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The soft tissue applications are for the coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissues including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

Dermatology: For hair removal (destruction of hair follicles) in all skin types and for coagulation and hemostasis of vascular lesions and soft tissue applications. In addition to the tissue types cited, pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; for patients with lesions that have not responded to other laser treatments. Also for the treatment of fine lines and wrinkles.

Endoscopic/Laparoscopic General Surgery: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic, laparoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy.

Gastroenterology: Tissue ablation and hemostasis in the Gl tract; esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; GI hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding ulcers, gastric erosions, GI tissue ablation, including benign and malignant neoplasms, angiodysplasia; polyps, ulcer, colitis, and hemorrhoids.

General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation.

Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intrauterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine spetum.

Head and Neck/Otorhinolaryngology (ENT): Coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissue.

Hemostasis during surgery: Adjunctive coagulation and hemostasis (control of bleeding) during surgery (endoscopic, laparoscopic, and open procedures).

Neurosurgery: Hemostasis of pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma.

Oculoplastics: Incision, excision, vaporization, ablation, and coagulation of soft tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation of the eyeball, exteneration of orbital contents.

Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthoscopic applications.

Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue.

Pulmonary/Thoracic Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.

Thoracic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue, including lung tissue, in thoracic applications including but not limited to isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets.

Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma accuminata).

Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neromas.

The CoolTouch Varia Laser System is an Nd:YAG laser producing laser emission at 1064 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 fiber optic handpiece setup.

The provided text is a 510(k) Premarket Notification for the CoolTouch Varia Nd:YAG Surgical Laser system. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials to prove efficacy against specific acceptance criteria. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of a new, independent clinical study are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices, meaning it has the same intended use and technological characteristics as one or more legally marketed devices.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics in the traditional sense for a new clinical study. The "acceptance criteria" for a 510(k) submission is that the device is "substantially equivalent" to predicate devices. This is achieved by demonstrating the same intended use and similar technological characteristics.
• Reported Device Performance: The primary "performance" reported is that "The CoolTouch Varia has the same principle of operation, the same wavelength and essentially the same pulse energy rate as the predicate devices." This is a statement of technological similarity to the predicates, not a measured performance against pre-defined clinical thresholds.

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 states "Clinical Performance Data: None requested at this time." This indicates that no clinical test set was used for this 510(k) submission.

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)

• Since no clinical test set was used, no experts were used to establish ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Since no clinical test set was used, no adjudication method was applicable.

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

• This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, no MRMC comparative effectiveness study was done, and this question is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This device is a surgical laser, not an algorithm. Therefore, no standalone algorithm performance study was done, and this question is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Since no clinical test set was used, no ground truth was established for the purpose of evaluating device performance in a clinical study. The ground for "substantial equivalence" is the regulatory approval of predicate devices.

8. The sample size for the training set

• Since no machine learning algorithm or AI component is mentioned, there is no training set in the context of this 510(k) submission.

9. How the ground truth for the training set was established

• As there is no training set, this question is not applicable.

In summary, this 510(k) submission relies on demonstrating substantial equivalence to already approved predicate devices based on technological characteristics and intended use, rather than presenting new clinical study data with predefined acceptance criteria.

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The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles.

The CoolTouch, Inc. CoolTouch "Varia" Nd:YAG Surgical Laser is a laser producing emissions at 1064nm. The lasers consist of several interconnected sections: the cabinet, which houses the power supply, cooling system, microcontroller, and the laser head, the fiber optics, and the handpiece. The systems provide safety features that are designed to protect the user and patient from high voltages and laser emissions.

This document, a 510(k) Summary of Safety and Effectiveness for the CoolTouch "Varia" laser system, primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical studies against acceptance criteria in the manner typically seen for novel diagnostic or AI-driven devices.

Therefore, many of the requested sections (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC study details, ground truth types) are not applicable or not present in the provided text.

Based on the available text, here is the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not list specific clinical acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or a reduction percentage in wrinkles) that the device was tested against. Instead, it states compliance with regulatory standards and claims substantial equivalence to a predicate device for its intended use.

The document asserts that the device is "substantially equivalent to the cited legally marketed predicate device for the indications requested." |

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. The document does not describe a clinical study with a "test set" in the context of evaluating performance against specific metrics. The claim is based on substantial equivalence, which typically involves demonstrating similar technological characteristics and intended use to an already approved device, rather than new clinical outcome data against set statistical criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. As no specific clinical performance study with a test set generating a ground truth is described, this information is not present.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical performance study with adjudication is described.

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/Not provided. This device is a laser system for dermatological applications, not an AI-driven diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable/Not provided. This is a hardware laser system, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided. No ground truth in the context of clinical performance evaluation is described. The "ground truth" for the submission is the regulatory acceptance of the predicate device for its specified indications.

8. The sample size for the training set

Not applicable/Not provided. This is a laser hardware system, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable/Not provided. As this is not an AI/ML device, the concept of a training set and its ground truth is not relevant.

Ask a specific question about this device

Ask a specific question about this device