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510(k) Data Aggregation
(232 days)
MYELOTEC MYELOSCOPE
The Myeloscope is intended to be used by physicians for the illumination and The Mydlescope is intenthe epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.
The Myelotec Myeloscope is a flexible fiberoptic system that includes a video guided catheter that allows steering of the fiberoptic scope. The fiberoptic scope is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The video guided catheter is a sterile, disposable device.
The provided document is a 510(k) premarket notification letter from the FDA for a device called Myeloscope. It does not contain acceptance criteria or a detailed study proving the device meets acceptance criteria.
The 510(k) summary only briefly mentions some performance and safety testing. Therefore, I cannot complete the table or answer most of the questions as the information is not present in the provided text.
Here's what can be extracted from the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Catheter is capable of flexing the Myeloscope optics 30 degrees to the right and left for 250 cycles without damage to the tip bonds or steering mechanism. |
| Not specified in document | Biocompatibility for patient contacting materials demonstrated. |
| Not specified in document | Optical and mechanical performance and materials are similar to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set or the data provenance. It only mentions "performance testing of the video guided catheter."
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 mentioned in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned in the document.
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
No MRMC study was mentioned. The device described is a physical scope, not an AI system for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not specified. The performance testing appears to be functional and safety testing of the device itself (e.g., flexibility, biocompatibility), not related to diagnostic accuracy against a ground truth for disease.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is a physical device subject to performance and safety testing, not an AI/ML model that requires training.
9. How the ground truth for the training set was established
Not applicable (see point 8).
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