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The SLIM Evolution II CO2 Laser and delivery device accessories are intended for use in surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Dermatology, Plastic Surgery and General Surgery procedures.
Laser skin resurfacing
Treatment of furrows and wrinkles
Removal of skin tags, actinic keratosis, acne scars, keloids, tattos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.
Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
Blepharoplasty
Site preparation for hair transplants
MiXto fractional scanner only for treatment of wrinkles and skin resurfacing

Dental procedure including.
Periodontal procedures such as - gingivectomy, removal of hyperplasias, gingivoplasty (incision and excision)
Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign/malignant lesion ablation, operculectomy and homeostasis

Podiatry procedures.
Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.

Otorhinolaryngology (ENT) procedures.
Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.

Gynecology
Treatment of condyloma acuminata, cervical intraevithelial neoplasia. leukoplakia and vulvar/vaginal intraepithelial neoplasia. cervical dysplasia.
Laparoscopic treatment endometrial lesions, ablation of endometriosis, fimbroplasty, Tubal microsurgery, salpingostomy, histerectomy, uterine myomas and fibroids

SLIM Evolution II CO2 Laser and Delivery Device Accessories.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a medical device called "SLIM Evolution II CO2 Laser and Delivery Device Accessories."

It mainly discusses:

• The FDA's determination of substantial equivalence to predicate devices.
• Regulatory requirements and general controls provisions.
• Specific indications for use of the device across various medical specialties (Dermatology, Plastic Surgery, General Surgery, Dental, Podiatry, Otorhinolaryngology, Gynecology).

There is no mention of:

• Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
• A study design (e.g., test set, sample size, data provenance).
• Ground truth establishment details (experts, adjudication, type of ground truth).
• Standalone algorithm performance or human-in-the-loop studies.
• Training set details.

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The SLIM Evolution Family of CO2 Lasers and delivery device accessories are intended for use in surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -

Laser skin resurfacing

Treatment of furrows and wrinkles

Removal of skin tags, actinic keratosis, acne scars, keloids, tattos,

telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.

Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. Blepharoplasty

Site preparation for hair transplants

Dental procedure including but not limited to -

Periodontal procedures such as -- gingivectomy, removal of hyperplasias,gingivoplasty (incision and excision) Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign/malignant lesion ablation, operculectomy and homeostasis

Podiatry procedures including but not limited to -

Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.

Otorhinolaryngology (ENT) procedures including but not limited to -

Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.

Gynecology

Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia. Laparoscopic treatment endometrial lesions, ablation of endometriosis, fimbroplasty,

Tubal microsurgery, salpingostomy, histerectomy, uterine myomas and fibroids

The SLIM Evolution Family of CO2 Lasers emit a beam of coherent light at the wavelength 10.6 microns in either continuous wave or pulse mode. Each laser consists of a self-contained console, an articulated arm delivery system, a footswitch, safety goggles and warning label set. The main console contains a DC-excited sealedoff CO2 gas tube, micro-controller, articulated arm mount, internal closed circuit cooling system and power supply. The console has an on-off key switch and emergency stop push button. The articulated arm connects the console to focusing handpieces, waveguides, scanner and micromanipulator delivery accessories. Refer to the enclosed brochure and instruction manual for complete published information.

1. Table of Acceptance Criteria and Reported Device Performance:

   The provided document does not specify quantitative acceptance criteria or provide
   performance metrics for the SLIM Evolution Family of CO2 Lasers. The submission states
   "Performance Data: None provided" and "Clinical Data: None provided."
   Therefore, a table of acceptance criteria and reported device performance cannot be
   generated from the provided text.

2. Sample Size Used for the Test Set and Data Provenance:

   Not applicable. The document explicitly states "Performance Data: None provided" and
   "Clinical Data: None provided." This indicates that no specific test set data was
   used or presented for the device's performance evaluation in the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

   Not applicable. As no performance or clinical data was provided, no ground truth
   establishment for a test set was conducted or reported in this submission.

4. Adjudication Method for the Test Set:

   Not applicable. No test set or associated adjudication method was mentioned or
   described in the provided document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

   Not applicable. The document concerns a CO2 laser device for surgical
   applications, not an AI-powered diagnostic or assistive technology for human readers.
   Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   Not applicable. The device is a physical CO2 laser system, not an algorithm.
   Standalone algorithmic performance is not relevant to this type of medical device submission.

7. The Type of Ground Truth Used:

   Not applicable. No performance or clinical data was provided, so no type of ground
   truth was used or documented in this submission. The device's substantial
   equivalence was based on comparison to legally marketed predicate devices, not on
   independent performance testing against a defined ground truth.

8. The Sample Size for the Training Set:

   Not applicable. The device is a physical CO2 laser system. There is no mention of a
   training set in the context of machine learning or algorithm development.

9. How the Ground Truth for the Training Set Was Established:

   Not applicable. As there is no training set for an algorithm, the establishment of
   ground truth for such a set is not relevant to this submission.

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The Velure Family of Diode Lasers are intended for use in dermatology, hair removal, oral, periodontal and surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue.

Velure S5 532nm (Green) Diode Laser Applications: Vascular Lesions, Pigmented Lesions

Velure S8/15, Velure S8/30 and Velure S800 808nm Diode Laser Applications: Vascular Lesions, Unwanted Hair Removal

Velure S9/15, Velure S9/30 980mm Diode Laser Applications: Surgical Cut and coagulate General Surgery GYN ENT Neuro Urgology

Velure S9/7D and Velure S9/15D 980nm Diode Laser Applications: Oral and Periodontal Surgery, Bleaching (tooth whitening)

The Velure Family of Diode Lasers emit a beam of coherent light in either continuous wave or pulse mode at the following wavelengths: 523nm - Velure S5, 808nm - Velure S8/15, Velure S8/30 and Velure S800, 980nm - Velure S9/7D, Velure S9/15, Velure S9/15D and Velure S9/30. Each laser consists of a self-contained console, an SMA fiber delivery system with handpiece, a footswitch, safety goggles and warning label set. The main console contains a Diode laser, a 635nm pilot laser, micro-controller, air cooling system and power supply. The console has an on-off key switch and emergency stop push button. The SMA fiber delivery system connects the console to a variety of fiber optic handpieces and scanner (Velure S5 only).

The provided document is a 510(k) summary for a medical device called the "Velure Family of Diode Lasers and Delivery Device Accessories." This type of submission to the FDA is typically used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study with detailed statistical outcomes.

Based on the content of the document, here's an analysis of the requested information:

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

The document does not provide a table of acceptance criteria or specific performance data from a clinical trial that would typically be used to demonstrate the device meets such criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "Performance Data" section explicitly states: "None provided."

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

No test set sample size is mentioned because no clinical performance study demonstrating acceptance criteria was conducted or provided in this summary.

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

Not applicable, as no ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable, as no test set requiring 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. This device is a laser system, not an AI-assisted diagnostic or imaging device used by readers. No MRMC study was conducted or is relevant.

6. 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.

7. The type of ground truth used

Not applicable, as no ground truth for a clinical study is described. The "ground truth" for this 510(k) summary is based on the performance and safety profiles of the predicate devices.

8. The sample size for the training set

Not applicable, as no training set for an algorithm is described.

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

Not applicable, as no training set for an algorithm is described.

Summary of the Document's Approach to Acceptance:

The "Velure Family of Diode Lasers and Delivery Device Accessories" received a 510(k) clearance by demonstrating substantial equivalence to existing legally marketed predicate devices, specifically the Adept Ultralite 532 (K042496) and the Intermedic Diode Laser Family (K053540).

The key "proof" of acceptance in this context is the FDA's letter stating: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

The document explicitly states:

• "Performance Data: None provided" (page 2)
• "Clinical Data: None provided" (page 2)

Therefore, the acceptance of this device for marketing in the US was based on a comparison of its design, materials, intended use, and technological characteristics to existing predicate devices, rather than on new clinical studies showing specific performance metrics against pre-defined acceptance criteria. The assumption is that if it's substantially equivalent to already approved devices, it is equally safe and effective.

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