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The LightScalpel LS-2010 SX, LS-2010 DX CO2 Laser Systems are intended for use intended for use in laser surgery procedures for incision, excision, vaporization, and/or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, orthopedic surgery, neurosurgery, podiatry, and urology.

Intended uses specific to the LS-2010 FX and LS-2010 DX in fractional mode are indicated by **.

Dermatology / Plastic Surgery:

Ablation, and Vaporization of soft tissue for performance of or treatment of: laser dermabrasion: laser burn debridement; wrinkles*, and furrows**; textural irregularities**; vascular dyschromia**; and benign pigmented lesions **

Intended uses specific to the LS-2010 SX and LS-2010 DX in surgical mode are listed below.

Dental Surgery:

Gingivectomy - Removal of hyperplasias; gingivoplasty; papillectomy; vestibuloplasty; epulis; sulcular debridement; removal of soft tissue, cysts, and fibroma (non-malignant tumor, mucosa, tongue); extraction site hemostasis; treatment of ulcerous lesions, including aphthous ulcers; a heat source to activate tooth bleaching materials: Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament no the root surface in the absence of long junctional epithelium).

Oral Surgery:

Frenum release/frenectomy; abscess (drainage); flap surgery; biopsy (incisional); aphthous ulcers (incision & excision); excision & ablation of lesions, benign lesions, oral cavity tumors, and hemangiomas; salivary gland pathologies; preprosthetic gum preparation, leukoplakia; partial glossectomy; periodontal gum resection; homeostasis; operculectomy; crown lengthening (soft tissue); incision when used with antibiotic therapy.

General and Thoracic Surgery:

Incision, excision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures for: debridement of decubitus ulcers, stasis, diabetic, and other ulcers; mastectomy; debridement of burns; rectal and anal hemorrhoidectorny; breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease, laparotomy and laparoscopic applications; mediastinal and thoracic lesions and abnormalities; skin tag vaporization; atheroma; cysts, including sebaceous and pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair: abscesses; other soft tissue applications.

Dermatology / Plastic Surgery:

Incision, Excision, Ablation, and Vaporization of soft tissue for performance of or treatment of: laser skin resurfacing: laser dermabrasion; laser burn debridement; wrinkles, rhytids, and furrows; textural irregularities; keratosis, including actinic and sebortheic keratosis, sebortheci wart, and verruca seborrheica; vermillionecomy of the lip; cutaneous horns; solar/actinic elastosis; cheilitis; including actinic cheilitis; lentigines, including lentigo maligna or Hutchinson's freckle; uneven pigmentation/vascular dyschromia;; surgical scars; keloids, including acne keloidalis nuchae; hemangiomas, including Buccal, port wine, and pyogenic granuloma, pyogenicum/granuloma telagiectatioum; tattoos; telangiectasias; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; benign pigmented lesions; adenosebaceous hypertrophy or sebaceous hyperplasia; thinophyma reduction; cutaneous papilloma (skin tags); milia; debridement of eczematous or infected skin; basal & squamous cell carcinoma. including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions: nevi, including spider, epidermal, and protruding; neurofibromas; laser de-epitheliomas; xanthelasma palpebrarum; syringoma; complete or partial natrixectomy; benign vascular/avascular skin lesions; Mohs surgery; lipectomy; verrucae and seborrhoecae vulgares, including; paronychial, periungual warts; blepharoplasty; and hair transplantation site preparation.

Gynecology / Genitourinary:

Incision, excision, ablation, and/or vaporization of soft tissue for treatment of: Conization of the cervix, including cervical intraepithelial neoplasia and vulvar and vaginal intraepithelial neoplasia; Condyloma, including cervical, genital, vulvar, perineal, and Bowenoid papulosa; leukoplakia (vulvar dystrophies); incision and drainage of Bartholin's and nabothian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; benign tumors; hemangiomas; benign lesions of external genitalia; condyloma; phimosis; erythroplasia.

Gyn Laparoscopic Surgery:

Laser incision, excision, vaporization, and photocoagulation of soft tissue for treatment of: endometrial lesions, including ablation for endometriosis; excision/lysis of adhesions; salpingotomy; oophorectomy; fimbrioplasty; metroplasty; uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy.

Otorhinolaryngology / ENT:

Laser incision, excision, ablation, vaporization, and / or photocoagulation of soft tissue in otorhinolaryngology for treatment of: leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue; adult and juvenile papillomatosis polyps; lymphangioma removal; removal of recurrent papillomas in the oral cavity, larynx, pharynx, and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue, and vocal cords; stenosis, including subglottic stenosis; tonsiller cryptolysis and neoplasma) and topsil ablation / tonsillotomy; benign tumors and fibromas (oral); superficial lesions of the ear, including chondrodermatits nondularis chronica helices / Winkler's disease;

uvulopalatoplasty (LAUP, laser UPPP); turbinate reduction / ablation; septal spur ablation/reduction. and septoplasty; partial glossectomy; tumor resection of oral, subfacial, and neck tissues; rhinophyma; verrucae vulgares (warts); gingivoplasty / gingivectomy

Podiatry:

Laser excision, ablation, and /or vaporization of soft tissue in podiatry for the reduction, removal and/or treatment of: Verrucae vulgares / plantar warts, including paronychial, periungual warts; fungal nail treatment: matrixectomy - partial and complete; porokeratoma ablation; neuromas/fibromas, including Morton's neuroma removal; ingrown toenail treatment; debridement of ulcers; treatment of other soft tissue lesions

Orthopedic Surgery:

Laser incision / excision, ablation, and /or vaporization of soft tissue in orthopedic surgery. Applications include: meniscectorny; chondromalacia ablation; chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy; debridement of traumatic wounds; debridement of decubitus & diabetic ulcers; and PMMA removal.

Neurosurgery:

Laser incision / excision, ablation, and /or vaporization of soft tissue in neurosurgery for the treatment of: posterior fossa tumors; peripheral neurectomy; benign tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors); arteriovenous malformation; and pituitary gland tumors (transphenoidal approach).

The LightScalpel LS-2010 SX, LS-2010 FX, and LS-2010 DX laser systems are mobile platforms that utilize a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength. Output parameters are summarized in Table 1. Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel.

A "calibration port" on the side of the laser systems allows checking and setting the power emitted from the distal laser aperture to the internal power meter and serves as a check on fiber waveguide transmission efficiency. Laser system power, rates, and durations are adjustable as tabulated below (7):

The laser systems have safety features complying with requirements in 21 CFR 1040. Performance Standards for Light Emitting Products.

Primary safety features are as follows:

System On-Off Keyswitch, Emergency Stop Switch, Remote Interlock, Fiber Interlock, Beam Blocking Shutter, Internal Laser Power Detector, RF Power Monitor, and required Laser Safety Labels and Labeling.

Laser system physical characteristics are: Delivery System:

LS-2010 SX, Flexible Fiber Waveguide; ~ 0.75mm ID, Handpieces with internal focusing lens ("tipless") and with disposable pre-sterilized ceramic tips.

LS-2010 FX & DX; Flexible Fiber Waveguide; ~ 0.50mm ID, Handpiece with internal beam steering galvanometers and laser diode aiming beam.

Purge Gas: Internal air pump purge through the Fiber and Handpiece.

System Cooling: Air; two thermostatically controlled fans with over-temperature protection.

Mobility: 4 wheels and handgrip on console for convenient system positioning.

This document is a 510(k) summary for the LightScalpel® LS-2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser Systems. It establishes substantial equivalence by comparing the device to predicate devices and provides non-clinical performance data.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable table as one might find for a software or diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices in several technological characteristics. The "performance" is implicitly deemed acceptable if these technological characteristics are sufficiently similar to those of legally marketed predicate devices.

The table below summarizes the technological characteristics compared across the new devices and predicate devices. The "reported device performance" is essentially the listed specifications of the LightScalpel LS-2010 SX, LS-2010 FX, and LS-2010 DX.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. The submission is for a laser surgical instrument, and the evaluation relies on a comparison of technological characteristics and non-clinical bench testing, not a clinical study with a patient "test set".
• Data Provenance: Not applicable in the context of patient data. The non-clinical performance data is generated internally by LightScalpel LLC through "electrical safety and output characteristics" testing (Bench Testing section). The country of origin of the data would be the US, where LightScalpel LLC is located. The data is prospective, generated specifically for this 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)

• Not applicable. This device is not an AI/diagnostic device that requires expert-established ground truth on a test set. The "ground truth" for the device's technical specifications is established through internal engineering and testing processes. The FDA's review process itself involves experts in medical device regulation and technology.

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

• Not applicable. There is no "test set" in the context of clinical images or patient cases requiring expert adjudication.

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 is a conventional CO2 laser surgical instrument, not an AI-assisted diagnostic or clinical decision support tool. Therefore, an MRMC study related to AI improvement is irrelevant.

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

• Not applicable. This device has no standalone algorithmic component for performance evaluation without human interaction. Its performance is directly tied to its physical operation and energy delivery.

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

• For the technical comparison: The "ground truth" for the comparison is the published technical specifications of the predicate devices, which have already gone through regulatory clearance and are considered substantially equivalent for their intended uses.
• For the new device's performance: The ground truth for the device's own reported performance values (e.g., power output, wavelength) is established through internal "electrical safety and output characteristics" bench testing, as stated in Section 8 of the summary. This would involve calibrated measurement equipment and adherence to recognized standards for laser performance testing.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. There is no training set for this device.

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The LightScalpel LS-1005 CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, podiatry, and urology.

Dental Procedures:

Gingivectomy - Removal of hyperplasias; Gingivoplasty; Papillectomy; Vestibuloplasty; Epulis: Sulcular Debridement; Removal of soft tissue, cysts, and fibroma (non-malignant turnor, mucosa, tongue); Extraction site hemostasis; treatment of ulcerous lesions, including aphthous ulcers; A heat source to activate tooth bleaching materials; Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium).

Oral Surgery Procedures:

Frenum Release/Frenectomy; Drainage (abscess); Flap Surgery; Biopsy (incisional & excisional); Aphthous Ulcers (incision & excision); Incision of Infection when used with antibiotic therapy; Excision & Ablation of lesions, benign & malignant lesions, oral cavity turnors, and hemangiomas; Salivary Gland Pathologies; Preprosthetic Gum Preparation, Leukoplakia; Partial Glossectomy; Periodontial Gum Resection; Homeostasis; Operculectorny; Crown Lengthening (soft tissue).

The LightScalpel LS-1005 laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 Watts Continuous Wave (CW). Laser energy is conducted to the point of application by a flexible fiber wavequide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.

The provided document is a 510(k) summary for the LightScalpel LS-1005 CO2 Laser System. This type of document is a premarket notification for new medical devices, demonstrating substantial equivalence to a legally marketed predicate device. It primarily focuses on comparing the new device's technological characteristics and intended use to existing, cleared devices.

As such, the provided text does not include information about acceptance criteria for device performance in the context of clinical or standalone studies using AI. It describes the device's technical specifications and safety standards, but not performance metrics like sensitivity, specificity, or accuracy that would typically be evaluated in a study demonstrating how well a device meets specific acceptance criteria that are relevant to an image-based AI medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC/standalone studies, as these aspects are not part of this 510(k) submission.

The document states:

• "Device performance evaluation did not involve Animal of Clinical Testing." (Page 4, Section 9)
• "The LightScalpel LS-10 CO2 Laser System has been evaluated for performance equivalent to predicate devices through a combination of (1) verification and validation tests per product requirements and specifications and (2) inspections and tests derived from applicable regulations and safety standards as noted below." (Page 4, Section 8)

This means the evaluation for this medical device primarily focused on meeting engineering and safety standards, and demonstrating substantial equivalence to existing devices through characteristic comparison, rather than through clinical performance studies with specific statistical acceptance criteria for diagnostic accuracy or similar metrics.

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The LightScalpel LS-10 CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, oral surgery, otorhinolaryngology, plastic & reconstructive surgery, podiatry, and urology.

The LightScalpel LS-10 laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO₂) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 Watts Continuous Wave (CW). Laser energy is conducted to the point of application by a flexible fiber wavequide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.

The provided document is a 510(k) Summary for the LightScalpel LS-10 CO2 Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the context typically seen for AI/ML medical devices.

The information primarily describes the device, its intended use, and a comparison of its technological characteristics to predicate devices. It does not contain the specific type of acceptance criteria and performance study details usually associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC, etc.).

Here's an attempt to extract relevant information based on the prompt, acknowledging the limitations of the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" appear to be defined by showing similar technological characteristics and performance to predicate devices and compliance with relevant safety and performance standards. The "reported device performance" is essentially the LightScalpel LS-10's specifications and features.

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

The document explicitly states: "Device performance evaluation did not involve Animal or Clinical Testing." This indicates there was no "test set" in the traditional sense of patient or sample data for evaluating clinical performance. The evaluation was based on verification and validation tests per product requirements and specifications, and inspections and tests derived from applicable regulations and safety standards. Details on the specific "sample size" of components tested or the nature of these verification/validation tests are not provided.

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

Not applicable, as no animal or clinical testing was conducted. The "ground truth" for demonstrating equivalence was based on meeting established engineering specifications and compliance with international standards, which would be assessed by engineers and regulatory experts, not clinical experts establishing ground truth for a medical image or diagnostic output.

4. Adjudication Method for the Test Set:

Not applicable, as no animal or clinical testing was conducted that would require an adjudication method by expert reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC study was not done. The device is a CO2 laser system, not an AI/ML diagnostic or assistive tool that would typically be evaluated with MRMC studies for human reader performance.

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

The concept of "standalone performance" as it relates to AI algorithms is not applicable here. The device is a surgical instrument. Its "performance" is inherent in its physical operation (e.g., power output, wavelength, safety features) and its ability to achieve the intended surgical effects when operated by a clinician.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to engineering specifications, safety standards, and the established performance characteristics of the predicate devices. For instance, the stated power output (2-10 Watts CW) is verifiable through direct measurement, representing its "ground truth" for that parameter. Compliance with standards like IEC 60601-2-22 serves as a "ground truth" for safety and essential performance requirements.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that undergoes "training." The device is a manufactured hardware system.

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

Not applicable, as there is no training set for this type of device.

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Intended use is to communicate the laser beam of a CO2 surgical laser to the target site for the incision, excision, ablation, or photocoagulation of soft tissue. Representative examples of indications for use:

Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts.

Dermatology – port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratosis, actinic keratosis and actinic cheilitis.

Dentistry/Oral Surgery – gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors

General Surgery - hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of deciditus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cyto-reduction for metastatic disease; many dermatological procedures.

Laparoscopic surgery – vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy.

Otorhinolaryngology - lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsillectomy, removal of vocal cord papillomas, nodules, and polyps.

Podiatry – plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment

Orthopedic - menisectomy, chondromalacia ablation, partial synovectomy, lateral release, PMMA removal

These tips are short, hollow lightpipes of alumina ceramic or stainless steel that provide a variety of spot sizes to target tissue when utilized in a mating laser handpiece.

The provided text describes a 510(k) submission for the LightScalpel family of handpiece tips for CO2 surgical lasers. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily due to a change in the sterilization method.

Here's an analysis of the acceptance criteria and supporting study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size for test set: Not explicitly stated in the provided text. The nonclinical performance data refers to "validation of sterilization parameters," which would involve a specific number of sterilization cycles and tests, but the exact sample size (e.g., number of test units) is not given.
• Data Provenance: The nature of the study (sterilization validation) suggests a controlled laboratory setting. The origin (e.g., country) of the tests or where the validation was performed is not mentioned. It is an internal study conducted by the manufacturer to support their 510(k) submission.

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

• Not applicable. This submission does not involve clinical data or expert evaluation of device performance in a diagnostic or treatment context that would require expert-established ground truth. The primary focus is on sterilization efficacy.

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

• Not applicable. There is no mention of adjudication, as the study is a nonclinical validation of sterilization rather than an assessment of subjective interpretations.

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:

• No. An MRMC study was not done. The device is a surgical laser handpiece tip, not an AI-assisted diagnostic or treatment system involving human readers.

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

• No. The device is a physical medical instrument, not a software algorithm.

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

• The "ground truth" for the sterilization validation would be a predetermined sterility assurance level (SAL), specifically 10⁻⁶ SAL. This is an objective, quantitative standard. The validation demonstrates that the chosen sterilization process consistently achieves this sterility level under defined conditions.

8. The sample size for the training set:

• Not applicable. This is a nonclinical validation study for a physical device, not a machine learning model that requires a training set.

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

• Not applicable, as there is no training set for a machine learning model.

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