(56 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 details a 510(k) premarket notification for the "Comprehensive® Reverse Shoulder - E1® Humeral Bearings." The focus of the submission is to demonstrate substantial equivalence to a predicate device, K080642, rather than to establish new safety and effectiveness through a comprehensive study meeting specific acceptance criteria as would be typical for an AI/ML device.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and reader studies for a novel AI/ML device is not applicable to this document. This document pertains to a medical device (humeral bearings for shoulder replacement) that is evaluated based on material characteristics and mechanical performance, not an AI/ML algorithm.
However, I can extract information about the non-clinical tests conducted, which serve a similar purpose of demonstrating performance for this type of medical device:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a physical medical device, not an AI/ML algorithm, the "acceptance criteria" are implied by demonstrating equivalence to a legally marketed predicate device through non-clinical testing. The "reported device performance" refers to the results of these non-clinical tests. Specific numerical acceptance criteria are not explicitly stated as they would be for an AI/ML diagnostic's sensitivity/specificity. Instead, the performance demonstrated that the new device "performed within the intended use" and did not raise new safety or efficacy issues when compared to the predicate.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Material characteristics are comparable to predicate. | UHMWPE (E1®) using 1050 Resin. (Predicate used UHMWPE (E-Poly™) with 1020 Resin). |
| Dimensions are comparable to predicate. | Internal Diameter: 31, 36, 41mm. Height: Standard, Standard +3mm, Retentive +3mm. (Identical to predicate). |
| Attachment mechanism is comparable to predicate. | Ringloc® snap ring. (Identical to predicate). |
| Tensile properties meet or exceed established standards. | Tensile Testing per ASTM D-638 conducted. Results indicated performance within intended use. |
| Impact strength properties meet or exceed established standards. | IZOD Impact Strength testing in accordance with ASTM F-648 conducted. Results indicated performance within intended use. |
| Humeral Bearing pull-out strength is adequate. | Humeral Bearing Pull-out testing conducted. Results indicated performance within intended use. |
| Humeral Bearing lever-out strength is adequate. | Humeral Bearing Lever-out testing conducted. Results indicated performance within intended use. |
| Humeral Bearing torque-out strength is adequate. | Humeral Bearing Torque-out testing conducted. Results indicated performance within intended use. |
| No new safety or efficacy issues are raised. | Testing indicated the material performed within the intended use, did not raise any new safety and efficacy issues. |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated for specific tests, but generally refers to a sufficient number of test articles/specimens to perform the mechanical tests listed (e.g., multiple specimens for tensile strength, impact strength, pull-out, lever-out, and torque-out tests).
- Data provenance: Not explicitly stated, but these are material and mechanical property tests typically conducted in a laboratory setting by the manufacturer (Biomet Manufacturing Corp.) or a qualified testing facility. The data would be prospective to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of mechanical device, "ground truth" is established by adherence to recognized ASTM standards for material and mechanical properties, not by expert consensus on clinical findings. The evaluation is based on scientific and engineering principles.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are for clinical evaluations or subjective assessments, not for objective mechanical property testing against standards.
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 physical medical device, not an AI/ML diagnostic or assistive tool. No MRMC study was conducted.
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 AI/ML algorithm.
7. The type of ground truth used
- Non-clinical/Mechanical Performance and Material Standards: The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ASTM D-638 for tensile testing, ASTM F-648 for IZOD impact strength) and the comparative performance against the predicate device.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" or ground truth for one.
§ 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.”