Search Results

The Picosecond Laser device is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The Picosecond Laser Device mainly consists of a main unit, a light guide arm, a standard handpiece, a foot switch, a power cord, and other auxiliary treatment accessories.

The main unit includes power supply unit, control unit, laser system, water circulation cooling system.

Accessories include goggles, eye mask, funnel assembly, drainage nozzle, fuse tubes, remote control interlock connector, and keys.

The Picosecond Laser Device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).

N/A

Ask a specific question about this device

The Picosecond Laser device is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

Composition of therapeutic device: main unit, light guide arm, handpiece and foot switch. The main unit includes display screen, laser, power supply, water circulation cooling system and electronic control components. Accessories include goggles, eye mask, standard hand tools, power cord, fuse tube, funnel component, drain faucet, user manual, remote control interlock connector, drain spout and keys.

The Picosecond Laser Device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions and removal of tattoos. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).

N/A

Ask a specific question about this device

PICOALEX is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma.

The PICOALEX laser system consists of an Alexandrite laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains Alexandrite laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity. To provide energy to the flash lamp, high voltage power supply charges to a storage capacitor. Then, a trieger pulse applied to the flash lamps causes the capacitor to discharge through the flash lamps. The resulting flash excites the Alexandrite laser medium, causing the emission of a pulse of laser energy. Power supply and the laser resonator to the laser resonator is calculated from a power supply to the laser energy is set via the LCD monitor is a certain amount of power. In the laser resonator is a certain amount of electrical energy to the flash lamp by changing the electrical energy into light Alexandrite broiling to momentarily strong light in the laser medium to generate a laser. The generated laser is a laser return to convert heat energy reaches thssue is cut by the heat energy, destruction, removal. The electro-optic modulator with a polarizer introduced into the cavity creates the picoseconds pulse irradiation pulses. The sealed top metal cover protects all optical components from dust and humidity and blocks the visible and invisible scattering light from the laser head. The system delivers laser energy at a wavelength of 755 nm. The output of the laser is delivered to the treatment area through an articulated Arm with a handpiece. A trigger (Foot Switch) controls the user selects and sets the treatment parameters and other functions operated by software on the graphical user interface.

The provided text describes a 510(k) submission for the PICOALEX laser system. It does not include information about acceptance criteria for a study proving device performance, nor does it detail such a study.

Instead, it focuses on demonstrating substantial equivalence to a predicate device (Cynosure, LLC's PicoSure Work Station, K210226) based on non-clinical testing and technical characteristics comparison.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device meets acceptance criteria, as this information is not present in the provided document. The document explicitly states:

• "No clinical studies were considered necessary and performed." (Page 9)

The non-clinical tests mentioned are for electrical safety, electromagnetic compatibility, software validation, and biocompatibility, as well as verification of laser performance specifications against established parameters. These are not a "study that proves the device meets the acceptance criteria" in the way you've outlined, which typically implies a clinical or comparative performance study.

**Here's a breakdown of what is available: **

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

The document presents a comparison to a predicate device, showing that its technical specifications (performance parameters) are either the same or similar, falling within acceptable ranges. These are not "acceptance criteria" in the sense of a performance study with a defined endpoint, but rather design specifications that were verified through bench testing.

Non-Clinical Test Summary (Page 9):
Performance Testing was conducted to define the PICOALEX's parameters:

• Laser wavelength: 755nm
• Laser output power: Max 300mJ ± 20%
• Pulse width: 600-800ps
• Pulse repetition rate: 1-10Hz

The following information is not available in the provided text, as no clinical performance study was conducted:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device

The PICOCAREMAJESTY is indicated for the following at the specified wavelength:

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

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

· Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.

The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 1064mm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

For treatment, the user can select the appropriate fluence value. (The treatmented is provided in the user Manual) The energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased / decreased by 0.1 J/cm2.

The selectable fluence values are 0.2 to 10.0 J/cm2 at 1064nm and 0.1 to 2.5 J/cm2 at 532nm

The provided text is a 510(k) summary for the WON TECH Co., Ltd. Picosecond Nd:YAG Laser (PICOCAREMAJESTY). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a novel device, especially not data related to complex AI algorithms or diagnostic accuracy studies.

Therefore, many of the specific details requested in your prompt, particularly those related to AI algorithm performance, human-in-the-loop studies, ground truth establishment, and training/test set sample sizes, are not present in this document. The device in question is a laser for tattoo and pigmented lesion removal, which typically undergoes performance testing based on physical parameters, and electrical/software safety, rather than diagnostic accuracy studies with expert readers.

However, I can extract information related to what is available in the document:

Acceptance Criteria and Device Performance (Based on provided documentation's summary of testing):

The document primarily relies on comparisons to predicate devices and adherence to established safety and performance standards for laser surgical instruments. It doesn't present "acceptance criteria" in the sense of a statistical threshold for diagnostic accuracy for a new AI algorithm, but rather lists the device's technical specifications and verifies compliance with recognized standards.

Missing Information and Why it's Not Applicable/Present:

The prompt asks for details typically found in submissions for Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices, particularly those for diagnostic purposes. This 510(k) pertains to a physical laser device for tattoo and lesion removal, which does not employ AI for decision-making or diagnosis. Therefore, the following information is not covered in this document:

1. Sample sizes used for the test set and data provenance: No test set in the context of diagnostic accuracy is described. Performance is based on bench testing of physical parameters.
2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there's no diagnostic component or "ground truth" to establish for a test set in this context.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not AI-enabled, nor is it a diagnostic aid for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable as there is no AI model being trained.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The PICO LEGEND Nd: Y AG Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

-The 1064nm wavelength of the PICO LEGEND Nd: Y AG Laser System is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).

-The 532mm wavelength of the PICO LEGEND Nd:YAG Laser System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

This device comprises the main body, including the optics laser generator, power supply, cooling system, operation panel, articulated arm, handpiece, foot-switch, protective goggles, power supply cord, etc. Applying a high voltage to the laser generator generates 1064nm and 532nm laser emission wavelengths. The maximum output is 500mJ.

The optical laser generator (optics), power supply, chiller, touch LCD panel, switching mode power supply, main control board, air pump, etc., are operated by a microprocessor.

The Optical Laser Generator (Optics) is comprised of Nd: YAG Rod, which is the solid laser medium, Flash lamp for optical generation, various Reflector for optical transmission, etc., and permits high voltage in flash lamp connected with power supply and operates to generate laser. After turning on the device, once the Wavelength, frequency, Frequency, Spot Size, etc., have been set, press the Foot Switch in the READY state; the laser energy will be produced and transferred through the Articulated Arm and handpiece.

The provided document is a 510(k) Premarket Notification for the PICO LEGEND Nd:YAG Laser System. This document does not describe a study involving an AI/Machine Learning device. Instead, it focuses on demonstrating substantial equivalence of a laser medical device to a predicate device.

Therefore, the specific information requested in the prompt regarding AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI, is not present in this document.

The document states:

• "9. Clinical Testing: No clinical testing provided." This explicitly indicates that no human subject studies were conducted to prove the device's efficacy or safety.
• The performance data section (Section 8) describes non-clinical testing related to electrical safety, EMC, usability, laser safety, and biocompatibility, as well as bench testing to confirm energy output specifications. It also mentions "Software Verification and Validation Testing" but this refers to traditional software engineering V&V, not AI/ML model performance evaluation against clinical ground truth.

In summary, this document is irrelevant to the request for information on an AI/ML device's acceptance criteria and performance study. The device is a laser system, and its clearance is based on substantial equivalence to a predicate device and compliance with applicable non-clinical performance standards.

Ask a specific question about this device

The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.

• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.

• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The BL-C10 Picosecond ND:YAG Laser Systems is designed with a mains electricity (AC-powered) light amplification by stimulated emission of radiation (LASER) device assembly based on neodymium-doped yttrium-aluminium-garnet (Nd:YAG) and frequency-doubled Nd:YAG laser technology. The laser system generates ultra-short pulses in the picosecond range (1 picosecond = 10^-12 seconds). The pulses are then amplified within the Nd:YAG crystal. The system operates at two wavelengths: 1064nm and 532mm. These wavelengths are chosen to target different colors of pigments in tattoos and pigmented lesions.

• 1064nm Wavelength: Used for treating tattoos with colors like black, brown, green, blue, and purple, as well as for treating benign pigmented lesions.

• 532nm Wavelength: Used for removing tattoos with colors such as red, yellow, and for treating benign pigmented lesions. The ultra-short pulses have very high peak power, allowing them to interact with target (tattoos or pigmented lesions) in a precise and controlled manner. The short duration of the pulses helps minimize heat buildup in surrounding tissues.

I am sorry, but the provided text from the FDA 510(k) K240386 submission for the "Picosecond Nd: YAG Laser Systems (BL-C10)" does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The document primarily focuses on:

• Regulatory correspondence: FDA's substantial equivalence determination letter.
• Device description: Information about the Picosecond Nd:YAG Laser System (BL-C10), its wavelengths, and intended uses.
• Comparison to predicate devices: Discussion of technological similarities and minor differences between the BL-C10 and its predicates.
• Non-clinical testing: A list of international standards (IEC 60601-1, IEC 60601-1-2, etc.) that the device complies with, related to electrical safety and electromagnetic compatibility.
• Conclusion: Statement that the device is substantially equivalent to the predicate based on performance testing and validation studies which are not detailed in this public summary.

Specifically, the section "Non-Clinical and/or Clinical Tests Summary & Conclusions" states:

• "Non-Clinical Testing: A battery of tests was performed to verify that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards: [lists electrical safety and EMC standards]."
• "Clinical Testing: It is not applicable."

This clearly indicates that no clinical studies were performed or reported for this device in this submission, which means there would be no data on human-in-the-loop performance, standalone AI performance, or ground truth for such studies.

Therefore, I cannot fulfill your request for the information outlined in your prompt because the provided text does not contain it. The device in question is a laser system, not an AI/ML-driven diagnostic or therapeutic device for which such detailed performance study information would be typically found in a public 510(k) summary.

Ask a specific question about this device

The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery: such as tattoos removal and benign pigmented lesions.

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

Picosecond Nd: YAG Laser Systems, pulse width: < 500ps; pulse energy up to 500mJ, instantaneous emission of laser energy efficient crushing lesions tissue chromophore, that is photon burst: laser accumulation energy is instantaneous emission. The instrument uses the laser-wave to break Chromatophore into pieces which can be naturally absorbed by the body. So that it achieves the purpose of de-freckling. The 1064 nm wavelength will shatter and removes the black, blue, purple and brown pigments while the 532 nm wavelength will shatter and removes red, pink, yellow and orange pigments of the tattoo or other pigmentations without damaging the normal tissue. Apply for tattoo and tattoo epidermal/ dermal lesion pigmented, lesions removal. Picosecond laser is being introduced as the first safe and effective aesthetic laser specifically designed to treat tattoos and pigmented lesions. This innovative laser delivers ultra short pulse bursts of energy to the skin in trillionths of a second. These pulses create a photomechanical effect, that target ink while avoiding unmarked tissue. The pulse shatters the ink into tiny, dust-like particles which are easily eliminated by the body.

This document describes the Smedtrum Medical Technology Co., Ltd. Picosecond Nd:YAG Laser System (K240118) and compares it to a predicate device (K200116).

Here's an analysis of the acceptance criteria and supporting studies, 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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The "testing" primarily refers to bench testing and electrical/software verification. Therefore, no information is available regarding sample size or data provenance (country of origin, retrospective/prospective) for a test set of patient data, as this kind of study was not conducted or reported.

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

Not applicable. No ground truth based on expert consensus for clinical data was established or reported.

4. Adjudication method for the test set

Not applicable. No adjudication method for clinical data was reported.

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-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant and was not conducted.

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

Not applicable. This device is a standalone hardware medical device (laser system) and does not involve an algorithm with human-in-the-loop performance. The "software verification and validation testing" refers to the control software of the laser system, not an AI algorithm.

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

For the technical performance of the device, the "ground truth" was based on engineering specifications and established international standards (IEC). These standards define acceptable ranges and behaviors for laser energy output, electrical safety, electromagnetic compatibility, and specific laser device performance parameters. The measurements obtained through bench testing were compared against these established standards and specifications.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is a laser system and does not utilize machine learning or AI models that require data training.

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

Not applicable. There is no mention of a "training set" for which ground truth would need to be established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria primarily consists of engineering and bench testing.

• Electrical safety and electromagnetic compatibility: The device was tested for compliance with recognized international standards: IEC 60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), and IEC 60601-2-22 (particular requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment).
• Laser Safety: Compliance with IEC 60825-1 (safety of laser products, equipment classification and requirements) was verified.
• Software Verification and Validation: Testing was conducted in accordance with FDA's guidance for software in medical devices, considering the software a "moderate" level of concern.
• Bench Testing: This involved instrumental measurements of key laser parameters:
  • Laser energy output: Verified within ±20% using a laser energy meter that meets IEC 60825 standards.
  • Wavelength: Checked with a Spectrum Analyzer to confirm 532 nm and 1064 nm.
  • Frequency and Pulse Width: Measured with an Oscilloscope to ensure consistency with specifications.
  • Spot Size: Determined by emitting a laser onto photo paper and measuring the spot size with a ruler.

The conclusion states that "The non-clinical data and performance testing reports in this submission demonstrate that Picosecond Nd:YAG Laser System meets the expected performance requirements." This indicates that the device's performance characteristics, as measured during these tests, fell within the acceptable ranges and standards established for safety and effectiveness.

Ask a specific question about this device

The PICOANDY is indicated for the following at the specified wavelength:

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

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

· Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.

The PICOANDY is the solid state laser capable of delivering energy at wavelengths of 1064nm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

The provided document lists information for a medical device called PICOANDY (Q-Switched Nd:YAG Laser), which is a laser surgical instrument. It includes a 510(k) summary for FDA clearance.

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

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

The document doesn't explicitly state "acceptance criteria" in a table format with specific target values for performance in the context of a clinical study or effectiveness evaluation. Instead, it details the technical specifications of the PICOANDY device and compares them against a predicate device (PICOHIGH), claiming "substantial equivalence."

However, we can infer performance specifications from the "Performance Testing" section and the comparison to the predicate device.

The "acceptance criteria" here are implicitly the specifications of the device and its demonstrated ability to perform within those specifications, and critically, to be "substantially equivalent" to a legally marketed predicate device.

Study Type and Details to Prove Acceptance:

The document states: "No clinical studies were considered necessary and performed." This indicates that the device's clearance was based on non-clinical data and comparison to a predicate device.

Therefore, the following information is not applicable or extractable from the provided document as no clinical or comparative effectiveness study was conducted:

• Sample size used for the test set and data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi Reader Multi Case (MRMC) comparative effectiveness study
• Effect size of human readers improving with AI vs. without AI assistance
• Standalone (algorithm only) performance study

Here's what was used to prove the device meets acceptance criteria (i.e., substantial equivalence):

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

• Not applicable / Not provided. No clinical test set. The evaluation relies on bench tests and comparison to a predicate device.

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

• Not applicable / Not provided. No ground truth established by experts for a clinical test set since no clinical studies were performed.

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

• Not applicable / Not provided. No clinical 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:

• No. An MRMC study was not done. This device is a laser system, not an AI-assisted diagnostic tool.

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

• Not applicable / Not provided. This device is a physical laser system, not a software algorithm for standalone performance. "Software Validation" refers to the internal software controlling the device, not a standalone diagnostic algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" implicitly refers to the engineering specifications and established safety and performance standards (e.g., IEC standards) and the characteristics of the predicate device. Compliance with these standards and demonstrating similar functionality to a predicate forms the basis of "truth" for substantial equivalence.

8. The sample size for the training set:

• Not applicable / Not provided. There is no "training set" in the context of an AI/ML algorithm for this device. The software validation mentioned is for the device's operational software, not for an AI model trained on data.

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

• Not applicable / Not provided. As there's no training set for an AI/ML algorithm described.

Ask a specific question about this device

The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

• The 1064nm wavelength of the PICOSECOND Nd:YAG Laser System (PICO PREMIUM ) is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
• The 532nm wavelength of the PICOSECOND Nd: YAG Laser System (PICO PREMIUM ) is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzparick skin types I-III.

The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is comprised of the Main Body which includes an optics laser generator, power supply, cooling system, operation panel, etc., and the Articulated Arm, Handpiece, Foot Switch, Protective Goggles, Power Supply Cord, etc. and by applying high voltage to the laser generator 1064nm and 532nm wavelength and emission wavelength of the laser, the maximum output is 5 00mJ. This device is comprised of an Optical Laser Generator (Optics), power supply, chiller, touch LCD panel and switching mode power supply, main control board, air pump, etc., and is operated by microprocessor software.

The Optical Laser Generator (Optics) is comprised of Nd: YAG Rod which is the solid laser medium, Flash lamp for optical generation, various Reflector for optical transmission, etc., and permits high voltage in flash lamp connected with power supply and operates to generate laser energy.

After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Foot Switch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. A cooling system controls the febrility caused by the laser output.

The provided text is a 510(k) summary for the PICOSECOND Nd:YAG Laser System (PICO PREMIUM). It outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, the document does not describe a clinical study with human subjects, nor does it present acceptance criteria and performance metrics in the context of an AI/algorithm-based diagnostic or therapeutic device.

The "Performance Data (Non-clinical)" section (Page 6, Section 8) explicitly states that "All acceptance criteria were met," but these listed criteria are for engineering and safety standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993 for biocompatibility, and FDA guidance for software verification and validation). These are not performance metrics related to diagnostic accuracy, sensitivity, specificity, or the improvement of human reader performance, as would be expected for an AI-enabled device that requires such rigorous clinical validation.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/algorithm-based device and its clinical performance. The provided document concerns a laser system device that is evaluated against established safety, electrical, and biocompatibility standards, not an AI or algorithm that would undergo the type of performance evaluation you've outlined.

Based on the provided document, the following information is either not applicable or not available:

1. A table of acceptance criteria and the reported device performance: The acceptance criteria mentioned are engineering standards (e.g., IEC, ISO) and the document states they "were met." No specific quantitative performance data for the device's clinical effectiveness (e.g., in terms of tattoo removal efficiency or safety in human subjects against specific metrics) is provided in a comparative table.

2. Sample sizes used for the test set and the data provenance: No test set for clinical performance is described. The "test set" here refers to the engineering tests.

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 ground truth establishment is described.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not mentioned. The device is a laser system, not a diagnostic AI that would typically undergo such a study.

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, as there's no mention of an algorithm 'training set'.

9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to demonstrate substantial equivalence to a predicate laser device based on technical characteristics and compliance with safety and performance standards, not clinical efficacy measured through a study design typically associated with AI/ML products.

Ask a specific question about this device

A surgical instrument used to occlude a blood vessel temporarily.

PICOCLAMP is Ethylene Oxide sterile single-use hemostasis clamp consisting of Polyetheretherketone (PEEK) and stainless steel (SUS series). PICOCLAMP is designed for use during surgery to temporarily occlude blood vessels during the anastomosis process. PICOCLAMP consists of three main direct patient-contacting parts, all of them are streilized; main body, axis, and spring. The body is consisting of two parts; the jaw which is used to occlude the blood vessel temporarily and the grip which functions to open and close jaws using the surgeon hand or the clamp forceps. The axis integrates the body and keep its parts intact. The spring functions to give clamping force to the jaws. Two types of clamps are provided: green color clamps used for arteries temporary occlusion and blue color clamps used for veins temporary occlusion. Both of the artery and vein clamp are having two types: single and double. PICOCLAMP is available in three different sizes; S (Small), M (Medium), and L (Large). PICOCLAMP is used for temporary occlusion of blood vessels with diameters ranging from 0.2mm to 2.0mm. The clipping power applied at the blood vessel differs depending on the size of the clamp and the pressure of the spring selected. Once the anastomosis process is complete, PICOCLAMP is removed from the patient.

This document is a 510(k) Premarket Notification from the FDA regarding the PICOCLAMP vascular clamp. It outlines the device's characteristics, indications for use, comparison with a predicate device, and the performance data submitted to demonstrate substantial equivalence.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. The document is a regulatory approval for a physical medical device (vascular clamp), not a software or AI/ML-driven device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI/ML, as the document does not pertain to such a device or study.

The performance data mentioned in the document are for:

• Sterilization & Shelf-life & Packaging Testing: This ensures the device remains sterile and functional over its shelf life and that its packaging is adequate.
• Biocompatibility Testing: This ensures the materials used in the device are safe for contact with biological tissues.
• Bench Performance Testing: This evaluates the physical performance of the clamp, such as clipping power, ability for repeated opening/closing, and resistance to dislodgement. These tests compare the proposed device (PICOCLAMP) to the predicate device to demonstrate substantial equivalence of their physical performance.

The document explicitly states:

• "Animal Performance Testing was not required to demonstrate safety and effectiveness of the device."
• "Clinical Performance Testing was not required to demonstrate the safety and effectiveness of the device."

In summary, none of the requested information regarding AI/ML acceptance criteria, test set sizes, expert ground truth, MRMC studies, standalone algorithm performance, or training set details can be extracted from this document, as it is completely unrelated to AI/ML device performance.

Ask a specific question about this device