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Helios Dermal Scaffold is intended for the management of wounds that include:

• Partial- and full- thickness wounds
• Pressure, diabetic, and venous ulcers
• Partial thickness burns
• Surgical wounds – donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
• Trauma wounds – abrasions, lacerations and skin tears
• Tunneled/undermined wounds
• Draining wounds

Helios Dermal Scaffold is an acellular dermal tissue matrix derived from fetal bovine dermis. The single-use device is supplied sterile and is provided in sheet form in a variety of sizes and configurations, including meshed, solid, and fenestrated designs ranging from 1.5 - 500 cm² to be trimmed by the surgeon to meet the individual patient's needs.

The provided FDA 510(k) clearance letter for the Helios Dermal Scaffold does not contain any information regarding acceptance criteria or the study details typically associated with AI/ML device performance validation.

This document is for a medical device (a dermal scaffold), which is a biological product, not a software or AI/ML-driven diagnostic device. The performance data section refers to physical and biological characteristics of the scaffold, such as:

• Device Characterization Testing: Dimensional verification, color and appearance, suture retention strength, acellularity (histology), collagen denaturation.
• Design Validations: Viral inactivation, sterilization.
• Biocompatibility
• Shelf-life
• Packaging testing

These tests are standard for biological and implantable materials, ensuring their physical integrity, safety, and compatibility with the human body. They do not involve AI/ML algorithms, image analysis, or diagnostic accuracy.

Therefore, it is not possible to extract the requested information (acceptance criteria, sample size, ground truth, expert opinions, MRMC studies, etc.) from this document, as those concepts are not applicable to the type of device described.

To answer your prompt with the requested information, the input document would need to be a 510(k) clearance letter for an AI/ML medical device, typically referencing a clinical study or performance study that evaluates diagnostic accuracy, sensitivity, specificity, or reader agreement.

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Helios+ is a 253.7nm wavelength, high intensity, germicidal UV-C light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. Helios+ is intended for use in unoccupied operating rooms, hospital rooms and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices. The system is for over-the-counter (OTC) use.

Surfacide Helios+ is a 253.7nm wavelength, high intensity, germicidal UV-C light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. Helios+ is intended for use in unoccupied operating rooms, hospital rooms and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices.

Helios+ delivers a defined dose to a defined distance and area sufficient for 2-log microbial reduction of vegetative bacteria and Clostridioides difficile spores.

Helios+ is used in operating rooms, hospital rooms, and other clinical settings where non-critical medical devices are present.

Helios+ includes 1-3 UV-C emitters, 1-3 safety sensors, a control tablet, and 2 joiners that link the emitters for transport and serve as warning stands when the device is in use. Simultaneous use of multiple UV-C emitters can reduce shadowed areas by providing multiple direct lines of sight to non-critical medical device surfaces.

The provided FDA 510(k) clearance letter for the Helios+ UV-C System (K242604) pertains to a whole-room microbial reduction device. This document focuses on the device's technical specifications, non-clinical performance (microbial reduction, safety, materials compatibility, etc.), and a comparison to a predicate device.

Crucially, the document explicitly states under "Non-Clinical Tests Summary" that "CLINICAL TESTING – Non – Applicable."

This means that this device's acceptance criteria and proven performance are based solely on non-clinical (laboratory and simulated use) studies, not on clinical studies involving human patients, human readers, or human interpretation of outputs. Therefore, several of the requested categories related to clinical study design, human expert adjudication, and multi-reader multi-case studies are not applicable to the information provided in this 510(k) summary.

Here's a breakdown of the applicable information based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Criteria for Helios+ UV-C System

The Helios+ UV-C System is a Whole Room Microbial Reduction Device, and its clearance is based on non-clinical performance data demonstrating its ability to reduce microbial load.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify exact numerical sample sizes for each non-clinical test (e.g., number of surfaces tested, number of rooms in in-use testing). It indicates "select bacterial organisms and C. difficile spores" were tested for microbial reduction and "Patient rooms, bathrooms, and operating rooms were sampled" for in-use testing.
• Data Provenance: The document does not explicitly state the country of origin of the data. Given it's an FDA 510(k) submission, the testing would typically be conducted by or for the submitting company, PreventaMed Technologies, Inc., dba Surfacide Manufacturing, Inc., which is based in Waukesha, Wisconsin, United States. The studies are described as non-clinical tests, encompassing lab-based and simulated use environments, rather than prospective or retrospective clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. The acceptance criteria and testing for this device are based on objective, quantifiable physical and microbial measurements (e.g., log reduction, ozone levels, material degradation standards, electrical safety standards). There is no "ground truth" established by human experts in a subjective interpretation sense (like radiologists interpreting images).

4. Adjudication Method for the Test Set

• Not Applicable. As the testing is non-clinical and relies on objective measurements, no adjudication by human experts is described or required.

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

• Not Applicable. No MRMC study was done because the device is a whole-room microbial reduction system, not an AI or imaging device that assists human readers. The document explicitly states "CLINICAL TESTING – Non – Applicable."

6. Standalone Performance

• Yes, in the context of device function. The "Non-Clinical Tests Summary" describes tests of the device's standalone performance in achieving microbial reduction and meeting various safety and performance standards without human intervention beyond operation. For example, "Simulated use performance testing demonstrated microbial log reduction..." and "Performance testing was completed to demonstrate the system will prevent exposure and ensure that device operation can only occur in an unoccupied environment."

7. Type of Ground Truth Used

• The ground truth for the non-clinical tests was established through:
  • Microbiological assays: Measuring log reduction of specific bacterial and spore organisms (e.g., on test coupons/surfaces).
  • Physical and Chemical Measurements: Quantifying UV-C dosage, ozone levels, material strength/degradation, electrical parameters.
  • Compliance with Industry Standards: Adherence to established standards like IEC 62471, ISO 4582, ASTM D256-10, ASTM A370-22, IEC 61010-1, IEC 61326-1, and 29 CFR 1910.1000.

8. Sample Size for the Training Set

• Not applicable in the typical AI/ML sense. The Helios+ UV-C System is a physical device that performs a function (UV-C disinfection), not a software or AI algorithm that "learns" from a training set of data to make predictions or classifications. Therefore, the concept of a "training set" as it applies to machine learning models is not relevant here. The device's parameters (e.g., UV-C output, cycle times) would be determined through engineering design and optimization based on scientific principles of UV-C disinfection, informed by tests like the optimized kill curve.

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

• Not applicable. As explained above, there is no "training set" in the context of an AI/ML algorithm for this device. The underlying scientific principles for UV-C effectiveness (e.g., wavelength, intensity, exposure time, distance) are well-established. The device's design and operating parameters are based on these principles and validated through the non-clinical tests described.

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Helios Dura Regeneration Matrix is indicated as a dura substitute for the repair of the dura mater.

Helios Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. The single-use device is supplied sterile in sheet form in a variety of sizes ranging from 6.5 - 250 cm² (~1 - 40-in²) to be trimmed and sutured or onlayed by the surgeon to meet the individual patient's needs.

The provided FDA 510(k) clearance letter and summary for the Helios Dura Regeneration Matrix do not contain the detailed information requested regarding acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system. The document describes a medical device, specifically a dura substitute, and its equivalence to a predicate device. The performance data section refers to standard device characterization, design validation, biocompatibility, shelf-life, and packaging testing, which are typical for physical medical implants, not for AI-powered diagnostic or assistive technologies.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment as it pertains to an AI system.

Based on the provided text, the device is a physical dura substitute and not an AI/software device whose performance would be measured with the kind of criteria listed in your prompt.

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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 Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is indicated for the gas enhanced ablation of soft tissue using helium-based plasma.

The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System produces a Helium-based cold plasma spray to deliver high frequency low energy current intended for the ablation of soft tissues.
The Canady Helios Cold Plasma™ XL-1000CP Ablation System includes the following items:

• Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator
• Canady Helios™ Cold Plasma Ablators
• Foot Pedal
• Trolley Cart
  The Canady Helios Cold Plasma™ XL-1000CP™ SMART Electrosurgical Generator is a transportable nonsterile electrical device compatible for use in the operating room environment. The Canady Helios Cold Plasma™ XL-1000CP SMART Electrosurgical Generator creates high frequency, short duration energy pulses with regulated Helium gas, which is delivered to the target tissue via the Canady Helios™ Cold Plasma Ablators. The Canady Helios™ Cold Plasma Ablators are sterile monopolar electrosurgical instruments intended for single use.

This document, K240297, is a 510(k) Premarket Notification for the Canady Helios Cold Plasma™ XL-1000CP™ Ablation System. It demonstrates substantial equivalence to a predicate device, not an AI/ML powered device. Therefore, the information requested about acceptance criteria, study details, ground truth establishment, sample sizes, and expert adjudication as pertains to AI/ML device performance is not applicable to this submission.

The document focuses on the safety and effectiveness of the electrosurgical ablation system itself, comparing it to an existing predicate device based on its intended use, technological characteristics, and performance testing against recognized standards.

Here's a breakdown of what is available in the document regarding the device's performance and acceptance, interpreted in a general sense rather than specifically for AI/ML:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria for performance; rather, it lists various tests conducted and generally states that the device "Met criteria." This is common for non-AI medical devices where performance is typically validated against engineering specifications and applicable standards, rather than statistical thresholds for diagnostic accuracy.

The document also notes in the Substantial Equivalence table:

• Performance: "Shown to ablate soft tissue at specified parameters." (For both subject and predicate device).

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

This information is not applicable as the document describes a traditional medical device (electrosurgical ablation system) and its performance validation, not an AI/ML-powered device requiring a test set for algorithmic performance evaluation. The "tests" mentioned are likely bench testing, in-vitro experiments, or potentially animal studies (though not specified), designed to verify physical and electrical properties, sterility, and basic function. Data provenance as typically understood for AI (e.g., country of origin of patient data, retrospective/prospective) is irrelevant here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. There is no "ground truth" in the AI/ML sense (e.g., clinical labels for images) established by experts for this type of device. Performance is assessed against engineering specifications, safety standards, and the ability to perform its stated function (ablation).

4. Adjudication Method for the Test Set:

Not applicable. No adjudication methods are described as there is no human interpretation of data for algorithmic ground truth establishment.

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

Not applicable. This type of study is relevant for AI/ML diagnostic or assistive technologies where human reader performance is a key metric. This is a therapeutic electrosurgical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. As this is not an AI/ML device, the concept of a standalone algorithm performance test is not relevant.

7. Type of Ground Truth Used:

Not applicable in the AI/ML sense. For this device, "ground truth" refers to established engineering principles, safety standards (e.g., electrical safety, electromagnetic compatibility), and the physical outcome of the ablation process (e.g., tissue ablation effectiveness, thermal effect), verified through laboratory testing against specifications.

8. Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/ML device that learns from data.

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

Not applicable. Similar to point 8, there is no training set or associated ground truth for this type of medical device submission.

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[Indication for use of Q-switched Nd:YAG Laser]

• Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm)
• Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm)
• Tattoo Removal (1064nm, 532nm)
  dark ink : blue and black (1064nm)
  light ink : red, sky blue, green (532nm)
• Treatment of Benign Vascular Lesions (532nm)
  port wine birthmarks
  telangiectaias
  spider angioma
  cherry angioma
  spider nevi
• Treatment of Benign Pigmented Lesions (1064nm, 532nm)
  café-au-lait birthmarks (532nm)
  solar lentiginos (532nm)
  senile lentiginos (532nm)
  becker's nevi (532nm)
  freckles (532nm)
  nevus spilus (532nm)
  nevus of ota (1064nm)
  [Indication for use of Ti:Sapphire Laser]
  Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. (785nm)
  Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously.

HELIOS 785 Pico consists of a Q-switched Nd:YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm). The device consists of a main body, color touch screen, articulated arm, foot switch and several handpieces, and is controlled by an embedded processor. The device uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis to achieve its intended purpose. It is for prescription use only.

The provided text is a 510(k) Premarket Notification submission for the HELIOS 785 Pico laser device. This document focuses on demonstrating substantial equivalence to existing predicate devices based on technical specifications and non-clinical testing, rather than presenting clinical study data to prove performance against specific acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, the information requested in points 1-9 cannot be fully extracted or inferred from this document. This device is a laser surgical instrument, not an AI/SaMD, and its clearance pathway typically does not involve extensive clinical studies with human readers, ground truth consensus, or the specific types of performance metrics associated with AI algorithms.

Here's a breakdown of why the information is not present and what can be extracted:

Information Not Present in the Document:

• 1. Table of acceptance criteria and reported device performance (in the context of AI/SaMD): This document details technical specifications and non-clinical test validations (e.g., electrical safety, EMC, laser safety standards). It does not present acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, or other measures typically used for AI/SaMD.
• 2. Sample size and data provenance for a test set: Not applicable as there's no clinical test set for AI performance. Non-clinical tests were conducted on the device itself.
• 3. Number of experts and qualifications for ground truth: Not applicable.
• 4. Adjudication method: Not applicable.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study or effect size for human reader improvement with AI assistance was performed or reported.
• 6. Standalone performance for an algorithm: Not applicable, as this is a hardware laser device, not a standalone algorithm.
• 7. Type of ground truth used: Not applicable.
• 8. Sample size for the training set: Not applicable, as there is no AI algorithm being trained.
• 9. How ground truth for the training set was established: Not applicable.

What can be extracted or inferred from the document:

• Device Type: Laser Surgical Instrument (specifically, a combination of Q-switched Nd:YAG and Ti:Sapphire lasers).
• Regulatory Class: Class II (Product Code: GEX).
• Indications for Use: Detailed for both Q-switched Nd:YAG Laser (incision, excision, ablation, vaporization of soft tissue; hair removal; tattoo removal of various colors; treatment of benign vascular lesions; treatment of benign pigmented lesions) and Ti:Sapphire Laser (removal of green and blue tattoos for Fitzpatrick skin types II-IV).
• Comparison to Predicate Devices: The submission is based on demonstrating substantial equivalence to the HELIOS IV 785 (K212663) as the primary predicate and PicoWay Laser System (K191685) as a reference predicate.
• Non-Clinical Testing: The document lists various non-clinical tests conducted to verify the device conforms to relevant mandatory performance standards and design specifications. These include:
  • IEC 60601-1:2005/A1:2012 (Medical Electrical Equipment General Requirements)
  • IEC 60601-1-2:2014 (Electromagnetic Compatibility)
  • IEC 60601-2-22:2012 (Specific Requirements for Laser Equipment)
  • IEC 60825-1: 2014 (Safety of laser products - Part 1: Equipment classification and requirements)
  • Biocompatibility evaluation per ISO 10993 and FDA guidance
  • Usability per IEC 60601-1-6 and IEC 62366
  • Risk management per ISO 14971
  • Software Validation & Verification Test
  • Bench Testing to verify the performance.
• No Clinical Study: The document explicitly states, "No clinical study is included in this submission." This indicates that the substantial equivalence determination for this device relies primarily on the demonstrated technical equivalence and non-clinical testing results, rather than clinical efficacy studies.

In summary, the provided document is a regulatory submission for a physical medical device (laser), not an AI/SaMD. Therefore, it does not contain the information typically associated with the acceptance criteria and study designs for proving AI device performance.

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[Indication for use of Q-switched Nd:YAG Laser]

• Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm)
• Removal or lightening of unwanted hair with or without adjuvant preparation (1064mm)
• Tattoo Removal (1064nm, 532nm)
• dark ink : blue and black (1064nm)
• · light ink : red, sky blue, green (532nm)
• Treatment of Vascular Lesions (532nm)
• · port wine birthmarks
• · telangiectaias
• · spider angioma
• · cherry angioma
• · spider nevi
• Treatment of Pigmented Lesions (1064nm, 532nm)
• · café-au-lait birthmarks (532nm)
• · solar lentiginos (532nm)
• · senile lentiginos (532nm)
• · becker's nevi (532nm)
• · freckles (532nm)
• · nevus spilus (532nm)
• nevus of ota (1064nm)
  [Indication for use of Ti:Sapphire Laser]
• Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. (785nm)

• O-switched Nd: Y AG Laser and Ti:Sapphire Laser cannot be used simultaneously *

HELIOS IV 785 consist of a set of Q-switched Nd: YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm), and controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

This is a 510(k) premarket notification for the Laseroptek Co., Ltd. HELIOS IV 785, a laser surgical instrument for use in general and plastic surgery and in dermatology. The document focuses on demonstrating substantial equivalence to predicate devices, rather than an AI-powered device. Therefore, the typical acceptance criteria and study design elements for AI/ML device performance are not applicable or described in this document.

The document does not describe the acceptance criteria and a study that proves a device meets them in the context of an AI/ML algorithm. Instead, it is a Premarket Notification (510(k)) for a medical device (a laser system), demonstrating substantial equivalence to already legally marketed predicate devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance for an AI device is not present in this document. The document focuses on the technical characteristics and intended use of the laser system.

Here's what can be extracted and what cannot:

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

• Not applicable in the context of AI/ML performance. This document describes a laser system. The "performance data" section refers to compliance with safety standards and electrical/mechanical performance, not diagnostic accuracy or AI model performance.

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

• Not applicable. There is no mention of a test set, data (images/signals), or data provenance in the context of an AI/ML algorithm.

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):

• Not applicable. There is no discussion of ground truth establishment by experts for an AI/ML output.

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

• Not applicable. No test set or adjudication method is described for an AI/ML algorithm.

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 is a hardware device (laser system), not an AI/ML diagnostic or assistive device. No MRMC study is mentioned.

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

• Not applicable. This is a laser system, not an algorithm.

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

• Not applicable. There is no AI/ML component discussed that would require ground truth.

8. The sample size for the training set:

• Not applicable. No AI/ML training set is mentioned.

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

• Not applicable. No AI/ML training set or ground truth process is mentioned.

Summary of what the document does describe (relevant to device performance, but not AI performance):

The document details the technical characteristics of the HELIOS IV 785 laser system and compares them to two predicate devices (Helios III Q-Switched Nd:YAG Laser System and PicoWay Laser System) to demonstrate substantial equivalence.

Performance Data (Non-clinical tests mentioned):

The device underwent non-clinical testing to ensure compliance with various standards related to laser products, general safety, electromagnetic compatibility, usability, and biocompatibility.

• 21 CFR 1040.10 and 1040.11 (mandatory performance standards for laser products)
• IEC 60601-1:2005+A1:2012 (general requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 (electromagnetic disturbances)
• IEC 60601-1-6:2010+AMD1:2013 (usability)
• IEC 60601-2-22:2019 (particular requirements for surgical, cosmetic, therapeutic and diagnostic laser equipment)
• IEC 60825-1:2014 (safety of laser products, classification and requirements)
• ISO 14971:2012 (risk management)
• IEC 62366:2008 (usability engineering)
• ISO 10993-5:2009 and ISO 10993-10:2013 (biocompatibility)

The "reported device performance" in this context is the successful evaluation and compliance with these non-clinical standards, which are considered sufficient to establish substantial equivalence for the safety and effectiveness of the laser device.

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Helioseal F Plus is used to seal fissures, pits and foramina caeca.

Helioseal® F Plus is a light-curing, white shaded fissure sealant featuring fluoride release. Helioseal F Plus is supplied in either a syringe or cavifil delivery form. The fissure sealant is composed of dimethacrylates. In the handling technique, the dental professional will clean the enamel surface to be sealed, isolate the working field, conditioning is performed, a thorough rinse and dry to remove the conditioner, before the application of Helioseal F Plus to the tooth surface.

This document is a 510(k) premarket notification for a dental device, specifically a pit and fissure sealant. It demonstrates substantial equivalence to a predicate device, rather than providing a performance study proving a device meets specific acceptance criteria as would be typical for an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes, expert involvement, ground truth establishment, and MRMC studies is not applicable to this document.

The document primarily focuses on demonstrating equivalence through:

• Comparison to Predicate Device: Detailed comparison of indications for use, contraindications, technology, principles of operation, and physical properties between Helioseal F Plus (subject device) and Helioseal F (predicate device).
• Bench Testing: Non-clinical performance testing for physical properties (flexural strength, curing depth, light intensity, wavelength for curing, water sorption, water solubility, radio-opacity) in accordance with FDA Guidance and EN ISO 6874:2015.
• Biocompatibility Testing: Evaluation for cytotoxicity and genotoxicity according to ISO 10993-1, ISO 7405, and ISO 14971.

The conclusion states that the devices are substantially equivalent, implying that the new device performs similarly to the already legally marketed predicate device. There are no acceptance criteria, in the sense of accuracy/recall/precision metrics for an AI/ML algorithm, or a human reader study, included in this type of submission.

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Instrument & Software:

The HELIOS® AUTOMATED IFA SYSTEM is an automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions. All suggested results obtained with the HELIOS® AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

Assay:

AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies (ANA) in human serum by manual microscopy or with HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS® AUTOMATED IFA SYSTEM instrument must be confirmed by trained personnel.

The HELIOS® AUTOMATED IFA SYSTEM is an automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions.

This document is a 510(k) premarket notification for the HELIOS® AUTOMATED IFA SYSTEM and AESKUSLIDES® ANA-HEp-2-Gamma. It describes the device's indications for use and confirms that the FDA has found it substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document primarily focuses on regulatory approval and the device's intended use. Information about the performance study, including acceptance criteria and results, would typically be found in a separate section of the 510(k) submission, such as a "Summary of Safety and Effectiveness" or a "Performance Data" section, which is not included in the provided snippets.

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Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) port wine birthmarks (532 nm) telangiectasias (532 nm) spider angioma (532 nm) cherry angioma (532 nm) spider nevi (532 nm) cafe-au-lait birthmarks (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles, nevus spilus (532 mm) nevus of ota (1064 nm)

The Helios III laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd–YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.

The provided text is a 510(k) summary for the Helios III Q-Switched Nd:YAG Laser System. It is an FDA submission seeking substantial equivalence to existing predicate devices, not a study proving the device meets specific acceptance criteria through clinical or AI-driven performance metrics.

The document primarily focuses on bench testing and comparison of technical specifications and intended uses with predicate devices to demonstrate substantial equivalence, rather than providing the kind of performance data you are asking for regarding AI/human reader studies.

Therefore, many of the requested items (e.g., acceptance criteria for AI performance, sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) are not applicable (N/A) because this is not a submission for an AI/ML medical device or a clinical outcome study in the traditional sense you have described.

Here's a breakdown of the information that is available in the provided text:

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

The document doesn't provide explicit "acceptance criteria" in the format of pass/fail thresholds for clinical or AI performance. Instead, it presents a comparison of the Helios III's technical specifications and intended uses against two predicate devices recognized as legally marketed. The "performance" is demonstrated by showing that these specifications are comparable to or within acceptable ranges of the predicates.

Table 1: Approved Indication of Uses for Helios III Predicate Devices (Comparative)

Table 2: Performance Specification Comparison with Predicate Devices (Comparative)

Regarding the Study:

The document states:

• Performance Data: "Non-clinical testing of Helios III included visual and mechanical inspection, electrical and mechanical safety testing, functional performance testing, etc., in bench. Some of these tests include visual inspection, earthbond testing, software testing, transit testing, leakage current testing and measurements. Test reports have been submitted."
• This refers to bench testing for safety and functional performance as a laser device, not a comparative clinical study or AI performance evaluation.

Specific Answers to Your Questions (based on the provided text):

2. Sample sizes used for the test set and the data provenance: N/A. This document describes non-clinical bench testing of a laser device, not performance on a test set of medical images or patient data. Data provenance (country, retrospective/prospective) is also N/A for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment by experts is not described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. No adjudication process for a test set is mentioned.
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: N/A. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A. For the bench testing, "ground truth" would be the engineering specifications and safety standards met by the device.
8. The sample size for the training set: N/A. This device does not involve a training set as it is not an AI/ML product.
9. How the ground truth for the training set was established: N/A. Not an AI/ML product.

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