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RelieVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence based behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.

RelievRx is an immersive virtual reality (VR) system with preloaded software content on a proprietary hardware platform that delivers automated cognitive behavioral therapy (CBT) and other behavioral methods to patients diagnosed with chronic pain. The VR content is delivered while incorporating CBT to enable diaphragmatic breathing exercises and mindfulness strategies, and is intended to be self-administered, unsupervised in the patient's home while the patient is in a seated position. The device is powered by a rechargeable lithium battery. Each device is intended for a single patient. The medical device is meant for repeated use, does not include non-medical software, and is only effective when treating chronic pain.

It appears there's a misunderstanding in the request. The provided FDA 510(k) clearance letter for RelieVRx (Pico G3) does not contain any information about clinical performance studies, acceptance criteria, sample sizes, expert involvement, or ground truth for the device's efficacy in pain relief.

This 510(k) clearance is specifically for a minor modification – the addition of a Predetermined Change Control Plan (PCCP) to allow future hardware updates (specifically to the VR headset) without requiring a new 510(k) submission, provided these changes adhere to predefined criteria and do not alter the intended use or therapeutic content.

The letter explicitly states:

• "No new nonclinical performance testing was conducted to demonstrate substantial equivalence."
• "The only changes that have been made to the RelieVRx in the current submission are the addition of a Predetermined Change Control Plan to accommodate potential future updates to the device hardware."
• "Please refer to K243417 for a comprehensive description of non-clinical testing that has been completed to validate the device."

Therefore, the information regarding the device's performance in reducing pain and pain interference, and the study that would demonstrate it meets acceptance criteria for its therapeutic effect, would be found in the original 510(k) clearance for the predicate device (K243417), not in this document.

Since the provided document K251519 does not contain the requested information about clinical performance studies, I cannot fill out the requested table or answer most of the questions.

However, I can extract the relevant information from this document regarding the nature of the submission and what it does discuss:

Based on the provided FDA 510(k) Clearance Letter (K251519) for RelieVRx (Pico G3):

This 510(k) does not describe a study proving the device meets acceptance criteria for its direct therapeutic effect on pain. Instead, it's a submission for a Predetermined Change Control Plan (PCCP) to streamline future hardware modifications. Therefore, most of the requested fields related to clinical performance testing cannot be filled from this document.

Here's what can be gathered regarding the purpose of this specific 510(k) and how it addresses a "change":

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: For this specific 510(k), the acceptance criteria are related to the Predetermined Change Control Plan (PCCP). The plan outlines that any future hardware modifications made under the PCCP must:
  • Maintain the same intended use and therapeutic content.
  • Meet predefined acceptance criteria aligned with "Table 6 of the PCCP" (which is not provided in this document). These criteria are for "safety, biocompatibility, and software performance" of the modified configurations.
  • Undergo specified verification and validation protocols (electrical and mechanical testing (IEC 60601-1/11), electromagnetic compatibility (IEC 60601-1-2), environmental and acoustic safety, performance benchmarking).
  • Be clearly communicated to users via updated labeling.
• Reported Device Performance (for this submission): No new clinical performance data is reported as "no new nonclinical performance testing was conducted to demonstrate substantial equivalence." The substantial equivalence claim is based on the subject device being identical to the predicate (K243417) in its intended use, indications, principles of operation, and technological characteristics, with the only change being the addition of the PCCP.

Therefore, a table describing "device performance" in terms of pain relief effectiveness cannot be constructed from this document. The "performance" discussed here is adherence to a change control plan.

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

• Not applicable for this 510(k). This submission did not involve new clinical performance testing on a test set to prove therapeutic efficacy.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable for this 510(k). No clinical ground truth for therapeutic efficacy was established in this submission.

4. Adjudication Method for the Test Set:

• Not applicable for this 510(k).

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

• No, not for this 510(k). This submission focuses on a change control plan, not a comparative effectiveness study for therapeutic outcomes.

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

• No, not for this 510(k). This device is a preloaded VR system for patient self-administration, not an AI algorithm with standalone performance metrics.

7. The Type of Ground Truth Used:

• Not applicable for this 510(k). No new clinical ground truth was established for this submission. The device's foundational efficacy would have been established in the predicate device's clearance (K243417).

8. The Sample Size for the Training Set:

• Not applicable for this 510(k). This submission pertains to a hardware change control plan, not the training of a new therapeutic algorithm.

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

• Not applicable for this 510(k).

Summary of what K251519 is about:
This 510(k) (K251519) is a software modification 510(k), specifically for adding a Predetermined Change Control Plan, not a clinical efficacy study for a new device or significant modification to the therapeutic content. All discussions about performance and validation in this document relate to ensuring that future hardware changes will not adversely affect the device's safety or effectiveness, building upon the substantial equivalence established by its predicate (K243417).

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The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery.

Specific indications by wavelength include:
1064 & 532 nm (Q-Switched, nanosecond mode): Treatment of benign vascular lesions, benign pigmented lesions, hair and tattoo removal, incision, excision, ablation, vaporization of soft tissue for General dermatology.

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:

• Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos.
• Treatment of benign vascular lesions including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, Cherry angioma, Spider nevi.
• Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, Ephalides, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus, Ota Nevus.
• Treatment of seborrheic keratosis.
• Treatment of post inflammatory hyperpigmentation.
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:

• Removal of dark ink (black, blue and brown) tattoos.
• Removal of benign pigmented lesions including: nevus of Ota, Café au lait spot, Ephalides, solar lentigo (lentigines), Becker Nevus, Nevus spilus.
• Treatment of common nevi.
• Removal or lightening of unwanted hair.
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (non Q-Switched – free running mode):

• 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.
• Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Treatment of wrinkles.
• Treatment of mild to moderate inflammatory acne vulgaris.

532 nm (picosecond mode), also with fractional and microbeam handpieces:

• Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
• Benign pigmented lesions removal for Fitzpatrick skin types I-IV.
• Only with fractional handpiece, treatment of wrinkles in Fitzpatrick Skin Types I-IV.

1064 nm (picosecond mode), also with fractional and microbeam handpieces:

• Removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
• Benign pigmented lesions removal for Fitzpatrick skin types I-IV.
• Only with fractional handpiece, treatment of wrinkles in Fitzpatrick Skin Types I-IV.
• Only with fractional handpiece, treatment of acne scars in Fitzpatrick Skin Types II-V.

694 nm (Q-Switched), including microbeam handpieces:

• Tattoo removal: Suggested for blue, sky blue, black, green and violet ink.
• Pigmented lesion removal (benign): Cafe au lait spot, Ephalides, solar lentigo (lentigines), Becker Nevus, Ota and Ito Nevus, Nevus spilus, Mongolian spot.

694 nm (non q-switch – free running mode):

• Remove benign dermal and epidermal pigmented lesions.
• Effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

IPL 590-1200nm; 625-1200nm; 650-1200nm:

• Permanent hair removal.

IPL 550-1200nm; 570-1200nm:

• Photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

IPL 400-1200nm:

• Inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler:

• Provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments.

Type of Use: Prescription Use

The Discovery Pico Family includes medical laser devices for dermatology and aesthetic medicine used by healthcare professionals (dermatologists) in professional healthcare environments. The family comprises Discovery Pico, Discovery Pico Plus, and Discovery Pico Derm models, which differ based on installed laser sources and the presence of a Twain connector.

The device is equipped with a graphical user interface (GUI) displayed on a screen for user interaction, allowing for laser parameter settings. It can be used with Twain IPL and Twain 2940 devices (Twain 2940 is separately FDA cleared K173002).

The laser beam is delivered via an articulated arm with a handpiece and activated by a footswitch. Four types of handpieces are available:

• Round (diameter): 2 to 12 mm
• Square (side): 2, 3, 4, 5, 7 mm
• Microbeam/fractional handpieces: 8, 9 mm (9 mm microbeam handpiece is also called "High Coverage")
• Rosso handpiece (separately FDA cleared: K211228)

The device incorporates four main sections:

• Power electronics: Manages power supply to all device components.
• Control electronics: Primarily consists of a microcontroller board housing the device's main firmware (FW).
• Cooling system: Cools the laser source pumping chamber and, for Twain IPL, the IPL flashlamp.
• Optical bench.

Twain IPL is an optional accessory handpiece for intense pulsed light (IPL), intended for hair reduction and treatment of various skin lesions. Twain IPL can be cooled or uncooled and supports fixed or changeable guides with wavelength ranges of 650-1200 nm, 625-1200 nm, 590-1200 nm, 570-1200 nm, 550-1200 nm, and 400-1200 nm. Each guide is available in two sizes: small (25x13 mm²) and large (48x13 mm²).

In picosecond (PS) mode, the device offers "VarioPulse" technology, allowing the user to select three pulse levels corresponding to different pulse durations:

• Short (S): 450 ps (1064 nm), 370 ps (532 nm)
• Medium (M): 600 ps (1064 nm), 500 ps (532 nm)
• Long (L): 800 ps (1064 nm), 600 ps (532 nm)

The provided text is an FDA 510(k) clearance letter for the Discovery Pico Family of laser devices. While it outlines the device's indications for use, its technical specifications, and the non-clinical tests performed to demonstrate safety and effectiveness, it explicitly states "Clinical testing: N/A."

This means that the submission for this particular device did not include a clinical study (such as an MRMC study or a standalone algorithm performance study) to prove specific performance criteria against a ground truth in a human-in-the-loop or algorithm-only setting. The clearance relies on non-clinical bench testing and comparison to predicate devices, demonstrating substantial equivalence rather than a direct clinical performance study against quantified acceptance criteria for a specific AI-driven task.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because a clinical study with those elements was not conducted or presented for this 510(k) submission.

Below is a table summarizing the information that is available from the document and indicating where the requested information is "N/A" (Not Applicable) or "Not Provided" due to the nature of this 510(k) submission (bench testing and predicate comparison, not a clinical trial proving AI performance).

Acceptance Criteria and Device Performance (Based on available information)

Study Details (Based on available information)

In summary: The FDA 510(k) clearance for the Discovery Pico Family is based on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical bench testing, adherence to recognized standards for safety and performance (electrical, software, biocompatibility, reprocessing), and comparison of technical specifications. It does not involve a clinical study to evaluate AI performance against specific clinical acceptance criteria or a ground truth derived from expert consensus or outcomes data. Therefore, the detailed questions related to such clinical studies are not applicable to this specific clearance document.

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The Medical 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 Medical Picosecond ND: YAG Laser System mainly consists of a host, a light guide arm, a treatment handle, a foot switch, a power cord, and other auxiliary treatment accessories. The host mainly includes laser power supply, laser, water circulation cooling system, control board, and display screen. Accessories include a foot switch, laser protective glasses, power cords, and a water filling funnel.

The Medical Picosecond ND: YAG Laser System 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).

I am sorry, but the provided FDA 510(k) clearance letter for the Medical Picosecond ND: YAG Laser System (PZ-6) does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "No clinical study is included in this submission." (Page 11, Section 8.0 Clinical Test Conclusion)
• The "Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device." (Page 11, Section 7.0 Non-Clinical Test Conclusion) These non-clinical tests relate to compliance with various IEC and ISO standards for medical electrical equipment, laser safety, and biocompatibility, as well as software validation. These are not performance acceptance criteria for the intended use (tattoo and lesion removal) in the way you are asking.

Therefore, I cannot provide the detailed information requested in your prompt as it is not present in the provided text.

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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.

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[Indications for use of Q-switched Nd:YAG Laser]
1064 nm (including RTP 1064 mode):

• Incision, excision, ablation, vaporization of soft tissue for general dermatology
• Removal or lightening of unwanted hair with or without adjuvant preparation
• Treatment melasma
• Treatment of Pigmented Lesions
• · nevus of ota
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Tattoo Removal
• dark ink: black, blue and brown

532 nm:

• Treatment of Vascular Lesions
• · port wine birthmarks
• · telangiectaias
• · spider angioma
• · cherry angioma
• · spider nevi
• Treatment of Pigmented Lesions
• · café-au-lait birthmarks
• · solar lentiginos
• · senile lentiginos
• · becker's nevi
• · freckles
• nevus spilus
• nevus of ota
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Tattoo Removal
• · light ink: red, sky blue, green, tan, purple, and orange

[Indications for use of FR mode in Nd:YAG Laser]

• Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofollicultis Barbae). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
• Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
  [Indications for use of Ti:Sapphire Laser]
  785nm:
• Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
  *Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously *

The flash lamp as a laser pumping source converts electric energy to light energy when a high voltage is applied. Nd:YAG crystal with the specific resonator emits an 1064nm single wavelength laser by absorbing light energy from the flash lamp. Q-switching mode is applied to the 1064nm laser resonator to amplify the 1064nm laser with about 10ns short pulse width.
The amplified O-switched 1064nm laser is secondarily amplified by an another Nd: YAG crystal and, then is converted to a second harmonic 532nm laser by passing through KTP crystal.
Finally a 785nm laser is emitted by the 785nm cavity with Ti:Sapphire crystal using the 532nm laser as a laser pumping source.
HELIOS 785 Pico Laser System can emit 1064nm, 532nm, and 785nm laser selectively by switching the wavelength conversion optical modules. The 1064nm laser is emitted by only Nd: Y AG crystal resonator and the 532nm laser can be emitted with the 1064nm laser and KTP crystal. The 785nm laser can be emitted by all optical modules.
The Q-switch mode normally produces polarized light, but it is also possible to set the FR(Free Running) mode, which emits light in all directions by removing the optics of the Q-switch module. Additionally, the RTP(Real Twin Pulse) mode can be set to generate two identical pulses with a very short interval instead of a single pulse.
The HELIOS 785 Pico laser system consists of:
a) A high voltage power supply, which converts and rectifies Alternating Current (AC) to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.
c) The micro processor based controller unit, which regulates the functions of both lasers and allows parameter selection by the user.
d) The Nd: YAG laser + Ti:sapphire laser head.

This document is a 510(k) summary for the HELIOS 785 Pico (1754V2) laser system. It describes the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain explicit acceptance criteria, performance data from a specific study to prove the device meets acceptance criteria, or details regarding ground truth establishment, expert adjudication, or sample sizes for training and test sets in the context of an AI/algorithm performance study.

The "Performance Data" section (page 13) refers to non-clinical tests for safety and performance according to consensus standards, but these are general engineering and safety standards for laser products, not typical performance metrics for an AI medical device like sensitivity, specificity, or accuracy derived from clinical data.

Therefore, many requested points cannot be extracted from the provided text.

Here is the information that can be extracted, with notes for the missing information:

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

This information is not provided in the document. The document refers to non-clinical safety and performance tests against consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971, IEC 60601-1-6, IEC 60601-2-22) for the laser device itself, but it does not specify quantitative acceptance criteria or clinical performance metrics (like accuracy, sensitivity, specificity) for a specific medical indication, which would typically be included for an AI/algorithm-based device.

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

This information is not provided. The document details the laser device's technical specifications and intended uses, but it does not mention a test set or data related to any clinical evaluation for performance.

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)

This information is not provided. As there's no mention of a test set or clinical performance evaluation, there's no information on experts for ground truth establishment.

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

This information is not provided.

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 information is not provided. The document is for a laser surgical instrument, not an AI-assisted diagnostic or treatment planning system that would typically undergo an MRMC study.

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

This information is not provided. The device is a laser system, not a standalone algorithm.

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

This information is not provided.

8. The sample size for the training set

This information is not provided.

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

This information is not provided.

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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.

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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.

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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.

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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:

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.

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The TitanPico Laser Workstation is indicated for the following at the specified wavelength:

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

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

The TitanPico Laser Workstation is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

TitanPico Laser Workstation is a laser system that delivers energy in the 532nm and 1064nm wavelength. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed.

This document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the new device. Therefore, much of the requested information regarding specific acceptance criteria, study design, and performance metrics for the proposed device is not explicitly stated in the provided text.

However, based on the document, I can extract information related to the comparison with the predicate devices and the non-clinical tests performed to demonstrate substantial equivalence.

Here's a breakdown of the information available and what is not explicitly stated in this FDA submission:

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

The document does not explicitly define "acceptance criteria" in the sense of quantitative performance targets for the new device itself. Instead, it aims to show substantial equivalence to predicate devices by comparing technical specifications. The "reported device performance" is mainly shown through the comparison table to the predicates and the assertion that non-clinical tests met standards.

Indications for Use (TitanPico Laser Workstation):

• 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat red, yellow, and orange tattoo colors.
• 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat black, brown, green, blue, and purple tattoo colors.
• Also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

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 states that no clinical tests were performed for the proposed device. The company "believes that the proposed device TitanPico Laser Workstation products does not need to carry out clinical tests, and the clinical study data that have been the legally marketed device can be used for reference."
• Therefore, there is no explicit test set sample size or data provenance provided for the proposed device in this submission. The "test set" in this context refers to non-clinical bench 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 tests were performed for the proposed device and therefore no ground truth was established by experts for a test set. Non-clinical tests typically rely on established engineering and safety standards.

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

• Not applicable, as no clinical tests or expert interpretation of results for a test set were conducted. Non-clinical tests are evaluated against predefined physical and engineering standards.

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 workstation, not an AI-assisted diagnostic or interpretation system. No MRMC study was performed.

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

• Not applicable. This device is a hardware laser system. The "software verification and validation" mentioned refers to the device's control software, not a standalone diagnostic algorithm.

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

• For the non-clinical tests, the "ground truth" is adherence to established international and national standards for medical electrical equipment, laser safety, and biocompatibility (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993 series). Performance was assessed against the specifications of these standards and the equivalence to the predicate devices.
• For the clinical effectiveness implied by substantial equivalence, the ground truth would have been established through the clinical studies conducted for the predicate devices, which are not detailed in this submission.

8. The sample size for the training set

• Not applicable, as this is a hardware device and not an AI/machine learning system that requires a training set.

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

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

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