(645 days)
The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact mode during surgical procedures. The device's 980mm laser is generally indicated for use in incision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The diode laser generates a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coaqulation of the target tissue. The diode laser generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Diode laser therapy device has following characteristics:
- Dual wavelengths A
- A Temperature monitoring system
This document is a 510(k) summary for the Diode laser therapy device, and it details the device's characteristics, intended use, and comparison to predicate devices, but it does not specify acceptance criteria or a study designed to prove the device meets those criteria in the typical sense of a clinical performance study. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through technical, performance, and safety comparisons.
Here's an analysis of the provided text based on your request, highlighting what is and isn't available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the form of performance thresholds that the device was required to meet for clearance. Instead, it relies on demonstrating that the proposed device is "as safe, as effective, and performs as well as or better than" the legally marketed predicate devices. The "reported device performance" is presented through technical specifications and safety comparisons to these predicate devices.
Table: Comparison of Proposed Device Performance to Predicate Devices (Implied Acceptance Based on Substantial Equivalence)
| Item | Implied Acceptance (Predicate Performance) | Proposed Device Performance (Reported) |
|---|---|---|
| Intended Use (980nm) | Incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in various specialties, including laser-assisted lipolysis. (Based on K081015) | Incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in otolaryngology, dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, and laser-assisted lipolysis. |
| Intended Use (1470nm) | Treatment of reflux of saphenous veins associated with varicose veins and varicosities. (Based on K073063) | Treatment of reflux of the saphenous veins associated with varicose veins and varicosities. |
| Wavelength | 980 nm, 1470 nm | 980nm±5nm, 1470nm±10nm |
| Max Power (980nm) | 15 Watt (Predicate K081015) | 16W/980nm±20% |
| Max Power (1470nm) | 15 Watt (Predicate K073063) | 4.5W/1470nm±20% |
| Aiming Beam | 635 nm, red 4 mW, user controlled intensity (Predicates) | 650 nm, red 0.5 mW, user controlled intensity |
| Treatment Mode | Continuous or Pulsed | Continuous or Pulsed, Single |
| Biocompatibility | Cytotoxicity, Irritation, Sensitization (Comply with ISO 10993-5, ISO 10993-10) | Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Pyrogen test, In vitro hemolytic test (Comply with ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4). (More extensive testing than predicates). |
| Electrical Safety | Comply with IEC 60601-1, IEC 60825-1, IEC 60601-2-22 | Comply with IEC 60601-1:2005+A1:2012, IEC 60825-1:2014, IEC 60601-2-22:2007+A1:2012 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2:2014 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "No clinical study implemented for the Diode laser therapy device." Therefore, there is no test set in the sense of patient data, nor data provenance information related to clinical performance. The assessment is based on non-clinical (bench) testing and comparison to predicate devices. For the 1470nm max power, it mentions "clinical survey data, and clinical literature" were collected to support efficacy, but no details on sample size or provenance are given for this supporting evidence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set.
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 therapy device, not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical study with a traditional "ground truth" was performed for the device itself. For the "clinical survey data and clinical literature" mentioned regarding the 1470nm laser power, the type of "ground truth" used there would depend on the nature of those external studies/surveys, but no details are provided.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The assessment is based on non-clinical testing and comparison to predicate devices.
9. How the ground truth for the training set was established
Not applicable. No training set.
§ 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.