(148 days)
The Laser Lancet® is intended for use for the perforation of skin to draw capillary blood for screening purposes.
The Laser Lancet® LB100 is a portable Er:YAG laser. The beam is focused within the unit and exits through a tube placed in the aperture allowing the focused beam to strike the finger of a patient placed against the unit's tip and perforate the skin. The resulting blood sample is used for clinical chemistry screening purposes.
The Laser Lancet® LB100 is a portable Er:YAG laser intended for skin perforation to draw capillary blood for screening purposes. The provided text outlines two clinical studies conducted to demonstrate its effectiveness and safety.
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria are implied from the study objectives and conclusions. No specific quantitative benchmarks are listed in the provided text, but rather a demonstration of equivalence and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effectiveness in perforating skin for capillary blood. | Clinical data from two studies demonstrated that the energy output of the Laser Lancet® LB100 is effective in perforating the skin in order to obtain capillary blood for screening tests. |
| Equivalence of clinical values (electrolytes and lipids) from blood obtained with Laser Lancet® LB100 compared to steel lancet. | The results of one clinical study demonstrated that the clinical values of electrolytes and lipids were the same whether the capillary blood was obtained after use of the Laser Lancet® LB100 or by a steel lancet. This also extended to "colorimetric analyses approved with the initial 510(k)". |
| Healing time of perforation sites. | The results of the second study demonstrated that the perforation sites, including multiple perforations on the same finger of diabetic patients, were healed within 48 hours after use of the Laser Lancet®. This provides reasonable assurance that the device "does not pose undue risks to patients, even after multiple perforations". |
2. Sample Size and Data Provenance:
- Sample Size for Test Set: The exact sample size for each study is not specified in the provided text. It merely states "two studies."
- Data Provenance: The text does not explicitly state the country of origin. Given the submission to the FDA (USA), it is highly likely the studies were conducted in the USA. The studies are prospective clinical studies as they involve patient application of the device to demonstrate effectiveness and safety.
3. Number of Experts and Qualifications:
The information regarding the number of experts used to establish ground truth and their qualifications is not provided in the given text.
4. Adjudication Method:
The adjudication method used for the test set is not specified in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the context of improving human reader performance with AI. The studies presented compare the Laser Lancet® LB100 to a steel lancet directly in terms of blood collection and resulting clinical values, and also assess healing time.
6. Standalone Performance (Algorithm Only):
This information is not applicable as the Laser Lancet® LB100 is a physical medical device, not an AI algorithm. Its performance is inherent to its physical operation and is evaluated directly through its use on patients.
7. Type of Ground Truth Used:
The ground truth used was:
- Clinical Efficacy/Effectiveness: Demonstraion of successful skin perforation to obtain capillary blood.
- Comparative Clinical Values: Clinical laboratory results for electrolytes and lipids from blood samples obtained by both the Laser Lancet® LB100 and a steel lancet.
- Observed Healing Outcomes: Physical observation of wound healing within a specified timeframe (48 hours).
8. Sample Size for Training Set:
This information is not applicable as the Laser Lancet® LB100 is a physical device and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How Ground Truth for Training Set was Established:
This information is not applicable for the same reasons as above. The device's performance is based on its physical design and operation, not on learned data.
§ 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.