(203 days)
The Cell Robotics Lasette Laser Skin Perforator is indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration, in both institutional and at-home settings.
The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
The provided 510(k) summary for the Cell Robotics' Lasette Laser Skin Perforator states that no acceptance criteria are explicitly defined within this document. The summary only mentions that two human clinical trials were conducted, and their results "indicate that the device is safe and effective." However, it does not provide specific performance metrics or thresholds for what constitutes "safe" or "effective."
Therefore, much of the requested information cannot be extracted directly from this document.
Here's the information that can be extracted, and where the document is lacking:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Results from the clinical trials indicate that the device is safe and effective." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The document only mentions "two human clinical trials."
- Data provenance: Not specified (e.g., country of origin). The trials were "human clinical trials relating to use in an at-home setting." It implies prospective data collection, but this is not explicitly stated.
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/Not specified. The device is a physical tool for obtaining blood samples. Ground truth in this context would likely relate to the quantity and quality of blood samples obtained and patient experience (e.g., pain, ease of use), rather than expert interpretation of images or data. No information about experts establishing ground truth is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically relevant for studies involving subjective interpretations (e.g., image reading by multiple experts). This document describes performance in obtaining capillary blood samples, which would involve objective measurements and patient feedback.
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 device is a laser skin perforator, not an AI-assisted diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical device, not an algorithm. Its performance is always with human interaction (the user applying the device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated. Given the device's function, ground truth would likely involve:
- Successful blood sample acquisition: Was enough blood obtained for analysis?
- Pain assessment: Patient-reported pain levels compared to traditional lancets.
- Ease of use: User feedback.
- Safety outcomes: Adverse events (e.g., skin reactions, infections, though none are mentioned).
- The summary states "Results from the clinical trials indicate that the device is safe and effective," implying these types of outcomes were measured.
8. The sample size for the training set
- Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical medical device, not an AI system.
9. How the ground truth for the training set was established
- Not applicable for the same reason as point 8.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.