Search Results

The BIOFLEX LD-R100 Treatment head device is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.

The BIOFLEX LD-R100 Treatment head device is to be used with the Low Intensity Laser Therapy System, BioFlex Professional System & the Prescription Unit and Related Treatment Heads. These systems were cleared under 510(k) submission K023621 & K051875 respectively. The treatment head device is a Class II Low Level Laser treatment head that apply energy, which penetrates the surface to the underlying tissues, and triggers normal cellular functions.

This document describes a 510(k) premarket notification for the BIOFLEX LD-R100 Treatment Head. The submission demonstrates substantial equivalence to predicate devices rather than providing a study specifically proving the device meets individual acceptance criteria through performance metrics.

Therefore, many of the requested categories (acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth types related to a study proving specific performance) are not applicable or cannot be extracted from this type of regulatory document.

However, based on the provided text, here's what can be answered:

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

This document does not present a table of acceptance criteria with reported device performance in the way a clinical study would for efficacy targets. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" in this context are the regulatory requirements for substantial equivalence, which include similar indications for use, technological characteristics (power density, wavelength, optical power, power source), and similar size and weight.

The reported "performance" is that the device meets these general equivalence criteria and is considered "safe and effective" based on its similarity to the predicate devices.

Table of Equivalence Claims (extracted from the document):

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. This is a 510(k) submission based on substantial equivalence to existing devices, not a clinical study with a test set of patient data. There is no information regarding sample sizes or data provenance in the context of a performance study.

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. No ground truth establishment for a patient test set is described or required for this type of submission.

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

Not applicable. No test set requiring adjudication is described.

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 not an AI/software device and no MRMC study was performed.

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

Not applicable. This is a physical medical device (treatment head for laser therapy), not a standalone algorithm.

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

Not applicable. The ground truth for this submission is the regulatory precedent set by the legally marketed predicate devices. The device is deemed safe and effective because its characteristics and intended use are substantially equivalent to devices that have already been cleared by the FDA.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable. No training set is mentioned.

Ask a specific question about this device

The APOLLO 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 promoting relaxation of muscle.

The APOLLO IR Heat Lamp System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy.

The APOLLO IR Heat Lamp System's 510(k) premarket notification (K060134) does not contain a study that proves the device meets specific acceptance criteria in the way described by your request. Instead, it relies on a demonstration of substantial equivalence to predicate devices already cleared by the FDA.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not specify quantitative acceptance criteria or provide performance metrics in the format of a clinical study with results alongside those criteria. The clearance is based on equivalence to predicate devices and functional/safety testing, not on achieving specific clinical performance thresholds.

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

Not applicable. This document is a 510(k) premarket notification. It does not describe a clinical study with a "test set" of patient data for performance evaluation in the usual sense. The "testing" mentioned refers to functional performance and electrical safety of the device itself, not evaluation on a dataset representing patient cases or outcomes.

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

Not applicable. There is no clinical study described that would require experts to establish ground truth for a test set of patient data.

4. Adjudication Method

Not applicable. As no clinical study on patient data is described, adjudication methods are irrelevant here.

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

No. The document makes no mention of an MRMC comparative effectiveness study involving human readers or AI assistance. The APOLLO IR Heat Lamp System is a physical therapy device that emits infrared energy, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI algorithm; it's a physical therapy device. Thus, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

Not applicable. Since no clinical study on patient data is described for performance evaluation, there is no "ground truth" established in that context. The "truth" demonstrated for the device's functionality is its ability to emit infrared energy and comply with safety standards.

8. Sample Size for the Training Set

Not applicable. As this device is not an AI/ML algorithm, there is no "training set."

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

Not applicable.

Summary of Device Acceptance and "Study" Information from the Document:

Instead of a clinical study proving acceptance criteria, the 510(k) process for the APOLLO IR Heat Lamp System relies on the following:

• Intended Use Equivalence: The device is intended to emit infrared energy for topical heating, temporary relief of pain and stiffness, arthritis pain, muscle spasm, increased local blood circulation, and muscle relaxation. This intended use is stated to be similar to that of predicate devices.
• Technical Characteristic Equivalence: The APOLLO IR Heat Lamp System and the listed predicate devices (e.g., Meditech International Inc BioFlex Professional Therapy System, Thor International, Ltd. DDII Laser System) are all classified as "Infrared Lamps" (21 CFR 890.5500) and utilize infrared/visible laser diodes for topical heating. The submission states the device has "similar functional and performance characteristics" to these predicates.
• Functional and Safety Testing: The document states:
  • "Testing of the APOLLO IR Heat Lamp System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device."
  • "The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration."

Conclusion:

The "acceptance criteria" for the APOLLO IR Heat Lamp System, as presented in the 510(k) notification, are met by demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, and by confirming functional and electrical safety through standard testing. There is no clinical study, patient dataset, or AI performance evaluation described in this documentation. The FDA clearance (K060134) letter confirms that the device was found substantially equivalent to predicate devices for its stated indications for use.

Ask a specific question about this device

The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrums 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 Maestro MDTL Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by AC power and can be used with a variety of laser probes.

The Maestro MDTL Laser System is comprised of a Base Unit and select Laser Probes. The Control Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Control Unit by a cable, which plugs into the rear of the Control Unit. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.

The provided text describes a 510(k) premarket notification for the Maestro MDTL Laser System, which is an infrared lamp. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance reporting as might be expected for novel or high-risk devices.

Therefore, the information you've requested regarding specific acceptance criteria, a study proving the device meets them, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance does not apply to this 510(k) submission.

Here's an breakdown of the available information based on your request, highlighting what is not present in this document:

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

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

• Not applicable. This 510(k) submission describes functional performance testing and electrical safety testing of the device itself, not a clinical study involving a "test set" of patients or data in the sense of a diagnostic or prognostic device. The testing described is against engineering and safety standards, and comparison to predicate devices, not clinical efficacy trials.

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. As above, there is no "test set" requiring expert ground truth in the context of this 510(k) notification. The "ground truth" for this device's performance is compliance with electrical and functional standards and similarity to already cleared predicate devices.

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

• Not applicable. No clinical test set or adjudication process 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:

• Not applicable. The Maestro MDTL Laser System is a therapeutic laser for pain relief, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study, AI assistance, or effect size on human readers is relevant or performed.

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

• Not applicable. This device is hardware, a therapeutic laser, not an algorithm.

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

• The "ground truth" for this 510(k) relies on:
  • Engineering and Safety Standards: Compliance with ISO 9000:2000, EN46001, Directive 89/336, 21 CFR 1010, and 1040.
  • Functional Testing: The device performing as per its specifications (e.g., emitting light in the specified spectrum, maintaining power output).
  • Comparison to Predicate Devices: Demonstrating the new device has "the same intended uses and similar technical and performance characteristics" to previously cleared predicate devices.

8. The sample size for the training set:

• Not applicable. As this is not an AI/ML device, there is no "training set."

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

• Not applicable. As this is not an AI/ML device, there is no "training set" ground truth to establish.

In summary, this 510(k) notification demonstrates substantial equivalence by comparing the Maestro MDTL Laser System to existing predicate devices based on intended use, performance (functional and electrical safety testing), and compliance with relevant standards. It does not involve clinical studies with patient test sets, AI algorithms, or expert ground truth adjudication in the way your questions imply for diagnostic AI systems.

Ask a specific question about this device