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The TempTouch® Dermal Thermometer is an infrared thermometer for the measurement of skin surface temperature of people of all ages.

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The provided text is a 510(k) clearance letter from the FDA for a device called "TempTouch®" Dermal Thermometer. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document states that the device is "substantially equivalent" to a predicate device already on the market.

Therefore, I cannot provide the requested information based on the given input.

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The VPT Meter is an instrument designed to measure simply and accurately the threshold of appreciation of vibration in human subjects.

The Xilas Medical VPT Meter is designed to identify patients with sensory neuropathy. These patients have lost sensation and the "gift of pain" from their extremities or elsewhere. The instrument provides a quantitative measurement of vibration perception threshold (VPT). The digital device allows the clinician to quantify the loss of sensation, initially to establish a baseline loss of sensation and subsequently monitor the progression of established pathology.

The provided text describes a 510(k) premarket notification for the Xilas Medical VPT Meter, which is a vibration threshold measurement device. However, the document does not contain explicit acceptance criteria, detailed study designs, or comprehensive performance data in the format requested.

The text focuses on establishing substantial equivalence to a predicate device (Vibrameter, Somedic AB) by comparing design, functionality, and intended use. While it mentions "Testing of the device (included with this submission) demonstrates the VPT Meter to be both safe and efficacious," it does not provide the specifics of these tests.

Therefore, much of the requested information cannot be extracted directly from the provided document. I can only report what is implicitly stated or where there is a lack of information.

Here's a breakdown based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:

• Safety: Implicitly, the device must be safe for human use. (Specific criteria not provided)
• Efficacy: Implicitly, the device must be efficacious in measuring vibration perception threshold. (Specific criteria not provided)
• Substantial Equivalence: The device must demonstrate similar intended use, characteristics, and performance to the predicate device, the Vibrameter. (Specific performance metrics for equivalence not provided)

Reported Device Performance:
The document states that "Testing of the device (included with this submission) demonstrates the VPT Meter to be both safe and efficacious." However, it does not provide any quantitative or qualitative data on how this safety and efficacy were demonstrated, nor does it present specific performance metrics like sensitivity, specificity, accuracy, or agreement with a gold standard. The primary performance assertion is that it is substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "Testing of the device (included with this submission)," but the sample size of subjects or data used in these tests is not provided.
• Data Provenance: Not explicitly stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: Not mentioned. The document focuses on device-to-predicate comparison rather than human reader performance with/without AI assistance. The device itself is a measurement tool, not an AI diagnostic aid for human readers.
• Effect Size: Not applicable as no MRMC study is mentioned.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Study: The device itself is a standalone measurement instrument. The document implies its performance was evaluated to ensure safety and efficacy, and substantial equivalence, but detailed "standalone performance" metrics (like accuracy against a true vibratory threshold) are not provided. The comparison made is against another device (the predicate), not an absolute ground truth.

7. Type of Ground Truth Used

• Ground Truth Type: Not explicitly stated. For a vibration perception threshold device, ground truth would ideally be derived from a highly accurate, perhaps laboratory-grade, reference vibratory stimulus or established clinical benchmarks. The document's closest mention to a "ground truth" is the comparison to the predicate device, implying that the predicate's measurements serve as a reference for equivalence, but not necessarily a "true" physiological ground truth.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a measurement instrument, not an AI/machine learning algorithm that requires a training set in the conventional sense.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

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