(133 days)
The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
The DIOMED 15 Plus is a diode laser capable of delivering up to 119 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-15 W of continuous wave radiation via an optical fiber coupled to the laser aperture. The DIOMED 30 Plus is a diode laser capable of delivering up to 400 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-30 W of continuous wave radiation via an optical fiber coupled to the laser aperture. An EVLT procedure kit is available which may contains a 400 -1000 micron corc, 2.5 meter long bare tip fiber with location markers, a 25-100 cm long, 4- 5 Fr graduated introducer sheath with dilator, a 19 Gauge, 7 cm percutaneous entry needle, and a 0.035" J guide wire.
The provided text is a 510(k) summary for the Diomed, Inc. EVLT Kit and D15Plus and D30Plus Lasers from 2004. It describes the device, its indications for use, and a clinical study. However, it does not contain the specific acceptance criteria or detailed results that would allow for the construction of a comprehensive table comparing acceptance criteria to reported device performance. It also lacks information regarding sample sizes for test and training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML device evaluations.
Therefore, much of the requested information cannot be extracted from this document, as it predates the widespread regulatory evaluation of AI/ML devices and the specific reporting requirements for such systems.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. 510(k) summaries from this era often refer to substantial equivalence and clinical data but rarely detail pre-defined acceptance criteria for performance metrics in the way modern AI/ML device submissions do.
- Reported Device Performance: The document only states: "Clinical data was presented on 213 subjects treated with endovenous laser treatment with the Diomed D15Plus Laser System and EVLT Kit." Specific performance metrics (e.g., success rates, complication rates, recurrence rates) are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Clinical data presented on 213 subjects. Specific performance metrics (e.g., success rate, complication rate) are not detailed in this summary. |
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 for Test Set: 213 subjects were treated in the clinical study. It is implied this forms the primary dataset used to support the device.
- Data Provenance: Not specified (country, retrospective/prospective). The document states "Clinical data was presented," which typically implies prospective clinical trials, but specific details are missing.
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 Applicable. This device is a surgical laser system, not an AI/ML diagnostic or prognostic device that relies on human expert-established ground truth for performance evaluation in the way contemporary AI devices do for image interpretation. The "ground truth" for this type of device would be patient outcomes (e.g., vein occlusion, symptom relief), which are typically assessed by treating physicians and follow-up examinations, not by a panel of independent experts establishing a "ground truth" label in a blinded fashion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3. Adjudication methods are relevant for expert consensus on AI ground truth, which is not the context here. Clinical outcomes are typically assessed by treating physicians and standard clinical follow-up protocols.
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
- No. This is a surgical laser device, not an AI-assisted diagnostic tool. MRMC studies and the concept of "human readers improving with AI assistance" are not applicable to the evaluation of this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a medical device (laser system) that requires direct human operation, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this type of device (a surgical laser for vein treatment), the "ground truth" for determining effectiveness would be based on clinical outcomes data. This would include measures such as successful vein occlusion, reduction in reflux, improvement in symptoms, and assessment of adverse events, typically determined through follow-up examinations (e.g., ultrasound, patient reported outcomes) and clinical evaluation by treating physicians.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set in the computational sense. The "training" for the device's development would refer to engineering and pre-clinical testing, not a dataset used to train an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. See 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.