(75 days)
The Dyaamic Newssreaing Device (DND) is intended to provide objective medical screening for peripheral newopathy by determining the patient's ability to discriminate temperature differences as well as determining vibration sensitivity.
The Dynamic Neuroscreening Device (DND) is intended to screen patients and allow the practitioner to observe uny changes of sensation over a period of time. The device will be available with a cradle which provides a docking location for the handle. The DND device provides medical practitioners with an objective method for screening patient's feet for neuropathy. The device uses two methods for long term screening with the objective of determining loss of sensation in the patient's foot: vibration sensitivity and temperature discrimination screening. The primary patient population is for those that arc at risk or have been diagnosed with diabetes.
The DND is designed to be ergonomically comfortable in the practitioner's hand and simple to use. In addition safety features are installed to provent the device from becoming excessively hot or cold to ensure untient safety. No electrical pathways are going to the patient and the power supply is UL upproved to the medical device standard.
The provided text is a 510(k) summary for the Dynamic Neuroscreening Device (DND). While it describes the device's technical characteristics and claims substantial equivalence to predicate devices, it explicitly states:
"No clinical testing was performed in association with this submission."
Therefore, a detailed description of the acceptance criteria and a study proving the device meets those criteria, as requested, cannot be fully provided from this document. The submission relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.
However, based on the provided text, we can glean some information, particularly regarding the technological characteristics comparison which acts as a proxy for performance criteria when clinical data is absent.
Here's the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study with explicit acceptance criteria for clinical performance (e.g., sensitivity, specificity) was conducted, the "acceptance criteria" here are effectively the "technological characteristics" of the predicate devices that the DND aims to match or be comparable to. The "reported device performance" would then be the DND's stated technological characteristics.
| Feature or Specification | Predicate Device (Sensortek NTE-2 Thermal Sensory Tester K864345) | Reported Device Performance (Dynamic Neuroscreening Device) |
|---|---|---|
| Minimum Temperature (deg C) | 0 | 15 |
| Maximum Temperature (deg C) | 50 | 40 |
| Control Accuracy (deg C) | 0.1 | 0.5 |
| Temperature Gradient Steps (deg C) | 5, 1, and 0.5 | Fixed at 2 |
| Feature or Specification | Predicate Device (Somedic Vibrameter K843486) | Reported Device Performance (Dynamic Neuroscreening Device) |
|---|---|---|
| Vibration Frequency (Hz) | 100-120 | 175 |
| Vibration Range (microns) | 0 to 40 and 0 to 400 | 4.5 to 23 |
| Vibration Amplitude Set Point Resolution (Microns) | 5% | 20% |
Note: The DND's characteristics are presented as comparable, but not always identical to the predicate devices. For example, its temperature range is narrower, and its vibration frequency is different. The submission implies these differences are acceptable for substantial equivalence, likely through arguing they do not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable (N/A) for clinical performance testing as no clinical testing was performed.
- Data Provenance: N/A for clinical data. The non-clinical testing (vibrational and temperature verification, electrical safety) would have been conducted by the manufacturer, Prosenex, LLC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No clinical testing was performed, so no ground truth established by experts for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No clinical testing was performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. The Dynamic Neuroscreening Device is a physical device, not an AI or imaging diagnostic tool that would typically involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical device, not an algorithm. However, the device itself is intended for use by a practitioner, suggesting an "in-the-loop" component in its clinical application.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A for clinical performance. For the non-clinical testing, the "ground truth" would be established by validated measurement standards and equipment for temperature and vibration characteristics, and electrical safety standards.
8. The sample size for the training set:
- N/A. No clinical data training set is mentioned as no clinical studies were performed.
9. How the ground truth for the training set was established:
- N/A. No clinical data training set is mentioned.
§ 882.1200 Two-point discriminator.
(a)
Identification. A two-point discriminator is a device with points used for testing a patient's touch discrimination.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.