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The D-RAD SMART PACK is intended for the fixation of fractures involving the distal radius.

The D-RAD SMART PACK is a cost-effective sterile procedural kit that contains an anatomically contoured volar distal radius plate and single-use instruments to treat extra-articular and intra-articular distal radius fractures. The Kit consists of an anatomically shaped distal radius fixation plate, associated locking and non-locking screws and pegs, and instrumentation to assist in implantation of the fixation construct.

The provided document, K132296, for the Smith & Nephew D-RAD SMART PACK is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information (like acceptance criteria, specific device performance metrics beyond mechanical testing, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) is not typically found or required in a 510(k) submission for this type of device.

The document explicitly states: "Mechanical testing and analysis has been conducted on the devices to ensure that they meet or exceed predicate standards in terms of fatigue, material strength, and biocompatibility." This indicates that mechanical testing was the primary method used to demonstrate that the device performs equivalently to the predicate devices.

Here's an attempt to answer the questions based on the available information, noting where information is not present in the document:

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

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

• Sample Size for Test Set: Not applicable or not specified for a clinical study. The "test set" here refers to the actual device components undergoing mechanical testing. The exact number of samples tested is not provided in this summary.
• Data Provenance: Not applicable for a clinical study. Data would be generated from laboratory mechanical testing. The country of origin for this testing is not specified. It is laboratory data, not patient data (retrospective or prospective).

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. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on diagnoses) is not relevant for this type of medical device submission. The "ground truth" for mechanical performance is established by standardized material and mechanical testing protocols, interpreted by engineers and regulatory experts.

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

• Not applicable. This is not a study involving human interpretation or adjudication of cases. Mechanical testing results are typically evaluated against pre-defined engineering specifications.

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

• No. This device is a bone plate and screw system, not an AI-assisted diagnostic or therapeutic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance was not conducted.

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

• No. This device is a physical implant and surgical instrumentation, not an algorithm.

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

• For mechanical performance: Compliance with established industry standards and engineering specifications for fatigue, material strength, and biocompatibility. These standards themselves are developed from extensive research and clinical experience.
• For substantial equivalence: Comparison against the design, materials, and mechanical properties of the predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. No training set for an algorithm was used.

Summary of the Study (Mechanical Testing for Substantial Equivalence):

The "study" referenced in this 510(k) submission is primarily a series of mechanical tests and analyses designed to demonstrate that the D-RAD SMART PACK meets or exceeds the performance standards of its predicate devices in terms of fatigue, material strength, and biocompatibility. This type of testing is standard for orthopedic implants. The document indicates that the device's functional characteristics, intended use, and materials were also compared directly to three predicate devices previously cleared by the FDA (K993106, K051735, K083032). The conclusion is based on this direct comparison and mechanical data rather than a clinical trial or AI performance study.

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