(143 days)
The PATHWAY- ATS/CHEPS is indicated for the use in evaluating the functionality of human pain reception and transmission of sensory pathways.
The PATHWAY- ATS/CHEPS is an advanced, computerized thermal stimulator designed for advanced pain research. This non-invasive device can be used as a stimulator for creating sensation and pain stimuli, in the sensory nerves fibers.
The provided document is a 510(k) summary for the PATHWAY- ATS/CHEPS device, which is an evoked response thermal stimulator. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about acceptance criteria and a standalone performance study.
Based on the information available in the provided text, I cannot fully answer all aspects of your request. Here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
The document does not explicitly state specific quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy targets) nor does it report detailed device performance metrics in comparison to such criteria. The core of a 510(k) submission is to argue substantial equivalence to a predicate device, not necessarily to meet new, independent performance benchmarks documented with extensive clinical study data.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|
| No specific quantifiable performance acceptance criteria (e.g., accuracy, sensitivity, specificity) are listed in the provided text. | No specific quantifiable performance metrics are listed in the provided text. |
| Substantial Equivalence to Predicate Device (Implied acceptance criterion for 510(k)) | The FDA determined the device is substantially equivalent to legally marketed predicate devices. (This is the "performance" outcome for a 510(k)) |
Study Details
The document refers to the "Modified Contact Heat-Evoked Potential Stimulator K051448" as the predicate device, implying that the PATHWAY- ATS/CHEPS's equivalence is based on similar technology and intended use. However, it does not describe a new clinical study with detailed performance data for the PATHWAY- ATS/CHEPS itself.
1. Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not specified. The document does not describe a clinical test set for new performance evaluation. The comparison is primarily based on technological characteristics and intended use.
- Data Provenance: Not applicable, as no new test set data is described. The comparison is based on existing knowledge and documentation for the predicate device.
2. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Not specified. Not applicable as no new test set or ground truth establishment process is described for performance evaluation.
- Qualifications of Experts: Not specified.
3. Adjudication method for the test set:
- Adjudication Method: Not specified. Not applicable as no new test set requiring adjudication is described.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- MRMC Study: No, the document does not indicate that an MRMC comparative effectiveness study was conducted. The device is a stimulator, not an interpretive diagnostic tool that involves human readers interpreting outputs in a comparative manner like AI systems often do.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable in the context of this device. The PATHWAY- ATS/CHEPS is a thermal stimulator, not an algorithm-only diagnostic device. Its function is to create stimuli, rather than interpret data from an algorithm.
6. The type of ground truth used:
- Type of Ground Truth: Not applicable. The document focuses on the device's ability to generate specific thermal stimuli for "evaluating the functionality of human pain reception and transmission of sensory pathways," implying its output is a stimulus, not a diagnostic result that requires a "ground truth" for validation in the typical AI sense. The focus is on the stimulator's ability to produce the intended physical effects safely and effectively, similar to the predicate device.
7. The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not a machine learning device that requires a training set.
8. How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable.
Summary of Limitations based on the Document:
The provided 510(k) summary is designed to demonstrate substantial equivalence to a predicate device for regulatory clearance. It does not include detailed clinical study data, performance metrics against specific acceptance criteria, or information on AI/ML model training or validation often found in submissions for AI-powered diagnostic devices. The device described is a thermal stimulator, which typically undergoes different validation procedures focusing on its ability to generate controlled stimuli safely and effectively, often by comparison to a legally marketed equivalent device.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).