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The Medical Diode Laser Systems, include model: VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

The Medical Diode Laser Systems, model: VELASⅡ-30B is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

The Medical Diode Laser Systems, model: VELASⅡ-30B is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The "Medical Diode Laser Systems", include model: VELASⅡ-30B, VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B which consist of three main components: Main device; Foot switch; Accessories.

Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.

The diode laser for this unit is GaAlAs diode bar, and the wavelength is 810nm and/or 980nm+/-10nm (pilot beam: 650nm+/-10nm). It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.

MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system. It supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.

The provided FDA 510(k) clearance letter for the Gigaalaser Medical Diode Laser Systems does not contain a study that proves the device meets specific acceptance criteria related to its clinical efficacy. Instead, it demonstrates substantial equivalence to legally marketed predicate devices based on technological characteristics and safety standards.

The document focuses on non-clinical performance data (electrical safety, EMC, software V&V, mechanical/acoustic, animal, and clinical studies are noted as "not applicable" for this submission type) to argue that the proposed device is as safe and effective as its predicates.

Therefore, I cannot directly provide a table of acceptance criteria and reported device performance in the context of a clinical efficacy study, as such a study is explicitly stated as "not applicable" in this 510(k) submission. Similarly, details about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance are not present because clinical efficacy testing was not required for this type of submission.

However, I can interpret the acceptance criteria in the context of a 510(k) submission as the requirements for demonstrating substantial equivalence to predicates, particularly regarding safety and technological characteristics. The "performance" reported is the demonstration that these criteria are met through compliance with recognized standards.

Here's an interpretation based on the provided document:

Overview of "Acceptance Criteria" for Substantial Equivalence and Device Performance (as demonstrated in the 510(k))

Within the context of a 510(k) submission, "acceptance criteria" are primarily established through demonstrating compliance with recognized performance standards and substantial equivalence to legally marketed predicate devices. The "study" proving this involves a comprehensive technical comparison and non-clinical testing.

The document explicitly states that clinical studies are "not applicable" for this 510(k) submission, meaning the acceptance criteria are focused on non-clinical performance and technological equivalence rather than empirical clinical efficacy data from a human trial.

1. Table of "Acceptance Criteria" (Substantial Equivalence) and "Reported Device Performance" (Demonstrated Compliance)

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

This document does not describe a "test set" in the context of clinical data for efficacy. The "testing" referred to is primarily bench testing and compliance validation with international safety and performance standards. Therefore, concepts like sample size for a patient test set and data provenance (country of origin, retrospective/prospective) are not applicable as no clinical study for efficacy was performed or presented.

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

Not applicable. As no clinical efficacy test set was used, there was no need for experts to establish ground truth on patient outcomes/diagnoses. The "ground truth" for the substantial equivalence argument relies on comparison to the published specifications and regulatory clearances of the predicate devices.

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

No. The document explicitly states "Clinical Studies: It is not applicable." Therefore, no MRMC study for human reader improvement with AI assistance was conducted or reported.

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

No. This device is a laser system hardware, not an AI algorithm. Its performance is inherent to its physical output characteristics, not an algorithm's classification or detection performance.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is primarily:

• Predicate Device Specifications: The established technical parameters and indications for use of the legally marketed predicate devices (K142078, K150138, K121363, K230047).
• Industry Standards: The requirements laid out in the cited IEC and other international standards for medical electrical equipment and laser safety.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not a machine learning model that requires a training set of data.

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

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

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Product Code ILY - 810 and 980 nm wavelength:

The SIRONA 100 Therapy Laser System emits energy in the visible and near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.

Product Code PDZ - 980 nm wavelength:

The SIRONA 100 Therapy Laser System is also indicated for use for the temporary increase of clear nail in patients with onychomycosis including dermatophyton rubrum and T. mentagrophytes, and/ or yeasts Candida albicans, etc.

Not Found

This FDA 510(k) clearance letter for the "SIRONA 100 Therapy Laser System" does not contain specific details about acceptance criteria or a study proving that the device meets those criteria.

FDA 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new efficacy or safety claims (unless specifically requested by FDA for certain types of devices).

Therefore, I cannot provide the requested information based on the provided document. The letter acknowledges the submission and states that the device is substantially equivalent to predicate devices, allowing it to be marketed. It does not detail the technical performance or the specifics of any studies used to validate performance against pre-defined acceptance criteria.

To get this information, one would typically need to refer to the actual 510(k) submission (if it were publicly available in more detail than this clearance letter) or directly contact the manufacturer.

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The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fines and wrinkles and increase in circulation within the perioral region.

The LED Lip Perfector (Model: ZC-05) is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat fine lines and increase circulation within the perioral region. The device contains four types of LEDs: 605nm, 630nm, and 850nm The LED Lip Perfector components include the main device, charging base, power cord, alternative mouthpiece, user manual, and storage bag. There is only one button on the top edge of the main unit. Short press the power button to turn on the device, and long press the power button to turn off the device. This device only has one treatment mode. The LED Lip Perfector is applied to the skin to ensure consistent light administration during each treatment. The device is sold Over the Counter (OTC).

The provided text is a 510(k) summary for the LED Lip Perfector (Model: ZC-05). It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to recognized standards. It does not contain information about acceptance criteria or a study proving device performance in the context of clinical effectiveness or statistical superiority/non-inferiority.

Specifically, the document states: "The LED Lip Perfector (Model: ZC-05) has been evaluated the safety and performance by lab bench testing as following:" and then lists a series of recognized standards (e.g., IEC 60601-1, ISO 10993) related to electrical safety, electromagnetic compatibility, usability, and biocompatibility.

The conclusion is based on comparing the subject device to the predicate device in terms of design, intended use, indications for use, functions, materials, and applicable standards, as well as adherence to these safety and performance standards. It explicitly states: "The subject device is as safe, as effective, and performs as well as the legally marketed predicated devices K172662." This implies that by meeting the same safety and performance benchmarks as the predicate, and having similar characteristics and indications for use, it is considered "effective" in the regulatory sense for substantial equivalence, rather than through a dedicated clinical performance study with specific acceptance criteria.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance or details about a study proving the device meets effectiveness criteria, as this information is not present in the provided text. The document is primarily a regulatory submission demonstrating substantial equivalence through technical and safety standards, not a clinical performance study report.

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The OLIZ LTB-1000A is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of min, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

The OLIZ LTB-1000A is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with biocompatible material, which uses specific wavelengths of light. OLIZ LTB-1000A produces light in the near infrared region of the spectrum (850nm) intended to provide topical heating for temporary pain relief. This device provides a soothing vibration function for the purpose of enhancing the user's satisfaction.

Here's a breakdown of the acceptance criteria and study information for the OLIZ LTB-1000A, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance is based on the device being "substantially equivalent" to a predicate device (BioPhotas Celluma3 K152280). Therefore, the acceptance criteria are implicitly those of the predicate device, and the device performance is demonstrated through a comparison to ensure no new questions of safety or effectiveness are raised. Explicit, numerical acceptance criteria for clinical efficacy are not provided in this document as it's a 510(k) for an infrared lamp, which typically relies on established performance standards and comparison to a legally marketed predicate.

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

The document does not describe a clinical test set with human participants for determining the device's efficacy. The performance evaluation is based on non-clinical (bench) testing and comparison to a predicate device. Therefore, a sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context.

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

Not applicable. As no clinical test set for efficacy/diagnostic performance was conducted, there were no experts used to establish ground truth in that sense. The "ground truth" for the device's substantial equivalence relies on established engineering standards and comparison with the predicate.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set with human data requiring adjudication was performed.

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

No, an MRMC comparative effectiveness study was not done. The document states "Clinical performance: Not applicable."

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

No, this device is an infrared lamp, not an algorithm, so the concept of standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is derived from:

• Established industry standards: Specifically, international and FDA-recognized consensus standards for medical electrical equipment (IEC 60601 series), software (IEC 62304), and biological evaluation of medical devices (ISO 10993 series).
• Performance of the predicate device: The BioPhotas Celluma3 (K152280) established the safety and effectiveness profile for similar infrared lamps, and the OLIZ LTB-1000A demonstrated equivalence to this predicate.

8. The Sample Size for the Training Set

Not applicable. This device is an infrared lamp; it does not involve machine learning or algorithms that require a "training set" of data. Testing was based on engineering and biocompatibility standards.

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

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

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The model CytonPro-5000 laser emits energy in the infrared spectrum to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue.

The CytonPro-5000 laser is a non-invasive, diode laser system consisting of an enclosure which contains the control unit and a treatment probe connected by an optic fiber.

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic performance or human-in-the-loop studies. The document describes a 510(k) submission for an infrared lamp (CytonPro-5000), which is a physical therapy device used for topical heating and pain relief.

The "studies" described are primarily non-clinical performance and safety testing to demonstrate substantial equivalence to a predicate device. This type of submission focuses on comparing the new device's technical specifications and safety profile to an already cleared device, rather than diagnostic accuracy or effectiveness trials involving human subjects to establish clinical improvement due to AI assistance.

Here's a breakdown of why many of your requested items cannot be answered from the provided text:

• Acceptance Criteria for Diagnostic Performance: Not applicable as this is not a diagnostic AI device. The "acceptance criteria" discussed are related to engineering specifications and safety standards.
• Study Proving Device Meets Acceptance Criteria (Diagnostic Performance): Not applicable. The "proof" is based on non-clinical engineering tests.

However, I can extract the information that is present concerning the device's characteristics and the testing performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present explicit "acceptance criteria" in the sense of a numerical threshold for clinical effectiveness or diagnostic accuracy. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device (Cell Gen CG-4000) through comparable performance characteristics and compliance with safety standards.

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

• Test Set Sample Size: For the temperature testing, "five subjects" were used.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Not mentioned. The temperature testing involved direct measurement of physical effects (heating) on subjects, not expert interpretation for establishing ground truth for a diagnostic task.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. This is not a study requiring adjudication of diagnostic findings.

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

• No. This is not an AI diagnostic imaging device, and no MRMC study was performed or needed for this type of device.

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

• Not applicable. This device is a physical therapy apparatus, not an AI algorithm performing a diagnostic task.

7. The type of ground truth used:

• For the temperature testing, the "ground truth" was direct physiological measurement (skin temperature elevation) in response to the device's energy emission, demonstrating its intended therapeutic heating effect. This is an outcomes data (physiological response) type of ground truth in the context of its function.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set in the conventional sense.

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

• Not applicable. As above, this is not an AI/ML device requiring a training set.

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Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris.

Intended to emit energy in the red and infrared spectrum for the use in dermatology for the treatment of periorbital and full face wrinkles.

The Dermalux® Flex MD is a Class II medical device for use on a treatment bed. The device emits specific wavelengths of low level, narrow band light for the treatment of certain dermatological and musculoskeletal indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm.

The Dermalux® Flex MD enables treatment of the face and the body via a flexible LED Array. The system is operated by a capacitive touch Controller, which allows one of 3 treatments to be selected, through selecting various wavelength combinations. The light is generated by Light Emitting Diodes (LED's) that are contained within the flexible LED Array. The LED Array can be placed into the Base, holding in the appropriate position to administer a facial treatment. For use on the body, the LED Array is removed from the Base unit and placed over the appropriate body part.

The Dermalux Flex MD device does not have explicit acceptance criteria or a study proving that it meets specific clinical or performance acceptance criteria in the provided text. The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices, rather than proving efficacy against acceptance criteria through clinical trials.

The "Performance Testing" section (Page 6) details bench testing to verify that the device met design specifications and complied with various international and FDA-recognized consensus standards related to electrical safety, electromagnetic compatibility, software lifecycle, photobiological safety, usability, and biological evaluation. These are related to the safety and fundamental functioning of the device, not clinical efficacy or specific performance metrics for the indicated uses.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present clinical acceptance criteria for efficacy in terms of specific performance metrics (like percentage reduction in acne or wrinkles) for the Dermalux Flex MD. Instead, it demonstrates compliance with safety and engineering standards. The table below lists the performance testing conducted, which can be seen as meeting "design specifications" and regulatory consensus standards, rather than clinical acceptance criteria.

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

• Sample Size for Test Set: Not applicable for clinical efficacy studies. The testing was bench-based for engineering and safety standards.
• Data Provenance: Not applicable for clinical studies as no clinical studies were performed. The "data" refers to engineering test results.

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

• Not applicable as no clinical ground truth was established; testing was focused on engineering and safety standards.

4. Adjudication method for the test set

• Not applicable as no clinical ground truth was established or adjudicated; testing was focused on engineering and safety standards.

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

• No MRMC comparative effectiveness study was performed as this device is a light therapy device, not an AI-assisted diagnostic tool.

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

• Not applicable as this device is a light therapy device, not an algorithm.

7. The type of ground truth used

• Not applicable for clinical efficacy. The "ground truth" for the performance testing refers to the established technical specifications of the device and the requirements of the international and FDA-recognized consensus standards.

8. The sample size for the training set

• Not applicable as no clinical training set was used. The focus was on engineering and safety testing.

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

• Not applicable as no clinical training set was used.

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The AXON IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

The AXON IR Heat Lamp System is intended for use as a therapeutic heat lamp. The System is a non-invasive device that emits light energy to the skinsurface of the human body for the purpose of causing the therapeutic elevation of tissue temperature.

The AXON IR Heat Lamp System deliver invisible laser light beams at 810 and 915 nm wavelengths using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic green laser guide light with 3 mW of power. TThe System consists of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable.

The control consoles are made of standard medical PVC material and are designed to be placed in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display.

The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probes contain a protective lens at the aperture, which is made of qlass suitable for medical applications.

The provided documentation describes a 510(k) premarket notification for the AXON IR Heat Lamp System, an infrared lamp intended for therapeutic heating. The submission focuses on demonstrating substantial equivalence to predicate devices and provides non-clinical performance data related to its heating capabilities.

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

Important Note: This document describes a relatively simple medical device (an infrared heat lamp). Therefore, the "acceptance criteria" and "study" are focused on demonstrating its ability to produce therapeutic heat safely and effectively, rather than complex diagnostic or treatment algorithms that would typically involve AI, expert ground truth, or MRMC studies. The questions in the prompt are more suited for AI/ML device evaluations. This submission primarily relies on bench testing and basic human subject testing for thermal performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Therapeutic Heating:

Study Proving Acceptance Criteria:

The study conducted was a non-clinical bench test with limited human subject data collection to evaluate the thermal performance of the AXON IR Heat Lamp System.

• Study Title/Description: "Non-Clinical Performance Data" for the AXON IR Heat Lamp System on Page 7.
• Objective: To demonstrate that the AXON IR Heat Lamp System can achieve and maintain a therapeutic temperature range accepted by the FDA (40-45 degrees Celsius) and produce at least a 5-degree Celsius increase in topical tissue temperature within one minute.

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

• Sample Size for Test Set (Human Subjects): 3 subjects.
• Data Provenance: The document does not explicitly state the country of origin for the human subject data. The device applicant is Crystal Medtech, LLC, located in Schofield, Wisconsin, USA, which suggests the study was likely conducted in the USA.
• Retrospective or Prospective: The study appears to be prospective as it describes conducting temperature measurements on subjects after the device was built.

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

• Number of Experts: Not applicable in the context of this thermal performance study.
• Qualifications of Experts: The "ground truth" (therapeutic temperature range of 40-45 degrees Celsius) is stated to be "as accepted by the FDA." This is a regulatory standard, not established by individual experts for this specific device test.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This study measures physical temperature outputs, not subjective interpretations requiring adjudication.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typical for diagnostic imaging AI tools where human readers are interpreting images. The AXON IR Heat Lamp is a therapeutic device, and its performance evaluation focused on physical parameters (temperature).

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

• Standalone Performance: Yes, the described "bench testing" and "temperature versus time measurements" are essentially a standalone performance evaluation of the device's ability to generate heat and maintain temperature, without a human actively interpreting or modifying the output in a typical AI "human-in-the-loop" sense. The device is the algorithm in this context – it delivers heat as designed.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance is the regulatory standard for therapeutic heating temperature range (40-45 degrees Celsius), as "accepted by the FDA." It is based on established medical understanding of what constitutes therapeutic heat for the stated indications, rather than expert consensus on individual cases, pathology, or outcomes data from a specific study for this device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is an infrared heat lamp; it does not appear to employ machine learning or AI models that require a "training set" in the conventional sense. Its "training" would be the engineering design and iteration process.

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

• Ground Truth for Training Set: Not applicable, as there is no mention or indication of a machine learning "training set" for this device. The design and performance targets would be based on established medical and engineering principles for heat therapy devices.

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Intended for the relaxation of muscle spasms, temporary relief of minor muscle and joint aches, pain and stiffness, temporarily relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation.

The HealthLight Footbed Model HL-FB is specifically indicated for treatment of the feet and lower legs.

Not Found

It appears there might be a misunderstanding or misinterpretation of the provided document. The document is a 510(k) Premarket Notification from the FDA for the HealthLight Footbed LED Light Therapy System Model HL-FB.

This document is a marketing clearance letter, not a clinical study report or a technical performance evaluation. It does not contain information about acceptance criteria, device performance against those criteria, or details of a study that proves the device meets specific performance metrics.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from this document.

The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, often without requiring new clinical performance studies of the type you're asking about if the technological characteristics and indications for use are similar.

If you have a different document that describes a study for this device, please provide that.

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The Softcure TM 96 is intended to emit energy in the visible spectrum (red 635mm) to provide topical heating for the purpose of elevating tissue temperature for the temporary relief/reduction of minor muscular and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

The Wellray® Medical Laser Softcure™ 96 is a therapeutic device using wavelengths of monochromatic light produced by semiconductor laser diodes to treat a variety of musculoskeletal concerns. The Softcure ™ 96 is a portable and wearable, battery powered, software controlled device intended for use on the body such as the back, legs, chest, arms or other areas where therapeutic light may be beneficial. A flexible pad, drawing power through an electrical cable from a carry able battery pack, emits red (635nm) light by means of semiconductor laser diodes to the desired body area. The flexible pad is designed to conform to the contour of the treatment site providing uniform treatment dosage over nonplanar body physique. The semiconductor laser diodes are monitored for temperature and light output by a microprocessor and cooled by variable speed fans to ensure the optimum light output. The lasers are allowed to energize only when four separate failsafe monitoring systems sense that the flexible pad is brought into close contact with the user's body. These failsafe systems include capacitive proximity sensors, body temperature sensors, an ambient light sensor and reference voltage monitoring.

The provided text describes a 510(k) premarket notification for the Softcure™ 96 device, an infrared therapeutic heating lamp. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) submission for a novel device.

As such, the document does not contain the level of detail typically associated with acceptance criteria and a study proving device performance for an AI/ML-based medical device. Specifically, it does not involve:

• A table of acceptance criteria for AI model performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for a test set in the context of AI model evaluation.
• Data provenance for AI training/test sets.
• Number of experts or their qualifications for establishing ground truth for AI.
• Adjudication methods for AI ground truth.
• MRMC comparative effectiveness studies.
• Stand-alone AI performance studies.
• Ground truth types like pathology or outcomes data for AI.
• Training set sample sizes or how their ground truth was established for AI models.

Instead, the document focuses on demonstrating the physical device's performance against its specifications and existing standards, primarily for electrical safety and its ability to generate therapeutic heat.

Here's a breakdown of the information that is available in the document, framed as closely as possible to the requested structure, while acknowledging the inherent differences:

Description of Device Performance and Acceptance Criteria (as per 510(k) equivalency)

The Softcure™ 96 is an infrared therapeutic heating lamp. Its performance evaluation is geared towards demonstrating its safety and ability to provide topical heating, which aligns with the intended use of known predicate devices.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: For the non-clinical performance testing (temperature measurements), "8 subjects" were used. This is explicitly stated.
• Data Provenance: The document does not specify the country of origin for the subjects or whether the study was retrospective or prospective. It implies a prospective bench or in-house non-clinical test.

3. Number of Experts and Qualifications for Ground Truth

This type of information is not applicable to this 510(k) submission. The "ground truth" for this device relates to physical parameters (temperature) and compliance with engineering standards, not diagnostic interpretations from experts. The "acceptance" of the temperature range (40-45 degrees Celsius) is stated as "accepted by the FDA," implying a regulatory standard rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable. There were no subjective interpretations requiring adjudication as would be the case for image-based diagnostic AI.

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

Not applicable. This device is a therapeutic heating lamp, not a diagnostic imaging aid that would typically involve human readers interpreting cases with or without AI assistance. The study described is a non-clinical performance test for the device itself.

6. Standalone Performance (Algorithm Only)

Not applicable. The Softcure™ 96 is a physical device, and its "performance" is its ability to generate heat and operate safely, not the output of a standalone algorithm.

7. Type of Ground Truth Used

• For the therapeutic heat performance, the ground truth was measured temperature readings from the device applied to subjects' skin, compared against a pre-defined therapeutic temperature range (40-45 degrees Celsius) "accepted by the FDA."
• For electrical and functional safety, the "ground truth" was compliance with established international and national standards (e.g., FDA 21 CFR J 1040.10, AAMI/ANSI ES 60601-1, IEC 60601-1-2).

8. Sample Size for the Training Set

Not applicable. This document does not describe the development of an AI/ML algorithm that would require a "training set." The device's operation is based on established physical principles and engineered controls, not learned from data in an AI sense.

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

Not applicable (as explained in point 8).

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Bashan TDP Heat Lamp is used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Bashan TDP Heat Lamp is used to provide topical heating to the body. It is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 5 to 25 microns, 110 volt power, 250 watts. It includes timer, safety fuses.

The provided text describes a 510(k) summary for the "Bashan TDP Heat Lamp," comparing it to predicate devices. This document focuses on demonstrating substantial equivalence to legally marketed devices, primarily through adherence to recognized standards and comparison of features. It does not contain information about acceptance criteria or a study that specifically "proves the device meets acceptance criteria" in the context of clinical performance metrics like sensitivity, specificity, or reader improvement.

However, based on the provided text, I can extract information related to safety and performance testing that serves as the basis for claiming substantial equivalence.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (e.g., target specificity or sensitivity) that a study would aim to meet for a diagnostic device. Instead, the "acceptance criteria" appear to be met by compliance with recognized electrical safety and electromagnetic compatibility standards, and by showing similar characteristics and intended use to predicate devices. The "reported device performance" is essentially that the device meets these standards and is comparable to the predicate devices.

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

The document mentions 500 eligible device users for the usability study.
The data provenance is not explicitly stated as "country of origin," but the submitter, Chongqing YUHE Medical Instruments Co., Ltd., is based in Chongqing, China. The study appears to be a prospective usability study where participants interacted with the device.

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

For the usability study, the document does not specify "experts" establishing ground truth in the sense of clinical reviewers. Instead, the "ground truth" for usability was likely derived from the successful interaction of the 500 device users with the product and its labeling, and the absence of reported safety issues. There were no clinical experts mentioned in evaluating the usability outcomes.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical adjudication process described for the usability study. The determination of "successfully operated" and "no safety issues" likely came directly from the observed outcomes of the 500 users.

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

No, an MRMC comparative effectiveness study was not done. This device is an infrared heat lamp for pain relief, not a diagnostic imaging device typically associated with MRMC studies to assess reader interpretations. The study conducted was a usability study and performance testing against standards.

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

No, a standalone "algorithm only" performance study was not done. This device is a physical therapeutic device, not an AI or algorithm-based product.

7. The Type of Ground Truth Used

• Usability Study: The "ground truth" was derived from directly observed user performance and self-reported issues (or lack thereof) during the study. Successful operation and absence of safety issues reported by the 500 users served as the "ground truth" for usability.
• Performance Tests: The "ground truth" for performance (e.g., output parameters, skin temperature) was established through measurement against predefined engineering specifications and recognized electrical safety and performance standards.

8. The Sample Size for the Training Set

Not applicable. This device does not use an AI algorithm that requires a training set.

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

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

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