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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 MacroBond® Surface Coating are indicated for either cemented or uncemented press-fit applications.
   Humeral components with a porous coated surface coating are indicated for either cemented or uncemented 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.

The Comprehensive Humeral Fracture Positioning Sleeves is composed of Polymethylmethacrylate (PMMA) and is used in conjunction with the Comprehensive Humeral Fracture System. The device is a sleeve that fits over the distal tapered end of the Comprehensive Humeral Fracture Stem and stops at a point below the fins of the stem.

The provided text is a 510(k) summary for a medical device (Comprehensive Humeral Fracture Positioning Sleeves) seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as one would expect for an AI algorithm or a diagnostic device.

Instead, this document focuses on demonstrating that the device, after a change in its bioburden reduction process, still has identical characteristics and performance to the previously cleared predicate devices. The "Summary of Performance Data (Nonclinical and/or Clinical)" section explicitly states:

• Non-Clinical Tests: "Testing was completed to demonstrate that the change in bioburden reduction process using REVOX technology does not have any impact on sterilization, shelf life, or biocompatibility of the device."
• Clinical Tests: "None provided"

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study or effect size.
• Standalone AI performance.
• Type of ground truth used.
• Training set sample size or ground truth establishment for the training set.

The document describes a submission for a physical medical device (positioning sleeves) where the primary change being evaluated is a manufacturing process change (bioburden reduction). It is not a software device or an AI/ML diagnostic system that would typically have the types of performance studies and acceptance criteria you are asking about.

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The Comprehensive Humeral Fracture Positioning Sleeve is indicated for 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthopathy, where other methods of treatment may not be suitable or may be inadequate. For Cemented Use Only

The Comprehensive Humeral Fracture Positioning Sleeve is composed of Polymethyimethacrylate (PMMA) and is used in conjunction with the Comprehensive Humeral Fracture System (K023063). The device is a sleeve that fits over the distal tapered stem of the Comprehensive Fracture system and stops at a point below the fins of the stem.

The provided text is a 510(k) summary for the Biomet Comprehensive Humeral Fracture Positioning Sleeve. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them, as no such study or criteria are detailed in the provided documents.

The document indicates that an "engineering justification was utilized to determine that no additional mechanical testing was required." This suggests that mechanical testing results might exist supporting the device's equivalence, but these are not disclosed with specific acceptance criteria or performance data in this summary.

In summary, based on the provided text, the device's clearance was based on substantial equivalence to predicate devices and an engineering justification, not on a clinical study demonstrating performance against specific acceptance criteria.

Ask a specific question about this device