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The Onycho Laser V is 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 Onycho Laser V' is a compact device that is positioned on the floor and is operated via a 7.0 inch TFT touch screen for ease of use. The device incorporates lasers and outputs light at two wavelengths, 405 nm and 635 nm, in order to achieve its therapeutic effect.

The provided text is a 510(k) premarket notification for the Onycho Laser V, a device used for the temporary increase of clear nail in patients with onychomycosis.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., x% accuracy, y sensitivity). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (AF Laser, K221363) through technological comparison and adherence to recognized standards. The "performance" in this context refers to the device meeting these standards and having similar technological characteristics and indications for use as the predicate.

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 does not describe a clinical study with a test set involving human subjects for assessing the device's efficacy in treating onychomycosis. The demonstration of substantial equivalence relies on non-clinical testing (electrical safety, EMC, laser safety, biocompatibility, software validation) and comparison to a legally marketed predicate device.

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

Not applicable, as no clinical study with a test set requiring expert ground truth establishment is described.

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

Not applicable, as no clinical study with a 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. The device is a laser for direct treatment of onychomycosis, not an AI-assisted diagnostic tool that would involve human readers.

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

Not applicable. This is a physical laser device, not an algorithm, and its performance is evaluated through non-clinical testing and comparison to the predicate's established safety and effectiveness.

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

For the non-clinical tests, the "ground truth" is defined by the requirements of the international consensus standards (IEC, ISO) for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility. Passing these tests demonstrates conformity to the established safety and performance benchmarks within those specific domains. For the claim of efficacy, it relies on the "ground truth" established by the predicate device's prior clearance for the same indication.

8. The sample size for the training set

Not applicable, as 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, as this is not an AI/machine learning device.

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The TFX-LT2000 Therapy Light device is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Not Found

This document is a 510(k) clearance letter for the ToeFX, Inc. TFX-LT2000 Therapy Light, a Class II medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The information provided (the FDA clearance letter) focuses on regulatory aspects such as:

• Confirmation of substantial equivalence to a predicate device.
• Regulatory class and product code.
• General controls and compliance requirements for medical devices.
• Indications for Use statement.

There is no mention of:

• Specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy).
• Any performance study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance).

Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study proving the device meets them based on the provided text. The document indicates regulatory clearance based on substantial equivalence, not detailed performance study data.

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The AF Laser device is 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 AF Laser is a medical laser used to treat nail fungus (onychomycosis) and promote the growth of healthy nails. The operating mechanism of this device is photochemical reaction that uses two wavelengths -- 635nm and 405nm. The AF laser is a compact, all-in-one device that is intended to be used on the floor and is operated by an intuitive 10.2 inch's wide LCD screen for ease of use. An LCD monitor incorporated into the deck of the device helps the operator check the exact location of treatment area during a procedure.

This document describes the FDA's 510(k) clearance for the AF Laser, a device intended for the temporary increase of clear nail in patients with onychomycosis.

Based on the provided text, the acceptance criteria and study proving the device meets these criteria can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the AF Laser is "substantially equivalent" to its predicate device, the LunulaLaser (K153164). The acceptance criteria appear to be met by demonstrating this substantial equivalence, rather than through specific performance metrics outlined in a dedicated clinical study against a predefined threshold.

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

The document explicitly states: "No Clinical testing was conducted as part of this submission." Therefore, there is no test set of clinical data from human subjects in the traditional sense for evaluating device performance against acceptance criteria for clinical efficacy. The submission relies on a comparison to a predicate device and engineering/bench testing.

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

Since no clinical testing was performed, there was no clinical test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

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 for direct treatment, not an AI-assisted diagnostic tool for human readers.

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

Not applicable, as this is not a diagnostic algorithm. Performance was assessed through engineering and safety standards compliance, and comparison to the predicate device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission appears to be the established safety and efficacy profile of the legally marketed predicate device (LunulaLaser K153164) and compliance with international safety and performance standards for laser devices.

8. The Sample Size for the Training Set:

Not applicable. As this is not a machine learning or AI device, there is no "training set."

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

Not applicable.

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The REMY device emits energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm: the temporary increase in local blood circulation; and the temporary relaxation of muscle.

The REMY is intended for use in Podiation, vaporization, incision, and coagulation of soft tissue) including periungual, subungual, and plantar warts.

The REMY is also indicated for use for the temporary increase of clear nail in patients with onychomycosis including dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc., and for the temporary increase of clear nail in patients with onychomycosis including dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc..

Not Found

The provided text is an FDA 510(k) clearance letter for the REMY Medical Therapy Laser System. This document is a regulatory communication and does not contain information about specific acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The letter confirms that the REMY Medical Therapy Laser System has been found substantially equivalent to pre-amendment devices or previously cleared predicate devices for its stated indications for use. This regulatory review primarily focuses on safety and effectiveness claims based on equivalence to existing devices, rather than requiring new clinical performance studies with specific acceptance criteria as might be seen for novel devices.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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The LunulaLaser™ device is indicated for use for the temporary increase of clear nail in patients with onychomyosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

Not Found

This document is a 510(k) clearance letter for the LunulaLaser, a Class II medical device. It does not provide information on acceptance criteria or a study that proves the device meets those criteria. Instead, it confirms that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indication of temporary increase of clear nail in patients with onychomycosis.

Therefore, I cannot extract the requested information based on the provided text. The document is administrative in nature, approving the device for marketing based on substantial equivalence, rather than detailing a performance study with acceptance criteria.

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Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: Matrixectomy, periungual and subungual warts, neuromas, and plantar warts. The VelasII is also 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.).

Not Found

The provided document is a 510(k) premarket notification letter for the VELASII Laser System, indicating substantial equivalence to predicate devices. It lists the device's indications for use but does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications for a device performance validation.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval and classification, not on the technical performance specifics or clinical trial data that would demonstrate acceptance criteria being met.

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810 nm and 980nm wavelength:

LiteCure Therapy System, Model L TS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

980nm wavelength:

LiteCure Therapy System, Model L TS-1500 is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.).

Not Found

The provided text focuses on the FDA's 510(k) clearance for the LiteCure Therapy System, Model LTS-1500. This is a regulatory document and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

Specifically, the document performs the following functions:

• Confirms 510(k) clearance: States that the device is substantially equivalent to a legally marketed predicate device.
• Lists device names and regulatory information: Provides the Trade/Device Name, Regulation Number, Regulation Name, and Regulatory Class.
• Defines Indications for Use: Specifies the medical conditions and purposes for which the device is intended (e.g., pain relief, increased local blood circulation, temporary increase of clear nail in onychomycosis).
• Provides regulatory guidance: Reminds the manufacturer of ongoing responsibilities under the Act.

The document does NOT contain any information about:

• Acceptance criteria: No specific metrics (e.g., sensitivity, specificity, accuracy, or a defined therapeutic outcome threshold) are mentioned.
• Device performance metrics: No reported performance data (e.g., how much pain relief was achieved, or the percentage increase in clear nail).
• Details of a study: No information on study design, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, based solely on the provided text, I cannot complete the table or answer the specific questions about the study that proves the device meets acceptance criteria. The FDA 510(k) clearance process primarily evaluates substantial equivalence to a predicate device, and while it requires evidence of safety and effectiveness, the detailed study results and acceptance criteria are typically found in the 510(k) submission itself (which is not provided here), rather than in the final clearance letter.

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Er:YAG laser (2940 nm wavelength) in dentistry:
Intra-oral soft tissue surgery (incision, excision, ablation coagulation)

• Leukoplakia
• Pulpotomy as adjunct to root canal retreatment
• Pulp extirpation
• Removal of fibromae
• Removal of granulated tissue
• Caries removal, cavity preparation, enamel roughening -Sulcular debridement
• Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement
• Cutting, shaving, contouring and resection of oral osseous tissue (bone)
• Osteotomy, osseous crown lengthening, osteoplasty
• Apicectomy surgery
• Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curetage

Er:YAG laser (2940 nm wavelength) in dermatology and other surgical areas:

• Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing;
• ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
• Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectorny;
• General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation;
• Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectorny;
• Ophthalmology Indications: Soft tissue surrounding the eye;
• Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;

Nd:YAG laser (1064 nm wavelength) in dentistry:

• Excisional and incisional biopsies
  Excision and vaporization of herpes simplex I and II
• Exposure of unerupted teeth
  Fibroma removal
  Frenectomy and frenotomy
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis Implant recovery
  Incision and drainage of abscess
  Laser assisted uvulopaletoplasty (LAUP)
• Operculectomy
  Oral papillectomies
• Pulpotomy and pulpotomy as an adjunct to root canal therapy
• Reduction of denture hyperplasia
• Reduction of gingival hypertrophy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
• Removal of post-surgical granulations
  Soft tissue crown lengthening
  Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility)
• Tissue retraction for impression Treatment of aphtous ulcers
  Vestibuloplasty

Nd: YAG laser (1064 nm wavelength) in dermatology and other surgical areas:

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
  Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins
  Treatment of wrinkles
  Treatment of mild to moderate inflammatory acne vulgaris
  General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal.
  Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy
  Periungual and subungual warts
  Plantar warts
  Radical nail excision
  Neuromas
  The Fotona Light Walker Laser System Family is 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 Fotona Light Walker Laser System Family is based on Er: YAG (2940 nm) and Nd: YAG (1064 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er: YAG and Nd: YAG crystals. A red diode aiming beam (650 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical manual or scanner hand piece (in the case of the Nd: YAG laser). Optionally, the Nd: YAG therapeutic and aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end. Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows control of the laser pulse duration. The user activates laser emission by means of a footswitch.

This submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a performance study against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a performance study is not available in this document.

The document states: "The Fotona LightWalker Er:YAG/Nd:YAG Laser System Family is substantially equivalent to Fotona LightWalker Laser System Family (K101817), Fotona Fidelis III Er:YAG/Nd: YAG Laser System Family (K093162), Fotona Dynamis Er:YAG/Nd:YAG Laser System Family (K101306), Fotona XP Nd:YAG Laser System Family (K090126) and (K113702), Cutera GenesisPlus Laser System (K103626) and PinPointe FootLaser (K093547). The Fotona LightWalker Er: YAG/Nd:YAG Laser System Family is substantially equivalent in terms of indications for use and technology based on technical characteristics."

This means the "study" demonstrating the device meets "acceptance criteria" (in the context of a 510(k)) is the comparison of technical specifications and intended uses to already cleared predicate devices. The "acceptance criteria" are effectively the specifications and intended uses of those predicate devices.

Here's the information that can be extracted, with explanations for what is not applicable or not provided:

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are the technical specifications and intended uses of the predicate devices. The "reported device performance" is the new device's technical specifications.

Table of Comparison for Nd:YAG Laser Wavelength

Table of Comparison for Er:YAG Laser Wavelength

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

• Not Applicable / Not Provided. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" in the traditional sense for evaluating diagnostic performance or clinical outcomes. The "test" is the comparison of technical specifications and intended uses.

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 / Not Provided. No "ground truth" for a performance study was established as part of this submission. The "ground truth" for substantial equivalence is the FDA's prior clearance of the predicate devices.

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

• Not Applicable / Not Provided. There was no "test set" requiring 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 / Not Provided. This device is a surgical laser, not an AI-based diagnostic tool. No MRMC studies were conducted or are relevant to this type of device and submission.

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

• Not Applicable / Not Provided. This is not an algorithm-only device. It is a physical laser system.

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

• The "ground truth" for this 510(k) submission is the FDA's prior clearance of the predicate devices, meaning their safety and effectiveness for their stated indications have already been accepted by the regulatory body.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no "training set" as this is not an AI/machine learning device. The "training" in a broad sense involved the design and testing of the laser system to ensure it met its own engineering specifications, but this is not reported in terms of a "training set."

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

• Not Applicable / Not Provided. As there is no training set mentioned, no ground truth for it was established.

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Intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic, laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonarythoracic surgery, podiatry and urology for surgical and aesthetic applications.

For intended use in Dermatology for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea, poikiloderma of civatte, and treatment of benign cutaneous lesions, such as warts, scars and striae. Also intended for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

For intended use on all skin types (Fitzpatrick I-VI), including tanned skin.

For intended use in Podiatry for the ablation, vaporization, incision, excision, and coagulation of soft tissue, including Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.

For intended use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).

The FREEDOM Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the FREEDOM Laser System and contains the Nd: YAG optical system, laser system control, fiber delivery system with handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the LCD display.

The provided document, a 510(k) summary for the Lutronic Corporation FREEDOM Laser System, explicitly states "Performance Data None presented." Therefore, based solely on the provided text, there is no study described that proves the device meets acceptance criteria, nor are there any acceptance criteria defined within this document.

Consequently, I cannot fill out the requested table or answer the specific questions related to a study's methodology, sample sizes, expert involvement, or comparative effectiveness.

Without any performance data or acceptance criteria detailed in the submission, the table would be empty for the "Acceptance Criteria" and "Reported Device Performance" columns. All other points requesting information about a study would also be unanswerable from the provided text.

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The PL-1064 laser, collimated handpiece will be indicated for ablation, vaporizing, excision, incision, and coagulation of soft tissue encountered in dermatology, plastic surgery, and podiatry including but not limited to plantar warts, periungual warts and telangiectasia. .

The PL-1064 will also be indicated for the temporary increase of clear nail in patients with onychomycosis (e.g., derniatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The Sheaumann PL-1064 is a medical grade, solid-state, infrared diode laser (AlGaAs). The laser is designed to deliver continuous or pulsed, infrared laser energy with a wavelength at 1064 nm. The touch screen display consists of a user interactive screens that allows selection of continuous, pulsed and the TMP/CLEAR NAIL/ Clear Nail modes of operation, repetition rates, aiming beam on/off, procedural information display keys, a Standby/Ready key, the manual emergency stop button and the master key switch.
THE LASER SYSTEM: The laser system consists of a laser diode optical deck, cooling system, voltage power supply and system control electronics that include the touch screen control panel.
The mail console: Contains major electrical components.
DELIVERY SYSTEM: The reusable 1.0 mm collimated handpiece has been designed to deliver a spot size of 1.0 mm. Safety glasses/goggles and a safety sign are also provided with the PL-1064.

The provided text states, "Non clinical Performance Data: None" and "Clinical Performance Data: None". This indicates that no specific studies were presented to demonstrate that the device meets acceptance criteria related to its performance.

Instead, the device, Sheaumann Laser PL-1064, received 510(k) clearance based on its substantial equivalence to a predicate device, the PathoLase PinPointe Foot Laser (K093547). The submission states, "From a design and clinical perspective, the predicate and candidate laser device, are the same technology and have the same intended use. Based upon the fact that the devices are extremely similar, the PL-1064 should not raise any concerns regarding its overall safety and/or effectiveness."

Therefore, the requested information elements related to performance studies, such as acceptance criteria tables, sample sizes, expert involvement, and ground truth, cannot be extracted from the provided document as they were not part of this specific 510(k) submission.

Summary based on the provided text:

• Acceptance Criteria and Reported Device Performance: Not provided, as clearance was based on substantial equivalence to a predicate device, not new performance data for this specific device.
• Sample Size for Test Set and Data Provenance: Not applicable. No test set data was provided.
• Number of Experts and Qualifications: Not applicable. No expert review of performance data for this device was described.
• Adjudication Method: Not applicable. No test set data to adjudicate.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. No such study was mentioned.
• Standalone Performance Study (algorithm only): No. This is a laser device, not an algorithm. No performance studies were conducted or reported for this device in the submission.
• Type of Ground Truth Used: Not applicable. No ground truth data was used for performance evaluation of this specific device.
• Sample Size for Training Set: Not applicable. No training set data was used or described.
• Ground Truth for Training Set: Not applicable.

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