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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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General intended use: Suprema 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 as follows.

Indications for use:
1064 nm (pulsed): Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

532 nm (pulsed): Intended for the coagulation and hemostasis of vascular lesions. For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins]; benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size).

755 nm (pulsed): Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

IPL 590-1200nm; 625-1200nm; 650-1200nm: Indicated for permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

IPL 550-1200nm; 570-1200nm: Indicated for photocoagulation of dermatological 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: Indicated for inflammatory acne (acne vulgaris).

Integrated Skin Cooler: The intended use of the integrated cooling system in Suprema Family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

Suprema family includes medical laser devices for dermatology and aesthetic medicine. It is used by health care professionals (dermatologists) in professional healthcare environments for the treatment of different skin conditions and hair removal. Suprema models differ for the installed laser sources only according to Table 1. Suprema devices are transportable mobile electrical equipment with a graphical user interface (GUI) for user-device interaction. Laser radiation is delivered through optical fibers connected to handpieces having fix or variable spot dimension. The device can be optionally equipped with an integrated skin cooler. In this case, a specific housing called Skin Cooler handpiece is provided to provide skin cooling the laser handpiece at the same time. Configurations without optional integrated skin cooler, can be used in conjunction with Cryo 6 skin cooler manufactured by Zimmer GmbH (K060395). In this case, an optional housing is provided which is called Skin Cryo handpiece. Laser handpieces cannot be used alone but only in conjunction to Skin Cooler and Skin Cryo handpieces. Laser emission can be activated by the footswitch or by a finger-switch placed on Skin Cooler and Skin Cryo handpieces. The device can be divided into four main sections: Power electronics, Control electronics, Cooling system, Optical bench. Suprema devices can be used in conjunction with Twain 2940 devices. Twain IPL and Twain 2940 are already FDA cleared (K202503, K173002, respectively).

This document describes a 510(k) premarket notification for a family of laser surgical instruments (Duetto Suprema, Domino Suprema, Suprema VT, Suprema VT+, Suprema 4V) for use in general and plastic surgery and in dermatology. The submission demonstrates substantial equivalence to predicate devices (Evo Platform K192160 and Chrome K202503).

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

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

The document does not present a formal table of quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for a diagnostic device) and then report performance against these criteria. Instead, it relies on demonstrating that the subject device's technical specifications and intended uses are comparable to those of already cleared predicate devices. The "acceptance criteria" here are implicitly that the new device's performance, as measured by its specifications and safety/efficacy profile, is substantially equivalent to the predicate devices.

The comparison table provided (Table 3 on pages 6-8) is the closest equivalent to reporting device performance relative to a benchmark.

• 1064nm & 755nm: Subject device max spot area 7% larger. Justified by lower energy/fluence for larger spots and no new thermal concerns.
• 532nm: Subject device max spot area 12x larger. Justified by 28x lower fluence for largest spots and equivalence of maximum fluence in small spots. |
  | Repetition Rate (max) | @1064 nm: 10 Hz
  @532 nm: 5 Hz
  @755 nm: 10 Hz | The same | Identical repetition rates. |
  | Skin Cooling | Three cooling levels | The same | Identical skin cooling capabilities. |
  | Twain IPL (Predicate: Chrome K202503) | (Specific IPL wavelengths for Chrome) | Same IPL wavelengths as Chrome | The Twain IPL accessory is identical to the Chrome family's. |
  | Twain IPL Pulse width (max) | 40 ms | The same | Identical pulse width for IPL. |
  | Twain IPL Spot size | 48mm x 13mm, 25mm x 13mm | The same | Identical spot sizes for IPL. |
  | Twain IPL Fluence (max) | 25 J/cm² | The same | Identical maximum fluence for IPL. |
  | Twain IPL Repetition rate | 3 Hz | The same | Identical repetition rate for IPL. |
  | Twain IPL Cooled waveguides | Three cooling levels | The same | Identical cooling for IPL waveguides. |
  | Indications for Use | Broad range of dermatological and surgical applications (vascular, pigmented lesions, hair reduction, wrinkles, acne for IPL) | The same | Indications for use are identical to the predicate device, across all wavelengths and IPL. |
  | Non-clinical testing | Compliance with various IEC/ISO standards | Compliance with various IEC/ISO standards | Tests (electrical safety, EMC, usability, software, laser safety, biocompatibility) were repeated for the subject device due to minor hardware/software changes or specific component differences. |

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

This submission is for a laser surgical instrument, and the provided text does not mention any clinical study involving patient data or a test set of clinical cases. The evaluation is based entirely on non-clinical testing (engineering verification and validation, performance testing against standards, and comparison of specifications to predicate devices). Therefore, there is no sample size for a test set or data provenance in the context of clinical performance.

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

Not applicable. As noted above, there was no clinical test set or ground truth established by experts in a clinical context. The evaluation relies on engineering standards and comparison to a predicate.

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

Not applicable, as there was no clinical test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

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

Not applicable. This is not an algorithm-only device. Its performance is related to its physical parameters (wavelength, fluence, spot size, etc.) and its electrical/mechanical safety and functionality.

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

For the non-clinical testing, the "ground truth" is defined by the technical specifications outlined in the predicate device's clearance and by compliance with recognized international standards (e.g., IEC 60601 series, IEC 60825-1, ISO 10993-1). The device's performance is measured against these engineering and safety standards, rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this device.

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General intended use

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 as follows.

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

The Discovery Pico Family is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

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 angiomaa
• Cherry angioma
• Spider nevi
• Treatment of benign pigmented lesions including, but not limited to:
• cafe-au-Iait 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:

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

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV

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

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

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV

Only with fractional handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V

694 nm (O-Switched), including microbeam handpieces

Indicated for:

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)

Intended to remove benign dermal pigmented lesions, and, to 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

Indicated for permanent hair removal.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime

IPL 550-1200nm; 570-1200nm

Indicated for 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

Indicated for inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the laser hand piece is to 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 lesson, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser)

The Discovery Pico Family systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm.

lt can also be connected to Er:YAG handpieces cleared under K173002.

The Discovery Pico Family systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems.

The optical delivery system is an articulated arm with fixed handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths.

All the models belonging to the Discovery Pico Family have the same components and the same controlling software. The only difference between different models is the optical bench that depends on the sources installed.

The Discovery Pico Family is controlled via a touch screen display housed in the front of the device.

Emission is triggered by means of a footswitch.

The provided text is a 510(k) summary for the Discovery Pico Family laser device, submitted to the FDA. It details a modification to an already cleared device, primarily the addition of microbeam handpieces. As such, the acceptance criteria and performance data presented are focused on engineering and safety performance, rather than clinical efficacy or diagnostic accuracy as would be the case for an AI/ML-driven diagnostic device.

Therefore, many of the requested fields related to clinical studies, human reader performance, ground truth establishment for clinical data, and training set information are not applicable to this type of device submission.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable / Not specified. The performance data described are related to engineering and safety bench tests (e.g., electrical safety, EMC, output measurements on microbeam handpieces) and software validation. These do not typically involve patient-specific test sets in the same way clinical diagnostic studies do. The phrase "Bench testing measurements were done" implies testing on physical units/components, not patient data.

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

• Not applicable. For engineering and safety tests, the "ground truth" is typically established by objective measurements against predefined specifications and recognized standards, not by expert human interpretation of clinical data.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in a clinical study. This device's testing involves objective measurements against engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI-assisted diagnostic device, but a physical laser device for surgical and aesthetic applications. Therefore, an MRMC study and AI assistance effect size are not relevant.

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

• No. This is a physical laser device, not an algorithm. The software verification and validation are for controlling the device, not for making independent diagnostic or therapeutic decisions.

7. The type of ground truth used:

• For electrical safety, EMC, and laser safety: Compliance with recognized consensus standards (e.g., IEC 60601 series, IEC 60825-1).
• For microbeam handpiece output: Physical bench measurements to confirm output against design specifications.
• For software: Verification and validation against software requirements as per FDA guidance.
• For biocompatibility: Reference to the predicate device.

8. The sample size for the training set:

• Not applicable. As this is not an AI/ML device, there is no "training set" in the context of machine learning.

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

• Not applicable. No training set was used for an AI/ML algorithm.

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