Search Results

The KMI Distal Volar Radius Plate is generally indicated for the reduction, stabilization and internal fixation of proximal radius bone fractures and osteotomies involving the distal radius.

Description device is intended for use in the reduction, stabilization, and internal Fixation of proximal radial bone fractures. The design incorporates the use of a plate and two sets of bone screw sets that are fixated perpendicular. The implant utilizes 'variable angle locking technology' (VALT) screw locking system which facilitates precise angular positioning of the bone screws relative to the distal volar radius plate.

Materials: Titanium; Ti-6A14V-ELI as per ASTM F136

Function: The system functions to fix proximal radial bone fractures together, thereby facilitating fixation.

This document describes a 510(k) premarket notification for a medical device and, as such, does not typically contain information about comprehensive clinical studies with detailed acceptance criteria and reported device performance metrics in the way a PMA (Premarket Approval) application or a clinical trial report would.

The provided text focuses on establishing substantial equivalence to a predicate device, which is the cornerstone of the 510(k) pathway. Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are generally not part of this type of submission.

However, I can extract the relevant information and explicitly state where information is not provided in the document.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance (Not applicable for this type of submission)

The provided document is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than demonstrating "acceptance criteria" and "reported device performance" through a novel clinical study with hard performance metrics. The "acceptance criteria" in this context are implicitly met by demonstrating technological characteristics and intended use that are substantially equivalent to a legally marketed predicate device.

Table 1: Acceptance Criteria and Reported Device Performance (N/A for 510(k) Summary)

Study Details (Information largely not provided in this 510(k) summary)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not applicable. This 510(k) submission does not describe a clinical study with a "test set" of patient data for performance evaluation in the way a clinical trial would. It relies on a comparison of technological characteristics to a predicate device.
   • Data Provenance: Not applicable. No clinical data is presented.

2. 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 clinical study with a "test set" requiring expert-established ground truth is described.

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

   • Not applicable. No clinical study requiring adjudication of a "test set" is described.

4. 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:

   • No. This device is a metallic bone fixation appliance, not an AI software/diagnostic device, and thus an MRMC study is not relevant to its regulatory pathway.

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

   • Not applicable. This device is a physical implant, not an algorithm, so standalone performance in this context is not relevant.

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

   • Not applicable as no clinical study for performance evaluation is described. The "ground truth" for this submission revolves around demonstrating that the device's design, materials, and intended use are fundamentally similar to a previously cleared device.

7. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • Not applicable. No "training set" or establishment of ground truth for such a set is relevant to this submission.

Summary of what the document does provide regarding "proof" and "acceptance criteria":

• Substantial Equivalence Pathway: The entire submission serves as proof that the device is "substantially equivalent" to a legally marketed predicate device (Hand Innovations Distal Volar Radius Fracture Repair System, K002775).
• Technological Characteristics Comparison: The document states that there are "no significant differences between the KMI Distal Volar Radius Plate and other systems currently being marketed which would adversely affect the use of the product." It explicitly mentions the use of "the same basic mechanical features as the predicate."
• Material Equivalence: The material (Titanium; Ti-6A14V-ELI as per ASTM F136) is specified, implying it's a known, safe, and effective material for this application, likely consistent with the predicate.
• Intended Use Equivalence: The "Indications for Use" of the KMI Distal Volar Radius Plate are aligned with the general use of similar devices for distal radius fracture fixation, indicating it serves the same clinical purpose as the predicate.
• Regulatory Acceptance: The letter from the FDA (AUG 16 2004) explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This FDA determination serves as the "acceptance" that the device meets the substantial equivalence criteria.

Ask a specific question about this device