Search Results

For CoolTouch VariaBreeze™ with CoolBreeze® Handpiece: Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. For CoolTouch VariaBreeze™ with Toenail Handpiece: Indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The CoolTouch VariaBreeze Laser System is an Nd: YAG laser using a flashlamp-pumped solid state laser rod to produce laser emission at 1064 nm. The laser consists of a cabinet that houses the following: Control panel with microcontroller and emergency stop button, standby button, ready button, and key switch; Connector port for fiber optic delivery system; Remote interlock connector; 630 to 680 nm diode aiming beam; Power supply; Cooling system; Connector port for footswitch and power cord. Delivery devices for the VariaBreeze include: CoolBreeze Handpiece for CoolBreeze Mode—Contains non-replaceable fiber optic within a flexible cable connected to the laser. A standoff at the tip allows for non-contact use, and a control dial is used to set the spot size from 2mm to 10mm. The handpiece also has cryogen for topical cooling. The handpiece is cleanable and reusable. Toenail Handpiece for Toenail Mode—The fiber optic cable attaches to the laser. The handpiece features a standoff at the tip to provide the correct placement for laser delivery to the treatment site and is reusable and cleanable.

This submission pertains to the CoolTouch VariaBreeze Nd:YAG Surgical Laser system.

The provided document does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with performance metrics. This is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through new clinical data.

Specifically, the document states:

• "Nonclinical Performance Data: None"
• "Clinical Performance Data: None"

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions about sample sizes, ground truth establishment, or multi-reader multi-case studies, as these types of studies were not conducted or reported in this 510(k) submission.

The "study" referenced in this 510(k) is a comparison to predicate devices to demonstrate technological equivalence. The conclusion drawn is: "The CoolTouch VariaBreeze Nd:YAG Laser System is substantially equivalent to the predicate devices for the indications requested."

Here's what can be extracted based on the provided text, addressing the relevant points:

1. A table of acceptance criteria and the reported device performance:
   As stated above, no specific acceptance criteria or de novo device performance data from a dedicated study are present in this 510(k) summary. The "performance" assessment is primarily a comparison of technological characteristics to predicate devices.

   Characteristic (Predicate vs. New Device)	CoolTouch Varia Laser System (K092964)	CoolTouch Varia Breeze Laser System (K103338)	Patholase PinPointe FootLaser (K093547)	CoolTouch Varia Breeze Laser System (K103338)
   Laser Medium	Nd:YAG	Nd:YAG	Nd:YAG	Nd:YAG
   Wavelength	1064 nm	1064 nm	1064 nm	1064 nm
   Aiming Beam	532 nm	532 nm	630-680 nm	532 nm
   Output Power (max)	36W max	30W	6W	30W
   Energy per Pulse	Variable to 3.9 Joules	20-200 mJ, 500-1000 mJ	20-200 mJ	20-200 mJ, 500-1000 mJ
   Pulse Duration	600 µsec	100-700 µsec	100-700 µsec	100-700 µsec
   Exposure	Single pulse or repeat for continuous burst	Continuous	Continuous	Continuous
   Repetition Rate	6-200 Hz	5-100 Hz	5-100 Hz	5-100 Hz
   Spot Size	2 - 10 mm	2 - 10 mm	1 mm (published)	1 mm (for Toenail Handpiece) and 2-10mm (for CoolBreeze Handpiece)
   Dimensions	31"H x 18"W x 21"D	31"H x 18"W x 21"D	14"H x 7"W x 16"D	31"H x 18"W x 21"D
   Weight	160 lbs (73kg) console	160 lbs (73 kg) console	36 lbs (16kg) console	160 lbs (73 kg) console
   Power Requirements	115VAC, 230VAC, 50/60Hz	115VAC, 230VAC, 50/60Hz	90-130VAC, 200-240 VAC, 50/60 Hz	115VAC, 230VAC, 50/60Hz

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   No test set clinical data was provided or referenced. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."

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, as no test set requiring expert ground truth was utilized or reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no test set requiring adjudication was utilized or reported.

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 system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this device is a laser system and does not involve algorithms or AI for standalone performance evaluation in this context.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
   Not applicable, as no clinical studies requiring ground truth were conducted or reported.

8. The sample size for the training set:
   Not applicable, as no training set for an algorithm was used or reported.

9. How the ground truth for the training set was established:
   Not applicable, as no training set was used or reported.

In summary, the CoolTouch VariaBreeze Nd:YAG Surgical Laser system received 510(k) clearance based on its substantial equivalence to previously cleared predicate devices through a comparison of their technological characteristics, rather than through new clinical performance studies.

Ask a specific question about this device