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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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• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.

5. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
   Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
   Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications.
   The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
   The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.
   The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.
   The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy 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 who lack suspected material sensitivity to cobalt alloy.

Comprehensive Shoulder System consists of partial and total shoulder replacement components use in cemented and uncemented applications. The devices are modular components consisting of humeral stems, modular heads and glenoid components.

The provided text is a 510(k) summary for the Comprehensive Shoulder System. It describes the device, its intended use, and its substantial equivalence to predicate devices based on technological characteristics and performance data. However, this document does not describe acceptance criteria for a device, nor does it detail a study proving that the device meets specific performance criteria with associated metrics (e.g., sensitivity, specificity, accuracy).

Instead, it focuses on demonstrating that the new device is "substantially equivalent" to previously cleared devices. The "Summary of Performance Data" section primarily addresses non-clinical tests related to material fatigue, porous coating characteristics, and biocompatibility, which are standard for implantable devices but do not involve "device performance" in the sense of clinical effectiveness or diagnostic accuracy that would typically have acceptance criteria.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer the questions about sample sizes, experts, adjudication methods, MRMC studies, or standalone performance, as these details are not present in the provided 510(k) summary.

The closest information related to "performance" is:

• Non-Clinical Tests:
  • Fatigue testing of Titanium Alloy Forged Humeral Stems, Titanium Alloy Wrought Humeral Stems, and Cobalt Alloy Humeral Stems: Five samples of each type were subjected to a fatigue load of 400N or greater for 5 million cycles in reverse configuration at a worst-case orientation. All samples withstood the applied fatigue without fracture of the stem.
  • Porous coating characterization
  • Biocompatibility

This information describes the types of tests performed and a high-level outcome for the fatigue test (all samples withstood the load without fracture), but it does not provide specific acceptance criteria or detailed results that would allow for a direct comparison in a structured table.

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