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The Red Light is intended to treat full face wrinkles.
The Blue Light is intended to treat mild to moderate inflammatory acne.
The Yellow Light is intended to treat wrinkles.

The GLAM LED light therapy mask is a home use wearable light emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full face wrinkles and mild to moderate acne of the face. The outer shell of the mask is manufactured from Polyethylene terephthalate (PET). The inner shell is a clear Polycarbonate (PC). The Light emitting diodes are mounted behind the clear Polycarbonate. The LEDs generate the light. The ear hooks are made of Acrylonitrile butadiene styrene (ABS) and the silicone goggle protect the eyes from LED lights. Unfold the ear hooks and place the mask on your face, the mask will automatically activate the light therapy mode. The LEDs produce blue, red and yellow light in the visible spectrum (Blue:415nm +/- 10nm, Yellow: 590nm +/-10nm, Red: 625nm +/-10nm.). The device works by emitting the specified wavelengths to treat full face of wrinkles or to treat mild to moderate inflammatory acne. Press the touch switch on the right ear hook twice to select the light therapy mode you want to use. Each mode operates in a 15-minute cycle. After 15 minutes, the device automatically deactivates the light mode and enters the standby mode.

This FDA 510(k) clearance letter for the GLAM LED Facial Mask (TB-2386F) does not include any information regarding clinical testing, acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction or acne treatment), or studies comparing the device's performance against such criteria.

The letter focuses on the substantial equivalence based on:

• Technological Comparison: Comparing light wavelengths, power density, and treatment time to predicates.
• Safety Standards Compliance: Verification through non-clinical tests (electrical safety, EMC, biocompatibility, photobiological safety, software verification).

Therefore, I cannot provide details on the specific acceptance criteria for efficacy or a study proving the device meets those criteria from the provided document. The 510(k) summary explicitly states: "No animal or clinical study is included in this submission."

However, if we were to hypothesize what acceptance criteria and a study might look like for a device with these indications, and then illustrate what would be missing from this document:

Hypothetical Acceptance Criteria and Performance Study (Not Found in Provided Document):

Since the provided document explicitly states no clinical study was included, the following tables and sections represent what would typically be expected for a device claiming therapeutic efficacy, but none of this information is present in the provided 510(k) clearance letter.

Hypothetical Acceptance Criteria and Reported Device Performance (If Clinical Data Existed)

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The Heager Medical Laser Family device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The Heager Medical Laser Family generates a 980nm wavelength laser to act on a target tissue to achieve hemostasis, ablation, and coagulation of the target tissue. The Heager Medical Laser Family generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The Heager Medical Laser Family has following characteristics:

• Dual wavelengths
• Temperature monitoring system

This document is a 510(k) clearance letter for a medical laser device, not a study report. Therefore, it does not contain the specific details about acceptance criteria and study results you requested in the format typically found in a clinical or performance study.

Based on the provided FDA 510(k) clearance letter for the Heager Medical Laser Family, here's what can be extracted and what information is not available within this document:

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

The document does not explicitly state acceptance criteria in a quantitative, measurable way for device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it demonstrates substantial equivalence to predicate devices based on technical specifications and adherence to recognized electrical and safety standards.

The "reported device performance" is primarily presented as technical specifications and compliance with safety standards rather than clinical performance metrics.

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 available in the provided document. As this is a 510(k) for a laser surgical instrument, the primary "test set" would be the device itself tested against engineering and safety standards, not a clinical data set in the way an AI/diagnostic device would have. The document explicitly states: "No clinical study implemented for the Diode laser therapy device."

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 available. Given that "No clinical study implemented," there would be no ground truth established by experts in a clinical context for the purpose of a study demonstrating effectiveness. The "ground truth" here is the adherence to engineering standards and technical specifications.

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

This information is not available. Adjudication methods are typically associated with clinical studies involving human observers or raters, which were not conducted for this 510(k) submission.

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 applicable and not available. This is a laser surgical instrument, not an AI software/diagnostic device that would involve human readers or AI assistance in interpretation.

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

This information is not applicable and not available. This is not an algorithm or AI device.

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

The "ground truth" in this 510(k) context is primarily compliance with recognized electrical, safety, and performance standards (e.g., IEC standards) and technical specifications of the device, demonstrated through non-clinical testing.

8. The sample size for the training set

This information is not applicable and not available. There is no "training set" in the context of an AI/machine learning model for this type of laser device 510(k) submission.

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

This information is not applicable and not available for the same reason as point 8.

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The Diode laser device is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI),including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Diode laser device consists of a main unit, a handheld, a foot switch and a power cord.

Device composition and handle characteristics: The device includes a handle with a single-band 808nm semiconductor laser, and the semiconductor lasers of the handle are powered by the laser power supply in the host to emit the laser of the corresponding wavelength.

Working principle of semiconductor laser: Semiconductor laser uses semiconductor materials of different doping types as laser working substance, uses natural cleavage surface to form resonant cavity for laser oscillation and amplification, and adds forward voltage to PN junction area of semiconductor laser to form particle number inversion of non-equilibrium carrier between conduction band and valence band of semiconductor substance. When a large number of electrons and holes in particle number inversion state are recombined, excess energy will be released, and these energies will be expressed in the form of photons, that is, laser is formed. Due to resonance amplification of cleavage surface resonant cavity, stimulated feedback is realized, so that laser can be directionally emitted and output from semiconductor laser.

This 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to a predicate device, which is typical for Class II medical devices. The information provided does not contain a detailed study report with specific acceptance criteria related to a performance study for the device's efficacy (hair removal/reduction). Instead, it relies on comparison to a predicate device and adherence to recognized standards for safety and performance.

Here's an analysis based on the provided text:

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

The document does not explicitly state "acceptance criteria" in the context of a clinical or performance study with numerical targets for efficacy (e.g., a certain percentage of hair reduction). Instead, it relies on demonstrating substantial equivalence to a predicate device that is already legally marketed for the same indication. The "performance" assessment is based on the similarity of technical specifications and the successful completion of non-clinical tests to applicable standards, ensuring safety and basic functionality.

• Spot Size: Different, but argued not to affect safety and effectiveness, only treatment area.
• Fluence: Different from the primary predicate but similar to a reference device (K241642), ensuring effectiveness is "not affected." Safety argued to be no problem due to lower max fluence than the predicate.
• Dimension/Weight: Different but argued not to affect safety/effectiveness and comply with mechanical performance standards. |
  | Safety Testing | Compliance with recognized safety standards. | The device passed non-clinical tests verifying compliance with IEC 60601-1, IEC 60825-1, IEC 60601-2-22, ISO 10993-10, ISO 10993-23, ISO 10993-5, and IEC 60601-1-2. These standards cover general safety, laser safety, specific laser equipment safety, biocompatibility (skin sensitization, irritation, cytotoxicity), and electromagnetic compatibility. |

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

The document explicitly states: "No clinical study is included in this submission."

Therefore:

• Sample size for the test set: Not applicable (no clinical test set was used for this submission).
• Data provenance: Not applicable.

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

Not applicable, as no clinical study or test set with expert-established ground truth was part of this submission. The "ground truth" for clearance in this context is established by the FDA's acceptance of substantial equivalence to an already cleared device, which presumably had clinical data at the time of its own clearance.

4. Adjudication method for the test set

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

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

Not applicable. This device is a laser for hair removal, 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 a physical medical device (diode laser), not a software algorithm.

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

For the purpose of this 510(k) submission, the "ground truth" for the device's indications for use and general safety/effectiveness is implicitly the regulatory clearance and established performance of the predicate devices. The applicant is demonstrating that their device is sufficiently similar to these predicates to be considered equally safe and effective.

8. The sample size for the training set

Not applicable, as no clinical study was conducted. There is no "training set" in the context of this 510(k) submission for efficacy.

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

Not applicable, as no clinical study or training set was used.

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Olo is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissues.

Olo is a device which emits laser radiation with a wavelength of 532 nm, which is delivered to the tissue through a transfer fiber and a handpiece or a scanner.

The Olo device electrical specifications are: 100-240V~, 50/60Hz, 600VA.

The provided FDA 510(k) clearance letter for the El.En. S.p.A. Olo Laser Device does not contain information about acceptance criteria or a study proving that the device meets specific performance acceptance criteria for a diagnostic AI/ML device.

The document describes a laser surgical instrument, and its clearance is based on substantial equivalence to an existing predicate device (QuadroStar PRO). The "performance data" section explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" which refers to electrical safety, EMC, and software validation for the device's operational functions, not its diagnostic or an AI/ML component's performance.

Therefore, I cannot extract the requested information concerning acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or training set specifics from the provided text. The device described appears to be a physical medical device (laser) and not a software as a medical device (SaMD) or an AI/ML-powered diagnostic tool as indicated by the nature of the questions.

If the "Olo Laser Device" does incorporate AI/ML for diagnostic purposes, the provided FDA clearance letter is insufficient to detail how its performance was evaluated against specific diagnostic acceptance criteria. This type of information would typically be found in a separate Premarket Submission for AI/ML-enabled Medical Devices Guidance document or within the full submission details, which are not provided here.

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The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.

The wand can be rotated 135 degrees in either direction.

There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.

The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.

The provided FDA 510(k) clearance letter and summary for the KALA Therapy Wand (Model: KALA-03) primarily focus on demonstrating substantial equivalence to predicate devices through non-clinical testing. This type of clearance generally does not require extensive clinical performance studies with detailed acceptance criteria and human reader studies as would be seen for a new or complex AI/ML-driven diagnostic device.

Based on the provided information, the device is a light-based therapy device for over-the-counter use, intended for aesthetic purposes (facial wrinkles and mild to moderate inflammatory acne). The "study" proving the device meets acceptance criteria is a non-clinical performance testing approach demonstrating compliance with relevant electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility standards. Software verification and validation, and usability validation were also performed.

Here's the breakdown of the information requested, as extractable from the provided document:

Acceptance Criteria and Device Performance

Since this is a non-clinical submission, the "acceptance criteria" are compliance with established safety and performance standards. There isn't a table of statistical performance metrics, but rather successful adherence to defined technical and safety requirements.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Compliance)

Study Details (as applicable for a non-clinical submission):

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Device Testing): The "test set" here refers to the device prototypes/units that underwent the non-clinical tests. The document does not specify the number of units tested for electrical safety, EMC, etc., which is typical for such submissions.
   • Data Provenance: The testing was conducted by or for the manufacturer (Shenzhen Kaiyan Medical Equipment Co., Ltd) in China, as indicated by the submitter's information. It's inherently "prospective" in the sense that the tests were performed on the device designed for submission.

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

   • This is a non-clinical submission for a device used for aesthetic purposes. The concept of "ground truth" established by medical experts (like radiologists for image analysis) is not applicable here. The "ground truth" for these tests is defined by the passing criteria of the international standards themselves (e.g., specific thresholds for electrical leakage, EMC emissions, irradiance, etc.). Compliance is assessed by qualified test engineers and labs.

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

   • Not applicable. Adjudication methods are typically used in clinical studies, especially those involving subjective assessments or disagreements among human readers. Non-clinical testing against objective standards does not involve expert adjudication in this manner.

4. 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 is not relevant for this type of aesthetic, light-based therapy device where the claim is not for assisting human readers in diagnosis. The clearance is based on safety and functional equivalence.

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

   • Not applicable. This device is not an algorithm for diagnosis or image analysis. It is a physical device providing light therapy. Its "standalone" performance refers to its ability to meet the specified technical parameters and safety standards.

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

   • The "ground truth" for demonstrating substantial equivalence and safety in this context is compliance with recognized international consensus standards (e.g., IEC, ISO). The performance is measured against these technical specifications, not against clinical outcomes or expert consensus on medical conditions.

7. The sample size for the training set:

   • Not applicable. This device does not involve a machine learning algorithm that requires a "training set" in the traditional sense of AI/ML software. The software component, as described, is for controlling device functions ("Basic Documentation Level software"), not for learning from data.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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The Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

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

The proposed device, Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04), is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

The device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. According to the selective light absorption theory, the laser can be preferentially absorbed by the melanin in the hair follicle, thus achieving the purpose of 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. Hair growth must remain stable for a certain amount of time and must exceed the entire growth cycle of the hair follicle. Permanent hair removal does not mean that all hair in the treated area is completely lost. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

There are 5 models included, PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03 and PZ-BDT68-04, the five models have the same intended use, mechanism of action and principle, only the minimum values of energy density and pulse duration are different.

The provided FDA 510(k) clearance letter and synopsis are for a Medical Diode Laser Hair Removal Device. This document is a regulatory submission for a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this device submission.

The document describes the device, its intended use, a comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence for a hardware device. It explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide a table of AI acceptance criteria or details about AI-specific studies as requested, because this information is not present in the provided document and is not relevant to the type of device being cleared.

However, I can extract the acceptance criteria and performance information that is relevant to this type of physical device, based on the non-clinical testing mentioned:

Acceptance Criteria and Reported Device Performance (Non-Clinical for a Physical Device)

Regarding the AI/SaMD specific questions from your prompt:

1. Sample size used for the test set and the data provenance: Not applicable. No AI/SaMD test set described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/SaMD ground truth described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
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.
8. How the ground truth for the training set was established: Not applicable.

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The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Urology

• Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
• Laser Resection of the Prostrate (LRP)
• Laser Enucleation of the Prostate (LEP)
• Laser Ablation of the Prostate (LAP)
• Transurethral Incision of the Prostate (TUIP)
• Condylomas
• Urethral/ureteral structures
• Lesions of external genitalia
• Bladder neck incisions (BNI)
• Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
• Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
• Endoscopic fragmentation of renal calculi
• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

• Appendectomy
• Polyps
• Biopsy
• Gall Bladder calculi
• Biliary/Bile duct calculi
• Ulcers
• Gastric ulcers
• Duodenal ulcers
• Non Bleeding Ulcers
• Pancreatitis
• Haemorrhoids
• Cholecystectomy
• Benign and Malignant Neoplasm Gynecology
• Angiodysplasia
• Colorectal cancer
• Telangiectasias
• Telangiectasias of the Osler-Weber-Renu disease
• Vascular Malformation
• Gastritis
• Esophagitis
• Esophageal ulcers
• Varices
• Colitis
• Mallory-Weiss tear
• Gastric Erosions

Gynecology
Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.

All variants of the laser family LEONARDO® Duster are laser systems with functions and ergonomics specially developed for medical applications. A touchscreen is used to set treatment parameters, such as Power in Continuous mode, Pulse energy (J) and Frequency (Hz) with Pulse width options in Pulse mode. User-friendly menu navigation and microprocessor-supported control ensure reliable operation while allowing physicians to concentrate on the essential aspects of treatment. The Thulium doped fiber laser module produce a coherent laser radiation with the wavelength of 1940nm±3nm (aiming beam 525nm +/-10nm). An optical fiber delivers this energy to affected surfaces and organs. All fields of application are listed in the indications for use statement.

The subject model LEONARDO® Duster laser has a maximum laser output power of 60W. @ 1940nm The LEONARDO® Duster is available only as a single-wavelength device with 1940nm. All LEONARDO® Duster lasers can be operated in two basic modes, CONTINUOUS or PULSE MODE. Two application modes are available which defines the intended use of the device: Lithotripsy and Other. For safety reasons, the LEONARDO® Duster laser is equipped with a system for automatic recognition of the used optical fibers. Application fibers from CeramOptec are RFID encoded for communicating with the laser device. Reusable fiber probes are available in 6 different sizes. They are initially EO sterilized. Subsequent sterilization is via autoclave. Single patient use fiber probes come in 7 different sizes. They are initially EO sterilized.

This document is a 510(k) clearance letter for the Leonardo Duster laser system. It asserts substantial equivalence to a predicate device based on non-clinical testing. This type of clearance typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials for effectiveness if the indications for use and technological characteristics are sufficiently similar.

Therefore, the provided text does not describe a study involving acceptance criteria related to device performance in a clinical or AI-centric context, nor does it present acceptance criteria for an AI-powered device. It primarily focuses on the safety and effectiveness of a physical medical device (a laser surgical instrument) compared to a predicate device, which is a common pathway for 510(k) clearance.

The "acceptance criteria" presented here are inferred from the regulatory requirements for 510(k) clearance, namely, demonstrating substantial equivalence to a predicate device based on:

1. Identical Indications for Use.
2. Similar technological characteristics without raising new questions of safety or effectiveness.
3. Compliance with relevant performance standards and non-clinical testing (e.g., software validation, reprocessing validation, biocompatibility, sterilization, electrical safety, EMC, usability, laser safety).

Since this is not an AI/ML device or a comparative effectiveness study, many of the requested fields (e.g., sample size for test set, data provenance, ground truth experts, adjudication, MRMC study, standalone performance, training set size) are not applicable.

Here's the breakdown based on the provided text's focus on a physical laser device clearance:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Determination)

Study Details Pertaining to the Leonardo Duster 510(k) Clearance

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

   • N/A. This 510(k) clearance is based on non-clinical (bench) testing and comparison to a predicate device, not a performance study on a test set of data (like for an AI/ML device). The "test set" in this context refers to physical devices and components being tested in a lab setting. These tests were conducted by "accredited testing laboratories," but the location is not specified beyond "Bonn, Nordrhein-Westfalen, Germany" for the manufacturer. No patient data is involved in this type of submission.

2. 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):

   • N/A. No ground truth established by medical experts for a "test set" of patient data was carried out. The "ground truth" for a physical device like this is its adherence to engineering specifications and regulatory performance standards.

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

   • N/A. No adjudication of expert opinions on medical cases was performed as this is not a clinical or AI performance study.

4. 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 is a physical laser surgical instrument, and the clearance is for the device itself, not an AI/ML component assisting human readers.

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

   • No. This is not an algorithm, but a physical medical device. Software validation was performed for the device's firmware, but this does not represent a "standalone algorithm" performance in the context of AI/ML.

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

   • N/A. As this is a physical device, the "ground truth" for its clearance is based on its adherence to engineering specifications, national and international consensus standards for medical devices (e.g., electrical safety, laser safety, biocompatibility, sterilization, usability), and its functional output parameters (e.g., laser power, wavelength, pulse characteristics). There's no clinical "ground truth" like pathology or outcomes data presented for this 510(k) summary, as "Clinical testing was not required to establish substantial equivalence."

7. The sample size for the training set:

   • N/A. No training set was used as this device is a physical laser surgical instrument, not an AI/ML algorithm.

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

   • N/A. No training set was used.

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The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.

The AviClear Laser System is an infrared diode laser device with a nominal wavelength of 1726 nm. Similar to other well-established infrared laser devices, the device uses a combination of the treatment spot size, beam characteristics, and tissue absorption and scattering coefficients at the output wavelength to deliver energy to tissues at depth. The wavelength of the laser energy, when combined with the pre, parallel (during energy delivery), and post cooling of epidermal and superficial dermal structures, causes selective heating of dermal tissue at different depths. The 1726 nm laser energy heats the chromophore, sebum within sebaceous glands, which results in controlled thermal injury of the sebaceous glands, the ultimate treatment target, thus reducing or eliminating sebum production and causing an improvement in acne vulgaris.

The diode laser and associated beam delivery optics, laser and electronics power supplies, control electronics, and cooling system are housed inside a console equipped with a touchscreen user interface. The laser treatment parameters are selected using the touchscreen. Two treatment handpieces are available. Each handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern; a temperature-controlled skin-contact cooling window to provide thermal protection for the epidermis and superficial dermis and through which energy is delivered to the patient; and skin-contact pressure sensors that enable laser energy delivery when the system is in Ready mode and the footswitch is depressed.

The provided FDA 510(k) clearance letter and summary for the AviClear Laser System (K251149) indicate that this submission is for a modification of an already cleared device (K230660), rather than a completely new device or a device incorporating AI for diagnostic or predictive purposes. As such, the study described is a safety study comparing the modified device to the predicate device, not a performance study to prove the device meets specific diagnostic efficacy acceptance criteria in the way an AI/ML medical device would.

Therefore, many of the requested categories related to AI/ML device performance, such as MRMC studies, ground truth establishment for training sets, and detailed performance metrics (sensitivity, specificity, AUC), are not applicable to this specific submission type. The "acceptance criteria" here primarily relate to the comparable safety and thermal effects to the predicate device.

However, I will extract and present the information available from the provided text in the closest applicable format.

Device Acceptance Criteria and Study Overview for AviClear Laser System (K251149)

The AviClear Laser System (K251149) is a modified version of a previously cleared device (K230660). The Acceptance Criteria, in this context, are not about diagnostic performance metrics for an AI system, but rather demonstrating comparable safety and efficacy to the predicate device, specifically regarding its thermal effects and adverse event profile, despite changes to the handpiece and cooling duration.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a safety study for a modified laser system, the "acceptance criteria" are implied by the study's primary and secondary outcomes, focusing on comparability to the predicate.

2. Sample Size and Data Provenance

• Test Set Sample Size: 10 subjects.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but assumed to be the United States as it is an FDA submission.
  • Retrospective/Prospective: Prospective, comparative double-arm safety study. Subjects underwent procedures specifically for the study.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: At least one independent dermatopathologist.
• Qualifications of Experts: Independent dermatopathologist. No further details on experience (e.g., years) are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The histological assessment was done by "an independent dermatopathologist," suggesting a single expert's assessment was used, not a consensus or adjudication process involving multiple reads.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, an MRMC comparative effectiveness study was not performed. This type of study (comparing human reader performance with and without AI assistance) is not applicable to a laser system clearance without AI integration. The study was a safety and comparability study of a medical device itself.

6. Standalone Performance (Algorithm Only)

• Was standalone performance done? Not applicable. This phrase typically refers to the performance of an AI algorithm on its own. The AviClear Laser System is a physical medical device (laser system), not primarily a software algorithm. Its "performance" is evaluated through clinical safety and histological outcomes rather than diagnostic metrics.

7. Type of Ground Truth Used

• Ground Truth Type:
  • Observed Adverse Events (AEs) and Adverse Device Effects (ADEs): Self-reported or clinician-observed events during follow-up.
  • Histological Tissue Evaluation: Microscopic examination of excised tissue by a dermatopathologist to assess thermal impact, cellular changes, etc. This is considered a pathology-based ground truth for thermal effects.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The device is a laser system hardware, not a machine learning algorithm that requires a "training set" in the conventional AI/ML sense. The "training" for the device, if any, would be its design and engineering iterations, followed by verification and validation testing (nonclinical and clinical) as described.

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

• How Ground Truth for Training Set Was Established: Not applicable for the same reason as above.

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Flexiva Pulse and Flexiva Pulse TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse and Flexiva Pulse TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.

Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use

Flexiva Pulse, Flexiva Pulse TracTip, Flexiva Pulse ID and Flexiva Pulse ID TracTip Single Use Laser Fibers are fiber optic laser energy delivery devices consisting of a SMA connector (Black Hole design), and an ETFE jacketed silica core fiber. Flexiva Pulse and Flexiva Pulse ID fibers are equipped with a polished, flat output tip (242µm, 365µm, 550µm and 910µm size) and the Flexiva Pulse TracTip and Flexiva Pulse ID TracTip fibers are equipped with a polished and reinforced ball-shaped output tip (242µm size).

These fibers may be used in a variety of laser-based surgical cases. For Flexiva Pulse ID laser fibers, an RFID (Radio-frequency identification) tag enables read/write data storage for compatible RFID-equipped laser systems (closed systems).

The provided FDA 510(k) clearance letter and summary for the Flexiva Pulse Laser Fibers does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and study particulars for a medical device. This document is a premarket notification for laser fibers, which are physical components and not typically subject to the same kind of performance studies as, for example, an AI diagnostic algorithm.

Specifically, it lacks information about:

• Acceptance Criteria for a diagnostic output: As the device is a laser fiber for surgical use, its "performance" is about its physical properties and ability to transmit laser energy, not diagnostic accuracy.
• Study proving device meets acceptance criteria in the context of diagnostic accuracy.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test and training sets, and training set sample size and ground truth establishment for AI-based devices. These are all concepts related to clinical performance evaluation, particularly for AI/Machine Learning devices, which is not the nature of the Flexiva Pulse Laser Fibers.

The document does describe performance testing related to the physical and functional attributes of the laser fiber. I will present the information contained in the document that most closely aligns with the spirit of your request, interpreting "acceptance criteria" and "reported device performance" in the context of a physical medical device.

Overview of Device Performance and Testing (Flexiva Pulse Laser Fibers)

The document describes a Special 510(k) submission for the Flexiva Pulse Laser Fibers, indicating that it is a modification to a previously cleared device (predicate device K210925). The core of the submission is to demonstrate substantial equivalence to the predicate device, primarily due to a "secondary coating resin material change." Therefore, the "study" described is focused on validating that this material change does not negatively impact the critical performance characteristics of the laser fiber.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (laser fiber), the "acceptance criteria" and "reported device performance" are related to its functional integrity and safety. These are not performance metrics like sensitivity, specificity, or accuracy, which would be relevant for a diagnostic AI device.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample sizes (e.g., number of fibers tested) for the performance tests (Bent Transmission, Fiber Durability, etc.). It generally states that a "Design Verification was executed." The data provenance is internal testing performed by Boston Scientific Corporation. The studies are by nature prospective in the sense that they are performed on newly manufactured devices with the changed coating resin material to verify their performance. There is no mention of country of origin for test data, but it would typically be conducted at the manufacturer's R&D facilities.

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

Not applicable. This is not a diagnostic device where expert ground truth is established for clinical outcomes or interpretations. The "ground truth" for the performance tests mentioned above would be engineering and physical measurement standards.

4. Adjudication Method

Not applicable. This is not a diagnostic device requiring adjudication of clinical interpretations.

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

No. This type of study is for evaluating human performance (e.g., diagnostic accuracy) with and without AI assistance, which is irrelevant for a laser fiber.

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

No. This refers to the performance of a diagnostic algorithm without human intervention, which is not applicable to a laser fiber.

7. The Type of Ground Truth Used

For the physical performance tests:

• Engineering Specifications/Standards: The "ground truth" is adherence to predefined engineering specifications for power transmission, temperature limits, durability, etc. These would be established based on industry standards, the predicate device's performance, and safety requirements.
• Biocompatibility Standards: For biocompatibility, the ground truth is compliance with recognized biological evaluation standards (e.g., ISO 10993 series), ensuring the materials are safe for human contact.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of what the document indicates about the "study":

The study was a "Design Verification" executed by Boston Scientific Corporation to support the "safe and effective use" of the proposed laser fibers after a "secondary coating resin material change." The purpose was to demonstrate that the modified device remains "substantially equivalent" to its predicate device (K210925). The tests involved evaluating the fiber's ability to transmit laser energy (Bent Transmission), its resilience during use (Fiber Durability while Firing), and safety (Fiber Connector Temperature, Laser System Output Accuracy, Biocompatibility). The document implies that all these tests were successfully completed, confirming that the material change did not compromise the device's performance or safety.

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