(349 days)
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 cemented of cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.
The ARROW® reverse shoulder system is a shoulder joint prosthesis, composed of the following elements :
- Humeral stems, ・
- STD humeral inserts, •
- Glenospheres -
- Metal-back glenoid bases -
- And fixation screws for the metal back glenoid base (cancellous and cortical bone screws)
The ARROW® reverse shoulder system is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
This document is a 510(k) premarket notification for the ARROW® Reverse Shoulder System, outlining its request for substantial equivalence to legally marketed predicate devices. It focuses on the device's design, materials, and mechanical performance, rather than clinical performance (e.g., diagnostic accuracy or treatment efficacy measured through patient outcomes).
Therefore, the requested information regarding acceptance criteria for clinical performance, study types like MRMC, accuracy metrics, ground truth establishment, or training set details cannot be fully provided from this document. This document is primarily focused on demonstrating mechanical and material equivalence and safety.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (How the device performed) |
|---|---|
| Mechanical performance of glenoid components per ASTM F1378-05 | "After the testing was completed, it was determined that the ARROW reverse shoulder system performances were substantially equivalent to those of the selected predicated devices." |
| Mechanical performance of glenoid components per ASTM F1829-98 | "After the testing was completed, it was determined that the ARROW reverse shoulder system performances were substantially equivalent to those of the selected predicated devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test (ASTM F1378-05 and ASTM F1829-98). Mechanical testing standards typicaly specify the number of samples to be tested, but this document does not provide the specific number of ARROW® devices tested.
- Data Provenance: The device manufacturer, Fournitures Hospitalières Industrie, is based in Quimper, France. The testing was conducted internally or by a third-party laboratory usually located in the country of origin or a specialized testing facility. Details about the exact location of testing are not provided. The study is a prospective engineering study (i.e., testing of the device for regulatory submission) not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable (N/A). This is a mechanical/material engineering study, not a study requiring expert clinical ground truth evaluation. The "ground truth" for these tests are the established parameters and failure modes defined by the ASTM standards, which are objective and quantitative.
4. Adjudication Method for the Test Set
- N/A. Adjudication methods like 2+1 or 3+1 are used in clinical studies for expert consensus, which is not relevant for mechanical testing against industry standards. The compliance with the ASTM standards is objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This document focuses on demonstrating mechanical equivalence and safety for a medical device (reverse shoulder system). MRMC studies are typically performed for diagnostic imaging devices or AI-assisted diagnostic tools to assess the impact of the technology on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This is a physical medical device, not an algorithm. Standalone performance analysis is not applicable here.
7. The Type of Ground Truth Used
- Established ASTM (American Society for Testing and Materials) Standards for mechanical performance. The device's performance was compared against the requirements and benchmarks set by these recognized industry standards (F1378-05 and F1829-98) and against the performance of predicate devices.
8. The Sample Size for the Training Set
- N/A. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- N/A. This device does not involve a "training set" or "ground truth" in the context of machine learning for which such establishment would be necessary.
§ 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.”