Search Results

The LUMIX ULTRA IR Lamp Systems are intended to emit energy in the visible and 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 LUMIX ULTRA IR Lamp Systems are intended for use as therapeutic heat lamps. The Systems are non-invasive devices that emit light energy to the skin-surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature.

The LUMIX ULTRA IR Lamp Systems deliver visible and invisible laser light beams at wavelengths between 650 and 1064 nm 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 red laser quide light with 3 mW of power. The Systems consist 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 on a desktop or table 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 glass suitable for medical applications.

The provided text describes a 510(k) premarket notification for the LUMIX ULTRA IR Lamp Systems, which are infrared therapeutic heat lamps. This document reviews the device's substantial equivalence to predicate devices and its compliance with safety standards, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical data or algorithm-based performance metrics.

The document primarily focuses on:

• Indications for Use: Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; temporary increase in local blood circulation; and/or temporary relaxation of muscle.
• Device Description: Non-invasive devices emitting visible and invisible laser light beams (650-1064 nm) for therapeutic elevation of tissue temperature.
• Predicate Devices: Other therapeutic heat lamps (LUMIX 3 Series, NEXUS Series, CYNOSURE 1064nm Diode Laser, ELTECH s.r.l. K-Laser Cube).
• Testing: Functional performance testing and electrical safety testing to comply with international standards (e.g., IEC 60601-1, IEC 60825-1, ISO 14971).

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy or AI performance, as this type of information is not present in the provided text. The document confirms that the device is "substantially equivalent" to existing predicate devices based on intended use, functional, and performance characteristics, and compliance with general safety standards.

In summary, the document does not provide the information needed to fill out the table and answer the specific questions about acceptance criteria and a study proving device performance in the manner you've outlined for an AI/diagnostic device.

Ask a specific question about this device

The LUMIX CPS Series IR Lamp Systems are intended to emit energy in the visible and 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 LUMIX CPS Series IR Lamp Systems are intended for use as therapeutic heat lamps. The Systems are non-invasive devices that emit light energy to the skin-surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature. The LUMIX CPS Series IR Lamp Systems deliver visible and invisible laser light beams at wavelengths between 650 and 1064 nm 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 red laser guide light with 3 mW of power. The Systems consist 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 on a desktop or table 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 fiber optic cables. The probes contain a protective lens at the aperture, which is made of glass suitable for medical applications.

This document is a 510(k) premarket notification for the LUMIX CPS Series IR Lamp Systems. It does not describe a study involving an algorithm or artificial intelligence, so many of the requested categories are not applicable.

Here's an analysis based on the provided text, focusing on what is applicable to this medical device submission:

1. Acceptance criteria and reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a numerical threshold for a study. Instead, it demonstrates compliance with recognized medical device standards and establishes "substantial equivalence" to predicate devices. The reported device performance is primarily described through its intended therapeutic action and compliance with safety and performance standards.

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

Not Applicable. This submission focuses on demonstrating substantial equivalence through compliance with recognized standards and comparison to predicate devices, rather than a clinical trial with a "test set" of patient data. The "testing" mentioned refers to engineering and performance testing of the device itself (functional, electrical safety).

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

Not Applicable. As there was no clinical test set of patient data, there was no need for expert adjudication of ground truth for medical conditions.

4. Adjudication method for the test set

Not Applicable. No 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 an infrared lamp, not an AI-powered diagnostic or assistive tool for human readers.

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

Not Applicable. This device is a physical infrared lamp system, not an algorithm.

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

Not Applicable. The "ground truth" for this submission revolves around engineering specifications, safety standards, and the established therapeutic principles of infrared heating, rather than clinical outcome "ground truth" in an AI context. The document states that "The use of light energy to generate heat for therapeutic use has been well documented and is a generally accepted alternative treatment modality for the temporary relief of pain," implying reliance on existing medical literature and accepted practices.

8. The sample size for the training set

Not Applicable. This is not an AI/algorithm device that requires a training set.

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

Not Applicable. No training set was used.

Ask a specific question about this device

The Nexus BioWave Series IR Lamp Systems are 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 Nexus Series IR Lamp Systems are intended for use as infrared heat lamps. The Systems are non-invasive devices that emit light energy to the skin-surface of human body for the purpose of causing the therapeutic elevation of tissue temperature.

The Nexus Series IR Lamp Systems deliver an invisible laser light beam in the infrared spectrum at wavelengths of 810 and 980 nm using a gallium aluminum arsenide (GaAlAs) source. 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 red laser guide light. The Systems consist 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 place on a desktop or table 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 focusing lens at the aperture, which is made of glass suitable for medical applications.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nexus Series IR Lamp Systems:

The provided document is a 510(k) Notification Supplement for an Infrared Lamp. It describes the device, its intended use, and summarizes the testing performed. However, it's important to note that this document does not describe a study in the context of typical AI/ML medical device evaluations, which involve large datasets, expert ground truth, and statistical performance metrics like sensitivity, specificity, or AUC.

Instead, this document describes bench testing and limited human subject testing to demonstrate physical performance specifications of a medical device (an infrared lamp) and its compliance with relevant standards. The "acceptance criteria" here relate to the device's ability to achieve and maintain a specific therapeutic temperature range on tissue.

Acceptance Criteria and Reported Device Performance

Study Details and Data Provenance

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

   • Sample Size: 3 human subjects.
   • Data Provenance: The document does not specify the country of origin of the data, but the applicant (USA Laser Biotech Inc.) is based in the USA. The testing appears to be prospective bench testing and limited human subject testing, not a retrospective or prospective clinical trial with a large patient cohort.

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

   • Not Applicable. For this type of device (infrared lamp) and the specific testing described (temperature achievement on skin), there are no "experts" establishing a diagnostic "ground truth" in the way one would for an imaging or AI diagnosis device. The "ground truth" is the objective measurement of temperature using calibrated equipment, conforming to generally accepted physiological temperature ranges for therapeutic heat. The document refers to "generally accepted topical temperature range for therapeutic heat of 40 - 45 degrees centigrade" as the standard.

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

   • None. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on ambiguous medical cases in AI/ML performance studies. This is not reported as such a study. The data appears to be direct physical measurements (temperature readings).

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 or applicable to this device or the described testing. This device is an infrared heat lamp, not an AI-powered diagnostic tool intended to assist human readers.

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

   • Yes, in spirit, but not as an "algorithm." The core "performance" tested was the device's inherent ability to generate and maintain heat. This is a standalone device function, independent of human interpretation or AI algorithms. The measurements of temperature were objective, not subjective "readings."

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

   • The "ground truth" for this device's performance is objective physical measurement (temperature) against established physiological and therapeutic thresholds. Specifically, reaching and maintaining a topical tissue temperature of 40-45 degrees Centigrade, and increasing pre-exposed temperature by at least 5 degrees Centigrade within one minute. There is no expert consensus, pathology, or outcomes data used to establish this specific "ground truth."

7. The sample size for the training set:

   • Not Applicable. This device does not employ an AI/ML algorithm that requires a training set. The "testing" described is for functional and electrical safety performance of a physical medical device.

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

   • Not Applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

Ask a specific question about this device

The Nexus XPulse IR Lamp Systems are 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 Nexus XPulse 805 and the Nexus XPulse 980 IR Lamp Systems are intended for use as infrared heat lamps. The Systems are noninvasive devices that emit light energy to the skin-surface of human body for the purpose of causing the therapeutic elevation of tissue temperature. The Nexus XPulse Systems deliver an invisible laser light beam in the infrared spectrum at wavelengths of 805 nm and 980 nm using a gallium aluminum arsenide (GaAlAs) source. 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 red laser quide light. The Systems consist of 2 main hardware sub-systems: 1) he control console and 2) he treatment handpiece probe with its connecting cable. The control console is made of standard medical PVC material and is designed to be place on a desktop or table 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 probe is made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probe contains a focusing lens at the aperture, which is made of glass suitable for medical applications.

This document describes the Nexus XPulse 805 and Nexus XPulse 980 IR Lamp Systems, intended for use as infrared heat lamps for therapeutic elevation of tissue temperature.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document describes testing as "functional performance testing and electrical safety testing" against international standards and comparison to predicate devices. It does not mention a specific "test set" in terms of patient data or clinical trials. The evaluation is based on engineering and regulatory compliance rather than clinical performance data from a specific study.

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

Not applicable. The document describes compliance with technical standards and comparison to predicate devices, not clinical studies requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a test set requiring adjudication in the context of clinical or image-based evaluations.

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

No, an MRMC comparative effectiveness study was not conducted or described in this document. This submission is for an infrared lamp, and the evaluation focuses on electrical safety, functional performance, and substantial equivalence to existing predicate devices, not on human reader performance with or without AI assistance.

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

Not applicable. This device is an infrared lamp, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• International Standards Compliance: Verification that the device meets the safety and performance requirements outlined in EN 60601-1, EN 60601-1-2, and ISO 14971.
• Comparison to Predicate Devices: Assessment that the device's intended uses, functional, and performance characteristics are "substantially equivalent" to already legally marketed infrared lamps (e.g., USA Laser Biotech, Inc. LUMINA 1600, Avicenna Laser Technology, Inc. ALT Laser, Model VTR 75).

8. The Sample Size for the Training Set:

Not applicable. This document pertains to an infrared lamp device, not a machine learning algorithm that requires a training set.

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

Not applicable, as no training set is relevant to the information provided.

Ask a specific question about this device

The LUMINA Systems are 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 promoting relaxation of muscle.

The LUMINA 1600, 3300 and 6600 Systems are easy to use, non-invasive therapeutic device that provides continuous heat therapy. The Systems consist of a Console that houses the electronics and controls and a treatment probe applicators that deliver the infrared energy to the target area.

The provided document is a 510(k) Premarket Notification Summary for the LUMINA Infrared Heat Lamp Therapy Systems. This type of submission is a regulatory pathway to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the document does not contain the detailed study information typically associated with establishing acceptance criteria and proving performance through a clinical trial with human subjects.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria here are primarily based on demonstrating substantial equivalence to predicate devices, focusing on functional performance, safety, and intended use, rather than specific quantitative clinical efficacy thresholds. The "reported device performance" reflects the general claims made about the device's capabilities and its alignment with predicate devices.

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

Not applicable. The document describes a 510(k) submission, which relies on demonstrating substantial equivalence to existing devices rather than a clinical study with a "test set" in the traditional sense. The testing mentioned (functional performance and electrical safety) is laboratory-based and doesn't involve human subjects as a "test set" for clinical efficacy.

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

Not applicable. This information is relevant for clinical studies where expert review is used to establish ground truth for a diagnostic or predictive device. This 510(k) premarket notification does not describe such a study.

4. Adjudication Method for the Test Set

Not applicable. (See explanation for point 3).

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. The LUMINA Systems are infrared heat lamps, not AI-powered diagnostic or assistive devices that would involve human readers or an MRMC study.

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

Not applicable. The LUMINA Systems are therapeutic devices that physically deliver infrared energy, not standalone algorithms.

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

Not applicable for clinical efficacy. The "ground truth" for the 510(k) submission primarily revolved around:

• Regulatory Standards: Compliance with 21 CFR 890.5500 for infrared lamps.
• Literature: The device's ability to produce "a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration" for the indications. This implies that existing scientific and medical literature on infrared therapy serves as the basis for what constitutes an effective tissue temperature.
• Predicate Device Characteristics: The functional and performance characteristics of legally marketed predicate devices served as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

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

Not applicable. (See explanation for point 8).

Summary of the Study and Device Proof:

The "study" in this context is the 510(k) premarket notification process, not a clinical trial. The device, LUMINA Infrared Heat Lamp Therapy Systems, meets acceptance criteria by demonstrating substantial equivalence to already legally marketed predicate devices.

The proof relies on:

• Functional Performance Testing: Confirming the device operates as intended (e.g., emits infrared energy, provides continuous heat).
• Electrical Safety Testing: Ensuring compliance with all applicable safety standards.
• Comparison to Predicate Devices: Explicitly stating that the LUMINA Systems have the "same intended uses, with similar functional and performance characteristics" as the predicate devices (Avicenna Laser Therapy, Inc. ALT Laser Model VTR 75, Light Force Therapy, Inc. Super Nova and Acubeam Systems, and Meditech International, Inc. BioFlex Professional Therapy System).
• Compliance with Literature and FDA Acceptance: The systems are designed to produce tissue temperatures known to be therapeutically effective, as supported by existing literature and prior FDA acceptances for similar devices.

There is no mention of a human test set, experts establishing ground truth for a clinical study, or any form of AI involvement. The focus is on regulatory compliance and equivalence to established technology.

Ask a specific question about this device

The ICL IR Heat Lamp Systems are 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 promoting relaxation of muscle.

Not Found

This document is a 510(k) premarket notification summary for an infrared lamp system. It establishes substantial equivalence to predicate devices but does not contain information about acceptance criteria or specific studies demonstrating device performance against such criteria.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and study data based on the provided text. The document focuses on regulatory approval based on equivalence, not on presenting performance data from studies.

The provided text does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Information about MRMC comparative effectiveness studies or effect sizes.
• Information about standalone algorithm performance studies.
• Details on the type of ground truth used.
• Sample sizes for training sets.
• How ground truth for training sets was established.

Ask a specific question about this device