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510(k) Data Aggregation
(143 days)
MEDOC LTD. ADVANCED MEDICAL SYSTEMS
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.
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(27 days)
MEDOC LTD. ADVANCED MEDICAL SYSTEMS
The Modified Contact Heat-Evoked Potential (CHEPS) is indicated finaloations in evaluating the functionality of human pain reception and transmission of sensory pathways.
The Modified Contact Heat-Evoked Potential Stimulator (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.
This document is a 510(k) summary for a medical device called the "Modified Contact Heat-Evoked Potential Stimulator (CHEPS)". It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study details, or performance metrics for the device.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on regulatory approval based on substantial equivalence, not on performance studies against specific criteria.
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(225 days)
MEDOC LTD. ADVANCED MEDICAL SYSTEMS
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.
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(171 days)
MEDOC LTD. ADVANCED MEDICAL SYSTEMS
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