(392 days)
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System can be used to provide additional fixation.
The Reverse Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation.
The humeral short stem is intended for cementless use.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The Glenoid Reconstruction System is a Medacta Shoulder System line extension to provide a larger product offering. It includes GRS baseplates and central screws, sterile implantable devices used to replace only the glenoid side of the gleno-humeral joint in a shoulder reverse configuration.
The GRS baseplate, intended for cementless application, is designed to be fixed into the glenoid bone by means of both a press-fit central post and Glenoid Polyaxial Screws. If desired, a GRS Central Screw can be used to provide additional stability. The GRS baseplate is designed to provide an interface for glenosphere coupling.
The subject baseplate is available in two taper diameters (024.5 and 027) with two different lengths (20 and 30 mm) of the central post and 3 lateralization options (0 mm, +3 mm and +6 mm). It is made of Ti6A17Nb according to ISO 5832-11 and double coated with Ti coating according to ASTM F1580-18 and HA coating according to ASTM F1185-03.
The GRS central screw is available in 4 different lengths, from 15 to 30 mm and it is made of Ti6Al4V according to ISO 5832-3.
The provided text describes a 510(k) premarket notification for the Glenoid Reconstruction System, specifically for new GRS baseplates and central screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with acceptance criteria based on patient outcomes.
Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.
Here's why and what can be extracted from the document in relation to device performance and testing:
Why the requested information is not present:
- Device Type: The Glenoid Reconstruction System is a medical implant (shoulder prosthesis components), not an AI/ML-powered diagnostic or therapeutic device. The types of evaluations, acceptance criteria, and studies are fundamentally different.
- Regulatory Pathway (510(k)): A 510(k) submission primarily relies on demonstrating that a new device is "substantially equivalent" to an existing legally marketed device (the predicate). This often involves comparing technological characteristics and performing bench testing (non-clinical studies) to ensure it performs as intended and is as safe and effective as the predicate. Clinical studies are often not required for 510(k)s, especially for incremental changes or extensions of existing product lines, which is the case here.
- Focus on Performance Data: The "Performance Data" section lists non-clinical studies (design validation, fatigue testing, micromotion assessment, static tests, material characterization, biocompatibility, shelf-life). These are engineering and material science tests, not AI/ML performance metrics like sensitivity, specificity, or AUC.
What information can be extracted/inferred related to the device's performance, but not in the AI/ML context you've asked for:
- No Acceptance Criteria for AI/ML performance: As it's not an AI/ML device, there are no acceptance criteria related to metrics like sensitivity, specificity, accuracy, etc.
- No Reported Device Performance (as AI/ML metrics): The document doesn't report performance in terms of AI/ML metrics.
- Sample Size (for an AI/ML test set): Not applicable. The "test set" here refers to physical components undergoing engineering tests.
- Data Provenance (for an AI/ML test set): Not applicable.
- Number of experts / Adjudication Method: Not applicable. These relate to establishing ground truth for AI/ML studies. The "experts" involved here would be materials scientists or mechanical engineers for the non-clinical tests.
- Multi-reader Multi-case (MRMC) study: Not applicable. This is specific to diagnostic imaging interpretation, often with human interpretation.
- Standalone (algorithm-only) performance: Not applicable.
- Type of Ground Truth (for AI/ML): Not applicable. The "ground truth" for the a glenoid reconstruction system is established through engineering principles, material standards, and biomechanical testing. For example, for fatigue testing, the ground truth is whether the component withstands a specified number of cycles at a certain load without failure, according to a standard. For material characterization, the ground truth is the chemical composition and microstructure matching specifications.
- Training Set Sample Size & Ground Truth (for AI/ML): Not applicable.
In summary, the provided document describes the regulatory approval of a physical medical implant, not an AI/ML-powered device. Therefore, it does not contain the specific information you've requested regarding AI/ML acceptance criteria and performance studies.
§ 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.”