(98 days)
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- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
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- Rheumatoid arthritis.
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- Correction of functional deformity.
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- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
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- Difficult clinical management problems, where other methods of treatment may not be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
The Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.
The Alliance Glenoid system is a series of glenoid components which includes previously cleared (K191814) monoblock glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs. In addition to the predicate neutral (flat) modular 4-pegged design, an augmented configuration for correction of glenoid bone defects is being added to the product line. All glenoid types are available in various sizes. The posts of the modular glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium® substrate with Porous Plasma Spray (PPS) coating.
The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.
The provided FDA 510(k) document for the Alliance Augmented Glenoid focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that a device meets specific acceptance criteria for performance in an AI/software context.
The document discusses a medical device (an augmented glenoid component for shoulder replacement), not an AI/software device. Therefore, the questions related to AI/software performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance are not applicable to this document.
The "Summary of Performance Data" explicitly states "Non-Clinical Tests: o Glenoid Loosening (Rocking Horse) (ASTM F2028)" and "Clinical Tests: o None provided." This indicates that the performance evaluation was based on mechanical testing, a common approach for physical medical implants, not a clinical study involving human patients or an evaluation of an AI algorithm's diagnostic capabilities.
Here's a breakdown of the relevant information provided in the document based on your request, along with explanations of why certain points are not applicable:
1. A table of acceptance criteria and the reported device performance:
The document doesn't define specific "acceptance criteria" in terms of numerical performance thresholds for diagnostic accuracy, sensitivity, or specificity, as would be expected for an AI/software device. Instead, it relies on demonstrating that the Alliance Augmented Glenoid is substantially equivalent to a legally marketed predicate device (Alliance Glenoid K191814) through design similarities and non-clinical mechanical testing.
The primary performance data reported is for Glenoid Loosening (Rocking Horse) (ASTM F2028). The document implies that the results of this test demonstrated comparable performance to the predicate device, thereby supporting the claim of substantial equivalence. However, the specific metrics or acceptance values from this test are not explicitly detailed in the provided text.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Glenoid Loosening (Rocking Horse) | Comparable to predicate device (Alliance Glenoid K191814) | "information provided herein demonstrates that: any differences do not raise new questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate device" |
| (ASTM F2028) mechanical testing results | No new questions of safety or effectiveness compared to predicate. | Implied to meet or exceed predicate performance. Details not provided. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. This is a physical medical device (implant), not an AI/software device evaluated on patient data. The "test set" would refer to the physical components subjected to mechanical testing. The document does not specify the number of physical samples tested under ASTM F2028.
3. 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. Ground truth, in the context of diagnostic performance, is not relevant here as this is a physical implant. The evaluation is based on engineering and materials science principles, typically involving qualified engineers and technicians performing the ASTM F2028 mechanical test.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used to establish ground truth in diagnostic studies, which is not relevant for this physical device.
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. MRMC studies are for evaluating diagnostic performance (often with AI assistance), which is not the subject of this 510(k). The document explicitly states "Clinical Tests: o None provided."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Ground truth in the diagnostic sense is not relevant here. The "ground truth" for the device's mechanical integrity would be derived from the objective results of the ASTM F2028 mechanical stress test.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
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.”