(212 days)
The nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement.
The Tornier Perform® Humeral System - Stemless is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide mobility, stability, and to relieve pain. The Tornier Perform Humeral System -Stemless is indicated for use as a replacement of shoulder joints disabled by:
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- · Post-traumatic arthritis
Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.
All components are single use and intended for cementless use.
The Tornier Perform Humeral System - Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.
The Tornier Perform Humeral System - Stemless is metaphyseal humeral system intended for anatomic total shoulder arthroplasty. The Perform Humeral System - Stemless is implanted with existing Tornier anatomic glenoid systems.
The Tornier Perform Humeral System – Stemless includes new titanium nucleus components and previously-cleared modular humeral heads (K201315). The system also includes reusable instruments used to implant the shoulder prosthesis.
The provided document is a 510(k) premarket notification for a medical device, the Tornier Perform Humeral System - Stemless. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies proving acceptance criteria through device performance.
Therefore, the requested information on acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance, is largely not applicable to this document. The document explicitly states: "No clinical studies were performed."
However, I can extract information about the non-clinical testing performed to demonstrate substantial equivalence, which serves a similar purpose in the context of a 510(k) by showing the device performs comparably to an already cleared device.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
Since no clinical studies were performed to establish performance against pre-defined acceptance criteria in terms of human-in-the-loop performance or diagnostic accuracy, such a table cannot be created from this document. The document focuses on demonstrating substantial equivalence to an existing predicate device through non-clinical performance testing.
The types of "performance" mentioned are related to mechanical and material properties:
| Acceptance Criteria (Implied by equivalence to predicate) | Reported Device Performance (as demonstrated by non-clinical testing) |
|---|---|
| Fatigue Resistance (Comparable to predicate device) | Fatigue testing performed. (Specific results not detailed in this summary, but presumed to meet standards for equivalence.) |
| Displacement under load (Comparable to predicate device) | Displacement finite element analysis performed. (Specific results not detailed.) |
| Static Nucleus Strength (Comparable to predicate device) | Comparative static nucleus testing performed. (Specific results not detailed.) |
| Taper Integrity (Comparable to predicate device) | Static taper evaluation performed. (Specific results not detailed.) |
| Wear Properties (Comparable to predicate device; with caveat for titanium) | Wear and range of motion evaluations performed. (Specific results not detailed. Noted: "The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.") |
| MRI Safety/Compatibility (Compatible with MRI) | MRI compatibility evaluation performed. (Specific protocol or limits not detailed.) |
| Particulate Release (Acceptable levels) | Particulate testing performed. (Specific results not detailed.) |
| Biocompatibility (Biocompatible) | Assessed in accordance with recognized consensus standards. |
| Sterilization Efficacy (Sterile) | Assessed in accordance with recognized consensus standards. |
| Cleaning Efficacy (Clean) | Assessed in accordance with recognized consensus standards. |
| Endotoxin Levels (Safe) | Assessed in accordance with recognized consensus standards. |
| Packaging Integrity (Maintains sterility/integrity) | Assessed in accordance with recognized consensus standards. |
| Shelf Life Stability (Stable over intended shelf life) | Assessed in accordance with recognized consensus standards. |
| Distribution Safety (Safe for distribution) | Assessed in accordance with recognized consensus standards. |
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. No "test set" in the context of clinical or AI performance evaluation was used. The testing was non-clinical (laboratory/mechanical).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No "ground truth" for a test set based on expert review was established or required for this type of submission focused on mechanical device equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No "test set" requiring adjudication by experts 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 mechanical orthopedic implant, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a mechanical orthopedic implant, not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for the non-clinical tests would have been established engineering specifications, material standards, and performance of the predicate device.
8. The sample size for the training set:
Not applicable. This is a mechanical orthopedic implant, not an AI or algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.”