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The BioPoly Radial Head Implant is indicated for:

• · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain. crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
  • o joint destruction and/or subluxation visible on x-ray; and/or
  • o 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 BioPoly Radial Head Implant is a hemiarthroplasty device designed to restore the articular surface and spacing of the proximal head of the radius in patients following fracture resection and/or degenerative disability The implant is supplied with head diameters of 20mm, 23mm, and 26mm; and stem diameters of 6mm, 7mm, 8mm, +3mm, and +6mm height offsets for the radius in patients following fracture, resection, and/or degenerative disability.

This document is a 510(k) Premarket Notification from the FDA regarding the BioPoly Radial Head Implant. It certifies the device's substantial equivalence to previously marketed predicate devices. The document outlines the device's intended use and provides a summary of non-clinical tests conducted.

However, the provided text does not contain any information about a study proving the device meets acceptance criteria through human-in-the-loop performance, nor does it refer to an AI/ML powered device. The acceptance criteria discussed are for non-clinical, mechanical, and material properties of the implant itself, not related to an AI's performance or a clinical study that would involve the elements requested in the prompt (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance of an algorithm).

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related clinical study design (sample size, expert adjudication, MRMC, etc.). The document focuses on the mechanical and material aspects of a physical implant and its substantial equivalence to predicate devices, which is a different regulatory pathway than for AI/ML-powered medical devices.

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The KMI Katalyst Radial Head Implant is generally indicated for radial head replacement arthroplasty. Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.

The KMI Katalyst Radial Head implant is intended for use in radial head replacement arthroplasty. The system consists of modular stem and head components to accommodate variations in human anatomy. The design incorporates an adjustable stem length capability to allow stem length adjustment in-sito.
Materials: -Cobalt Chrome, per ASTM F75 -Stainless Steel BioDur 108 Alloy per ASTM F2229 -UHMWPE per ASTM 648-00
Function: The system functions as a replacement for the proximal radial head.

The provided text is related to a 510(k) premarket notification for a medical device called the "Katalyst Radial Head Implant." It describes the device, its intended use, and its substantial equivalence to other legally marketed devices.

However, the document does not contain any information about acceptance criteria, study design, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details. The document is a regulatory submission for premarket clearance based on substantial equivalence, not a report of a clinical performance study.

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Use of the Modular Radial Head Implant may be considered for :

• . Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepation, and decreased motion at the radio-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 EVOLVE® Ceramic Radial Head Implant is identical to the head component previously submitted and cleared under 510(k): K991915- EVOLVE® Modular Radial Head. The only difference between the two devices is the type of materials used to manufacture the head components. The EVOLVE® Modular Radial Head system is approved with a CoCr head component, and a CoCr stem component. Wright Medical Technology is now adding a ceramic head component for use with the CoCr stem component previously cleared under the EVOLVE® Modular Radial Head (510(k): K991915).

The design features for both EVOLVE® radial head components are as follows:

• The proximal portion of the radial head will have a concave design to provide . stability to the bearing surface and closely approximate the natural anatomy of the radial head and humeral-capitellum articulating surface.
• The sides of the head are designed with a radius of curvature that articulates with the . proximal radial-ulnar joint and closely approximates the natural anatomy.
• The heads are interchangeable, since the interface has the same dimensions ● throughout the system.
• Heads are available in 2.0mm increments, ranging from 20.0mm to 28.0mm in . diameter.

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device (EVOLVE® Ceramic Radial Head Implant), focusing on its substantial equivalence to previously cleared devices.

Therefore, I cannot extract the requested information.

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Avanta Orthopaedics Radial Head implant 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 the radiohumeral and or proximal radio-ulnar joint with:
  • joint destruction or subluxation visible on x-ray .
  • resistance to conservative treatment .
• Primary replacement after fracture of the radial head .
  • Symptomatic sequelae after radial head resection .

The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

The provided text is a 510(k) Summary for a Radial Head Implant (K023604). This document focuses on demonstrating substantial equivalence to a predicate device through comparison of design characteristics, intended use, and materials, rather than establishing acceptance criteria or reporting performance metrics from a clinical study as would be typical for artificial intelligence/machine learning (AI/ML) devices.

Therefore, the requested information, which is highly relevant to AI/ML device performance and testing, cannot be extracted from this document. This document describes a traditional medical device (implant) and its clearance process, which relies on a comparison to an already-marketed device and mechanical testing, not a study evaluating algorithm performance.

Specifically:

• No acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) are present because this is a physical implant, not an AI/ML diagnostic tool. The "performance" discussed is in terms of material properties and mechanical strength, which are assessed through bench testing.
• No sample size for test set or data provenance is mentioned, as there is no "test set" of clinical cases for an algorithm.
• No number or qualifications of experts for ground truth, adjudication method, MRMC study, or standalone performance study is mentioned. These are all concepts related to evaluating diagnostic algorithms.
• No type of ground truth, training set size, or method for establishing training set ground truth is mentioned. Again, these are AI/ML specific details not applicable to this device submission.

The document indicates "Mechanical testing has been performed to demonstrate substantial equivalence." (p.2/2), implying the device's physical properties are comparable to the predicate. However, it does not detail the nature of this testing, specific metrics, or any defined acceptance criteria for these mechanical tests.

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Avanta Orthopaedics Radial Head implant 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 the radiohumeral and or proximal radio-ulnar joint with:
  • joint destruction or subluxation visible on x-ray
  • 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 radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

This submission describes a medical device, the Avanta Orthopaedics Radial Head Implant, and seeks to establish its substantial equivalence to a legally marketed predicate device, the Wright Medical Swanson Titanium Radial Head Implant. It is not a study proving device meets acceptance criteria in the traditional sense of a clinical trial or performance study against pre-defined statistical endpoints for a novel device. Instead, the submission argues for substantial equivalence based on similarities in design, materials, and intended use to a device already on the market.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable or explicitly stated in this type of 510(k) submission. However, I will extract and infer information where possible based on the provided text.

Here’s the information based on the provided 510(k) summary:

1. A table of acceptance criteria and the reported device performance

   Since this is a substantial equivalence submission, the "acceptance criteria" are not performance metrics in the typical sense (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance criteria are satisfied by demonstrating the new device is sufficiently similar to the predicate device in terms of design, materials, and intended use, such that it raises no new questions of safety or effectiveness. The reported "performance" is the comparison against the predicate.

   Item	Acceptance Criteria (Similarity to Predicate)	Reported Device Performance (Avanta Product)
   Product Name	Similar type of implant functionality	Radial Head Implant
   Use	Single use	Single use
   Fixation	Stem in intramedullary canal	Stem in intramedullary canal
   Constraint	Non-constrained	Non-constrained
   Material	Industry standard materials	Co-Cr/CpTi (predicate is Titanium)
   Sizes	Comparably sized	3 sizes (1, 2, 3) (predicate has 5 sizes)
   Indications for Use	Same indications for use	Same as predicate

   Conclusion of Performance: The submission states, "The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device." This indicates the device met the acceptance criteria for substantial equivalence.

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. This is a submission for substantial equivalence based on design and material comparison to a predicate device, not a performance study involving a test set of patient data. There is no mention of a test set, patient data, or data provenance.

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. No test set or ground truth in this context. The "ground truth" for the substantial equivalence claim relies on the established safety and effectiveness of the existing predicate device and comparison by regulatory bodies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   Not applicable. No test set. The "adjudication" for substantial equivalence is carried out by the FDA during its review process.

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/imaging device, nor is it a comparative effectiveness study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   Not applicable. This device is a passive implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   Not applicable to a conventional performance study. For substantial equivalence, the "ground truth" is effectively the regulatory approval and established safety and efficacy profile of the predicate device (Swanson Titanium Radial Head Implant), which has been marketed since 1994. The Avanta device is deemed safe and effective because it is substantially equivalent to the predicate.

8. The sample size for the training set

   Not applicable. There is no training set mentioned, as this is not a machine learning or diagnostic device performance study.

9. How the ground truth for the training set was established

   Not applicable. No training set.

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Avanta Orthopaedics Radial Head implant 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 the radiohumeral and or proximal radio-ulnar joint with:
  • joint destruction or subluxation visible on x-ray .
  • resistance to conservative treatment .
• Primary replacement after fracture of the radial head .
• Symptomatic sequelae after radial head resection .

The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

This appears to be a 510(k) premarket notification for a medical device (radial head implant), not a study analyzing the performance of a device or an AI algorithm. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not present in the provided text.

The document is a regulatory submission demonstrating substantial equivalence to a predicate device, focusing on design characteristics and intended use, rather than a clinical or performance study report.

If you have a document that describes a study on a device's performance, I can analyze it for the requested information.

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