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1. To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain
2. Muscle re-education
3. Increasing blood flow
4. Maintain or increase mandibular range of motion

This device is a current stimulation device with Therapeutic Electro Muscle Stimulator function. Power is supplied by the built-in rechargeable lithium batter. The stimulation current generated by the output circuit of the main body is supplied to the user through the electrode to realize current stimulation. The device is equipped with PAIN mode and MCR mode. Each CH can output independently and be adjusted. If it outputs in CARE mode, it can be used for both outputs at the same time.

Upon reviewing the provided document, it appears to be an FDA 510(k) clearance letter for a medical device called "D function," a powered muscle stimulator. The document primarily focuses on demonstrating the substantial equivalence of the "D function" to legally marketed predicate devices, rather than presenting a detailed study proving the device meets specific performance acceptance criteria for diagnostic accuracy or clinical effectiveness in the way one might expect for an AI/ML-based diagnostic device.

The document does not contain the following information typically found in a study proving a device meets acceptance criteria:

• A table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy.
• Sample sizes used for test sets or data provenance for such studies.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods for test sets.
• MRMC comparative effectiveness study results.
• Standalone performance results.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for and ground truth establishment for training sets (this device is a stimulator, not an AI/ML diagnostic).

Instead, the document focuses on:

• Regulatory information: Device classification, product codes, predicate devices.
• Device description: How the device works (current stimulation).
• Indications for Use: What the device is intended to treat (muscle spasm, TMJ dysfunction, muscle re-education, blood flow, range of motion).
• Comparison of technological characteristics: Comparing pulse width, output frequency, and output current with predicate and reference devices, highlighting differences and justifying how these differences are supported by existing devices.
• Performance Data (Non-clinical Testing): This section refers to compliance with standards (e.g., electrical safety, EMC, software life cycle processes), and verification/validation that the device meets design/software requirements. It states that "The verification results demonstrate that the proposed device complies with the standard, IEC62304:2006/ Amd.1: 2015 Medical device software - Software life cycle processes. Additionally, the proposed device meets its design requirements in accordance with the requirements of FDA's guidance for the Content of Premarket Submissions for Software." It also states "The validation results demonstrate that the software specifications conform to user needs and that the particular requiremented through the proposed device can be consistently fulfilled."

Given the nature of this document (510(k) for a powered muscle stimulator), the "acceptance criteria" and "study" are primarily focused on non-clinical performance (electrical safety, electromagnetic compatibility, software validation, and physical/electrical specifications) to ensure the new device is as safe and effective as existing legally marketed predicate devices, despite some technological differences. It is not an AI/ML device, so typical AI/ML performance metrics (accuracy, sensitivity, specificity, AUC) are not applicable or presented.

Therefore, I cannot extract the information requested in the prompt as it pertains to AI/ML diagnostic device regulatory submissions, because this document describes a traditional medical device (a stimulator).

If you can provide a document related to an AI/ML medical device, I would be happy to attempt to extract that information.

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The US-101L, US-103S are indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.

US-101L, US-103S are portable type ultrasound therapy units with built in ultrasound transducer. Ultrasound head (probe) is integral with the main body. Two sizes, US-101L (L size) for 1MHz and US-103S (S size) for 3MHz are available. In the output mode, continuous output (100%) or pulsed output (50%, 40%, 20%, 10%, 5%) are used. These units are intended to treat the affected area by applying the treatment head to skin.

The provided text describes a 510(k) summary for the US-101L and US-103S ultrasound therapy units. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria as would be expected for a novel AI/software medical device.

Therefore, much of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission process.

Here's an attempt to answer the questions based on the provided text, highlighting what is not available:

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

This information is not provided in the document. The submission focuses on substantial equivalence to predicate devices based on similar features and safety functions, not on specific performance metrics or acceptance criteria for a new AI/software device.

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

This information is not provided. The document makes no mention of a "test set" in the context of an AI/software device's performance evaluation. The non-clinical testing mentioned refers to device verification and validation, likely evaluating hardware and software functions (e.g., output accuracy, safety) rather than diagnostic or therapeutic efficacy based on patient data.

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)

This information is not provided. The concept of "ground truth" established by experts for a test set is not applicable to the type of device and submission described.

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

This information is not provided. Adjudication methods are not relevant to this type of device 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

This information is not provided. An MRMC study is not relevant to this traditional ultrasound therapy device. This device does not involve human readers interpreting images or an AI component assisting in diagnosis.

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

This information is not applicable/not provided. The US-101L and US-103S are physical ultrasound therapy units, not an algorithm or AI software for standalone performance evaluation.

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

This information is not provided. The concept of "ground truth" for a performance evaluation is not relevant to this device.

8. The sample size for the training set

This information is not provided. No training set is mentioned as this is not an AI/ML device.

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

This information is not provided. No training set or ground truth establishment relevant to AI/ML is mentioned.

Summary based on the provided text:

The submission for the US-101L and US-103S ultrasound therapy units is a 510(k) premarket notification. The core of the submission is to demonstrate substantial equivalence to existing predicate devices (K032793- US-100 Ultrasound Therapy Unit and K024307- Dermosonic Non-Invasive Subdermal Therapy System).

The basis for this substantial equivalence is stated as the proposed devices incorporating "similar features as the predicate devices such as the main ultrasound output specification and safety functions."

Non-clinical testing was conducted, and its results are referenced in Section 15 of the submission. This testing likely focused on:

• Compliance with recognized standards (IEC 60601-1, IEC60601-1-2, IEC60601-2-5) related to electrical safety, electromagnetic compatibility, and specific requirements for medical ultrasonic equipment.
• Verification of device specifications (e.g., ultrasound frequency, output power, pulsed modes) against stated claims and comparison to predicate devices.
• Validation of safety functions.

The document does not contain information related to acceptance criteria, performance studies, sample sizes, ground truth, expert involvement, or AI/ML-specific evaluations, which are typically required for novel AI/software medical devices.

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The intended use of the ES-130 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

ES-130 is a palm-size ELECTRO-ACUPUNCTURE DEVICE equipped with three independent output channels. This unit has incorporated similar features as the predicate devices such as: Variable Frequency Settings & Similar Frequency Range, Variable Intensity Settings & Similar Output Range, Biphasic Pulse Waveform, Similar Pulse Shape & Pulse Charge, Battery Power & Portability.

The provided text discusses the ES-130 Electro-Acupuncture Device and its submission for FDA 510(k) clearance. The crucial point for your request is that no clinical testing or performance study with acceptance criteria was conducted for this device beyond non-clinical verification and validation testing, as explicitly stated in the document.

Therefore, I cannot populate a table of acceptance criteria and reported device performance based on a human-in-the-loop or standalone AI study from this document, nor can I provide information about sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or training sets.

Here's a breakdown of what the document does state in relation to your questions:

1. Table of acceptance criteria and the reported device performance

No acceptance criteria for clinical performance are reported, as no clinical studies were performed. The "performance" described focuses on demonstrating equivalence to predicate devices based on technical specifications.

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. No clinical test set was used. "Non-clinical verification and validation testing was conducted on ES-130 device" but details on sample size or data provenance for these engineering tests are not provided.

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 clinical test set requiring expert ground truth was used.

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

Not applicable. No clinical test set requiring adjudication was used.

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. No MRMC study was done, as this is an electro-acupuncture device and not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm or AI system. Its performance was assessed through non-clinical verification and validation to demonstrate technical equivalence to predicate devices, not as a standalone AI.

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

Not applicable. No clinical ground truth was established because no clinical studies were conducted. The "ground truth" for the submission was established by comparing the device's technical specifications and electrical outputs to those of three predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/algorithm-based system requiring a training set.

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

Not applicable. This device is not an AI/algorithm-based system requiring a training set.

Summary of the Study Discussed in the Document:

The study referenced in the document is a non-clinical verification and validation testing of the ES-130 device. Its purpose was to demonstrate substantial equivalence to three legally marketed predicate devices (K051197: ACULIFE/Model SMW-01, K840983: Pulselife Model PL2, and Pre-Amendment: Model WQ-10B).

The submission states: "Using three similar predicate devices, detailed comparisons of specific ES-130 features and characteristics are contained in Section 8 of this submission... This side-by-side comparison demonstrates that the performance characteristics of the predicate devices encompass the entire range of performance characteristics of the proposed ES-130 device including frequency values, output intensity values, number of channels, supply voltage value, pulse width value, pulse charge value, delivered current density, and delivered power density."

Crucially, the document explicitly states: "Clinical testing was neither required nor conducted regarding the ES-130 submission." Therefore, there are no acceptance criteria or performance metrics related to human or clinical outcomes in this document. The device gained market clearance based on its technical specifications falling within the range of existing, legally marketed devices.

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Use of the TM-400 powered traction device is indicated for the following:

• Providing standard therapeutic and custom user-defined treatments in static, intermittent, . progressive, regressive, cyclical and combination distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder).
• Providing traction and mobilization of skeletal structures and skeletal muscles. .
• . Relieving peripheral radiation / sciatica and pain associated with:

Discs:

• A Protruding, bulging, herniated and prolapsed discs
• A Degenerative disc disease
• A Discogenic pain

Facets:

• A Facet syndrome
• A Posterior facet syndrome
• Acute facet problem A

Muscles & Joints:

• Muscle pain and spasms A
• Degenerative joint disease A

Spinal Structures:

• Spinal root impingement A
• a Pinched nerves
• A Compression fractures

Pain:

• Back, lower back, neck, joint, sciatic and radicular pain A
  Mobility & Flexibility:

• Hypomobility

• Limited spinal and joint flexibility

The TM-400 is a simple to use powered traction unit that offers static, intermittent, and cycle traction with user-definable hold, rest and treatment times. The unit consists of a software-controlled electro-mechanical traction system. The physical characteristics of the TM-400 are substantially equivalent to the predicate traction devices including size, weight, materials of construction, and user interface. In addition, the unit has incorporated similar features as the predicate devices such as:

• ア Automatic calibration of traction force

• An internal memory that stores up to 30 treatment patterns

• A Traction speed selectable from five preset values
• 公 Eight traction modes
• A Remote patient-controlled treatment shutoff switch
• ﺮ Large and high-visibility LCD screen

The TM-400 traction device operates by attaching the cable hook to a harness accessory, which is in turn attached to the patient treatment area, for traction and mobilization of skeletal muscles according to the detailed indications of use.

The provided text describes the TM-400 powered traction device and its intended use, but it 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 for a medical device submitted to the FDA, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance study results based solely on the provided text.

Here's why and what information would typically be expected for such a request:

• Acceptance Criteria and Reported Device Performance: This would require a table outlining quantitative or qualitative performance targets (e.g., accuracy of traction force, speed consistency) and the actual validated performance values from testing. The document states "Testing was carried out to assure compliance to FDA recognized electrical safety standards," and "Non-clinical verification and validation testing was conducted on final TM-400 production units, and the results of such testing appear in Section 12 and Section 14 of this submission." However, these sections are not provided in the input, so the specific acceptance criteria and performance data are missing.
• Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, ground truth type, training set size, and training set ground truth establishment: These are all elements typically found in detailed clinical or non-clinical performance studies, often in sections beyond a 510(k) summary. The provided text only mentions "non-clinical verification and validation testing." For a powered traction device, these studies would likely focus on mechanical performance, safety, and potentially effectiveness if a clinical study were performed (though typically not required for substantial equivalence).

In summary, the provided document focuses on:

• Device description and features.
• Intended use and indications for use.
• Comparison to predicate devices (K992545 and K053223).
• Compliance with electrical safety (UL60601-1) and electromagnetic compatibility (IEC60601-1-2) standards.
• The FDA's decision of substantial equivalence.

It does not disclose the detailed results of non-clinical verification and validation testing or any clinical studies that would address the acceptance criteria and performance metrics you've requested.

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The US-100 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.

The US-100 Ultrasound Therapy Unit consists of a main unit and two applicators. The device may be operated in continuous or pulsed modes. The US-100 has an output power of 8 W and operates at 0.8 MHz. It is supplied with one applicator, and another smaller applicator is available as an option. The device has an LCD screen that serves as the interface with the user to specify options, provide messages, and display parameters.

The provided document is a 510(k) summary for the US-100 Ultrasound Therapy Unit. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and safety testing. It does not contain information regarding clinical studies, acceptance criteria related to clinical performance, or studies proving the device meets specific clinical performance acceptance criteria.

Therefore, I am unable to provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions related to sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The document only states the following regarding "performance data":

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

• Acceptance Criteria: Not explicitly stated in terms of clinical performance. The document refers to "performance data ... which demonstrate equivalence" for "a few characteristics" and "performance testing carried out by Ito Co, Ltd. on the US-100 addressed the following issues: Electrical Safety, Electromagnetic Emissions, Various Safety and Integrity Issues, and Performance Standard of 21 CFR 1050."
• Reported Device Performance: No specific numerical performance metrics are reported in this summary. The summary states that the device "has the same technological characteristics as the predicate device" and that "performance data were provided, which demonstrate equivalence" for a few characteristics (listed as Electrical Safety, Electromagnetic Emissions, Various Safety and Integrity Issues, and Performance Standard of 21 CFR 1050). The results of these tests, however, are not detailed.

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

• Not provided. The testing mentioned (Electrical Safety, EMC, etc.) is likely laboratory-based engineering performance testing of the device itself, not a clinical test set with patient data.

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. This information would be relevant for clinical performance studies, which are not described here.

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, 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-enabled device, and no MRMC study is mentioned.

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

• Not applicable. This is not an AI-enabled device.

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

• Not applicable for clinical performance. For the engineering performance tests mentioned, the "ground truth" would be established by relevant engineering standards and specifications (e.g., electrical safety standards).

8. The sample size for the training set

• Not applicable. No training set is mentioned for this type of device and submission.

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

• Not applicable.

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The SW-180 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.

The SW-180 Shortwave Therapy Unit consists of a main unit and a standard applicator. Several other types of applicators are available as options. The device may be operated in continuous or pulsed modes. The SW-180 has an output power of 80 W and operates at 27.12 ± .16 MHz. The device has an LED screen that serves as the interface with the user to specify options, provide messages, and display parameters. The SW-180 Shortwave Therapy Unit device is a prescription device and the prescription statement is contained in the labeling as required.

The provided text describes a 510(k) premarket notification for the SW-180 Shortwave Therapy Unit. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for an AI-powered diagnostic device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert involvement, and ground truth establishment is not available in the provided text.

Here's an attempt to answer the questions based on the available information, noting where data is absent:

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

   • Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a diagnostic outcome. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate device, which involved performance testing on general device characteristics.
   • Reported Device Performance:

     Characteristic	Performance
     Electrical Safety	Testing conducted, assumed to meet predicate standards.
     Electromagnetic Compatibility	Testing conducted, assumed to meet predicate standards.
     Heating Patterns	Testing conducted, assumed to be similar to predicate.
     Various Integrity Checks	Testing conducted, assumed to meet predicate standards.

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 as this is a physical therapy device, not a diagnostic AI. The "testing" mentioned refers to engineering performance validation, not clinical studies with patient data.

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. Ground truth as typically defined for AI/diagnostic studies is not relevant here. The ground truth for the engineering performance tests would be established through industry standards and internal specifications.

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, 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-powered diagnostic device, and no MRMC study was mentioned.

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 concensus, pathology, outcomes data, etc)

   • Not applicable in the context of diagnostic AI. For the engineering tests, the "ground truth" would be the established engineering specifications and benchmarks for electrical safety, EMC, heating patterns, and integrity.

8. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable.

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The TENS and Microcurrent modes of the Trio 300 are indicated for the symptomatic relief of chronic intractable pain. They are also indicated for the treatment of post-traumatic and post-surgical pain. The electrical muscle stimulation (EMS) mode is indicated for relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

The Trio 300 Multi-Mode Electrical Stimulator is a small, portable, battery-powered electrical stimulator device that has four stimulation modes, (1) TENS, (2) EMS, (3) microcurrent, and (4) programmable. The device has an LED screen that serves as the interface with the user to specify options, provide messages, and display parameters. The device is supplied with an AC adaptor for line current operation.

The Trio 300 consists of the pulse generator, A/C power adapter, and the surface electrodes.

The Trio 300 is a dual-channel electrical stimulator with four output modes. The device is equipped with a liquid crystal display (LCD) for communication with the user. The SELECT key allows the user to scroll through the options (e.g., mode) available at a particular point and the SET key allows the selection of the displayed option. The UP-ARROW and DOWN-ARROW keys allow the user to increase or decrease certain selected parameters.

The provided text is a 510(k) summary for the Trio 300 Multi-Mode Electrical Stimulator, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of regulatory submission. This document primarily addresses electrical safety and electromagnetic compatibility, and design qualification to meet internal specifications, not clinical performance against acceptance criteria for an AI/algorithm-based device.

Here's an breakdown of what can be extracted and what information is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. The described testing is for electrical safety, electromagnetic compatibility, and design qualification, not for clinical performance using a "test set" in the context of an AI/algorithm study. There's no mention of patient data.

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

• Not Applicable. No clinical ground truth was established from experts for the stated testing.

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

• Not Applicable. No clinical ground truth adjudication method 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:

• No. This is not an AI-assisted device, and no MRMC study was conducted.

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

• Not Applicable. This is a direct electrical stimulator, not an algorithm.

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

• Not Applicable. The "ground truth" for the reported tests refers to standards (electrical safety, EMC) and internal design specifications, not clinical outcomes or expert labels.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set mentioned.

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

• Not Applicable. There is no training set.

Summary based on the provided document:

The Trio 300 Multi-Mode Electrical Stimulator is a hardware device. The "acceptance criteria" and "study" described in the 510(k) summary pertain to basic device safety and functionality standards (electrical safety, electromagnetic compatibility, and meeting design specifications). These are not performance criteria related to clinical efficacy or diagnostic accuracy, which would be typical for an AI/algorithm-based medical device where the requested information would be relevant. The document's purpose is to demonstrate substantial equivalence to existing predicate devices based on technological characteristics and intended use, supported by adherence to safety and design standards.

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The TM-300 Traction System is indicated for relief of pain in cases of low back pain. Each treatment consists of a physician-prescribed session designed to provide static, intermittent, or cycling distraction forces to relieve pressure on structures that may be causing low back pain. The TM-300 relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

The TM-300 Traction System is an automatic intermittent traction system for traction therapy. The patient always holds a safety switch that can interrupt treatment if it becomes uncomfortable. Several "mechanical waveforms" are available for selection by the operator, including: (1) Basic intermittent traction, (2) Incremental intermittent traction, (3) Incremental and decremental intermittent traction, (4) Residual intermittent traction, (5) Incremental and residual intermittent traction, (6) Incremental, decremental and residual intermittent traction, (7) Basic continuous traction, (8) Incremental continuous traction. The residual tractive force, the duration time setting, the pause time setting, the tow speed, and the treatment time setting are all programmable up to specified limits. For forces selected above 18 kg, the system always asks for confirmation of the selected value by the operator before proceeding. A limit switch prohibits output exceeding 100 kg.

The provided K992545 510(k) Summary for the TM-300 Traction System does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of clinical effectiveness or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device and compliance with electrical safety and electromagnetic compatibility standards.

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

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not provide a table of acceptance criteria for clinical performance (e.g., pain reduction, disc decompression) or diagnostic accuracy. The "acceptance criteria" discussed are related to safety and manufacturing standards, and "reported device performance" is primarily about compliance with these standards and the device's functional capabilities.

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

No sample size for a test set or information about data provenance (e.g., country of origin, retrospective/prospective) is mentioned for clinical effectiveness or diagnostic accuracy. The testing mentioned refers to engineering and safety performance tests, not clinical trials with patient data.

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

Not applicable. The submission does not describe a test set requiring expert-established ground truth for clinical outcomes or diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication process is described in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The device is a therapeutic traction system, not a diagnostic imaging or interpretation tool where MRMC studies are typically performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. The TM-300 is a physical medical device (traction system) that interacts directly with the patient, not a software algorithm with standalone performance. Its operation involves an operator, and a safety switch held by the patient allows interruption.

7. The Type of Ground Truth Used

For the engineering and safety tests, the "ground truth" would be established by the specifications defined during the device's design and the relevant regulatory standards (EN-60601, EN 60601-1-2). For clinical efficacy, no ground truth data from studies are provided in this submission; instead, reliance is placed on the substantial equivalence to a predicate device that presumably established its efficacy.

8. The Sample Size for the Training Set

Not applicable. This device is a physical traction system, not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set is described for this device.

Summary of the Study/Evidence Provided in the K992545 510(k) Summary:

The provided document describes a technical performance and safety validation study rather than a clinical efficacy study. The main focus of the testing was to demonstrate:

• Compliance with electrical safety standards: The device underwent testing to ensure it met the requirements of the EN-60601 standard, with a certificate of compliance issued by TÜV.
• Compliance with electromagnetic compatibility standards: The device was tested to meet the EN 60601-1-2 standard, with an Attestation of Conformity from TÜV.
• Adherence to design specifications: "Design qualification testing demonstrated that the TM-300 met its design specifications," implying that its functional outputs (e.g., force levels, timing, waveform generation) performed as intended.

The basis for the device's clinical indications (relief of low back pain associated with herniated discs, etc.) is its substantial equivalence to a previously cleared predicate device (DRS System, K981822), rather than independent clinical trials conducted for the TM-300 itself. The submission asserts that the TM-300 has the "same indications for use and target population as the legally marketed predicate devices" and "the same technological characteristics." Therefore, the "study" proving the device meets clinical acceptance criteria is essentially the prior clearance and presumed efficacy of the predicate device.

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