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The weberneedle@basic laser is indicated to provide topical heating for the following:

• temporary increase of local blood circulation.
• temporary relief of minor muscle and joint aches, pains, and stiffness.
• temporary relaxation of muscles.
• temporary relief of muscle spasms.
• temporary relief of minor pain and stiffness associated with arthritis.

The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are non-invasive, portable therapeutic medical laser systems designed to deliver light energy to the target tissue. The red and infrared lamps provide continuous heat therapy at a fixed frequency. The System operates by AC power and is used with 8 up to 12 faser modules, as standard 4 red and 4 infrared modules. The system consists of a Control Unit / Power Supply that houses the electronics and controls the power and varies the frequency of the each laser module. The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are equipped with single fibre optics to bring the emitted energy to the tissue. That allows treatment either of small or of expanded pain areas as well as both at the same time.

The provided document (K073352) describes the 510(k) premarket notification for the "weberneedle®basic laser" and "weberneedle®basic "compact edition" laser." It does not contain an acceptance criteria table or a study that proves the device meets specific acceptance criteria in the way typically expected for a diagnostic or AI-powered medical device.

This submission is for an infrared lamp, a therapeutic device that provides topical heating. The FDA determined substantial equivalence to legally marketed predicate devices, meaning it has the same intended uses and similar technical and performance characteristics. The testing described is "functional performance testing and electrical safety testing," rather than a clinical efficacy study with acceptance criteria for device performance against a ground truth.

Here's why the requested information cannot be fully provided based on the input:

• Type of Device: The weberneedle®basic laser is a therapeutic device (infrared lamp) for topical heating, not a diagnostic device or an AI-powered system that generates a "performance" metric (like sensitivity, specificity, AUC) against a ground truth.
• 510(k) Pathway: The 510(k) pathway for medical devices focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy against a specific quantitative acceptance criterion as might be seen for novel devices or high-risk devices.

Therefore, many of the requested fields are not applicable to this type of submission.

However, I can extract the closest information available:

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

The document states that the device 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 Federal Food and Drug Administration." It also says "The weberneedle®basic laser and the weberneedle®basic "compact edition" laser perform as intended and do not raise any new safety or efficacy issues."

No specific quantitative acceptance criteria or performance metrics (like temperature ranges, duration of heat, etc.) are provided in this summary. The "performance" is implicitly tied to its ability to function as an infrared lamp and deliver topical heating, and its equivalence to predicate devices for the stated indications.

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

The document refers to "functional performance testing and electrical safety testing." It does not describe a clinical study with a "test set" of patients or data in the way an AI/diagnostic device would. Therefore, sample size and data provenance are not applicable or described.

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

Not applicable, as there is no "test set" requiring ground truth establishment by experts for a diagnostic performance evaluation.

4. Adjudication method for the test set

Not applicable.

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, as this is not an AI-assisted diagnostic device.

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

Not applicable, as this is a physical therapeutic device, not an algorithm.

7. The type of ground truth used

Not applicable. For this type of device, "ground truth" would relate to its physical properties (e.g., emitted wavelength, power, temperature achieve d) and safety standards adherence, rather than a diagnostic label. The "ground truth" for substantial equivalence is derived from the characteristics and clearances of the predicate devices.

8. The sample size for the training set

Not applicable, as this device does not use a "training set" in the context of machine learning.

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

Not applicable.

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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.

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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.

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