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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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The Omega Xp Laser System is indicated for use as an adjunctive treatment modality to provide temporary relief of pain associated with rotator cuff tendonitis.

The Omega Xp Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by either AC or battery power and can be used with a variety of laser probes. The Omega Xp Laser System is intended to emit energy in the infrared spectrum to provide temporary relief of pain associated with rotator cuff tendonitis.

The Omega Xp Laser System is comprised of a Base Unit and select Laser Probes. The Base Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Base Unit by an umbilical cord. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.

The provided text describes the Omega Xp Therapeutic Laser System, a Class II device for temporary relief of pain associated with rotator cuff tendonitis. However, it does not provide explicit acceptance criteria in a quantitative or tabular format for device performance. Instead, it relies on a determination of substantial equivalence to predicate devices and summarizes the safety and efficacy studies with general statements.

Below is an attempt to structure the information based on your request, highlighting where specific details are missing or implied:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantified acceptance criteria are not provided in the document. The "reported device performance" is primarily the conclusion of substantial equivalence and a statement that the device performs as intended without new safety or efficacy issues.

• ISO 9000:2000
• EN46001
• Directive 89/336 (electromagnetic compatibility)
• 21 CFR 1010 and 1040 (applicable performance standards) | The device is manufactured to comply with these international standards and applicable FDA performance standards. |

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "the randomized, blinded clinical trial conducted."
• Data Provenance: Not explicitly stated. The documentation is from a US FDA submission, but the origin of the clinical trial data (e.g., country) is not specified. It is a retrospective summary for a 510(k) submission, confirming the clinical trial was completed prior to submission.

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

This information is not provided in the given text. For a device like a therapeutic laser, "ground truth" often refers to patient-reported pain scores or functional outcomes, not necessarily expert consensus on images.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

• Was an MRMC study done? This type of study (MRMC) is typically relevant for diagnostic imaging devices where different readers interpret cases. For a therapeutic device like the Omega Xp Laser System, a "multi-reader multi-case" study in the traditional sense is not applicable or mentioned. The study was a "randomized, blinded clinical trial," which compares the device's effect to a control (e.g., sham treatment or standard care).
• Effect size of human readers with/without AI assistance: This is not applicable as the device is a therapeutic laser, not an AI-assisted diagnostic tool for human readers.

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

• Was a standalone study done? This concept is also not applicable as the Omega Xp Laser System is a physical therapeutic device operated by a human, not an AI algorithm. Its "performance" is its ability to deliver light energy and the resulting clinical outcome in patients, which is always with human involvement for operation and patient interaction.

7. Type of Ground Truth Used

For a therapeutic device, the "ground truth" for efficacy is typically clinical outcomes data, such as:

• Patient-reported pain reduction (e.g., using a Visual Analog Scale - VAS or Numeric Rating Scale - NRS).
• Improvement in functional ability.
• Other subjective or objective measures of disease activity related to rotator cuff tendonitis.

The text states "Further evidence of the safety and efficacy of the Omega System was assessed by the randomized, blinded clinical trial conducted," implying that clinical outcomes were the "ground truth" for efficacy.

8. Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided in the text. For a traditional medical device (non-AI), there isn't typically a "training set" in the machine learning sense. The clinical trial data would be the primary evidence for efficacy.

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

• Ground Truth for Training Set: This is not applicable in the context of this device. The efficacy of the device was established through a "randomized, blinded clinical trial," where the "ground truth" for participant outcomes would have been gathered during the trial (e.g., pain scores, functional assessments, etc.).

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