(48 days)
The Cell Robotics Lasette Laser Skin Perforator is intended for use by qualified healthcare professionals for collecting capillary blood samples from adult patients, for subsequent determination of blood glucose concentration and hematocrit using optically based measurement techniques.
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 text does not contain specific acceptance criteria or detailed results from the clinical studies. It merely states that "Results from the clinical trials indicate that the device is safe and effective." Therefore, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide detailed answers to most of the other questions.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in text | 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: Not specified.
- Data Provenance: The text states the device was investigated in "two human clinical trials under approved Investigational Device Exemptions." This implies prospective data collection, likely within the United States given the FDA context, but the country of origin 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 specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- The device is a laser skin perforator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study is not applicable, and no effect size would be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable as the device is a physical medical device (laser skin perforator) and not an algorithm. Its performance is inherent to its mechanical and optical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The purpose of the device is to "ablate skin tissue to establish capillary blood access" for collecting samples for glucose and hematocrit determination. The ground truth for safety and effectiveness would likely involve measures such as:
- Successful blood collection rate: The ability to consistently obtain a sufficient capillary blood sample.
- Pain assessment: Patient-reported pain levels compared to traditional lancets.
- Ablation characteristics: Depth, diameter, and consistency of the perforation.
- Healing time/side effects: Observation of the skin after perforation.
- Blood sample quality: Comparison of blood glucose and hematocrit results with those obtained via venous draws or standard lancets.
- The text does not specify which of these were used, only that the device was found "safe and effective."
8. The sample size for the training set
- Not applicable. The device is a hardware product, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable (as above).
§ 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.