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510(k) Data Aggregation
(108 days)
NODECREST LLC
The range of Nodecrest Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system:
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For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values
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To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye.
The Nodecrest Transcranial Doppler is intended for use during:
- a) Diagnostic exams
b) Surgical interventions
The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
The EMS9U range is a Transcranial Doppler (TCD) diagnostic ultrasound system, with a pulse wave and / or continuous wave Doppler transducer that can be used free hand (or head frame mounted for longer term monitoring). A supplementary M-mode disala ( nay be used to help locate blood flow signals to position the sample gate for Doppler signal, and for detection of emboli signals. Each of the three models in the range is identical in terms of hardware the difference being features that the end user does not request are turned off in the software.
The provided document K060112 is a 510(k) premarket notification for the Nodecrest Transcranial Doppler Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document does not contain the kind of detailed information about acceptance criteria and a study proving their fulfillment that would typically be found in a De Novo or PMA submission.
However, based on the provided text, we can infer the "acceptance criteria" were primarily related to demonstrating substantial equivalence to the predicate device (Rimed Smart-Lite™ Transcranial Doppler) in terms of technical specifications and safety standards.
Here's an analysis of the provided information within that context:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are implied by the features and performance of the predicate device (Rimed Smart-Lite™ Transcranial Doppler). The sponsor (Nodecrest LLC) demonstrates its device's performance by showing it has similar specifications to the predicate.
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Nodecrest) |
|---|---|
| Transducer Frequency: 2MHz, 4MHz, 8MHz | Transducer Frequency: 2MHz, 4MHz, 8MHz |
| Frequency Spectrum: 64-512 dots | Frequency Spectrum: FFT 256/512 dots |
| Frequency Ranges: 2-32 MHz | Frequency Ranges: 1-16 MHz |
| Depth Measurement: 15-150 mm | Depth Measurement: 5-136 mm |
| Gain: Manually controlled, 20 steps | Gain: 0-40db |
| Clinical Application (2MHz PWD): Ophthalmic, Adult Cephalic | Clinical Application (2MHz PWD): Ophthalmic, Adult Cephalic & Peripheral Vascular |
| Clinical Application (2MHz CWD): Ophthalmic & Peripheral Vascular | Clinical Application (2MHz CWD): Ophthalmic & Peripheral Vascular |
| Clinical Application (4MHz PWD): Peripheral Vascular (predicate implied from other CWD entry) | Clinical Application (4MHz PWD): Peripheral Vascular |
| Clinical Application (4MHz CWD): Peripheral Vascular | Clinical Application (4MHz CWD): Peripheral Vascular |
| Clinical Application (8MHz PWD): Peripheral Vascular (predicate implied from other CWD entry) | Clinical Application (8MHz PWD): Peripheral Vascular |
| Clinical Application (8MHz CWD): Ophthalmic & Peripheral Vascular | Clinical Application (8MHz CWD): Peripheral Vascular |
| General Electrical Testing: EN 60601-1-1 & EN 60601-1-2 | General Electrical Testing: IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, UL 2601-1 |
| Biocompatibility Tests: Unknown (for predicate) | Biocompatibility Tests (ISO 10993): Cytotoxicity, Sensitization, Skin Irritation, USP: Acute Toxicity, Intracutaneous Reactivity, Implantation & Cytotoxicity |
Note on Device Performance: For a 510(k), "performance" in this context refers to technical specifications matching or being similar to the predicate, rather than clinical performance metrics like sensitivity/specificity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set or clinical study to prove performance against specific acceptance criteria. The submission relies on technical comparison and compliance with electrical and biocompatibility standards. Therefore, information regarding "sample size," "data provenance," "retrospective or prospective" is not applicable in the context of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no clinical test set is described, there's no mention of experts or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process is described.
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
Not applicable. This is a Transcranial Doppler Ultrasound System, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic ultrasound system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no clinical study described that required a ground truth for performance evaluation. The "ground truth" for this submission would be the established equivalency of performance and safety specifications to the predicate device.
8. The sample size for the training set
Not applicable. As a hardware device for diagnostic ultrasound, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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