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The Avenger Radial Head System is intended for replacement of the proximal end of the radius:
• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at radial-humeral and/or proximal radio-ulnar joint with:

• a. Joint destruction and/or subluxation visible on x-ray; and/or
• b. Resistance to conservative treatment.
• · Primary replacement after fracture of the radial head.
• · Symptomatic sequelae after radial head resection.
• Revision following failed radial head arthroplasty.
  The components are intended for uncemented use.

The Avenger Radial Head System is a two-piece modular system comprised of cobalt chrome (ASTM F 1537) head and stem components. The system consists of a range of lengths and diameters for the stem as well as heads in a range of diameters and heights to accommodate the patient anatomy. The subject of this 510(k) is to clear a new range of stem implants (+4mm offset stems) that can be used to extend the current range of the Avenger Radial Headle modular system. The implant allows for replacement of the radial head.

The provided document describes the clearance of the "Avenger Radial Head System" by the FDA. However, it does not include detailed information regarding acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to previously cleared predicate devices. It mentions "Performance Testing: Head disassembly (ASTM F2009) was performed for the Avenger Radial Head System, +4mm offset stems comparing to the previously cleared K192754 devices. Fatigue testing, sterilization and endotoxin testing were able to adopt into the previously cleared devices." This indicates that some performance testing was done, but the specific acceptance criteria and the quantitative results are not provided in this document.

Therefore, I cannot populate the table or answer most of your specific questions based on the input text.

Information NOT available in the provided document:

• A table of acceptance criteria and the reported device performance: While performance testing related to head disassembly, fatigue, sterilization, and endotoxin is mentioned, the specific acceptance criteria (e.g., maximum force for disassembly, number of cycles for fatigue) and the actual reported device performance values are not detailed.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical medical device (radial head prosthesis) and not an AI/diagnostic software.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical medical device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For a physical device, "ground truth" typically refers to established engineering standards or physical measurements, which are implied by the mention of ASTM F2009 and other testing, but not explicitly detailed as "ground truth."
• The sample size for the training set: Not applicable for a physical device.
• How the ground truth for the training set was established: Not applicable for a physical device.

What is available (though limited in detail):

• Study that proves the device meets the acceptance criteria: Performance Testing, including "Head disassembly (ASTM F2009)," "Fatigue testing," "sterilization," and "endotoxin testing." The document states these tests were performed and were "able to adopt into the previously cleared devices," suggesting the results were consistent with or met the requirements established for the predicate devices.
• Type of device: Physical medical device (radial head prosthesis).
• Indications for Use: Replacement of the proximal end of the radius for various conditions, including degenerative/post-traumatic disabilities, primary replacement after fracture, symptomatic sequelae after radial head resection, and revision after failed arthroplasty. Intended for uncemented use.

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The Avenger Radial Head System is intended for replacement of the proximal end of the radius:

• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at radial-humeral and/or proximal radio-ulnar joint with:
  • a. Joint destruction and/or subluxation visible on x-ray; and/or
  • b. Resistance to conservative treatment.
• Primary replacement after fracture of the radial head.
• Symptomatic sequelae after radial head resection.
• Revision following failed radial head arthroplasty.

The components are intended for uncemented use.

The Avenger Radial Head System is a two-piece modular system comprised of cobalt chrome (ASTM F 1537) head and stem components. The system consists of a range of lengths and diameters for the stem as well as heads in a range of diameters and heights to accommodate the patient anatomy. The stems are offered in short and long lengths. The heads are offered in heights of standard, +2 and +4 configurations. The implant allows for replacement of the radial head.

The provided text describes the Avenger Radial Head System, a medical device, and its FDA 510(k) clearance. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding AI/algorithm performance. The document focuses on regulatory clearance based on substantial equivalence to predicate devices and general performance testing (mechanical and biocompatibility).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study evaluating AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth types related to an AI device.

The document primarily discusses:

• Device Name: Avenger Radial Head System
• Intended Use/Indications for Use: Replacement of the proximal end of the radius for various conditions (degenerative/post-traumatic disabilities, radial head fracture, sequelae after radial head resection, revision of failed arthroplasty). The components are intended for uncemented use.
• Regulatory Information: Class II device, Regulation Number 21 CFR 888.3170 (Elbow joint radial (hemi elbow) polymer prosthesis), Product Code KWI.
• Material: Cobalt chrome (ASTM F 1537) for the head and stem components.
• Substantial Equivalence: Demonstrated to be substantially equivalent to previously cleared devices (Wright Medical Evolve® Modular Radial Head - K060731, K991915; Stryker (SBI/Avanta) Radial Head - K982288) based on similar indications, materials, and geometry.
• Performance Testing (Mechanical/Biocompatibility):
  • Head disassembly (ASTM F2009)
  • Fatigue testing (ASTM F2887)
  • Bacterial endotoxin testing (LAL)

No information regarding AI, algorithm performance, or the other specific points requested is available in the provided text.

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