(18 days)
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthoplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.
The Zimmer Trabecular Metal Humeral Stem is intended to be a single use only implant that is used to replace a shoulder joint. This humeral stem uses Trabecular Metal around the proximal part of the stem for biological ingrowth. It also has an anti-rotational fin, a proximal stem collar, suture holes, and a distal fluted stem body. The product line has been extended to include 6mm and 8mm humeral stems.
This Zimmer 510(k) submission describes a device modification (new sizes 6mm and 8mm) to an already cleared Trabecular Metal Humeral Stem. The submission explicitly states that "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Humeral Stem, Sizes 6mm and 8mm is as safe and effective as the predicate device."
This is a Special 510(k), which is typically used for well-understood modifications to existing devices where the fundamental technology, materials, and intended use remain the same. In such cases, extensive new clinical trials or complex performance studies are often not required. The primary focus is on demonstrating that the modification does not negatively impact the safety and effectiveness established for the predicate device.
Given this context, the document does not contain the detailed, quantitative acceptance criteria and AI performance study information that would be expected for a novel AI/ML device. Instead, it relies on demonstrating equivalence to a predicate device through non-clinical testing.
Here's an analysis based on the provided document, acknowledging its limitations regarding typical AI/ML performance metrics:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The implicit acceptance criterion for this Special 510(k) is that the modified device (new 6mm and 8mm sizes) performs as safely and effectively as the predicate device (Zimmer Trabecular Metal Humeral Stem, K041459) through non-clinical testing. The critical aspects for equivalence in orthopedic implants typically include mechanical strength, durability, and biocompatibility in the context of the intended use. While specific numerical acceptance criteria (e.g., minimum fatigue strength, maximum wear rates) are inherent to the non-clinical tests conducted, they are not explicitly enumerated in this summary document.
Reported Device Performance:
| Performance Metric (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Safety & Effectiveness | "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Humeral Stem, Sizes 6mm and 8mm is as safe and effective as the predicate device." |
Note: The document does not provide specific numerical results from the non-clinical tests (e.g., specific fatigue life in cycles, ultimate tensile strength, etc.). It only provides a high-level conclusion of equivalence.
The subsequent points (2-9) are not applicable to this 510(k) submission as they relate specifically to the evaluation of AI/ML-driven devices with a focus on diagnostic performance, reader studies, and training data. This submission is for a medical implant and relies on demonstrating equivalence through mechanical and material-based non-clinical testing, not AI/ML performance evaluation.
To directly address the prompt's structure in the context of this document:
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 document describes the modification of a medical implant, not an AI/ML device. The "test set" would refer to mechanical samples used in non-clinical testing (e.g., fatigue specimens, wear simulators), not a dataset of medical images or patient records. The document does not specify the number of physical samples tested or their "provenance."
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 AI/ML typically refers to expert labels on data. For an implant, "ground truth" would be established by validated engineering tests and measurements, comparing the performance of the new sizes to the predicate device. This does not involve medical experts establishing image-based ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in reader studies for AI/ML diagnostics to resolve discrepancies in expert interpretation of data. This is irrelevant to the engineering and materials testing performed for an orthopedic implant.
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 specifically designed for evaluating the performance of AI/ML diagnostic tools, often in conjunction with human readers. This submission is for a physical medical device (humeral stem), not a diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to the performance of an AI algorithm operating independently. The device described is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Implicit. For this kind of device, the "ground truth" for non-clinical testing would be derived from established engineering standards and performance metrics for orthopedic implants. This would include parameters like material properties (tensile strength, yield strength), fatigue life, and wear characteristics, as measured by standardized testing procedures in a lab setting, rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set
- Not applicable. This submission does not involve an AI/ML algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/ML training set, this question is not relevant.
§ 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.”