(88 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 tear Difficult cinnoul mailing methods of treatment may not be suitable or may be inadequate.
The Versa-Dial™ Humeral Head Prosthesis is intended for use with the Comprehensive The Versa-Dial - Trainer either cemented or uncemented (press-fit) usc.
The Versa-Dial™ Humeral Head Prosthesis is intended for use with the glenoid The Velsa-Dai- Thumeral Includer System, either all polyethylene for cemented components of the "Ho-Modala" Biological fixation with optional screw fixation) use.
The Versa-Dial™ Humeral Head Prosthesis is a metallic humeral head designed to function as the articulating surface component of the Comprehensive Humeral Fracture System (K030710) and incorporates the glenoid components of the Bio-Modular® Shoulder System (K023063) that are either all polyethylene for cemented use or Bio-Modular® (biological fixation with optional screw fixation) use. The Versa-Dial™ Humeral Head Prosthesis are manufactured of Co-Cr-Mo alloy conforming to ASTM F 75.
This FDA 510(k) summary for the Versa-Dial Humeral Head Prosthesis indicates that clinical testing was NOT required for this device. Therefore, there is no study to prove the device meets acceptance criteria in the traditional sense of a clinical trial or performance study against specific criteria.
Instead, the device gained clearance based on demonstrated substantial equivalence to legally marketed predicate devices through non-clinical mechanical testing.
Here's the breakdown of the information requested, based on the provided document:
1. Table of acceptance criteria and the reported device performance
Since clinical testing was not performed, there are no specific performance acceptance criteria or reported device performance metrics in the way one would expect from a diagnostic or AI device study. The acceptance criterion for mechanical testing would generally be "meets or exceeds the mechanical properties of the predicate device" or "meets relevant ASTM standards for shoulder prostheses."
| Acceptance Criteria (Implied for Mechanical Testing) | Reported Device Performance |
|---|---|
| Substantially equivalent mechanical properties to predicate devices (Biomet Comprehensive Humeral Fracture System K023063 and Bio-Modular® Shoulder System K030710) | "The testing indicated that the Versa-Dial™ Humeral Head Prosthesis is substantially equivalent to the predicate device." |
| Conformance to ASTM F 75 for Co-Cr-Mo alloy | "are manufactured of Co-Cr-Mo alloy conforming to ASTM F 75." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. Mechanical testing is typically performed on a limited number of manufactured units of the device and its predicate, not a "test set" of patients or data points. The document does not specify the number of prostheses tested for the mechanical evaluation.
- Data Provenance: Not applicable in the context of clinical data. The mechanical testing would have been conducted in a laboratory setting, likely by Biomet or a contract laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no clinical ground truth established for a test set of human subjects.
4. Adjudication method for the test set
- Not applicable. There was no clinical test set requiring adjudication.
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
- No. This device is a shoulder prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a shoulder prosthesis, not solely an algorithm. The "standalone" performance of the device refers to its mechanical integrity, which was assessed through non-clinical testing.
7. The type of ground truth used
- The "ground truth" for this device's approval was based on demonstrating mechanical equivalence to previously approved, legally marketed predicate devices and compliance with relevant material standards (ASTM F 75). This is a regulatory "ground truth" rather than a clinical or pathological one.
8. The sample size for the training set
- Not applicable. There was no "training set" in the context of an AI/algorithm.
9. How the ground truth for the training set was established
- Not applicable. There was no "training set."
§ 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.”