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The ORTIV is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.

ORTIV laser lancet is a portable, battery-operated laser lancing device, and is indicated for obtaining capillary blood samples in both institutional and at-home settings. The laser is a pulsed Erbium YAG (ER: YAG). It outputs a single pulse of laser light with a wavelength of 2940 nm, which ablates a small hole in the skin to a depth sufficient to access capillary blood.

This document is an FDA 510(k) clearance letter for a medical device called ORTIV, a laser lancing device. It indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, the letter and the accompanying 510(k) summary do not contain any information about clinical study data, acceptance criteria, or performance data beyond non-clinical testing for safety and electrical compatibility.

The provided text only outlines the regulatory clearance process and technical characteristics of the device compared to a predicate device. It explicitly states, "Non-clinical tests for laser lancet: The safety of laser product, electromagnetic compatibility and electrical safety, etc, were tested using following consensus standards." This means the submission was based on non-clinical performance data, likely demonstrating safety and physical/electrical characteristics, rather than clinical performance for accuracy or diagnostic capability, which would be typical for medical imaging AI.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details because this information is not present in the provided FDA 510(k) documentation. The 510(k) summary only lists non-clinical tests for device safety and electrical compliance.

To answer your questions, there would need to be a section detailing clinical performance studies, including:

1. A table of acceptance criteria and the reported device performance: This would be found in a clinical study report within the 510(k) submission, not typically summarized in the public 510(k) clearance letter or summary.
2. Sample sizes used for the test set and the data provenance: Clinical study details are needed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Clinical study details are needed.
4. Adjudication method for the test set: Clinical study details are needed.
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: This implies an AI device, but the ORTIV is a laser lancing device, not an AI diagnostic tool. If it were an AI device, MRMC study results would be needed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Again, this implies an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Clinical study details are needed.
8. The sample size for the training set: Clinical study details are needed; often for an AI device.
9. How the ground truth for the training set was established: Clinical study details are needed; often for an AI device.

Conclusion: The provided document is a 510(k) clearance for a physical medical device (laser lancet), not a software device, and it relies on non-clinical safety and performance data for substantial equivalence, not clinical performance data in the context of diagnostic accuracy or AI assistance. Therefore, the specific details you've requested about clinical acceptance criteria, study design (MRMC, standalone), ground truth, and training data are not available in this document.

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