(87 days)
The Cell Robotic's Laser Skin Perforator is indicated for use for the perforation of skin to draw capillary blood for screening purposes.
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 Robotic's Lasette Laser Skin Perforator states that no nonclinical performance data was provided and that clinical performance data from three human clinical trials indicated the device is safe and effective. However, the summary does not provide specific acceptance criteria or detailed results from these trials. Therefore, much of the requested information cannot be extracted from the given text.
Here is a summary of what can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "Results from the clinical trials indicate that the device is safe and effective." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: The document states "three human clinical trials under approved Investigational Device Exemptions." This implies the data is prospective and collected from human subjects, but the country of origin is not specified (though the company is US-based).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not specified. The document only mentions "clinical trials," but no details are provided regarding how ground truth was established, or if experts were involved in a review capacity for the test set.
4. Adjudication Method for the Test Set
- Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an algorithm. This is a physical device.
7. The Type of Ground Truth Used
- Not explicitly stated. Given the nature of a skin perforator for blood collection, ground truth would likely relate to efficacy of blood collection (e.g., successful blood draw, volume obtained) and safety (e.g., perforation depth, pain, infection rates). However, the document does not specify these metrics or how they were assessed.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that would have a distinct "training set." The clinical trials would serve as the primary data for demonstrating safety and effectiveness. The sample size for these trials is not provided.
9. How the Ground Truth for the Training Set was Established
- Not applicable as there is no training set in the AI/ML context. For the clinical trials, the "ground truth" (i.e., objective measures of performance) would have been established through standard clinical assessment protocols, but these details are not provided in the summary.
§ 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.