(203 days)
The Humelock Cemented Shoulder Prosthesis is indicated for use in hemi-shoulder replacement to treat:
- Proximal humeral fractures
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
The Humelock Cemented Shoulder Prosthesis is intended for cemented use only.
The Humelock Cemented Shoulder Prosthesis is a hemi-shoulder prosthesis consisting of a humeral stem and a humeral head.
The humeral stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-15mm. The distal end of the humeral stem is cylindrical with a polished surface. The proximal portion of the humeral stem has a grit blasted surface.
The humeral stem incorporates a male taper for attachment of the humeral head.
The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 50mm with heights of 14 - 19mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the humeral stem.
The provided text describes a medical device, the Humelock Cemented Shoulder Prosthesis, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance metrics, or any studies involving a "test set" with ground truth established by experts or a multi-reader multi-case (MRMC) comparative effectiveness study.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them from the given input.
Here's a breakdown of why the requested information cannot be extracted:
- No Acceptance Criteria or Performance Metrics: The document focuses on device description, intended use, and substantial equivalence, not on specific performance targets (e.g., accuracy, sensitivity, specificity) or any numerical results of performance.
- No "Study" in the context of performance: The "Non-Clinical Testing" section mentions "Mechanical testing was conducted to demonstrate the stability of the modular connection between the modular heads and the humeral stem." This is a mechanical engineering test, not a clinical study involving human readers, images, or ground truth.
- "Clinical Testing: Clinical testing was not necessary...": This explicitly states that clinical testing (which would typically involve test sets, experts, and ground truth) was not conducted for substantial equivalence.
- Absence of AI/Algorithm: The device is a physical prosthetic. There is no mention of an algorithm or AI component, making questions about standalone algorithm performance or human-in-the-loop performance irrelevant to this document.
In summary, the provided content is a 510(k) summary for a physical medical device (a shoulder prosthesis), which does not involve the types of studies or criteria normally associated with evaluating AI/ML-based diagnostic devices. Therefore, a table of acceptance criteria and device performance, details on test sets, expert ground truth, MRMC studies, or standalone algorithm performance cannot be extracted.
§ 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.