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1. Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P) waveforms

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

2. Additional indications for Microcurrent, Interferential (4P), Premodulated (2P), Biphasic and TENS waveforms

• Symptomatic relief and management of chronic, intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain

3. Indications for DC (Direct Current) Mode

• Relaxation of muscle spasm

4. The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:

• Temporary increase in local blood circulation
• Temporary relief of minor muscle and joint aches, pains and stiffness
• Relaxation of muscles
• Temporary relief of muscle spasms
• Temporary relief of minor pain and stiffness associated with arthritis

The new Sys*Stim® 240 neuromuscular stimulator features nine discrete waveforms designed to facilitate clinical versatility. Waveforms may be combined with on-off programs for neuromuscular education as well as frequency and amplitude modulation programs for optimal pain management.

New touch-sensitive technology has been used to make starting a treatment easy. The high-resolution color display allows clinicians to monitor all treatment parameters continuously. The patented M Wheel™ provides easy navigation through all of the menus.

Clinicians can add full-featured light therapy capabilities to the SysStim 240 by purchasing either the cluster or laser applicator package. The laser applicator has an 80 mW, 785 nm, laser diode and the cluster emits 500 mW at 600 and 950 nm. Applicator holders are provided with each applicator and can be attached to the sides of the SysStim 240.

Treatment protocols complete with electrode placement quidance allow clinicians to quickly program treatment parameters for their patients. There is even space to save special treatment protocols for each waveform and for light therapy.

The Sys*Stim 240 has an optional battery pack so that clinicians can take either electrical stimulation or light therapy to their patients. A carrying case is also available which holds the units and all the accessories necessary for therapy on the road.

The Mettler Sys*Stim 240 is a neuromuscular stimulator and low-level light therapy device. The provided text describes its features, intended uses, and lists performance testing certifications but does not contain information about a study proving specific performance acceptance criteria for diagnostic or clinical efficacy aspects that would typically require a test set, ground truth, or expert evaluation.

Instead, the acceptance criteria and supporting "study" are focused on compliance with established electrical safety, electromagnetic compatibility (EMC), and laser safety standards, as well as showing substantial equivalence to a predicate device based on technical specifications and functional capabilities.

Here's a breakdown of the information requested, based on the provided text:

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

The acceptance criteria are primarily compliance with various electrical safety and performance standards. The "reported device performance" is the certification of compliance.

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

Not applicable. The "test" in this context refers to engineering and compliance testing of the physical device and its electrical outputs against standards, not a clinical study on a patient population. There is no test set of patient data described.

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

Not applicable. Ground truth for clinical assessment is not relevant to the compliance testing described. Certifications are typically issued by accredited testing bodies (e.g., ITS, ETL).

4. Adjudication method for the test set

Not applicable. This concept is for clinical studies, not product safety and performance standard compliance testing.

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 electrical stimulator and light therapy device, not an AI-powered diagnostic tool. No MRMC study was conducted or mentioned.

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

Not applicable. There is no algorithm for diagnostic performance described. The "standalone performance" would be the device's adherence to its electrical output specifications and safety standards, which are evaluated through engineering tests.

7. The type of ground truth used

For the engineering and safety compliance tests, the "ground truth" would be the defined parameters and limits specified by the electrical, EMC, and laser safety standards (e.g., IEC 60601-1, IEC 60825-1, FCC regulations).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable.

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Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as; 1. Relief of pain, muscle spasms and joint contractures: 2. Relief of pain, muscle spasms and joint contractures that may be associated with: Adhesive capsulitis, Bursitis with slight calcification, Myositis, Soft tissue injuries, Shortened tendons due to past injuries and scar tissues. 3. Relief of pain, muscle spasms and joint contractures resulting from: Capsular tightness, Capsular tightening.

4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms: 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain.

EMS, TENS, Hi Volt and Russian waveforms: 1. Relaxation of muscle spasms 2. Increase local blood circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion 6. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.

DC (Direct Current): 1. Relaxation of muscle spasms.

The Sonicator® Plus 920, Model ME 920 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator® Plus 920 provides interferential (4-pole), pre-modulated(2-pole interferential), medium frequency (Russian), EMS, High Volt, TENS, microcurrent and direct current (DC) waveforms with enhanced reliability and ease of use. In addition the Sonicator® Plus 920 offers 1 and 3 MHz ultrasound using dual frequency 5.5 cm2 applicator. An optional 0.9 cm applicator at 1 and 3 MHz is also available. The two-channel Sonicator® Plus 920 allows the clinician to utilize up to two different waveforms using two channels simultaneously. They can choose between several different amplitude modulation options such as the surge, reciprocation and vector sweep The interferential and pre-modulated modes offer frequency modulation as well as a static frequency option. The Sonicator Plus provides both a membrane panel and a touchsensitive screen to allow you to quickly set up treatments. 90 preset treatment setups allow quick set up of a treatment that is already in the memory, plus any of these programs may be customized with the clinician's own treatment protocols. The Sonicator® Plus 920 can provide electrical stimulation only, ultrasound only and combination therapy with the pre-modulated, TENS, High Voltage, microcurrent and DC waveforms.

The provided 510(k) summary for the SONICATOR® PLUS 920, Model ME 920, focuses on demonstrating substantial equivalence to a predicate device (Sonicator® Plus 940, Model ME 940) rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical context.

Therefore, much of the requested information regarding clinical study design, sample size, expert involvement, and ground truth establishment is not present in the provided document, as it is typical for a 510(k) submission based on substantial equivalence for this type of device. The acceptance criteria generally relate to meeting performance specifications similar to the predicate device and relevant industry standards.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the functional and physical specifications of the predicate device (Sonicator® Plus 940) and compliance with various international standards, as the proposed device claims substantial equivalence to it with minor differences. The reported device performance is presented as a direct comparison to the predicate device.

• Power Source: AC line | AC line | Predicate device, IEC/EN 60601-1
• Isolation: Reinforced insulation | Reinforced insulation | Predicate device, IEC/EN 60601-1
• Chassis Max Leakage Current: >50 µA under SFC | >50 µA under SFC | Predicate device, IEC/EN 60601-1
• Electrodes Max Leakage Current: >50 µA under SFC (Predicate: >50 µA) | >100 µA under SFC | Predicate device, IEC/EN 60601-1 (Note: This is a deviation to consider)
• Number of Output Modes: 8 | 8 | Predicate device
• Channel(s): 4 (Predicate) | 2 | Predicate device (A primary difference)
• Constant Current: Yes | Yes | Predicate device
• Automatic Overload Trip: Yes | Yes | Predicate device
• Automatic Over Current Trip: Yes | Yes | Predicate device
• Automatic No Load Trip: Yes | Yes | Predicate device
• Automatic Shut Off: Yes | Yes | Predicate device
• Timer Display: 0 - 60 minutes | 0 - 60 minutes | Predicate device
• Timer Accuracy: ± 3 % | ± 3 % | Predicate device
• Maximum Treatment Time: 30 minutes | 30 minutes | Predicate device
• Software/Firmware/Microprocessor Control: Yes | Yes | Predicate device
  Electrical Stimulation Waveform Characteristics (Selected Examples): | |
• EMS Max Output Voltage (500 Ω): 49 V (Predicate) | 50 V | Predicate device (Similar range)
• TENS Max Output Current (500 Ω): 90 mA (Predicate) | 100 mA | Predicate device (Similar range)
• Hi Volt Max Phase Charge (500 Ω): 48 µC | 48 µC | Predicate device
• Microcurrent Max Output Current (10 kΩ): 0.750 mA | 0.74 mA | Predicate device (Similar range)
  Therapeutic Ultrasound Specifications: | |
• Frequency: 1 MHz and 3 MHz, ± 5 % | 1 MHz and 3 MHz, ± 5 % | Predicate device, FDA 21 CFR 1050.10
• Modes: Continuous and Pulsed | Continuous and Pulsed | Predicate device
• Pulse Repetition Rate: 100 Hz ± 10 % | 100 Hz ± 10 % | Predicate device
• Pulse Duration: 0.5, 1.0, 2.0, 3.0, 4.0 and 5 ms (± 10 %) | 0.5, 1.0, 2.0, 3.0, 4.0 and 5 ms (± 10 %) | Predicate device
• Maximum Output Power (ME 9201/9401): 12 W | 12 W for ME 9201 | Predicate device
• Maximum Output Power (ME 9202/9402): 1.8 W | 1.8 W for ME 9202 | Predicate device
• Maximum Intensity: 2 W/cm² (continuous), 3 W/cm² (pulsed) | 2 W/cm² (continuous), 3 W/cm² (pulsed) | Predicate device
• Effective Radiating Area (5.5 cm² applicator): 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz) | 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz) | Predicate device
• Effective Radiating Area (0.9 cm² applicator): 0.9 cm² (1 MHz) / 0.9 cm² (3 MHz) (Predicate) | 0.9 cm² (1 MHz) / 0.8 cm² (3 MHz) | Predicate device (Slight difference for 3MHz)
• Maximum Beam Non-Uniformity Ratio (5.5 cm² applicable): 4.55:1 maximum (Predicate) | 4.6:1 (1 MHz) / 4.2:1 (3 MHz) maximum | Predicate device (Slight differences, but within acceptable range for equivalence according to submission)
  Standards Compliance: | |
• ISO 14971 : 2000 | Yes | Predicate device
• UL 2601-1 | Yes | Predicate device
• CSA C22.2 NO 601.1-M90 | Yes | Predicate device
• IEC/EN 60601-1 | Yes | Predicate device
• IEC/EN 60601-1-2 | Yes | Predicate device
• IEC/EN 60601-2-10 (For stimulators) | Yes | Predicate device
• IEC/EN 60601-2-5 (For ultrasonic therapy equipment) | Yes | Predicate device
• MDD 93/42/EEC, Annex II | Yes | Predicate device
• 21 CFR 898 (for sunlamp products, potentially a typo or reference to 21 CFR 1050.10 for ultrasonics) | Yes | Predicate device (Acknowledged for ultrasonic standards 21 CFR 1050.10)

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

This is a premarket notification (510(k)) for substantial equivalence for a medical device (an electrotherapy and ultrasound combination unit), not a clinical trial of a diagnostic or AI-driven device. Therefore, there is no "test set" in the sense of a patient cohort evaluated for diagnostic or AI performance.

The "testing" mentioned typically involves internal engineering verification and validation (V&V) to ensure the device meets its design specifications and complies with relevant safety and performance standards. This V&V data is generally proprietary and summarized in the 510(k) submission, not provided in detail here.

• Sample size for test set: Not applicable in the context of a clinical test set for diagnostic performance. Performance is evaluated against engineering specifications and comparison to the predicate device.
• Data provenance: Not applicable. The data is internal engineering test data.

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

This is not applicable for this type of 510(k) submission. There is no "ground truth" derived from expert review of cases, as this is not a diagnostic device or an AI application with human-in-the-loop performance evaluation. The "truth" is established by adherence to design specifications and compliance with standards.

4. Adjudication Method for the Test Set

This is not applicable for this type of device. Adjudication methods like "2+1" are used in clinical studies where expert consensus is needed to establish a definitive diagnosis or outcome for a test case.

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

This is not applicable. This is not an AI-driven device or a diagnostic imaging system that would involve human readers and AI assistance for interpretation.

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

This is not applicable. This device is a physical therapy unit, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This is not applicable in the context of clinical "ground truth." The "ground truth" for this device's performance evaluation would be its conformance to specified electrical and ultrasonic output parameters as measured by calibrated equipment, and verification against design requirements and safety standards. The primary "ground truth" supporting its marketing is its substantial equivalence to the predicate device which has a history of safe and effective use.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/ML model that requires a training set.

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

This is not applicable. As it's not an AI/ML model, there is no training set or associated ground truth.

In Summary:

The provided 510(k) summary demonstrates compliance by comparing the proposed device's technical specifications and intended uses to those of a legally marketed predicate device (Sonicator® Plus 940). The acceptance criteria are largely implicit in demonstrating that the Sonicator® Plus 920 performs as intended and is as safe and effective as the predicate device by meeting similar engineering specifications and conforming to recognized electrical and medical device safety standards (e.g., IEC/EN 60601 series, ISO 14971, FDA 21 CFR 1050.10).

The study that "proves" the device meets acceptance criteria, in this context, is the technical comparison report (the "Comparison of Technological Characteristics" tables in the document) and documentation of compliance with various international standards. This type of submission relies on the established safety and effectiveness of the predicate device. Differences are highlighted (e.g., 2 channels vs. 4 channels, minor variations in output parameters or applicator ERAs), and the manufacturer's responsibility is to demonstrate that these differences do not raise new questions of safety or effectiveness.

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The MTD 4000 traction device provides traction and mobilization of skeletal structures and skeletal muscles.

The MTD 4000 may be used to relieve peripheral radiation/sciatica and pain associated with:

• Protruding discs
• Bulging discs
• Herniated discs
• Degenerative disc disease
• Posterior facet syndrome
• Acute facet problems
• Radicular pain
• Prolapsed discs
• Spinal root impingement
• Hypomobility
• Degenerative joint disease
• Facet syndrome
• Compressions fractures
• Joint pain
• Discogenic pain

The MTD 4000 (Mettler Traction Decompression) system is an easy to use device that offers static and intermittent traction with user definable hold, rest, and treatment times. It gently pulls the cervical spine or lumbar spine in opposite directions to draw the soft tissue around the cervical or lumbar joints and separate the distance between bone sections of the vertebra.

The provided text is a 510(k) Summary Statement for the Mettler Traction Device, MTD 4000. It details the device's description, intended use, and a comparison to predicate devices for substantial equivalence.

However, the document does not contain information about specific acceptance criteria for a study, nor does it present the results of a study designed to prove the device meets such criteria.

The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for performance, a common requirement for new or higher-risk devices.

Therefore, I cannot fulfill your request for the following information based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing technological characteristics to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or study data is described.
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): No ground truth establishment or expert involvement in a study is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication 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: This device is a physical traction device and does not involve AI or human readers in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is mentioned in relation to performance criteria.
8. The sample size for the training set: Not applicable as it's not an AI/ML device that requires training.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide is a comparison table of the MTD 4000 with predicate devices, highlighting similar features and differences in physical characteristics and user interface configurations. This comparison serves to demonstrate substantial equivalence, rather than meeting specific performance acceptance criteria from a study.

The FDA's letter (Page 3-4) states that they "have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This confirms the nature of the submission and review process.

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Therapeutic Ultrasound:

1. Relief of pain, muscle spasms and joint contractures:
2. Relief of pain, muscle spasms and joint contractures that may be associated with:

• Adhesive capsulitis
• Bursitis with slight calcification
• Myositis
• Soft tissue injuries
• Shortened tendons due to past injuries and scar tissues

3. Relief of pain, muscle spasms and joint contractures resulting from:

• Capsular tightness
• Capsular tightening

4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms:

1. Symptomatic relief of chronic intractable pain
2. Post-traumatic pain
3. Post-surgical pain

EMS, TENS, Hi Volt and Russian waveforms:

1. Relaxation of muscle spasms
2. Increase local blood circulation
3. Prevention or retardation of disuse atrophy
4. Muscle re-education
5. Maintaining or increasing range of motion
6. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis

DC (Direct Current):
Relaxation of muscle spasms

The Sonicator® Plus 940 , Model ME 940 is a four-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator Plus 940 provides premodulated medium frequency and symmetrical biphasic waveforms with enhanced reliability and ease of use. In addition the Sonicator Plus 940 offers 1 and 3 MHz ultrasound using a variety of interchangeable applicators.

The four-channel Sonicator Plus 940 allows the clinician to utilize up to two different waveforms using four channels simultaneously. The clinician can choose between several different amplitude modulation options such as the surge, reciprocation and amplitude modulation (interferential only, vector rotation). The interferential and premodulated modes offer frequency modulation as well as a static frequency option.

The membrane panel provides both tactile and audio feedback when buttons are pressed. Blinking LED's guide the operator through the easy setup routine.

Large, soft-touch control knobs make adjusting power for ultrasound and stimulation easy to accomplish with no guesswork involved. A large LCD output display allows the clinician to monitor four channels simultaneously for four channel combination treatment protocols. It also allows the operator to adjust both channels of an interferential protocol simultaneously while monitoring the current.

The Sonicator Plus 940 can provide electrical stimulation only. ultrasound only and combination therapy with the pre-modulated, biphasic and medium frequency waveforms

The provided document is a 510(k) summary for the SONICATOR® PLUS 940, Model ME 940, an ultrasound and muscle stimulator device. The purpose of this summary is to demonstrate substantial equivalence to predicate devices, not to perform a clinical effectiveness study. As such, the document does not contain acceptance criteria for clinical performance, nor does it describe a study to prove the device meets such criteria.

Instead, the document focuses on comparing the technological characteristics and intended uses of the proposed device to two predicate devices: Sonicator® Plus 994, Model ME 994 (K984142) and Chattanooga Vectra Genesis (K031077). The underlying assumption for 510(k) clearance is that if the new device is substantially equivalent in terms of technology, safety, and intended use to a legally marketed device, it does not require new clinical performance data to enter the market.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) are not applicable or present in this type of regulatory submission.

However, I can extract the comparative information presented in the document, which serves as the basis for demonstrating equivalence in a 510(k) submission.

Comparative Information between Proposed and Predicate Devices

The "acceptance criteria" in this context are effectively the demonstrated characteristics and performance parameters that are comparable to the predicate devices, thereby establishing substantial equivalence. The "study" proving this is the detailed comparison provided in the 510(k) submission.

1. Table of "Acceptance Criteria" (Predicate Device Performance) and Reported Device Performance (Proposed Device)

The document provides extensive tables comparing the technical specifications of the Sonicator® Plus 940 (Proposed Device) with the Chattanooga Vectra Genesis (Predicate Device K031077) for Neuromuscular Stimulation, Pain Management, Muscle Spasm, and Therapeutic Ultrasound. The "acceptance criteria" here are essentially the specifications of the predicate device. If the proposed device meets or is comparable to these specifications, it is deemed acceptable for marketing.

Example Excerpts from Comparison Tables:

Note: The tables clearly show differences in some parameters (e.g., maximum output voltage/current, maximum power/intensity for ultrasound). The 510(k) process accepts such differences as long as they do not raise new questions of safety and effectiveness and the device remains substantially equivalent for its intended use. The submission implicitly argues that these differences are not significant enough to warrant new clinical trials.

2. Sample Size Used for the Test Set and the Data Provenance:
Not applicable as this is a 510(k) premarket notification demonstrating substantial equivalence based on technical and performance comparisons to predicate devices, not a clinical study involving test sets of patients or data. The "data" here refers to the device's measured technical specifications. The provenance is internal testing performed by Mettler Electronics Corp. to establish these specifications.

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 based on expert consensus for clinical outcomes was established as part of this 510(k) submission. The "ground truth" for the technical specifications is the output measured by the manufacturer against industry standards and the predicate device's published specifications.

4. Adjudication Method for the Test Set:
Not applicable. No clinical test set or adjudication process for clinical outcomes was part of this regulatory submission.

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, not an AI-powered diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device for therapeutic purposes; it is not an algorithm, and the concept of "standalone performance" in this context is not relevant for a 510(k) based on substantial equivalence. Its performance is measured by its physical output (e.g., electrical stimulation parameters, ultrasound intensity).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context refers to the technical specifications and performance characteristics of the device itself (e.g., voltage, current, frequency, power output, accuracy of timing). This "ground truth" is established through engineering and electrical testing, adhering to recognized standards (e.g., ISO, UL, CSA, IEC/EN, 21 CFR) and measurements against the predicate device's reported specifications.

8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established:
Not applicable. No training set was used.

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Ultrasound delivered to the body using an efficient couplant provides deep heating effects to body tissues. Ultrasound delivered at a frequency of 1 MHz penetrates to a depth of approximately 5 centimeters while ultrasound at a frequency of 3.3 or 3.2 MHz penetrates tissue to a depth of approximately 1-2 cm.

When therapeutic ultrasound is delivered to the body at intensities capable of generating a deep tissue temperature increase, some or all of the following effects may occur:

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

Sonicator® 740, Model ME 740

The provided text is a 510(k) premarket notification letter from the FDA for a device named Sonicator 740, Model ME 740, which is an ultrasonic diathermy device. This document does NOT contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy studies.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's clearance is based on its substantial equivalence to existing predicate devices, not on a new clinical study demonstrating specific performance metrics. The document details the regulatory classification, product code, and indications for use, but does not provide any data from a study that would include acceptance criteria for metrics like sensitivity, specificity, or F1-score, nor does it discuss sample sizes, ground truth establishment, or expert reviews as would be typical for studies evaluating AI/ML-driven diagnostic devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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The Laser Sys*Stim 540, Model ME 540 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 muscles.

The Laser Sys*Stim 540, Model ME 540, is a portable, AC and battery operated non-invasive, low level infrared lamp that provides continuous and pulsed heat therapy at a fixed frequency. The system consists of a drive unit/power supply that houses the electronics, controls and displays and optional treatment probes that contain the visible and infrared radiating elements.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary statement for the Laser Sys*Stim 540, Model ME 540, and primarily focuses on its substantial equivalence to predicate devices. It describes the device, its intended use, and a comparison with predicate devices, but lacks details about specific performance metrics, clinical trials, or validation studies.

The "Testing" section only states: "Production and quality control performance and safety testing shall be performed on each system pursuant to compliance with all applicable safety standards and regulations for low level laser therapy systems." This indicates planned testing for compliance with general standards but does not provide specific acceptance criteria or the results of a study.

Therefore, I cannot provide the requested table or information as the input text does not contain the necessary details.

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Shortwave diathermy delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used for the treatment of many conditions such as:

1. Relieving pain.
2. Reducing muscle spasm.
3. Increasing range of motion of contracted joints using heat and stretch techniques.
4. Increasing blood flow to tissues in the treatment area.

The AutoTherm 390 is a shortwave diathermy device that operates at 27.12 MHz. It provides shortwave diathermy therapy using condenser and electromagnetic inductive coil fields in both continuous and pulsed modes of operation. It is suited for all diathermy treatments in both the clinic and medical practice. The ME 390 is portable and easily transportable between treatment rooms. A four-wheel cart is provided when the optional induction electrode and arm are used. Two of these wheels have brakes that can be locked to prevent movement during use. The membrane control panel is mounted on the top of the unit. It is easily cleaned and contains all the controls and displays for operating the AutoTherm 390. The intensity control knob adjusts the output power via an encoder. The power switch is on the upper left side of the unit. Screw holes for attaching the arms are located on the rear of the unit. The sockets for connecting cables for the condenser and inductive coil applicators and the detachable mains power supply cable including fuses are also located on the back of the unit. The ripcord for the patient emergency-OFF switch passes through a bushing mounted on the back of the unit so that it can be pulled from all directions.

The provided documentation for the AUTO*THERM 390, MODEL ME 390 (K042554) does not include a study describing the acceptance criteria or a study proving the device meets said criteria.

The information primarily consists of:

• 510(k) Summary Statement: Details the device name, predicate device, a description of the proposed device, and its intended use.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence to a predicate device.
• Indications for Use Statement: Reiterates the intended uses of the device.

There is no mention of:

• Specific acceptance criteria (performance metrics, thresholds).
• A study design or execution.
• Sample sizes (test, training, or validation sets).
• Data provenance.
• Expert involvement or adjudication for ground truth.
• Comparative effectiveness studies (MRMC).
• Standalone performance studies.
• Ground truth methodologies.

The clearance of this device (K042554) was based on substantial equivalence to a predicate device (Auto*Therm 395, Model 395) as stated in the FDA clearance letter ("determined the device is substantially equivalent... to legally marketed predicate devices"). In substantial equivalence pathways, it is common for manufacturers to demonstrate that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate, rather than conducting new clinical performance studies with pre-defined acceptance criteria, especially for well-established technologies like shortwave diathermy.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post 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.

SysStim 208, Model ME 208: The microprocessor controlled SysStim 208 produces low volt current through one channel. The unit produces an asymmetrical electrically balanced waveform. There are three modes of operation: Pulse-1 to 80 Hz, Tetanize-Continuous Output, 80 Hz and Surge-80 Hz, On/Off times variable. The SysStim 208 is portable and beautifully designed. Up and down buttons control the timer while easy-to-use knobs allow you to select treatment parameters and adjust intensity. An optional accessory for the SysStim 208 is the Patient Termination Switch, which is connected to the jack located on back of the unit.

SysStim 208A, Model ME 208A: The microprocessor controlled SysStim 208A produces low volt current through two channels. The unit produces an asymmetrical electrically balanced waveform. There are four modes of operation: Pulse-1 to 80 Hz, Tetanize-Continuous Output, 80 Hz, Surge-80 Hz, On/Off times variable and Recip-80 Hz, output alternates between the two channels. The Sys*Stim 208A is portable and beautifully designed. Up and down buttons control the timer while easy-to-use knobs allow you to select treatment parameters and adjust intensity. An optional accessory for the Sys+Stim 208A is the Patient Termination Switch, which is connected to the jack located on back of the unit.

The provided 510(k) summary for the Sys*Stim® 208/208A, Model ME 208/208A does not describe acceptance criteria or a study to prove the device meets acceptance criteria.

The document is a "510(k) Summary" which serves to demonstrate substantial equivalence to previously cleared predicate devices. It provides a detailed comparison of the technological characteristics of the Sys*Stim® 208/208A with its predicate devices (Chattanooga's Intelect LV110/LV120 and AMREX' MS322/MS324). This comparison serves as the basis for the FDA's determination of substantial equivalence, meaning that the new device is as safe and effective as the predicate device(s) and does not raise new questions of safety or effectiveness.

Therefore, I cannot populate the requested table or answer most of the questions, as the information is not present in the provided text.

Here's a breakdown of what can be inferred or directly stated from the document, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a study. Instead, the document presents the specifications of the new device and compares them to predicate devices, implying that matching or being within acceptable ranges of the predicate device specifications is the "acceptance" for substantial equivalence.
• Reported Device Performance: The document lists the technical specifications and operational parameters of the Sys*Stim® 208/208A. These are not "reported performance" from a study but rather the design specifications of the device.

Missing Information (Not described in the provided document):

2. Sample size used for the test set and the data provenance: Not applicable. This document is a technical comparison for substantial equivalence, not a clinical or performance study.

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 establishment for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrical muscle stimulator, not an AI-assisted diagnostic tool or imaging device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is implicitly the established performance and safety of the predicate devices.

8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is a medical device clearance, not an AI/machine learning model submission.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (as described in the document):

The document does not describe a "study" in the traditional sense of a clinical trial or performance evaluation with specific acceptance criteria. Instead, it presents a technical comparison and declaration of substantial equivalence. The "study" is the comparison made between the Sys*Stim® 208/208A and its legally marketed predicate devices (Chattanooga's Intelect LV110/LV120 and AMREX' MS322/MS324). Mettler Electronics Corp. asserts that their devices are substantially equivalent to these predicates based on similar intended use, technological characteristics (waveform, output modes, power, timer settings, safety features like automatic shut-off and patient override), and compliance with relevant regulations (21 CFR 898).

The detailed tables comparing the specifications of the new device to the predicates serve as the evidence to "prove the device meets acceptance criteria" for regulatory clearance based on substantial equivalence. The acceptance criteria are implicitly that the new device's specifications and performance must be sufficiently similar to the predicate devices and not raise new questions of safety or effectiveness.

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The one megahertz ultrasound/peristaltic irrigation pump combination system, trade name Silberg T.P.S. (Tissue Preparation System), provides a method for the subcutaneous infusion and ultrasonic dispersion of tumescent fluid. It is not indicated for the administration of parenteral fluids, infusion of drugs, or for any life-sustaining purpose.

The Silberg Tissue Preparation System, Model ME 800, consists of a 1 MHz ultrasonic generator, 10 cm2 ultrasonic applicator, peristaltic pump irrigation unit. foot switch, hollow cannula, system cart, IV pole with saline solution bag and irrigation tubing set.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary statement for a medical device (Silberg's Vein Preparation System Model ME 800) which primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting detailed performance studies against defined acceptance criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document discusses the device's components and its intended use, stating that the ultrasound portion is functionally and electrically the same as a predicate device (Sonicator 716, ME 716) and the peristaltic irrigation pump system is the same as another predicate device (Barnant pump system used by KMI Kolster Methods, Inc. "Irrigation or Infusion Pump 'K' Pump"). This comparison of technological characteristics is the basis for the 510(k) clearance, implying that the device is considered safe and effective because its components are substantially equivalent to already approved devices. It does not detail new performance studies conducted for the ME 800 itself with specific acceptance criteria.

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Shortwave diathermy delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:

1. Relieving pain;
2. Reducing muscle spasm;
3. Increasing range of motion of contracted joints using heat and stretch techniques; and
4. Increasing blood flow to tissues in the treatment area.

The Auto*Therm 395 is a shortwave diathermy device that operates at 27.12 MHz. It provides traditional shortwave diathermy therapy using condenser and electromagnetic coil fields in both continuous and pulsed modes of operation. It is suited for all diathermy treatments in both the clinic and the medical practice.

The ME 395 has four wheels for easy transportation between treatment rooms. Two of these wheels have brakes that can be locked to prevent movement during use. The membrane control panel is mounted on top of the unit. It is easily cleaned and contains all the controls and displays for operating the Auto*Therm 395.

The intensity control knob adjusts the output power via an encoder. The power switch is on the upper left side of the unit. Screw holes for attaching the arms are located on the rear of the unit. The sockets for connecting the cables for the condenser and coll applicators and the detachable mains power supply cable including fuses are also located on the back of the unit. The ripcord for the patient emergency-OFF switch passes through a bushing mounted on the back of the unit so that it can be pulled from all directions.

The provided text is a 510(k) Summary for the AUTO*THERM ® 395, Model ME 395. This document focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance, rather than presenting a detailed clinical study with specific acceptance criteria and performance data in the format of a typical clinical trial.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study proving device performance against acceptance criteria cannot be extracted directly from this document.

This 510(k) summary primarily provides:

• Device Description: What the AUTO*THERM ® 395 is and how it functions.
• Intended Use Statement/Indications for Use: The medical conditions the device is intended to treat.
• Comparison to a Predicate Device: A table comparing the technological characteristics of the new device with a legally marketed predicate device (Curapuls 419). This comparison is the primary "study" that proves the device meets the regulatory acceptance criteria for substantial equivalence, not a clinical performance study.
• FDA Clearance Letter: Confirming the device's substantial equivalence to the predicate.

Based on the provided text, here is why a direct answer to your request is not possible in the format you've outlined:

• Acceptance Criteria & Reported Device Performance: These are not presented in terms of specific clinical metrics (e.g., pain reduction percentage, range of motion improvement with statistical significance). Instead, the "acceptance criteria" for this submission would be demonstrating that its technological characteristics and intended use are substantially equivalent to the predicate device. The "reported device performance" is implicitly that it operates similarly to the predicate and can achieve the stated indications for use.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth: These are all elements of a clinical study designed to test the performance or effectiveness of a device. A 510(k) submission, especially for a device like a shortwave diathermy which operates on well-understood physical principles and has a predicate, often relies on demonstrating engineering and functional equivalence rather than new clinical efficacy trials. The document does not describe such a clinical study.
• Training Set Information: No machine learning or AI components are mentioned, so there is no training set.

In summary, the provided document is a regulatory submission focused on substantial equivalence rather than a clinical study report. It does not contain the detailed clinical performance data, acceptance criteria, or study methodologies you've requested.

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