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The HOLLYWOOD SPECTRA System is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatological and general surgical procedures for coagulation and hemostasis.

1064nm in nanosecond mode, including microbeam handpieces:

• Tattoo removal: dark ink (black, blue, and brown)
• Removal of Nevus of Ota
• Removal or lightening of unwanted hair with or without adjuvant preparation
• Treatment of Common Nevi
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of melasma

1064nm in Spectra (long-pulse) mode:

• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532mm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585 nm and 650 mm with optional dye handpieces):

• Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
• Removal of Epidermal Pigmented Lesions
• Removal of Minor Vascular Lesions including but not limited to telangiectasias
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of Lentigines
• Treatment of Café-au-Lait
• Treatment of Seborrheic Keratoses
• Treatment of Post Inflammatory Hyperpigmentation
• Treatment of Becker's Nevi, Freckles, and Nevi spilus

The HOLLYWOOD SPECTRA Laser System contains a Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates Q-switched and/or pulsed laser sources at the nominal wavelength of 1064 nm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (655 nm) are delivered by articulated arm to a fixed (collimated), or focusing variable (zoom) spot handpiece, or a dual focused dots microbeam handpiece, or a 585nm/650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or 650 nm wavelengths, correspondingly.

When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromophores such as melanin and tattoo particles. This increases localized temperature of the chromophores. The instantaneous temperature-increase causes fragmentation of the chromophores to smaller particles. By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.

The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size. The HOLLYWOOD SPECTRA laser system is controlled via a touchscreen guided user interface in the front of the device.

The provided text is a 510(k) summary for the HOLLYWOOD SPECTRA Laser System. This document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and indications for use, rather than presenting performance data from clinical studies directly.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and performance data from a study that proves the device meets those criteria.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The tables provided (Table 1 and Table 2) are "Technical Characteristics Comparison" tables, comparing the proposed device's specifications to those of predicate devices. These are not acceptance criteria tables from a performance study.
• 2. Sample sized used for the test set and the data provenance: Not applicable, as no performance study with a test set is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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 a laser system, 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.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The "PERFORMANCE DATA" section (Page 13) of the summary lists various types of engineering and safety testing performed (Biocompatibility, Sterilization and Shelf-Life, Electrical Safety and EMC, Software Verification and Validation, Performance Bench Testing). However, these are bench tests and safety compliance tests, not clinical performance studies with acceptance criteria for specific medical outcomes or diagnostic accuracy. The purpose of these tests is to show that the device is safe and functions according to its design specifications, and is substantially equivalent to existing devices, not to demonstrate clinical efficacy against pre-defined acceptance criteria in a patient population.

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The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens).

The Smart LIO is indicated for use in the following photocoagulation procedures:

• Panretinal photocoagulation;
• Segmental peripheral photocoagulation;
• Retinopexy; and,
• Pediatric retinal repairs (under general anesthesia).

The Smart LIO is intended to work in conjunction with the following Lumenis laser systems in ophthalmic photocoagulation procedures:

• Lumenis Novus Spectra Laser System;
• Lumenis Vision One Laser System; and
• Lumenis Smart532TM Laser System.

The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens). The Smart LIO is used in conjunction with a compatible Lumenis ophthalmic laser systems. The LIO illuminates and magnifies the fundus image for observation, and when connected to a Lumenis ophthalmic laser system, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO.

The Smart LIO is a wireless headset worn on the physician's head and is used to treat patients in a supine position or who could not otherwise be treated using a standard slit lamp delivery system.

The provided text describes the regulatory filing for a medical device (Smart Laser Indirect Ophthalmoscope) and includes a summary of its performance testing for substantial equivalence. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria, reported performance, sample sizes, expert qualifications, or ground truth establishment in the context of diagnostic accuracy or effectiveness.

The document focuses on demonstrating that the Smart LIO performs similarly to its predicate device and meets safety and performance standards for a laser delivery device. It does not describe a study to assess diagnostic performance with human readers or AI.

Therefore, I cannot populate the requested table and provide answers to questions 2 through 9 based on the provided text.

Here is why:

• No Acceptance Criteria for Diagnostic Performance: The acceptance criteria listed are mostly related to engineering and safety standards (e.g., ISO 14971, IEC 60601-1) and physical characteristics of the device (e.g., laser spot size, transmission, communication with laser systems). There are no criteria provided for diagnostic accuracy, sensitivity, specificity, or similar metrics typically found when evaluating the performance of an AI-powered diagnostic device.
• No Reported Device Performance for Clinical Outcomes: The performance reported is that the device "performs in accordance with its requirements and specifications, in similarity to its predicate device" and "perform as well as its predicate, to be as safe and effective for its intended use as its predicate." This refers to its functionality as a laser delivery system, not its ability to interpret or diagnose.
• No Clinical Study Details: The document mentions "Performance testing was conducted," but this refers to engineering, electrical safety, electromagnetic compatibility, light hazard protection, and verification/validation testing of the device's optical and laser delivery components. It does not describe a clinical study involving patients, experts establishing ground truth, or an AI algorithm.
• Device Type: This device is a "Smart Laser Indirect Ophthalmoscope" used for viewing and delivering laser energy for photocoagulation procedures. It is a tool for a physician to perform a procedure, not a diagnostic AI system that interprets images or makes diagnoses.

In summary, the provided document does not contain the information requested in your prompt because the device being described is a surgical instrument (laser delivery device) and not a diagnostic device that would typically involve acceptance criteria, reported performance, sample sizes, and expert adjudication related to diagnostic accuracy or AI performance.

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The SPECTRA Laser System is indicated for: the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):
-Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
-Removal of Epidermal Pigmented Lesions
-Removal of Minor Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Café-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation.
-Treatment of Common Nevi
-Skin resurfacing procedures for the treatment of acne scars and wrinkle
-Treatment of melasma.

The SPECTRA Laser System produces a pulsed beam of coherent near infrared 11064 nm) and visible (532nm) light. This beam is directed to the treatment zone (100 Film) and risulated arm coupled to a handpiece. In addition, two dye handpieces are available that convert the 532 nm wavelength to 585 nm and 650 nm.

When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromospheres such as melanin and tattoo particles. This increases localized temperature of the chromospheres. The instantaneous temperature increase causes fragmentation of the chromospheres to smaller particles.

By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.

The provided 510(k) Summary for the Lutronic Corporation Spectra Laser System (K113588) does not include any performance data or a study demonstrating the device meets acceptance criteria.

Section 7, titled "Performance Data," explicitly states: "None presented."

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as this information is not present in the document.

The submission focuses solely on demonstrating substantial equivalence to predicate devices based on similarities in indications for use and technological characteristics.

Ask a specific question about this device

The SPECTRA Laser System is indicated for: the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):
-Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
-Removal of Epidermal Pigmented Lesions
-Removal of Minor Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Café-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation.
-Treatment of Common Nevi
-Skin resurfacing procedures for the treatment of acne scars and wrinkle

The SPECTRA Laser System produces a pulsed beam of coherent near infrared (1064 nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that convert the 532 nm wavelength to 585 nm and 650 nm. When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromospheres such as melanin and tattoo particles. This increases localized temperature of the chromospheres. The instantaneous temperature increase causes fragmentation of the chromospheres to smaller particles. By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.

The provided 510(k) summary for the Lutronic Corporation SPECTRA Laser System (K103455) does not include any performance data or a study to demonstrate that the device meets acceptance criteria.

The "Performance Data" section explicitly states: "None presented."

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided document.

The document primarily focuses on:

• General Information: Submitter, contact, preparation date, device name, classification.
• Predicate Devices: Identifying an earlier version of the same product and a competitor's product for substantial equivalence claim.
• Device Description: Explaining how the laser system works and its technical specifications (wavelengths, handpieces).
• Indications for Use: Listing the medical conditions and procedures for which the device is intended.

The FDA's decision to clear this device (as indicated by the letter from the Public Health Service) is based on a determination of substantial equivalence to legally marketed predicate devices, rather than on new clinical performance data for this specific iteration. Substantial equivalence generally implies that the device is as safe and effective as the predicate device without requiring new clinical studies if the technological characteristics are similar and the intended use is the same.

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