(266 days)
The LAD device is indicated for the rapid production of local dermal anesthesia using topical OTC lidocaine 4%.
The LAD is indicated for the ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.
The Norwood Abbey Model LAD-01 is a portable, battery powered, single pulse Er: Y AG laser. The radiant energy produced by this laser has a wavelength of 2.94 um, duration of approximately 300 us, and a beam diameter or spot-size of 3 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.
Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and the study that proves it meets them:
Device: LAD, Model LAD-01 (Laser surgical instrument for general and plastic surgery and in dermatology)
Intended Use: Rapid production of local dermal anesthesia using topical OTC lidocaine 4%.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Produce a rapid dermal anesthetic effect using topical OTC lidocaine 4%. | Results of the clinical study "revealed that the model LAD-01 can produce a rapid dermal anaesthetic effect using topical OTC lidocaine 4%." The study used full needle insertion as a standard pain stimulus and pain scores were analyzed. |
| No adverse events over those of the placebo treatment. | Clinical observations from 318 subjects, taken approximately 48 hours after treatment, "revealed no adverse events over those of the placebo treatment." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 320 subjects participated in the IRB, IDE approved study. Clinical observations were reported for 318 subjects.
- Data Provenance: The study was conducted over "two centers," suggesting a multi-site clinical trial. The document itself is from Norwood Abbey Limited, located in Australia, but the study is mentioned as being IRB, IDE approved, which implies a regulatory framework often associated with studies conducted in the US or under US regulatory guidance. The "retrospective or prospective" nature is not explicitly stated, but an "IRB, IDE approved study" involving subjects at two centers, with follow-up observations at 48 hours, strongly indicates a prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study protocols focused on subjective pain ratings by subjects and clinical observations by medical personnel, rather than expert interpretation of diagnostic images or data.
4. Adjudication Method for the Test Set
This information is not provided in the document. The study involved subjects rating their own pain and clinical observations by staff, not an adjudication process by multiple experts for a "ground truth" derived from interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?
No, an MRMC comparative effectiveness study was not conducted. This device is a laser surgical instrument, not an AI-powered diagnostic tool requiring human reader interpretation or improvement statistics. The study focused on the device's ability to achieve specific physiological and safety effects.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The LAD-01 is a physical device used in a medical procedure, not an algorithm. Its performance is inherent in its operation and interaction with the human body, not an "algorithm only" performance.
7. The Type of Ground Truth Used
- Pain Reduction: The "ground truth" for anesthetic efficacy was established by subjective pain ratings provided by the subjects themselves, after a standardized pain stimulus (full needle insertion).
- Safety: The "ground truth" for safety was established through clinical observations by medical personnel for adverse events, compared to a placebo.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The LAD-01 is a medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission. The study described is a clinical validation study, not a model training process.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons 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.