(22 days)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate
Non-coated (Interlok®) devices are indicated for cemented application only.
Manufactured from Ti-6Al-4V
Bi-planer tapered stem
30 grit blested Interlok® surface finish
Sizes 6mm x 70mm and 7-15mm x115mm, in 2mm increments, with fin, collar and alignment hole
Sizes 6-15mm x 70mm, modified devices with no collar, fin or alignment hole.
The provided text is a 510(k) summary for the Interlok® Bio-Modular® Shoulder Humeral Stems. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/ML device evaluations.
Instead, this document is a premarket notification for a medical implant (shoulder humeral stems) that demonstrates substantial equivalence based on design, materials, and processing similarities to a previously cleared device. Therefore, the questions related to AI/ML device performance, ground truth, experts, and sample sizes are not applicable to this specific regulatory submission.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
- None provided. The document states "Clinical/Non-Clinical Testing: None provided." This indicates that no specific performance metrics or acceptance criteria, as would be generated from a performance study, were included in this 510(k) submission. For medical implants seeking substantial equivalence, often the equivalence is based on materials, design, and manufacturing processes being similar to a predicate device, rather than specific performance numbers from a new study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set was used for a performance study.
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. No ground truth determination by experts was required for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set was used.
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. This is a hardware medical device, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was established as there was no performance study of this nature.
8. The sample size for the training set
- Not applicable. This is a hardware medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable.
Key takeaway from the document:
The device (Interlok® Bio-Modular® Shoulder Humeral Stems) received 510(k) clearance based on its substantial equivalence to a previously cleared predicate device (The Bio-Modular® Shoulder System cleared in 510(k) K992119). The justification for this equivalence rested on the "design, materials and processing of the device are similar to the predicate device." No new clinical or non-clinical performance studies were provided for this specific submission as stated in the document: "Clinical/Non-Clinical Testing: None provided."
§ 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.”