(125 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.
Intertok® 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 ioint and a polyethylene bearing surface on the humeral side of the joint. The components may be used as a primary procedure or during the revision of a failed shoulder prosthesis.
For a reverse shoulder application, a Glenosphere Baseplate with a Glenosphere is implanted into the glenoid side of the joint. The Glenoid Baseplate is attached to the natural bone with the use of a Central Screw and Peripheral Screws. A Humeral Tray with natural Bearing is attached to a Comprehensive® Humeral Stem to complete the a Hameral side of the joint. The use of a standard Comprehensive® humeral component namoral olde of the form of leaving a well-fixed humeral stem from a previous total or hemi-shoulder surgery in place while still being able to convert the shoulder to a reverse configuration. It also would facilitate the conversion of a reverse configured shoulder to a hemi-shoulder in the future if the need were to arise.
This document is a 510(k) premarket notification summary for the Comprehensive® Reverse Shoulder. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed acceptance criteria and a study proving device performance against those criteria in the way one might find for a software or AI/ML device.
Therefore, many of the requested elements are not applicable or cannot be extracted directly from this type of regulatory submission. This document describes a medical device (shoulder prosthesis) and its indications for use, not a diagnostic or prognostic algorithm that would typically undergo the kind of performance studies you're asking about.
Here's an attempt to address your points based on the provided text, indicating where information is not available:
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A table of acceptance criteria and the reported device performance
- This information is not provided in a quantitative table format suitable for strict acceptance criteria as one would find for a software's performance metrics (e.g., sensitivity, specificity). The document focuses on demonstrating substantial equivalence to predicate devices through design, material, and intended use similarities, and non-clinical testing.
- Acceptance Criteria (Implied for Substantial Equivalence): The device must be demonstrated to be as safe and effective as the predicate devices. This involves showing similar technological characteristics and performance through non-clinical testing.
- Reported Device Performance: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." No specific performance metrics (e.g., wear rates, fatigue life, range of motion under specific load, etc.) or their corresponding acceptance thresholds are detailed in this summary.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as this is a physical medical device. The "testing" mentioned is non-clinical laboratory testing (e.g., mechanical tests), not clinical studies with patient data. No "test set" in the context of patient data is described.
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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. This is for a physical device, not an AI/ML algorithm requiring expert ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication is described.
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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/ML device, and no MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical testing, the "ground truth" would be established engineering standards, material properties, and biomechanical principles against which the physical device components are tested. It would not typically involve expert consensus, pathology, or patient outcomes data in this context.
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The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set mentioned.
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How the ground truth for the training set was established
- Not applicable. As above, no training set.
Summary from the document:
The provided document, K080642, is a 510(k) summary for a physical medical device, the Comprehensive® Reverse Shoulder. For such devices, the regulatory pathway often relies on demonstrating substantial equivalence to existing, legally marketed predicate devices.
The key points regarding "performance" and "testing" from the document are:
- Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
- Clinical Testing: "None provided as a basis for substantial equivalence."
This indicates that the manufacturer relied on laboratory tests (e.g., mechanical, material, fatigue testing) to show the device performed similarly to its predicates and met its functional requirements, rather than clinical studies with human participants. The specific acceptance criteria and detailed performance results of these non-clinical tests are not disclosed in this summary but would have been part of the full 510(k) submission.
§ 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.”