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The BACK 4 device employs RF technology or EMS technology for the treatment of selected medical conditions.

The BACK 4 device in RF mode is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The BACK 4 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BACK 4 device in EMS mode is intended for:
*Prevention or retardation of disuse atrophy
*Increasing local blood circulation
*Muscle re-education
*Maintaining or increasing range of motion.

The RF treatment mode and EMS mode should not be used in combination or sequentially.

The BACK 4 device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld active electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a capacitive or resistive monopolar modes and a multipolar mode.

The product consists of a power console, LCD monitor, and accessories including capacitive, resistive and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300kHz to 1MHz.

The product can also employ EMS technology. It generates a 4kHz or 1.5kHz electrostimulation signal (modulated at a frequency set between 2Hz and 200Hz).

The two RF and EMS technologies should not be used in combination or sequentially.

An Emergency stop button feature allows the patient to shut down the unit in the event of any discomfort.

The provided text describes the regulatory clearance of a medical device (BACK 4) through a 510(k) premarket notification. The core of a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device is as safe and effective as the predicate, often through performance testing.

However, the provided document focuses heavily on comparing the technical characteristics and intended uses of the BACK 4 device to two predicate devices (BACK3 COLOR and Evolve System with T3 Applicator). It lists various performance parameters and notes where the BACK 4 is identical or differs from the predicates, consistently concluding that these differences do not raise new questions of safety and effectiveness because the device underwent required performance testing and validation.

Crucially, the document explicitly states that performance testing was done, but does not provide specific acceptance criteria for these tests or detailed results that quantify the device's performance against said criteria. It highlights that tests were conducted according to relevant IEC standards for electrical safety, EMC, and software validation, and that a "tissue temperature elevation study" was performed for the RF mode.

Given this, I can only construct the table and address the other points based on the inference from the document that these tests were performed and deemed satisfactory for substantial equivalence, rather than providing concrete numerical acceptance criteria and reported numerical performance values. The document asserts that performance was "satisfactory" and "demonstrated conformity," implying that the device met internal or standard-driven criteria.

Here's a breakdown based on the provided text, addressing your points where information is available:

Acceptance Criteria and Device Performance

Due to the nature of this 510(k) summary (focusing on substantial equivalence to predicates rather than presenting de novo clinical trial data with explicit performance metrics), specific numerical acceptance criteria and reported device performance values are not provided in the document. The document primarily asserts that the device met its design requirements and applicable standards, implying that it met the necessary performance thresholds established for substantial equivalence to the predicate devices.

Table 1. Acceptance Criteria and Reported Device Performance (Inferred from Document)

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Human Being Testing): The "tissue temperature elevation study" for the RF mode was conducted on "three different people on three body parts."
   • Data Provenance: Not explicitly stated, but given the company (SWIMS America Corp, White Plains, NY), it's likely US-based or conducted to US regulatory standards. The study type is prospective as it involved actual testing on human subjects for the purpose of demonstrating performance.

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

   • The document does not specify the number or qualifications of experts involved in establishing ground truth for the "human being testing" or any other performance studies. The ground truth for the human testing appears to be the directly measured skin and room temperatures and the clinical observation of whether therapeutic temperatures were maintained.

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

   • The document does not provide information on any adjudication methods. The performance testing described (electrical safety, EMC, biocompatibility, software validation, human temperature study) likely involves objective measurements against predefined criteria/standards rather than subjective assessments requiring adjudication.

4. 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, an MRMC comparative effectiveness study was not done. This device is a powered muscle stimulator/RF heating device, not an image analysis AI device that would typically involve human "readers" or AI assistance for diagnostic tasks.

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

   • This question is not directly applicable as the device is a therapeutic physical medicine device, not an algorithm-only diagnostic or analytical tool. Its performance is inherent in its physical outputs (RF heating, EMS signals) as applied to a patient, rather than an "algorithm-only" output in the sense of an AI diagnostic model. However, the performance parameters (e.g., RF frequency, output power, EMS specifications) are outputs of the device's internal algorithms and hardware configurations, and these were assessed in the various safety and performance tests.

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

   • For the RF mode's topical heating performance, the ground truth was direct physiological measurement (skin and room temperatures) against a defined therapeutic range (38-42°C).
   • For electrical safety, EMC, and biocompatibility, the ground truth was adherence to established international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1), verified through objective testing.
   • For software assessment, the ground truth was compliance with FDA software validation guidelines.
   • For usability and risk management, the ground truth was adherence to predefined worst-case assumptions and risk analysis principles.
   • For the EMS mode, the ground truth for parameters like burst characteristics was compliance with FDA Powered Muscle Stimulator Guidance.

7. The sample size for the training set:

   • This information is not applicable/provided as this is a medical device clearance, not an AI/machine learning model where "training sets" are explicitly discussed. The device's design and operation are based on engineering principles and regulatory standards, not on a machine learning training process.

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

   • Not applicable, as there is no "training set" in the context of this device's development as described. The device's design and verification relied on established engineering standards, predicate device characteristics, and performance testing data.

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The BACK 3 device employs RF technology or EMS technology for the treatment of selected medical conditions.

The BACK 3 device in RF mode is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The BACK 3 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BACK 3 device in EMS mode is intended for:

*Prevention or retardation of disuse atrophy
*Increasing local blood circulation
*Muscle re-education
*Maintaining or increasing range of motion.

The RF treatment mode and EMS mode should not be used in combination or sequentially.

The BACK 3 device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld active electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a capacitive or resistive monopolar modes and a multipolar mode.

The product consists of a power console, LCD monitor, and accessories including capacitive, resistive and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300kHz to 1MHz.

The product can also employ EMS technology. It generates a 4kHz or 1.5kHz electrostimulation signal (modulated at a frequency set between 2Hz and 200Hz).

The two RF and EMS technologies should not be used in combination or sequentially.

An Emergency stop button feature allows the patient to shut down the unit in the event of any discomfort.

The provided text describes a 510(k) premarket notification for the "BACK 3" medical device. It focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and various types of performance testing.

However, the document does not contain the level of detail typically found in a clinical study report that would establish specific acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) and then prove the device meets those criteria through a test set. This document is a regulatory submission for a physical therapy device that uses RF and EMS technology, not an AI/algorithm-based diagnostic device. Therefore, a study demonstrating performance against a fixed set of accuracy metrics on a test set (like for an imaging AI) is not applicable in the way queried.

The "studies" mentioned are primarily non-clinical performance tests proving the device functions as intended and meets safety standards, rather than clinical efficacy studies or diagnostic accuracy studies.

Here's a breakdown of what can be extracted, and what cannot be derived from the provided text based on your request:

What can be extracted:

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

The acceptance criteria here are based on meeting safety and performance standards equivalent to the predicate devices, rather than specific accuracy metrics like sensitivity or specificity. No numerical performance metrics for diagnostic accuracy are provided, as this is not a diagnostic device.

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The RSHOCK device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The RSHOCK massage device is intended to provide a temporary reduction in the appearance of cellulite.

The RSHOCK device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a handheld electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a resistive monopolar mode. The product consists of a power console, LCD monitor, and accessories including resistive electrodes. The unit can provide one level of treatment frequency at 300kHz.

The provided text is a 510(k) summary for the RSHOCK device, a radiofrequency cutting and coagulation device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Winback Back 3SE) rather than detailing a study that proves the device meets specific acceptance criteria based on clinical performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this document because this is a 510(k) submission, not a clinical trial report. 510(k) clearances typically rely on demonstrating equivalence to a legally marketed predicate device through technical and performance comparisons, rather than extensive new clinical studies proving efficacy or specific performance metrics that would require the detailed information you've requested.

However, I can extract the information that is present and explain why other information is not available in this type of document.

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

The document does not present a table of acceptance criteria for clinical performance and reported device performance in the way a clinical study report would. Instead, it demonstrates substantial equivalence to a predicate device (Winback Back 3SE) by comparing their characteristics. The "acceptance criteria" here are implicitly that the RSHOCK device's characteristics are similar enough to the predicate device to be considered substantially equivalent, particularly regarding safety and intended use.

Here's a table based on the "Predicate Device Comparison Table" provided, highlighting key comparisons:

The "acceptance criteria" are implied by the "Explanation of Differences" column, which consistently states "None," "Identical," or "No significant difference." This indicates that the device's characteristics meet the implicit criterion of being sufficiently similar to the predicate to warrant substantial equivalence.

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

This document does not describe a clinical "test set" with a sample size for evaluating clinical performance. The testing mentioned (Electrical Safety, Biocompatibility, Software Assessment, EMC, Usability, Risk Management) is regulatory compliance testing, not a clinical trial. Therefore, information about data provenance (country, retrospective/prospective) for a clinical test set is not applicable here.

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

Not applicable. As no clinical "test set" for performance evaluation against a ground truth is described, there's no information about experts or their qualifications for establishing ground truth.

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

Not applicable. No clinical test set.

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 not an AI-assisted diagnostic tool; it's an electrosurgical device for therapeutic heating. Therefore, an MRMC study is not relevant to its clearance.

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

Not applicable. This is not an algorithm, but a physical device.

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

Not applicable. No clinical performance study against a ground truth is described. The "ground truth" for this 510(k) submission is the demonstrated safety and performance of the substantially equivalent predicate device, as well as the successful completion of various engineering and safety tests.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device undergoing model training.

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

Not applicable. This is not an AI/machine learning device undergoing model training.

Summary of the study/evidence presented in the 510(k) submission:

The "study" in this context refers to the due diligence and testing conducted to demonstrate Substantial Equivalence (SE) to a legally marketed predicate device (Winback Back 3SE, K162828). The core of the evidence is a comparison of technical characteristics and the completion of regulatory safety and performance testing.

• Acceptance Criteria (Implicit): That the RSHOCK device's technical specifications, intended use, and safety profile are "substantially equivalent" to (i.e., do not raise different questions of safety and effectiveness from) the Winback Back 3SE predicate device. The detailed comparison table illustrates how these criteria were met by showing similarities or non-significant differences.
• Performance/Testing:
  • Electrical Safety: Complied with IEC 60601-1.
  • Biocompatibility: Samples of tissue-contacting probes tested for cytotoxicity, sensitization, and intracutaneous reactivity.
  • Software Assessment: Assessed in accordance with FDA software validation guidelines (Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing).
  • Electromagnetic Compatibility (EMC): Evaluated emissions and immunity to electromagnetic fields in accordance with IEC 60601-1-2.
  • Usability and Risk Management: Assessments done using "worst-case assumptions" to verify user interface, safety features, and satisfactory performance.

The document concludes that the RSHOCK device is substantially equivalent based on these assessments, indicating that it meets the regulatory requirements for clearance.

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The BACK3 COLOR device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The BACK3 COLOR massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BACK3 COLOR generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a handheld electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a capacitor resistive monopolar mode and a multipolar mode.

The product consists of a power console on a moveable trolley, LCD monitor, and accessories including capacitive resistive electrodes and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300kHz to 1MHz.

The provided text describes the BACK3 COLOR device, which is an electrosurgical cutting and coagulation device. The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Winback Back 3SE, K162828) rather than presenting specific performance criteria and a study to prove meeting those criteria in the traditional sense of a clinical trial for diagnostic devices.

Instead, the acceptance criteria and study detailed here are focused on demonstrating that the new device (BACK3 COLOR) functions safely and effectively, and is technologically equivalent to the previously cleared predicate device, without introducing new questions of safety or effectiveness.

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

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

Since this is a substantial equivalence submission, the "acceptance criteria" are generally that the new device performs equivalently to the predicate device in terms of safety and technical specifications. The "reported device performance" is essentially the confirmation that these specifications are met for the new device.

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

• Sample Size: The "Human being testing" for tissue temperature elevation involved three different people.
• Data Provenance: The document does not specify the country of origin or whether the study was retrospective or prospective. Given it's a testing requirement for the device's performance, it is highly likely to be a prospective study.

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 type of information is not typically applicable or detailed in a substantial equivalence filing for an electrosurgical device like this. The specific "Human being testing" described focused on physical measurements (temperature) directly from the device's application, rather than subjective interpretation by experts to establish a "ground truth" for a diagnostic outcome. Therefore, no experts for "ground truth" establishment in this sense are mentioned.

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

Not applicable. The human being testing involved direct measurement of physical parameters (skin and room temperature) rather than subjective assessments that would require adjudication.

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 electrosurgical and radiofrequency therapy device, not a diagnostic imaging device with AI assistance for human readers. No MRMC study was mentioned or required.

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

Not applicable. This device delivers energy therapy; it is not an algorithm-based diagnostic tool. The "Software Assessment" done was for the device's operational software, not for a standalone diagnostic algorithm.

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

For the "Human being testing," the "ground truth" was the direct measurement of skin and room temperatures to demonstrate the device's ability to maintain a therapeutic temperature. This is a direct physical measurement, not a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This document describes a medical device for physical therapy, not a machine learning model that requires a training set in that context. The "Software Assessment" refers to validation testing of the device's operational software.

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

Not applicable, as there is no mention of a training set for a machine learning model.

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