(225 days)
The Contact Heat-Evoked Potential Stimulator (CHEPS) is indicated for the use in evaluating the functionality of human pain reception and transmission of sensory pathways.
The Contact Heat-Evoked Potential Stimulator (CHEPS) is a computerized thermal stimulator that produces a heating stimulation in rate of 70°C/sec, enabling delivery of painful stimuli from a baseline to 55℃ in 250 milliseconds. The system consists of the CHEPS control unit, external cooling unit, 27mm diameter thermode probe, thermode cables, and software. The software program requires the use of an IBM compatible notebook or desktop computer, which is not supplied. Also, the following are optional components: MRI-safe thermode and cables and cart.
The Contact Heat-Evoked Potential Stimulator (CHEPS) is a computerized thermal stimulator that produces a heating stimulation, enabling the delivery of painful stimuli from a baseline to 55℃ in 250 milliseconds at a rate of 70°C/sec.
1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used:
The provided document specifies the device underwent functional and safety testing. However, it does not detail specific quantitative acceptance criteria or corresponding reported performance metrics for the device's primary function of evaluating pain reception and transmission. Instead, it offers a general statement regarding the successful completion of tests.
| Acceptance Criterion | Reported Device Performance | Type of Ground Truth |
|---|---|---|
| Functional Testing | "The device performed as designed and met, or exceeded, all product specifications." | Device Specifications (internal, not detailed) |
| Safety Testing | "The results of testing were successful." | Safety standards/protocols (not detailed) |
| Mechanical Testing | "The device underwent mechanical...testing...The results of testing were successful." | Device Specifications/Engineering Standards (not detailed) |
| Physical Testing | "The device underwent...physical...testing...The results of testing were successful." | Device Specifications/Engineering Standards (not detailed) |
| Biocompatibility Testing | "The device underwent...biocompatibility testing...The results of testing were successful." | Biocompatibility standards (not detailed) |
The ground truth for these evaluations appears to be based on internal product specifications, design requirements, and possibly established safety/biocompatibility standards, rather than clinical outcomes or expert consensus on human pain perception.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information regarding a specific "test set" in the context of clinical or performance data. The device underwent "mechanical, physical, and biocompatibility testing," but details on the sample sizes for these engineering-focused tests are not given. There is no mention of data provenance (e.g., country of origin, retrospective or prospective) for any performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Since no clinical "test set" and associated ground truth based on expert assessment are described, this information is not available in the provided document. The "ground truth" for the device's engineering and safety performance was likely internal product specifications and compliance with relevant standards, rather than expert clinical judgment.
4. Adjudication Method for the Test Set:
As no clinical "test set" requiring expert adjudication is described, this information is not available in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission focuses on substantial equivalence to predicate devices based on function, design, materials, and indication for use, not on demonstrating an improvement in human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The CHEPS device is a thermal stimulator intended for "evaluating the functionality of human pain reception and transmission of sensory pathways." It is a diagnostic tool that interacts directly with a human; therefore, the concept of "algorithm only without human-in-the-loop performance" as typically applied to image analysis or AI diagnostics does not directly apply in the same way. The device's performance is inherently tied to its interaction with a human subject. No standalone algorithm performance is described.
8. The Sample Size for the Training Set:
The document does not describe a "training set" for an algorithm or AI. The CHEPS device is a hardware and software system for thermal stimulation, not a machine learning model that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established:
As no "training set" is described, this information is not applicable and not available regarding how ground truth for it would have been established.
§ 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).