(258 days)
THE ARROW ANATOMICAL POROUS GLENOID, DEPENDING ON THE COMPONENTS USED, IS DESIGNED FOR:
- CENTRED GLENOHUMERAL OSTEOARTHRITIS -
- RHEUMATOID POLYARTHRITIS -
- POST-TRAUMATIC SEQUELA WITH GLENOID INJURY -
- -FRACTURES OF THE PROXIMAL HUMERUS WITH GLENOID INJURY
- REVISION FOR GLENOID LOOSENING -
- GLENOID BONE LOSS. WHERE BONE GRAFT IS NEEDED -
- A FUNCTIONAL ROTATOR CUFF IS NECESSARY TO USE THIS DEVICE
THE POROUS GLENOID BASE IS INTENDED FOR CEMENTLESS APPLICATION WITH THE ADDITION OF BONE SCREWS FOR FIXATION
The ARROW anatomical porous glenoid consists of a glenoid insert and a porous glenoid base. The porous glenoid base is used with bone screws for fixation (cleared in K112193). The glenoid inserts and the porous glenoid bases are used in total anatomical prosthesis and are designed to articulate with the ARROW anatomical shoulder system (cleared in K093599).
The ARROW anatomical porous glenoid is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis namely: simple humeral prosthesis, total anatomical prosthesis (cemented glenoid implant with 4 pegs), total anatomical prosthesis (porous glenoid implant), pending, and reverse prosthesis.
The provided text is a 510(k) Summary for a medical device called "ARROW® ANATOMICAL POROUS GLENOID." This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and performance testing, rather than reporting on a clinical study involving human subjects or AI-assisted diagnostic performance.
Therefore, the requested information regarding acceptance criteria and performance data from a study involving AI assistance or human-in-the-loop performance cannot be extracted from this document. The document describes mechanical performance testing, not clinical performance for diagnostic or treatment effectiveness in the way an AI diagnostic device would.
Here's what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
The document states: "The ARROW anatomical porous glenoid was tested according to the ASTM F 1829 and ASTM F 2028 standards. After the tests were completed, it was determined that the ARROW anatomical porous glenoid performances were substantially equivalent to those of the selected predicate devices."
It does not provide specific numerical acceptance criteria or detailed results from these tests, only that the device met the standards and was "substantially equivalent."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes mechanical testing of a medical implant, not a clinical study involving a test set of data.
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. Ground truth for mechanical testing is established by engineering specifications and standard test methods (ASTM F 1829 and ASTM F 2028), not by expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a diagnostic performance study requiring adjudication.
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. This document does not describe any MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For mechanical testing, the "ground truth" would be established by the ASTM standards themselves and the physical properties of the materials and design, verified through laboratory measurements.
8. The sample size for the training set
Not applicable. This document describes mechanical performance testing, not the development of an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in this document.
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”