(99 days)
The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.
Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.
The provided document is a 510(k) premarket notification for a medical device called the "Comprehensive® Reverse Shoulder - E1® Polyethylene Claims". It details the device's indications for use, regulatory classification, and claims related to its E1® Antioxidant Infused Technology.
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Claim | Reported Device Performance and Test Details |
|---|---|
| Claim 1: E1® Antioxidant Infused Technology prevents oxidative degradation of polyethylene. | Test: Environmental Stress Cracking Testing. Cyclically loaded GUR1020 and GUR1050 E1® test specimens in an air atmosphere at 80°C for 5 weeks. Testing per Nabar, Sean, et al. Transactions of the 54th Annual Meeting of the ORS, Poster No. 1684. |
| Performance: E1® specimens showed no evidence of environmental stress cracking. Infrared spectroscopy showed no detectable oxidation in loaded or unloaded samples (oxidation indices 0.05) in ultimate load, ultimate tensile strength, or yield strength after accelerated aging for either E1® GUR1050 or E1® GUR1020 material. |
- E1® GUR1020: Ultimate load (before/after aging) 97.2±6.4N / 100.0±5.0N. Ultimate tensile strength 45.8±1.6 MPa / 46.1±2.9 MPa. Yield strength 22.6±0.2 MPa / 22.8±0.3 MPa.
- E1® GUR1050: Ultimate load (before/after aging) 105.0±5.5N / 115.0±3.2N. Ultimate tensile strength 43±3 MPa / 43±2 MPa. Yield strength 24.2±0.2 MPa / 24.4±0.2 MPa. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document describes material testing, not patient-level data. The "test sets" refer to the numbers of material specimens or samples used in the mechanical and chemical tests.
- Sample Size: Not explicitly stated as a single number. For Claim 3, ultimate loads are given with standard deviations (e.g., 105±5.5N), implying multiple samples were tested for each group, but the exact number of replicates is not provided. Similarly for Claim 4, multiple samples are implied. For Claims 1 and 2, it refers to "specimens" without numerical counts.
- Data Provenance: Not applicable in the context of patient data. The tests are bench tests conducted on materials. The "provenance" refers to the specific materials (GUR1020 and GUR1050 UHMWPE) and their processing methods (isostatically compression molded, crosslinked, gamma irradiation, vitamin E infusion, etc.). It's a laboratory-based study.
- Retrospective/Prospective: Not applicable. These are in-vitro, bench-top material tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This document details material properties and performance through standardized mechanical and chemical testing, not expert interpretation of clinical data. The "ground truth" is established by the results of these physical tests, which are objective measurements.
4. Adjudication Method for the Test Set
Not applicable. This refers to consensus-building among experts for ambiguous cases in clinical studies. For material performance tests, observations (like presence/absence of cracks, oxidation indices, ultimate load measurements) are objective and do not require expert adjudication to establish truth.
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 a material science study to evaluate the properties of polyethylene used in a shoulder prosthesis, not an AI-based diagnostic or assistive device. There are no human readers or AI involved in interpreting the results.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a material science study, not an algorithm or AI performance evaluation.
7. The Type of Ground Truth Used
The ground truth is established by objective measurements and observations from validated laboratory tests on material samples. Examples include:
- Absence of environmental stress cracking (visual inspection/microscopy).
- Oxidation indices from infrared spectroscopy (quantitative chemical analysis).
- Ultimate load measurements from small punch testing (quantitative mechanical test).
- Ultimate tensile strength and yield strength from tensile testing (quantitative mechanical test).
These are direct physical and chemical properties of the material, measured using established scientific methods, rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in these material performance studies. The tests are conducted on representative samples of the manufactured material to evaluate its inherent properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.”