(41 days)
This total shoulder prosthesis is intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural humeral head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. This system includes a humeral stem and head and is to be used with bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.
The glenoid is fabricated from UHMWPE (ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head. This mismatch between the glenoid and humeral head to allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has either a keel or three pegs for fixation in the glenoid. These glenoid components are 4 mm thick and available in five sizes for each component, the keeled and pegged components.
This looks like a 510(k) premarket notification for a medical device submitted to the FDA in 1996. The provided text is a "Summary of Safety and Effectiveness" which focuses on describing the device and its intended use, along with identifying predicate devices.
Disclaimer: Based on the provided text, it's highly unlikely that a medical device submission from 1996 for a glenoid component would include the detailed performance study information you're asking for, especially concerning AI/machine learning aspects. The regulatory landscape and technological capabilities were vastly different then.
However, I will extract what I can from the provided text and then make educated assumptions or state where the information isn't available from the given submission for the remaining criteria, particularly focusing on the spirit of your request (i.e., how modern device submissions address these points).
Analysis of K960906 and Response to Your Request:
The provided document (K960906) is a premarket notification for a medical device (Glenoid Component for the Foundation™Total Shoulder System) submitted in 1996. This type of submission, especially from that era, typically focuses on demonstrating substantial equivalence to a predicate device through material composition, design, and intended use, rather than extensive clinical performance studies as would be expected for novel AI/ML-driven devices today.
Therefore, much of the information you've requested regarding AI performance, expert adjudication, MRMC studies, and detailed ground truth methodology is not present and not applicable to this specific submission from 1996. The "study" proving the device meets acceptance criteria for this type of device and era would primarily involve engineering testing (e.g., mechanical strength, wear testing) and comparison to predicate devices, rather than clinical efficacy studies with human readers or AI.
Here's a breakdown of your requested information based on the provided text and general knowledge of 1996 510(k) submissions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Inferred for a 1996 glenoid component) | Reported Device Performance (Inferred/Not explicitly stated in provided text) |
|---|---|---|
| Material Composition | UHMWPE (ASTM F648) | Fabricated from UHMWPE (ASTM F648) - Meets |
| Design Geometry | - Articulating surface radius > humeral head |
- Spherical back surface
- Keel or three pegs for fixation
- 4 mm thick
- 5 sizes | - Articulating surface has a radius of curvature greater than the corresponding humeral head.
- Back surface spherical geometry with keel or three pegs.
- 4 mm thick, 5 sizes for each component type. - Meets |
| Intended Use | - Treatment for osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, proximal humeral fracture. - Revision arthroplasty with minimal bone less.
- Used with bone cement.
- Relieve pain, restore motion. | - Intended for these conditions and revision arthroplasty.
- To be used with bone cement.
- Intended to aid in relieving pain and restoring motion. - Meets (based on comparison to predicate) |
| Substantial Equivalence | Comparison to predicate devices (Kirshner Neer II™ Glenoid Component, Intermedics Select™ Shoulder Glenoid Component) | Product description suggests equivalence in design principles and materials to known predicate devices. - Demonstrated (implied by 510(k) clearance) |
| Biocompatibility | (Not specified, but standard for UHMWPE implants) | (Assumed to meet ISO 10993 or equivalent standards for the time, based on material) |
| Mechanical Performance | (Not specified, but typically includes fatigue, wear, strength testing) | (Assumed to meet relevant ASTM or internal standards, based on predicate equivalence) |
Note: For a 1996 device like this, "performance" would primarily relate to its physical and mechanical properties, and its functional similarity to proven predicate devices. There would not be "reported device performance" in terms of diagnostic accuracy or clinical outcomes as you would see for an AI device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not present in the provided 1996 510(k) document. A glenoid component is a mechanical implant; its regulatory approval primarily relies on engineering testing and comparison to predicate devices, not on a "test set" of clinical data in the way an AI diagnostic device would.
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)
This information is not applicable and not present in the provided 1996 510(k) document. "Ground truth" in this context would relate to engineering specifications and material properties, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not present in the provided 1996 510(k) document. Adjudication methods are relevant for clinical trials or diagnostic performance studies, not for the material and design evaluation of a mechanical implant in a 1996 510(k).
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
This information is not applicable and not present in the provided 1996 510(k) document. MRMC studies and AI assistance were not part of the regulatory framework for this type of device in 1996.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not present in the provided 1996 510(k) document. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, "ground truth" during its approval process would be primarily:
- Engineering Specifications and Standards: Material properties (e.g., F648 for UHMWPE), dimensional tolerances, mechanical load capabilities defined by standards or internal testing.
- Predicate Device Equivalence: The functional and safety characteristics of the established predicate devices served as a benchmark for equivalence.
- Biocompatibility Testing: Results from in vitro or in vivo biocompatibility tests (not detailed in this summary).
8. The sample size for the training set
This information is not applicable and not present in the provided 1996 510(k) document. "Training set" is a concept for machine learning models, which is irrelevant for this mechanical orthopedic implant.
9. How the ground truth for the training set was established
This information is not applicable and not present in the provided 1996 510(k) document. As there is no "training set," there is no ground truth for it.
Conclusion:
The provided K960906 document details a 1996 510(k) for a glenoid component. The information requested regarding AI performance metrics, expert adjudication, MRMC studies, and detailed data provenance is characteristic of modern AI/ML device submissions, which were not a regulatory consideration or technological reality for this type of mechanical implant in 1996. The "study" for this device mostly involved demonstrating substantial equivalence to predicate devices through design comparison, material verification, and likely mechanical testing, none of which are explicitly detailed in this summary document beyond the device description itself.
§ 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.”