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510(k) Data Aggregation
(457 days)
OSACHI CO., LTD.
PS-2100 is a device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used include any individual capable of communicating their perception of cutaneous sensation. PS-2100's examination may be conducted as part of a routine neurological examination or as a screening procedure. This device may be used by healthcare professionals to evaluate or diagnose a patient for peripheral neuropathy.
The PS-2100 is a type of Sensory Nerve Threshold Measurement System Device. The electrical stimulus is applied in gradually increasing amounts to the electrode attached to the patient. Disposable gel electrodes are attached to the patient connecting the electrode. The current value at which the patient initially senses the stimulation is referred to as the Current Perception Threshold (C.P.T.) value. Measurement may be conducted in one of two modes - Standalone mode by which the device itself is used for measurements, and System mode whereby the device is connected to a personal computer for administration of data. The patient is provided a hand switch to cease measurement at any time during the test.
The provided text is a 510(k) summary for the PS-2100 device, which is a Sensory Nerve Threshold Measurement System. This document focuses on demonstrating substantial equivalence to a predicate device (NEUROMETER K853608) rather than presenting a detailed clinical study for acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted from this document. The document lists the device's indications for use and general information but does not contain the specifics of a clinical validation study with performance metrics, sample sizes for test or training sets, expert qualifications, or comparative effectiveness.
Here’s what can be inferred or directly stated from the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Not Explicitly Stated in Document) |
|---|---|
| The document does not explicitly state quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or specific thresholds for CPT values relative to a gold standard). | The document does not provide quantitative reported device performance data against specific acceptance criteria. It states the PS-2100 is a "Sensory Nerve Threshold Measurement System" and measures the "Current Perception Threshold (C.P.T.) value," but no performance metrics are given. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document. The document is a 510(k) summary focused on substantial equivalence, not a clinical study report.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: An MRMC comparative effectiveness study is not mentioned in this document. The focus is on demonstrating substantial equivalence to a predicate device, which usually involves comparing technical characteristics and indications for use, rather than a direct comparison of human performance with and without the device.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study is detailed.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: Not explicitly described as a performance study in the context of clinical metrics. The document mentions a "Standalone mode by which the device itself is used for measurements," but this refers to the operational mode of the device without a connected computer, not an algorithm-only performance study in the regulatory sense. The device measures "Current Perception Threshold" (CPT), which is a direct physiological measurement, not an AI algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not specified in relation to a performance study. The device measures the "Current Perception Threshold (C.P.T.) value," which itself could be considered a form of "ground truth" for sensory perception at a given point in time, but the document does not describe how this would be validated against an independent, objective ground truth for clinical performance.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The PS-2100 is described as a "Sensory Nerve Threshold Measurement System" that applies an electrical stimulus and measures the C.P.T. value. This is a direct measurement device, not an AI/ML-based algorithm that would typically require a training set.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no mention of a training set for an AI/ML algorithm.
In summary, the provided document is a regulatory submission (510(k) summary) aiming to establish substantial equivalence for the PS-2100 device. It does not contain the detailed information typically found in a clinical study report that would describe acceptance criteria and performance data for a device, especially not for an AI/ML system.
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