(223 days)
The BWF-5 Medical Laser Series (810nm, 930nm, 980nm, 1080nm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery.
The device is specifically indicated for use as follows:
LASER 980nm:
Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
LASER 1320nm:
Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.
BWF-5 Medical Laser Series are compact medical laser systems. The laser light delivery system consists of a flexible optical fiber. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
Here's an analysis of the provided text regarding the LiteCure, LLC BWF-5 Medical Laser Series, focusing on acceptance criteria and study details.
Based solely on the provided text, there is no information available about a separate study that proves the device meets specific acceptance criteria in terms of clinical performance, diagnostic accuracy, or comparative effectiveness with human readers.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance through a clinical study with detailed acceptance criteria.
Therefore, many of your requested items cannot be fulfilled from this document. However, I can provide what is available.
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this 510(k) document refers to the device's compliance with safety and technical standards, and its substantial equivalence to predicate devices, rather than clinical performance metrics. The "reported device performance" is essentially that it meets these standards and is equivalent.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety and Effectiveness | Substantial equivalence to predicate devices regarding intended uses, indications, technological characteristics (wavelength, laser safety class, etc.), and principles of operation. Minor technological differences should raise no new issues of safety or effectiveness. | The BWF-5 Medical Laser Series is "as safe and effective as the predicate devices." It has "the same intended uses and similar indications, technological characteristics (such as wavelength, laser safety class, etc), and principles of operation as its predicate device. The minor technological differences between the BWF-5 Medical Laser Series and its predicate devices raise no new issues of safety or effectiveness." |
| Regulatory Compliance | 21 C.F.R. § 1040.10 & 1040.11 Performance Standards for Light Emitting Products. | Implied compliance by mention. |
| IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 (2nd Edition). | Implied compliance by mention. | |
| IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004). | Implied compliance by mention. | |
| IEC 60601-2-22 1995, 2nd Edition, "Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment". | Implied compliance by mention. | |
| IEC 60825-1 Ed. 2.0 (2007), Safety of laser products - Part 1: Equipment classification, and requirements. | Implied compliance by mention. |
Study Information (Based on Available Text)
Unfortunately, the provided document does not describe a clinical study or performance study that would typically involve a test set, experts, ground truth, or comparative effectiveness measurements for an AI/device performance. The 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, primarily through engineering specifications and adherence to recognized standards.
Here's a breakdown of what can be answered, and what cannot:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document does not describe a clinical performance study with a test set.
-
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 / Not provided. This information would be relevant to a performance study, which is not described here.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. This is relevant for studies involving human interpretation or performance evaluation, which is not described.
-
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. The document does not describe an MRMC study. This device is a laser system, not an AI-assisted diagnostic or interpretive tool that would typically involve comparing human reader performance with and without AI.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not provided. Given that this is a surgical laser device, "standalone algorithm performance" is not a relevant concept in the context of this 510(k). The device performs physical actions (laser light delivery for incision, excision, etc.), not algorithmic analysis.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. There is no described performance study requiring a ground truth for clinical outcomes. The "ground truth" for the 510(k) process is essentially compliance with engineering standards and demonstration of substantial equivalence.
-
The sample size for the training set:
- Not applicable / Not provided. This device is a laser hardware system, not an AI/machine learning algorithm that requires a "training set."
-
How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set for an algorithm, this question is not relevant to the information provided.
Conclusion:
The provided 510(k) summary for the LiteCure, LLC BWF-5 Medical Laser Series primarily demonstrates the device's substantial equivalence to predicate devices and adherence to relevant safety and performance standards (like IEC and CFR). It does not contain information about a clinical performance study with detailed acceptance criteria, test sets, expert adjudication, or AI performance metrics as these are not typically required for a device of this nature to achieve 510(k) clearance by demonstrating substantial equivalence.
§ 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.