(57 days)
The Checkpoint™ is a single-use 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 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.
The NDI Medical Checkpoint™ is a surgical nerve stimulator/locator. The provided text from the 510(k) submission describes the device, its intended use, and substantial equivalence to predicate devices. However, it does not contain details about specific acceptance criteria or an analytical study comparing the device's performance against such criteria.
The "PERFORMANCE TESTING" section states that testing included "biocompatibility testing, electrical testing (safety and electromagnetic compatibility), as well as design verification and validation testing." This is a general statement about the types of tests conducted, but it doesn't provide specific device performance metrics or the acceptance criteria for those metrics.
Therefore, many of the requested details about acceptance criteria and study design cannot be extracted from the provided text.
Here's an attempt to answer the questions based on the available information, noting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document only states that "biocompatibility testing, electrical testing (safety and electromagnetic compatibility), as well as design verification and validation testing" were performed. Specific quantitative or qualitative acceptance criteria for these tests, or the results demonstrating the device met them, are not detailed in this summary. | Not provided in the document. The document states testing was performed, implying the device met the necessary performance standards to gain 510(k) clearance, but no specific performance statistics or metrics are reported. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not provided.
- Data provenance: Not provided. The document mentions general testing categories but does not specify the origin or nature of the data used for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
4. Adjudication method for the test set
- Adjudication method: Not provided.
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
- MRMC study done: No. This device is a surgical nerve stimulator/locator, not an AI-powered diagnostic imaging device that would typically involve human "readers" or AI assistance in interpretation. The document does not mention any AI component.
- Effect size: Not applicable, as there was no MRMC study or AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study done: Not applicable. The device itself is a "small handheld device used by a surgeon to deliver electrical stimulation intraoperatively." Its performance is inherently linked to the surgeon's use, and there's no mention of an "algorithm only" component in the context of its primary function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not provided. For a device like this, ground truth would likely be established through objective measurements (e.g., electrical output, duration, mechanical integrity) and potentially clinical observation of its ability to stimulate nerves/muscles as expected. However, the document does not specify.
8. The sample size for the training set
- Sample size for training set: Not applicable. This document describes a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable, as there is no training set for this type of device.
§ 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.