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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.

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.

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The Ignite Anatomic Shoulder System is intended for use in total or hemi-shoulder replacement procedures the following:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• · Rheumatoid arthritis.
• · Revision where other devices or treatments have failed.
• · Correction of functional deformity.
• · Fracture of the humeral head
• · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods
The humeral stem is intended for cementless use. The glenoid is intended for cemented use only.

The Ignite Anatomic Shoulder System is total shoulder arthroplasty system consisting of humeral heads (38 - 57mm diameters), offset taper adapters (multiple offsets), stems (66-82mm lengths), and glenoid components (multiple sizes).

The anatomic humeral consists of a wrought Cobalt-Chromium Humeral Head, a wrought Ti-6Al-4V Taper Adapter, and an additively manufactured Ti-6Al-4V Stem.

The All-Poly Anatomic Glenoid consists of Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene. 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 FDA 510(k) document is for the Ignite Anatomic Shoulder System, a medical device. This document describes the device itself and its equivalence to previously cleared devices. It does not contain information about an AI/ML powered device or a study involving acceptance criteria for such a device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Ignite Anatomic Shoulder System to the predicate devices." This indicates that the regulatory clearance was based on non-clinical testing and comparison to predicate devices, not on a clinical study evaluating its performance against specific acceptance criteria in patient populations.

The "Non-Clinical Testing" section lists various mechanical and material-related tests (e.g., Range of Motion, Biocompatibility, Wear Testing, Fatigue Testing) conducted to demonstrate the device's substantial equivalence to predicate devices, but these are for the physical implant itself, not an AI/ML component.

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