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Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties:

• · Dermatology
• · Cosmetic surgery
• · Plastic and general surgery
• · Oral surgery
• · Gynecology
• · Otorhinolaryngology
• · Podiatry

The Lite Touch™ is an Er:YAG Laser Treatment System intended for use in the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Gynecology; Otorhinolaryngology; and Podiatry.

The Lite Touch™ was previously cleared under K974460 in October 1997. This submission contains an expansion of the previously cleared indications for use. The Lite Touch™ consists of a streamlined, maneuverable cabinet that contains the laser source, control system, power supply and internal cooling system. The laser beam has a light wavelength of 2940nm and is delivered through a counterbalanced articulated arm and hand piece. There is a two stage process of dissimilar actions required to activate the laser beam. The operation of the Lite Touch™ are completely under the physician's control.

This document is a 510(k) summary for the Lite Touch™ Er YAG Laser Treatment System. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies to prove device performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., sample sizes, expert qualifications, MRMC studies) are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria or detailed device performance metrics in the way one might expect for an AI/device performance study (e.g., sensitivity, specificity, or accuracy targets). Instead, it focuses on demonstrating compliance with recognized safety and performance standards, and substantial equivalence to a predicate device based on technological characteristics.

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

This document describes a medical device clearance process based on demonstrating substantial equivalence to a predicate device and compliance with standards, not a clinical study involving a "test set" of patient data. Therefore, this information is not applicable and not provided.

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

Not applicable, as this is not a study requiring a ground truth established by experts on a test set of data.

4. Adjudication method for the test set

Not 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

Not applicable. This device is an Er:YAG laser system for surgical procedures, not an AI diagnostic tool that assists human readers.

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

Not applicable. The Lite Touch™ is a surgical tool, operated by a physician.

7. The type of ground truth used

Not applicable in the context of clinical performance evaluation studies for AI/diagnostic devices. The "ground truth" here is the device's adherence to engineering specifications and safety standards, and its perceived equivalence to an existing device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a 'training set.'

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

Not applicable.

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NaturaLase CO2 laser operating in tractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.

The NaturaLase CO2 is an RF excited CO2 laser. The main console of the NaturaLase CO2 laser system contains the following components:

• CO2 laser tube
• Power Supply
• Optical bench assembly
• Articulated Arm
• Hand-pieces: scanning and surgical
• Touch screen controller/user interface

The laser source is a sealed CO2 laser tube that is mounted vertically within the main cabinet and the laser beam is passed from the laser tube into the articulated arm. The NaturaLase CO2 laser unit is equipped with a switching-mode power supply, which converts the input line voltage to the high voltage required for laser operation. The optical bench assembly consists of the articulated arm mount, the aiming beam diode laser (3mW @ 650nm) and optics to align the laser beam and the aiming beam to the articulated arm. The laser energy is delivered through an articulated arm to a hand-piece (scanner or surgical) that distributes the laser energy on the target in a controlled and uniformed way. The user-interface microprocessor-based touch screen allows operator to control all operating functions.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "NaturaLase CO2 Laser System." This document aims to demonstrate the substantial equivalence of the new device to previously cleared predicate devices, rather than proving its performance against specific acceptance criteria for a new clinical indication or a new type of device requiring complex performance studies (like AI/ML-driven diagnostic devices).

Therefore, many of the typical acceptance criteria and study elements listed in your request (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, ground truth types for training data) are not applicable to this type of regulatory submission. This document focuses on showing that the NaturaLase CO2 Laser System operates similarly to predicate devices and does not introduce new questions of safety or effectiveness.

Here's how to address your request based on the provided document:

Acceptance Criteria and Device Performance

For a device like the NaturaLase CO2 Laser System seeking 510(k) clearance, the primary "acceptance criterion" is demonstrating substantial equivalence to existing predicate devices. This is achieved by showing that the new device has the same intended use and technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

The document demonstrates this through:

• Comparison of Technical Specifications: The core method of proving substantial equivalence is through direct comparison of the new device's technical specifications and operating principles with those of the predicate devices.
• Performance Testing (Bench Testing): The document refers to engineering verification and validation tests to ensure the device performs according to its own specifications and functions as intended, and conforms to relevant safety standards. This is not clinical performance testing against a disease state, but rather engineering and safety performance.

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

The "acceptance criteria" here are implicitly the parameters of the predicate devices a new device must match or fall within to demonstrate substantial equivalence, alongside compliance with relevant safety standards. The "reported device performance" are the specifications of the NaturaLase CO2 Laser System.

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NaturaLase PiQo4 - The NaturaLase Nd: Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module -is indicated for use in aesthetic applications for the following at the specified wavelength:

532 nm - Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

1064 nm - Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat tattoo colors: black, brown, green, blue and purple.

The NaturaLase PiQo4 laser is a Nd:YAG 1064 Q-Switched laser with 532 KTP Optics and Pulse Slicing Module. The 532 KTP Optics is available to convert the basic 1064 nm wavelength to 532 nm and the pulse slicing electro-optics allows diverting the leading and trailing portions of the laser pulse away from the delivery system for the purpose of shortening the pulse duration without reducing the peak power.

The NaturaLase PiO04 laser offers fast and efficient treatment of tattoos and benign pigmented lesions removal through a variety of spot sizes, fluences and repetition rates. The laser energy is delivered via an articulated arm with interchangeable hand-pieces. A liquid crystal display (LCD) provides visual feedback of control settings and operating parameters. The mechanism of action for tattoo or pigmented lesion removal lies in delivering laser energy at very high peak power.

The provided text is a 510(k) summary for a medical device (NaturaLase PiQo4 laser). It details the device's characteristics and its equivalence to a predicate device but does not describe a clinical study or acceptance criteria related to device performance in a clinical setting.

Instead, the "Testing Performance" section refers to engineering and safety performance testing. Therefore, I cannot extract the information required for the requested table and study details.

Here's how to interpret the available information:

• Acceptance Criteria and Reported Device Performance: This section would typically involve clinical metrics like success rates, adverse event rates, or specific measurements related to the intended clinical effect. The document does not provide this. The "Testing Performance" section mentions compliance with safety and electrical standards (IEC 60601-1, IEC 62366, 60601-1-6, 60601-2-22, IEC 60825-1) and biocompatibility (ISO 10993), as well as software verification and validation. These are engineering/safety criteria, not clinical performance criteria.

Therefore, most of your requested points cannot be answered from the provided text.

Here's a breakdown of what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided text does not describe a clinical study to prove the device meets clinical acceptance criteria. The "Testing Performance" section refers to engineering and safety testing, not clinical efficacy or effectiveness.

Therefore, the following cannot be answered from the provided document:

2. Sample size used for the test set and the data provenance: N/A (No clinical test set described)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A
4. Adjudication method for the test set: N/A
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: N/A (This device is a laser, not an AI diagnostic tool involving human readers)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an algorithm)
7. The type of ground truth used: N/A
8. The sample size for the training set: N/A
9. How the ground truth for the training set was established: N/A

Conclusion:

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (PicoWay Laser System, K142372) based on similar intended use, indications for use, technological characteristics, and safety testing. It explicitly states that "differences between the NaturaLase PiQ04 laser and predicate device in specific maximum energy levels and fluence delivered do not raise any new safety or effectiveness issues because the NaturaLase PiQo4 laser parameters fall within the range of parameters delivered by the predicate device."

This type of 510(k) submission typically relies on non-clinical performance data (like electrical safety, EMC, biocompatibility, and functional testing) and a comparison to a predicate device's established safety and effectiveness, rather than requiring a dedicated clinical study from the applicant to prove clinical acceptance criteria.

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The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue.

The NaturaLase CO2 is an RF excited CO2 laser. The laser energy is delivered through an articulated arm and with a scanner that distributes the laser energy on the skin in a controlled way with uniform distribution. The scanner design allows the system to ablate small micro spots of tissue. The system has the ability to deliver micro spots with a size of 120 microns and up to 45 mJ of optical energy per micro spot.

The NaturaLase CO2 Laser is a medical device, and this document does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria in the way artificial intelligence models are typically evaluated.

Instead, this is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device (Lutronic Mosaic eCO2 Laser System). For such devices, the "acceptance criteria" are generally that the device has the same intended use and fundamental technology as a legally marketed predicate device, and that it raises no new issues of safety and effectiveness.

Here's an analysis based on the provided text, addressing the points where information is available or relevant:

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

Since this is a medical device submission for substantial equivalence rather than an AI model evaluation, "acceptance criteria" are not reported as quantitative metrics with specific thresholds and device performance results in the same way. Instead, the "acceptance" is based on demonstrating equivalence to an existing, legally marketed device.

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: The document mentions "laser treatment of human skin" for histology data, but does not specify the number of human subjects or punch biopsies in the study.
• Data Provenance: The data is from "human skin," implying it's prospective ("treated" human skin). The country of origin is not specified, but the applicant (Focus Medical) is based in Bethel, CT, USA.

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

This type of information is not applicable to this document. The study described focuses on objective histological measurements (spot size, treatment depth, healing process) of laser effects on tissue, not on subjective interpretations requiring expert consensus for ground truth.

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

This information is not applicable. The study involves objective measurements of tissue response, not interpretive assessments that would require 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

This is not applicable. This document describes a medical device (laser system), not an AI algorithm. Therefore, an MRMC study related to AI assistance for human readers was not performed.

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

This is not applicable. This describes a physical medical device, not an algorithm.

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

The ground truth for the "histology data" study was based on objective measurements derived from punch biopsies, which falls under pathology/histology. These measurements included "spot size, treatment depth and the healing process."

8. The sample size for the training set

This is not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

This is not applicable for the same reasons as point 8.

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NaturaLase 980 Laser System is intended for laser assisted lipolysis. The NaturaLase 980 Laser System is intended for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, plastic surgery, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, orthopedics, pulmonology, thoracic surgery arthroscopy and podiatry.

The NaturaLase 980 Laser System is a diode laser system with 980 nm wavelength light.

The provided text is a 510(k) summary for the Focus Medical NaturaLase 980 Laser System. It outlines the device's description, indications for use, and its substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets specific performance metrics.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical performance studies with specific acceptance criteria in the same way a PMA (Pre-Market Approval) or de novo classification would. The "conclusion" section states: "The specifications, indications for use and performance of the NaturaLase 980 Laser System is substantially equivalent to the legally marketed predicate devices. It raises no new issues of safety and effectiveness and should be approved for marketing under the general controls provisions of the Federal Food, Drug, and Cosmetic Act." This indicates that the review focused on comparability rather than new performance testing against set criteria.

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NaturaLight IPL System (intense pulsed light) is indicated for: The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. The treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait. treatment of vascular lesions, including port wine stains, hemangiomas, telangiectasias, rosacea, facial and leg veins.

The Focus Medical NaturaLase LP Laser System and the NaturaLase LP+ System when used in Laser Mode is indicated for: General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue dermatology/plastic surgery, endoscopic/laparoscopic general surgerv. in gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology.

Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the NaturaLase LP is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The NaturaLase LP Laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery. The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The NaturaLase LP Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The NaturaLase LP Laser is indicated for use on all skin types (Fitzpatrick I - VI) including tanned skin.

Endoscopic/Laparoscopic Surgery: The Natural.ase LP Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied.

Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestinal hemostasis including varices, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, gastrointestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, and hemorrhoids.

General Surgery: Incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids.

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

Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis.

Hemostasis During Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.

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

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

Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.

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

Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets, vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).

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

The Focus Medical NaturaLase LP and NaturaLight Family of Products consists of the NaturaLase LP Nd: YAG Laser System, the NaturaLight IPL System and the NaturaLase LP+ a simple combination of the NaturaLase LP and the NaturaLight.

This document is a 510(k) premarket notification for a medical device submitted to the FDA in 2004. It outlines the device's summary and indications for use, but does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to predicate devices, not on performance studies with specific acceptance criteria.

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The 532 Hand Piece Adapter and the Dye Pack Accessories (Red or Yellow), when attached to the NaturaLase 1064 Laser, are indicated for: Tattoo removal Red inks (532 nm Hand Piece Adapter) Blue and light blue inks (Yellow Dye Pack) Green inks (Red Dye Pack) Treatment of Vascular Lesions - Using the 532 nm Hand Piece Adapter Port wine birthmark Telangiectasias Spider angiomas Cherry angiomas Spider nevi Treatment of Pigmented Lesions - Using the 532 nm Hand Piece Adapter Café-au-lait birthmarks Solar lentigines Senile lentigines Becker's nevi Freckles Nevus spilus Nevus of ota Incision, excision, ablation, and vaporization of soft tissue in dermatology - Using the 532 Hand Piece Adapter.

The Focus Medical 532 Hand Piece Adapter and the Dye Pack Accessory are accessories to the NaturaLase 1064 O-Switched laser. The 532 Hand Piece Adapter converts the 1064 nm laser energy of the NaturaLase to 532 nm laser energy. The Red Dye Pack Accessory converts the 532 nm laser energy to a red beam (595-660 nm) and the Yellow Dye Pack Accessory converts the 532 nm laser energy to a yellow beam (568 - 590 nm).

The provided text states: "Performance Data: None required. The claim of substantial equivalence is based on comparisons of specifications, characteristics, and indications for use of the claimed predicates."

Therefore, based on the input document, no specific acceptance criteria or study data demonstrating the device meets such criteria are provided. The device's submission relied on substantial equivalence to predicate devices rather than direct performance data.

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The Focus Medical NaturaLase LP Laser is indicated for: General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology. Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the NaturaLase LP is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The NaturaLase LP Laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery. The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The NaturaLase LP Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The NaturaLase LP Laser is indicated for use on all skin types (Fitzpatrick I - IV) including tanned skin. Endoscopic/Laparoscopic Surgery: The NaturaLase LP Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied. Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestinal hemostasis including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, gastrointestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, and hemorrhoids. General Surgery: Incision, excision, vaporization, ablation, and hemostasis of soft tissue 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, tonsillectomy, and hemorrhoids. Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum. Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis. Hemostasis During Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures. Neurosurgery: Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma. Oculoplastics: Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents. Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications. Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy). Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).

The Focus Medical NaturaLase LP Laser in a long-pulse Nd: YAG Laser operating at 1064 nm.

This document approves the Focus Medical NaturaLase LP Laser as substantially equivalent to predicate devices. However, it explicitly states "Performance Data: None required," and does not include any studies or acceptance criteria for device performance. Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them.

The information relevant to your request is the clear statement: "The claim of substantial equivalence is based on comparisons of specifications, characteristics, and indications for use of the claimed predicates. Performance Data: None required."

This means that:

• Acceptance Criteria: No specific performance metrics or acceptance criteria are detailed in this document. The device's approval is based on its similarity to existing, legally marketed devices.
• Study Proving Acceptance Criteria: No study demonstrating the device meets specific acceptance criteria is provided or referenced in this submission.

Therefore, a table of acceptance criteria and reported device performance, details on sample sizes, ground truth establishment, expert involvement, adjudication methods, MRMC studies, or standalone performance are explicitly stated as not required and thus not present in the provided text.

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alone or in combination with an adjuvant lotion for the removal or lightening of unwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair without the adjuvant lotion;

in combination with an adjuvant lotion for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery;

dermal pigmented lesions (dermal melanocytosis); and

for tattoo removal (dark and blue inks).

The adjuvant lotion is a suspension of carbon powder in a base of Light Mineral Oil, NF.

The LT-100 will be limited to use by licensed professionals (as provided in 21 CFR 801.109).

The LT-100 Laser Treatment System is a Q-Switched Nd:YAG which emits its energy at 1064 nm.

This document is a 510(k) summary of safety and effectiveness for the LT-100 Laser Treatment System. It states that performance data was not required for this device because its specifications and intended uses are the same as or very similar (substantially equivalent) to those of the claimed predicate devices (ThermoLase SoftLight, Continuum Biomedical, Inc., Medlite™ and Medlite™ IV Q-Switched Nd:YAG Lasers). Therefore, there is no study provided within this document that details acceptance criteria and device performance in the way typically expected for novel devices requiring clinical validation.

As a result, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The core of the submission is a claim of substantial equivalence, meaning the FDA did not require new performance data to be submitted for this device.

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