(97 days)
In addition to previously cleared indications for use, the CoolTouch Model NS160 CoolLipo Nd: Y AG Surgical Laser is indicated for laser-assisted lipolysis.
CoolTouch CoolLipo The NS160 Nd: YAG Surgical Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with microcannula setup.
The provided document K072751 is a 510(k) Premarket Notification and primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study for a novel device. As such, it does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for performance studies.
The "study" mentioned is a "Nonclinical performance data" that produced results indicating the device is "effective for laser-assisted lipolysis." However, no specific metrics, acceptance criteria, or detailed study design are provided.
Here's an analysis based on the information available and why most of your requested points cannot be filled:
-
A table of acceptance criteria and the reported device performance:
- No specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc.) are provided in this 510(k) summary. The document establishes substantial equivalence based on the same indication for use, principle of operation, and similar wavelength/pulse energy rate to a predicate device (Cynosure SmartLipo Nd:YAG laser system K062321).
- The "reported device performance" is simply a general statement: "Nonclinical performance data produced results that indicate the Cooltouch NS160 CoolLipo laser system is effective for laser-assisted lipolysis." No quantitative data is offered.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No clinical test set data or sample size is mentioned. The submission relies on "Nonclinical performance data."
-
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. There is no mention of an expert panel or ground truth establishment for a test set.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set or adjudication process is 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:
- Not applicable. This device is a laser system, not an AI diagnostic tool involving human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser system, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No specific "ground truth" for clinical efficacy or performance is detailed, as the submission focuses on substantial equivalence based on known technology and "Nonclinical performance data."
-
The sample size for the training set:
- Not applicable. There is no mention of a "training set" of data, as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not applicable. As above, no training set is discussed.
Summary based on the provided text:
The submission K072751 for the CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser system is a substantial equivalence determination based on comparison to a predicate device (Cynosure SmartLipo Nd:YAG laser system K062321). The core argument is that the device has the "same indication for use, the same principle of operation, and essentially the same wavelength and pulse energy rate" as the predicate device.
The only "study" referenced is "Nonclinical performance data" that "produced results that indicate the Cooltouch NS160 CoolLipo laser system is effective for laser-assisted lipolysis." However, this is a general statement and lacks any specific data, metrics, or detailed methodology typically found in a clinical study report. The document does not provide acceptance criteria or detailed evidence of meeting them.
§ 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.