(17 days)
Ablation of skin for collecting capillary blood samples for subsequent analysis.
The Cell Robotic's Lasette Laser Skin Perforator is indicated for use by qualified healthcare professionals 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 document is a 510(k) summary for the Cell Robotics' Clinical Lasette P-200 Laser Skin Perforator. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical performance data or detailed acceptance criteria for an AI/algorithm-based device.
Therefore, many of the requested details, particularly those related to acceptance criteria, sample sizes, ground truth establishment, expert involvement, and AI-specific studies (MRMC, standalone), are not applicable to this submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (N/A for this type of submission) | Reported Device Performance |
|---|---|
| Not applicable. This submission relies on substantial equivalence to a predicate device. No specific performance metrics or acceptance criteria for this device were reported in the summary in the typical sense of measuring accuracy, sensitivity, or specificity against predefined thresholds. | 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. |
Explanation: In a 510(k) for a device like this, the primary "acceptance criterion" is demonstrating that the new device is substantially equivalent to a legally marketed predicate device in terms of intended use, indications for use, technological characteristics, and safety and effectiveness. The summary explicitly states: "The Cell Robotic's Clinical Lasette P-200 Laser Skin Perforator is substantially equivalent to the predicate device."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This indicates that no new clinical or nonclinical studies were conducted to generate a test set for this 510(k) submission.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set was described, and therefore, no expert-established ground truth for a test set was created for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set was described.
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/algorithm-based diagnostic or assistive system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser skin perforator, not an AI/algorithm-based system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth in the context of diagnostic accuracy was established for this submission. The comparison is to "commonly used stainless steel blood lancets" based on the physiological outcome of creating a comparable perforation.
8. The sample size for the training set:
- Not applicable. This device is not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/algorithm that requires a training set.
Summary of Study (Based on 510(k) Content):
- Study Type: This is a 510(k) Premarket Notification submission, which is not a "study" in the traditional sense of generating new clinical or performance data for the device. Instead, it's a regulatory process to demonstrate substantial equivalence to a legally marketed predicate device.
- Proof of Meeting Acceptance Criteria: The "proof" is the claim of "substantial equivalence" to the predicate device (Cell Robotics, Inc. Lasette Plus). The FDA's letter (K033799) confirms that they reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications.
- Rationale for Substantial Equivalence: The summary indicates the device's functional description (portable, battery-operated, single pulse laser, ablates a small hole comparable to blood lancets) and its intended use/indications (ablation of skin for capillary blood sampling) are equivalent to the predicate. The absence of new nonclinical or clinical performance data implies that the manufacturer relied on the established safety and effectiveness of the predicate device and the new device's similar technological characteristics and performance claims.
§ 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.