(56 days)
Total shoulder or hemi-shoulder replacement is indicated for:
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- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
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- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
- Other difficult clinical problems where shoulder arthrodesis or 3. resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
Hemi-shoulder replacement is also indicated for:
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- Ununited humeral head fractures.
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- Avascular necrosis of the humeral head.
The humeral stem is manufactured from titanium 6-Al-4V alloy and has a corundum blasted surface to enhance bone cement fixation. Lateral fins with suture holes are designed for soft tissue attachment. There is a 6 degree male taper to mate with humeral heads. The devices features an anatomical neck/shaft angle. The humeral head is fabricated from cobalt chromium alloy. The head has a low profile and manufactured with a 6 degree taper to mate with the humeral stem. There are numerous head diameters to accommodate anatomical patient variations. An offset head at 4 mm is also available to permit soft tissue balancing and to enhance joint stability. The glenoid component is fabricated from ultra-high molecular-weight polyethylene. It is designed with a pear shaped frontal profile for anatomical fit to the glenoid which avoids soft tissue impingement. The articular surface radius of curvature is oversized to the humeral heads to accommodate multiple humeral head sizes. The device is designed with 3 peg fixation. The pegs are co-linear to help avoid punch through of thin cortical walls at the outer edges of the glenoid. The undersurface is keeled to enhance bone cement fixation.
This document describes a 510(k) summary for the Genesis Total Shoulder Replacement, a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data demonstrating device performance against granular acceptance criteria. Therefore, the provided text does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving their attainment.
Here's an analysis based on the provided text, highlighting what is and isn't available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. For 510(k) submissions, the “acceptance criteria” are primarily demonstrating substantial equivalence to a predicate device, as opposed to functional or performance metrics with specific thresholds that would be met by a clinical study. The document focuses on demonstrating that the Genesis Total Shoulder Replacement has "similar intended use, design intent, dimensions, surgical technique, materials, biocompatibility and labeling as that of predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document does not describe a "test set" in the context of a clinical study or a dataset for performance evaluation. The submission relies on technological characteristics and comparison to predicate devices, not on de novo clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. As there's no clinical study with a "test set" described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method
This information is not provided. Without a clinical study and ground truth establishment, adjudication methods are not applicable here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided. The document does not describe an MRMC study or any study comparing human readers with and without AI assistance. This device is a shoulder prosthesis, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
This information is not provided. This device is a physical implant, not an algorithm, so a standalone performance study in that context is not applicable.
7. Type of Ground Truth Used
This information is not provided. There is no ground truth, in the typical sense of clinical study evaluation, mentioned in the document. The "truth" for this submission is the substantial equivalence to predicate devices already approved for market.
8. Sample Size for the Training Set
This information is not provided. The device is a physical implant; it does not involve machine learning algorithms that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As there's no training set, this question is not applicable.
Summary of Approach in the Document:
The provided document is a 510(k) summary for a medical device. The core of a 510(k) submission is to demonstrate substantial equivalence to one or more legally marketed predicate devices, not to establish new safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria for novel device performance.
The document states: "Substantial equivalence is derived from a composite of characteristics from multiple predicate devices including the Zimmer Select, the Biomet Bio-Modular total shoulder, Tornier Aequalis, the Global Total Shoulder and the Solar shoulder system."
It further elaborates on the basis of substantial equivalence: "The Genesis Total Shoulder replacement has similar intended use, design intent, dimensions, surgical technique, materials, biocompatibility and labeling as that of predicate devices. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues."
Therefore, the "acceptance criteria" for this submission are met by successfully arguing that the Genesis Total Shoulder Replacement is substantially equivalent to existing, legally marketed devices. The "study that proves the device meets the acceptance criteria" is the comprehensive comparison presented in the 510(k) submission itself, demonstrating this substantial equivalence across various technical and functional aspects.
§ 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.”