ground Truth: Ground truth (pathology, outcomes data) usually applies to diagnostic accuracy studies. While outcomes data would eventually be collected on this prosthesis in a clinical setting, this document is for premarket clearance based on equivalence, not a clinical trial demonstrating new outcomes.
- Sample Size for Training Set / How Ground Truth was Established (for training set): These relate to machine learning model development, which is not applicable to a shoulder prosthesis.
What can be extracted from the document related to "acceptance" in a regulatory sense and "study":
The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence and meeting the performance of the predicate device through bench testing.
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Implicit Acceptance Criteria (for mechanical properties):
- Survivability of dynamic fatigue testing for 10 million cycles for both compression and torsion loading conditions.
- Abrasion resistance using the new Humeral Suture Cups that "exceeded the predicate."
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Study Proving Device Meets Implicit Acceptance Criteria:
- Study Name: Dynamic fatigue testing and abrasion testing.
- Reported Device Performance:
- Dynamic Fatigue Testing: All constructs survived 10 million cycles for both compression and torsion loading conditions.
- Abrasion Testing: Abrasion resistance exceeded the predicate.
- Sample Size for Test Set: Not specified, but generally refers to the number of physical device constructs tested in the lab.
- Data Provenance (Test Set): Not applicable in the clinical sense. These would be lab-generated test results.
- Ground Truth: Not applicable in the clinical sense. The "ground truth" for these tests are the physical properties and failure points observed in a controlled lab environment.
- Other points (Experts, Adjudication, MRMC, Standalone, Training Set): Not applicable to this type of regulatory submission and testing.
In summary, the provided text is a 510(k) clearance letter and summary, which focuses on regulatory equivalence and non-clinical bench testing for a physical implant, not a clinical performance study with acceptance criteria for patient outcomes or diagnostic performance.
§ 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.