(91 days)
The Checkpoint® is a single-use sterile device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability. The Checkpoint is available for prescription use only.
The Checkpoint® is a small handheld device used by a surgeon to deliver electrical stimulation intraoperatively to test nerve integrity and muscle excitability. This is a sterile disposable device designed to be simple to use with one-handed control.
This 510(k) summary for the NDI Medical Checkpoint® Surgical Nerve Stimulator/Locator does not describe a study involving acceptance criteria and device performance in the manner typically associated with clinical trials or AI algorithm validation.
Instead, the document details a submission for a substantial equivalence determination for a modified version of an existing device (K061365 - Checkpoint Surgical Nerve Stimulator/Locator). The focus is on demonstrating that the modified device is as safe and effective as the predicate device, primarily through technological comparison and standard performance testing (biocompatibility, electrical safety).
Therefore, I cannot provide the requested information in the format you specified, as the provided document does not contain the elements of a study proving device performance against acceptance criteria in the context of, for example, a diagnostic accuracy study or an AI algorithm's performance.
Here's an analysis based on the information available in the document, explaining why the requested details are not present:
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A table of acceptance criteria and the reported device performance:
- Not applicable in the provided context. The document presents a table comparing "Feature/Characteristic" between the predicate and modified device, showing "Yes" for each characteristic, indicating technological equivalence rather than performance against specific clinical acceptance criteria. Performance testing mentioned (biocompatibility, electrical testing, design verification and validation) are general categories, not detailed outcome measures with thresholds.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. There is no mention of a "test set" in the context of clinical data for performance evaluation in this document. The assessment is based on technological characteristics and general performance testing (electrical, biocompatibility).
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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. There is no "ground truth" to be established by experts in this type of submission, as it's not a diagnostic or decision-support device requiring interpretation of complex data by human experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication is described.
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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 device is a surgical nerve stimulator/locator, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical, handheld surgical tool. There is no "algorithm only" performance to evaluate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for demonstrating substantial equivalence here relies on documented design specifications, manufacturing controls, and standardized performance tests (like electrical conductivity, biocompatibility) rather than clinical outcome measures requiring expert comparison.
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The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable. No training set is mentioned.
In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of a modified medical device to a legally marketed predicate device. This process typically involves:
- Comparison of intended use and indications for use. (Explicitly stated as equivalent)
- Comparison of technological characteristics. (Provided in a table)
- Assessment of performance testing. (Mentioned as "biocompatibility testing, electrical testing (safety and electromagnetic compatibility), as well as design verification and validation testing.") These are typically engineering and materials tests rather than clinical performance studies against specific acceptance criteria.
The document does not describe a clinical study with a test set, ground truth acquisition, expert involvement, or statistical performance metrics that would be typically found in an AI/diagnostic device submission.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.