(274 days)
The Ignite Stemless Anatomic Shoulder Prosthesis is intended for use in total shoulder replacement procedures to address the following:
- · Osteoarthritis;
- Posttraumatic arthrosis;
- · Focal avascular necrosis of the humeral head;
- · Previous surgeries of the shoulder that do not compromise the fixation.
The Ignite Stemless Anatomic Shoulder System is total shoulder arthroplasty system consisting of stemless humeral implants (multiple sizes), offset taper adapter, humeral heads (38 - 57mm diameters), and glenoid components (multiple sizes).
The anatomic stemless humeral construct consists of an additively manufactured Ti-6A1-4V Stemless Humeral Implant, a wrought Cobalt-Chromium Humeral Head, and a wrought Ti-6Al-4V Taper Adapter. The all-poly Anatomic Glenoid consists of a Highly Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene articulation surface. This device also has a 316L stainless steel pin pressed into it as an x-ray marker.
The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.
The provided text describes the "Ignite Stemless Anatomic Shoulder System" and its FDA 510(k) clearance. This document pertains to a medical device (shoulder prosthesis) and not an AI/ML powered device. Therefore, many of the requested fields regarding acceptance criteria and study design for AI/ML devices are not applicable.
Here's the information that can be extracted or noted as not applicable based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device clearance, the "acceptance criteria" are typically related to mechanical performance, material properties, and biocompatibility rather than AI/ML performance metrics like accuracy, sensitivity, or specificity. The text states that "acceptance criteria were met" for various tests.
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Exceeded clinically relevant loading conditions with application of adequate safety factor (Humeral Anchor Loosening - Static Stability) | Acceptance criteria were met. |
| Exceeded clinically relevant loosening displacement requirements (Humeral Anchor Loosening - Cyclic Loosening Evaluation) | Acceptance criteria were met. |
| Meet established specifications per ASTM F1378 (Range of Motion (RoM) Evaluation) | RoM targets were met. |
| Biocompatible per ISO 10993-1 and FDA Guidance Document | Devices were found to be biocompatible. |
| Strength of the device exceeds that required for the intended use (Construct Fatigue Testing) | Acceptance criteria were met. |
| Compliance with ASTM F2009 (Taper Disassembly Evaluation) | Acceptance criteria were met. |
| Compliance with ISO 11607-1 and ISO 11607-2 (Shelf Life Evaluation) | Five year shelf life was established. |
| Sterility Assurance Level (SAL) of 10^-6 per ISO 11137-1 and ISO 11137-2 (Sterilization Validation) | SAL was found to be 10^-6. |
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. The clearance is for a physical medical device, not an AI/ML system. Testing involved mechanical and material evaluations, not data sets for AI/ML.
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 as typically defined for AI/ML (e.g., expert labels on images) is not relevant to the mechanical and material testing performed for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML output, not for physical device testing.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device like a shoulder prosthesis, "ground truth" would relate to accepted engineering standards, material properties, and biological responses.
- Mechanical Testing: Based on established industry standards (e.g., ASTM F1378, ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1978, ASTM F1854, ASTM F2009) and "clinically relevant loading conditions."
- Biocompatibility: Based on ISO 10993-1 and FDA Guidance.
- Sterilization: Based on ISO 11137-1 and ISO 11137-2.
- Shelf Life: Based on ISO 11607-1 and ISO 11607-2.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.”