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Therapeutic Ultrasound:

1. Pain relief
2. Reduction of muscle spasm
3. Localized increase of blood flow
4. Increase range of motion of contracted joints using heat and stretch techniques

Neuromuscular Stimulation:

1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
2. Temporary relaxation of muscle spasm
3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
4. Increase of blood flow in the treatment area.
5. Prevention or retardation of disuse atrophy in post-injury type conditions
6. Muscle re-education
7. Maintaining or increasing range of motion

Therapeutic Massager:

1. Relieves muscle spasms
2. Provides temporary relief of minor muscle aches and pains
3. Temporarily improves local blood circulation
4. Temporarily reduces the appearance of cellulite

The TNN-DU810 Non-Invasive Subdermal Therapy System is comprised of the following main components:
A system console including software and control electrodes;
A control and display panel: .
Device accessories including muscle stimulator electrodes (ME2221, Mettler Corp., K#013192) and cables, ultrasound transducers (applicators) (ME7513, Mettler Corp.) acoustic gel (Sonigel, Mettler Corp), and cables. The electrodes. ultrasound transducers and acoustic gel have all been cleared under the Mettler Electronics Corp. 510(k). Also included is a Dermosonic vacuum treatment roller head, cleared under the Dermosonic device. K024307.
The TNN-DU810 device has dual frequencies ultrasound therapy, muscle stimulator systems and therapeutic vacuum massager.
The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation.
The system consists of the Alfatech DU857 device (K#052340) and the Dermosonic Therapeutic Vacuum Applicator, a component cleared in the Dermosonic K#024307 ..
The frequency Ultrasound Therapy, Muscle Stimulator System is identical to the DU857. It is important to note that there is no electric connection between the ultrasound therapy, muscle stimulator system and the therapeutic vacuum massager.
Each of the two components of the system (ultrasound plus neuromuscular stimulation) and the therapeutic massager function independently and have no connection between them.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TNN-DU810 Non-Invasive Subdermal Therapy System:

Summary of Device Performance and Acceptance Criteria:

The provided document is a 510(k) summary for a medical device. In this context, "acceptance criteria" and "device performance" are typically demonstrated by showing substantial equivalence to a legally marketed predicate device, rather than explicit quantitative performance metrics against pre-defined thresholds. The device aims to achieve similar functionality and safety as the predicate devices.

The "acceptance criteria" can be inferred from the comparison table (Table 1) and the overall conclusion of substantial equivalence. The device is 'accepted' if it can demonstrate equivalent characteristics and performance to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Rationale for "Acceptance": The document concludes that the TNN-DU810 device is "substantially equivalent" to the predicate device (K#024307) in design and function, particularly noting the use of the predicate's rollers and vacuum suction components to achieve increased blood flow and temporarily reduce the appearance of cellulite. The FDA accepted this submission (K063728) based on this demonstration of substantial equivalence.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. This is a premarket notification based on substantial equivalence, not a clinical trial with a defined test set of patients or images. The "test set" here refers to the performance characteristics compared with the predicate device.
• Data Provenance: Not applicable. The "data" consists of the device's technical specifications and a comparison to predicate devices, along with non-clinical testing results. There is no mention of patient data, clinical images, or country of origin for such data.

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

• Number of Experts: Not applicable. This submission does not involve expert-established ground truth for a clinical test set.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There was no clinical test set requiring adjudication.

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

• MRMC Study: No. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This device's clearance was based on substantial equivalence to predicate devices and non-clinical performance testing, not a comparative effectiveness study involving human readers or AI assistance.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical therapy system, not an AI algorithm.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not applicable. In the context of a 510(k) for substantial equivalence, the "ground truth" is typically the established safety and effectiveness of the legally marketed predicate devices, as demonstrated through their own prior clearances and regulatory compliance. For the TNN-DU810, the "ground truth" for its performance claims (e.g., vacuum pressure, frequency) would be verified through non-clinical laboratory testing against its own specifications, which are compared to the predicate's specifications.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device does not involve machine learning algorithms that require a training set.

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

• Ground Truth for Training Set: Not applicable.

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Therapeutic Ultrasound:

1. Pain relief
2. Reduction of muscle spasm
3. Localized increase of blood flow
4. Increase range of motion of contracted joints using heat and stretch techniques.

Neuromuscular Stimulation:

1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
2. Temporary relaxation of muscle spasm
3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
4. Increase of blood flow in the treatment area.
5. Prevention or retardation of disuse atrophy in post-injury type conditions
6. Muscle re-education
7. Maintaining or increasing range of motion

The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System is comprised of the following main components:
· A system console including software and control electronics;
· A control and display panel;
· Device accessories including Muscle Stimulator electrodes (ME2221, Mettler Com.), ultrasound applicators (ME7513, Mettler Corp.), acoustic gel (Sonigel, Mettler Corp.) and cables, supplied by Alpha Tech.

The DU857 is a two-channel unit for therapeutic ultrasound and muscle stimulation folded into a specially designed cart. The microprocessor controlled DU857 provides Muscle Stimulator alternating current with enhanced reliability and user friendly interface. The DU857 offers 1 and 3 MHz ultrasound treatment.

The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intensities. Large control soft knobs on the touch screen make easy adjusting of power for ultrasound and muscle stimulation.

The provided document (K052340) is a 510(k) summary for a medical device called "The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System." This type of submission is for substantiating that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a high-risk device or novel technology.

The document explicitly states:

• "Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Not applicable"
• "Discussion of Clinical Tests Performed: Not applicable"

This means that the manufacturer did not perform studies with acceptance criteria in the way you're asking, for example, a study to demonstrate a certain level of diagnostic accuracy (like sensitivity, specificity, AUC) or a specific clinical outcome. Instead, substantial equivalence was established by demonstrating that the DU857 has the same intended use and similar technological characteristics to the predicate device (Mettler Electronics Corp., Sonicator Plus 930, Model ME 930, K013192), and that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these types of studies were not performed or reported in this 510(k) submission.

The "acceptance criteria" in this context refer to demonstrating substantial equivalence to a predicate device based on comparison of technical specifications and adherence to relevant safety standards, rather than performance metrics from a diagnostic or interventional study.

Here's what can be extracted based on the provided document and the typical nature of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. No clinical "test set" was used as no clinical study was performed for this 510(k) submission. The equivalence was established through technical comparison to the predicate device and adherence to recognized safety standards.

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

• Not applicable. No ground truth for a test set was established as no clinical study was performed.

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

• Not applicable. No adjudication method was used as no clinical study was performed.

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 ultrasound and muscle stimulator for physiotherapy, not a diagnostic AI device requiring MRMC studies.

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

• Not applicable. This device is a physical therapy device, not an algorithm-based diagnostic or therapeutic system that would have a "standalone performance" study in the typical sense.

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

• Not applicable. No clinical ground truth was established or used for performance evaluation in this 510(k). The "ground truth" for this submission concerned the technical specifications and safety profile of the device being equivalent to a predicate.

8. The sample size for the training set:

• Not applicable. This device is hardware-based with some software for control, not an AI/ML algorithm that requires a "training set" in the context of machine learning.

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

• Not applicable. As above, no training set or associated ground truth was relevant for this type of device submission.

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