(51 days)
The indications for use for the Discovery™ – Mosaic™ Total Humerus System include:
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- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
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- Rheumatoid arthritis
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- Revision where other devices or treatments have failed
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- Correction of functional deformity
- Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods
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- Oncology applications
The Discovery™ - Mosaic™ Total Humerus System is intended for cemented use only.
- Oncology applications
The Discovery™ - Mosaic™ Total Humerus System includes the components of the Discovery Elbow, the components of the 3 Piece Proximal Humeral Replacement System, and an intercalary segment designed to connect them. The Discovery™ - Mosaic™ Total Humerus System uses the same modular heads and glenoid components that were cleared for use in the predicate 3 Piece Proximal Humeral Replacement System.
The provided 510(k) summary for the Discovery™ - Mosaic™ Total Humerus System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing that would typically be described in an AI/Software as a Medical Device (SaMD) context.
This documentation is for a physical medical device (a shoulder prosthesis), and the submission focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against quantitative acceptance criteria through new clinical or technological studies in the way you've laid out questions.
Therefore, many of your specific questions regarding AI/SaMD performance evaluation metrics (e.g., sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.
Here's what can be extracted and what cannot be from the provided text:
Summary of Device Performance and Equivalence
| Acceptance Criterion (Typical for SaMD) | Reported Device Performance (as per 510(k)) |
|---|---|
| Specific quantitative performance metrics (e.g., sensitivity, specificity, AUC for AI/SaMD) | Not applicable. No such criteria or metrics are presented. The device is a physical prosthesis. |
| Substantial Equivalence | The device is substantially equivalent to the predicate devices (Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System: K033280 and 3 Piece Proximal Humeral Replacement System: K020045) for the stated indications for use. |
| Material Equivalence | The components of the Discovery™ - Mosaic™ Total Humerus System are made from the same materials as the predicate devices. |
| Intended Use Equivalence | The device has the same intended use as the predicate devices. |
| Safety and Effectiveness | Implied through substantial equivalence to legally marketed devices. |
Device Study Details (As applicable to this physical device)
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Sample size used for the test set and the data provenance:
- Not applicable. This submission did not involve a "test set" in the context of evaluating an algorithm or AI model. Performance was based on non-clinical testing (mechanical properties) and comparison to predicate devices, not data analysis of a test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set or expert-established ground truth as typically understood for AI/SaMD.
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Adjudication method for the test set:
- Not applicable.
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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 relates to human-AI collaboration in diagnostics/interpretation, not a physical implant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used:
- For the non-clinical testing, the "ground truth" would be the engineering specifications and mechanical test results that demonstrate the device meets performance standards (e.g., strength, durability) comparable to the predicate devices. This is not explicitly detailed in the summary, but it's the basis for "Non-Clinical Testing" claim ("performance data indicated that the Discovery™ - Mosaic™ Total Humerus System is I ric performally equivalent to the predicate devices for the uses indicated.")
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The sample size for the training set:
- Not applicable. No training set was used for an AI/ML model for this physical device.
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How the ground truth for the training set was established:
- Not applicable.
Key Takeaways from the Provided Text:
- Device Type: Physical shoulder prosthesis, not a software or AI device.
- Regulatory Pathway: 510(k) Premarket Notification, relying on substantial equivalence to predicate devices.
- Performance Demonstration:
- Non-Clinical Testing: Was performed, and indicated "performally equivalent" to predicate devices. Specifics of this testing (e.g., types of tests, specific results, acceptance criteria for these tests) are not provided in this summary.
- Clinical Testing: "was not required for these components to support substantial equivalence." This is common for devices following the 510(k) pathway when substantial equivalence can be demonstrated through non-clinical means and similarity to well-established predicates.
- Indications for Use: Clearly stated, covering degenerative joint disease, rheumatoid arthritis, revisions, deformity correction, fractures, and oncology applications, for cemented use only.
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”