(222 days)
REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT) The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cementless application while the glenoid baseplate (metal-back or porous) is intended for cementless application with the addition of bone screws for fixation.
The ARROW® Reverse porous glenoid base is used in total reverse shoulder prosthesis and is designed to articulate with the ARROW® Reverse shoulder system (cleared in K112193). The porous glenoid base is used with bone screws for fixation (cleared in K112193). The ARROW® Reverse 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: simple humeral prosthesis, total anatomical prosthesis and reverse prosthesis.
This document is a 510(k) Premarket Notification from the FDA regarding the ARROW® Reverse Porous Glenoid. It is a submission for a Class II medical device (shoulder joint prosthesis) and primarily focuses on demonstrating substantial equivalence to existing predicate devices.
This document describes a medical device (shoulder prosthesis), NOT an AI/ML powered device.
Therefore, most of the requested information about acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance:
Since this is a submission for a physical medical device (shoulder prosthesis) and not an AI/ML powered device, the "acceptance criteria" are related to mechanical and material performance, and "device performance" refers to the results of engineering tests.
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance (Compliance) |
|---|---|
| ASTM F1829-16 | Met |
| ASTM F2028-14 | Met |
| ASTM F1378-12 | Met |
| LAL testing (20 EU/device limit) | Met the specified 20 EU/device limit |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (e.g., number of prostheses tested) for the ASTM standards or LAL testing. These are typically engineering tests performed on a defined number of device units or material samples per the standard's requirements.
- Data Provenance: The tests were conducted by the manufacturer, Fournitures Hospitalières Industrie, based in France. The data would be "prospective" in the sense that the tests were performed specifically for this 510(k) submission on newly manufactured devices or samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device submission. "Ground truth" in the context of AI/ML models (e.g., expert annotation of medical images) is not relevant here. Device performance is assessed through standardized mechanical and biological tests. The "experts" would be the engineers and technicians performing and interpreting these standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, adjudication methods common in AI/ML performance evaluation (e.g., for reconciling expert disagreements) are not pertinent to the mechanical testing of a medical implant.
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 is not an AI-assisted device, so MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable for AI/ML "ground truth". For a physical device, "ground truth" relates to established engineering principles and the specifications within the ASTM standards. The device is expected to perform in accordance with the established mechanical and material properties defined by these standards.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" or "ground truth" establishment in the AI/ML sense.
In summary, this document is a regulatory submission for a traditional implantable medical device, demonstrating its substantial equivalence to previously cleared devices through adherence to established material and mechanical performance standards, rather than through AI/machine learning performance metrics.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”