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The Curapuls 670 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of 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 Curapuls 670 is a two-channel microprocessor-controlled unit for pulsed shortwave therapy. Through inductive electrodes (Circuplodes), high-frequency electric currents are produced within the body. Pulsed energy at 27.12 MHz is absorbed by soft tissues. Three sizes of Circuplodes (140mm, 90mm and elliptical) are available to accommodate different size treatment areas.

Deep heating of tissue is achieved with ease by means of inductive electrodes. The user can connect two applicators. Activation of each applicator can be controlled from the console menu.

This device is a prescription equipment. Use by any persons other than physicians is prohibited.

This document is a 510(k) clearance letter for a medical device called Curapuls 670, a shortwave diathermy unit. It details the device's characteristics, its comparison to a predicate device (BTL-703), and the non-clinical testing performed to establish its substantial equivalence.

However, the provided text does not contain information related to an AI/ML-driven device or a study involving human-in-the-loop performance, such as a multi-reader multi-case (MRMC) study. It describes a physical therapy device used for applying therapeutic deep heat. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML evaluation (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.

The "acceptance criteria" and "study" described in this document are focused on demonstrating the safety and effectiveness of the Curapuls 670 as a medical device for therapeutic deep heating, primarily through non-clinical testing and comparison to a predicate device.

Let's extract what is available regarding acceptance criteria and the "study" (non-clinical testing) from the provided text:

Acceptance Criteria and Study for Curapuls 670 (Non-AI Device)

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

The document doesn't present a formal table of quantitative acceptance criteria for performance in the way one might expect for an AI model (e.g., specific sensitivity/specificity thresholds). Instead, the "acceptance criteria" for this device are primarily met by demonstrating compliance with recognized medical device safety and performance standards and showing substantial equivalence to a legally marketed predicate device.

The reported "device performance" is primarily qualitative and centered around its stated indications for use and its electrical/thermal properties.

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

• Sample Size: Not applicable in the context of a dataset for an AI model. The document refers to "final, finished devices" undergoing testing. The number of physical devices tested isn't specified, but it's a small manufacturing sample for validation, not a large patient data sample.
• Data Provenance: Not applicable for an AI dataset. The "data" here refers to test results from physical devices.

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

• Not applicable as this is not an AI/ML device requiring expert labeling of data. The ground truth for performance is based on established engineering and medical device standards (e.g., temperature measurements, electrical safety parameters, usability assessments).

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

• Not applicable. This is not a study involving human reader interpretations that 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:

• No. An MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic or interpretative device.

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

• Not applicable. This is not an algorithm. The device's performance is inherently "standalone" in the sense that it performs its physical function (producing heat) independently, but it is operated by a human user (a physician).

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

• The "ground truth" for this device's performance is based on:
  • Engineering specifications and regulatory standards: Compliance with IEC, ISO, and ANSI/AAMI standards for electrical safety, EMC, biocompatibility, and software quality.
  • In vivo thermal measurements: Direct measurement of tissue temperature increase (40-45°C) to validate the therapeutic heating capability.
  • Usability assessments: Evaluation of the user interface and safety features by presumably qualified personnel to ensure satisfactory operation.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device trained on a dataset.

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

• Not applicable. There is no training set for an AI model.

In summary, the provided FDA 510(k) clearance letter pertains to a non-AI medical device (Shortwave Diathermy). Therefore, the detailed questions appropriate for an AI/ML device's validation study are largely irrelevant to this document. The "acceptance criteria" are met by demonstrating compliance with established safety and performance standards relevant to physical therapy equipment and showing substantial equivalence to a predicate device.

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The Reprieve by Regenesis™ device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.

The Reprieve by Regenesis™ device (Reprieve) is a prescription shortwave diathermy (SWD) device consisting of a single base unit connected to one or two treatment applicators. The device connects to A/C power through an external, off-the-shelf, power supply generating radiofrequency energy which delivers SWD through the treatment applicator(s).

The base unit houses an LCD screen with four raised buttons, two on each side of the LCD screen, and an LED light bar. The back of the base unit has a molded slot to accommodate the treatment applicator(s), a pouch to store the power supply, and a cable wrapping loop to organize the treatment applicator cables. The bottom of the base unit has an opening to connect the A/C power supply. The treatment factory-affixed coaxial cables. The top is the treatment side of the applicator is a darker color to distinguish it from the lighter-colored bottom, the non-treatment side. The top also has circular imagery denoting the center of the applicator. The Reprieve device generates a 27.12 MHz RF signal that has a 100% duty cycle when programmed to continuous wave (CW) mode. When prescribed for pulsed wave (PW) mode, the pulse rate (e.g., pulses per second) can be varied from 200Hz to 1000Hz in 200Hz increments, and the pulse width (e.g., the elapsed time the pulse is on) from 20µsec to 100µsec in 20µsec increments.

The provided text describes the acceptance criteria and the studies performed for the Reprieve by Regenesis™ device, a shortwave diathermy system.

Here's a breakdown of the requested information:

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

The document does not explicitly present a table of acceptance criteria and reported device performance in the format of specific numerical values for each criterion. Instead, it states that the device "complies with" or "meets the requirements" of various standards and that usability results were "positive" and demonstrated effectiveness. The thermal performance is given as achieving a "4°C temperature rise at 25 minutes," which matches the predicate.

Below is a table summarizing the mentioned performance aspects and the statements regarding their compliance/results:

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

• Sample Size for Test Set:
  • Usability/Human Factors: "representative naïve users" were used. A specific number is not provided.
  • Bench Testing: An "in vitro muscle phantom" was used. This is not a human sample size.
  • Other tests (Electrical Safety, Biocompatibility, Software V&V) are compliance or engineering tests and do not involve human test sets in the same way.
• Data Provenance:
  • The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests (bench, usability validation), they would typically be prospective studies.

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)

• For the technical tests (electrical safety, EMC, biocompatibility, software V&V, bench testing), the ground truth is established by adherence to recognized international standards and guidances (e.g., IEC, ISO, FDA guidances). These are not typically evaluated by human experts establishing ground truth in a clinical sense, but by qualified personnel performing the testing and analyses according to standard protocols.
• For the Usability/Human Factors study, "representative naïve users" were observed performing tasks. The "ground truth" here is compliance with usability principles and demonstration that mitigations were effective. There is no mention of external experts defining ground truth for the users' performance; rather, the study itself assesses user performance against predefined objectives.

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

• The document does not describe any adjudication method for the test sets. The studies conducted are primarily performance, safety, and compliance tests against engineering standards and usability goals, rather than studies requiring expert consensus on clinical diagnoses or outcomes.

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, an MRMC comparative effectiveness study was not done.
• The device described is a medical device for therapeutic deep heating, not an AI-assisted diagnostic tool for human readers. Therefore, there is no discussion of human readers, AI assistance, or effect sizes related to such a study.

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

• The concept of "standalone" algorithm performance without human-in-the-loop is relevant to AI/imaging devices. This device is a shortwave diathermy system. Its performance evaluation involves bench testing (e.g., thermal performance in a phantom) and usability studies with human users, but not an "algorithm-only" performance in the context of diagnostic AI.

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

• Electrical Safety and EMC: Ground truth is defined by the requirements of the specified IEC standards.
• Usability/Human Factors: Ground truth is established by predefined success criteria for tasks performed by users and adherence to FDA guidance and IEC standards for usability.
• Biocompatibility: Ground truth is defined by meeting the requirements of ISO 10993-1:2018 and FDA guidances.
• Software Verification and Validation: Ground truth is defined by compliance with FDA guidance documents and IEC 62304.
• Bench Testing: Ground truth for thermal performance is established by objective temperature measurements within an in vitro muscle phantom against predefined therapeutic temperature ranges and safety limits.

8. The sample size for the training set

• This device is a physical medical device (shortwave diathermy system), not an AI/machine learning algorithm that requires a training set in that context. Therefore, the concept of a "training set" for an algorithm is not applicable here. The design and development of the device would involve engineering, prototyping, and iterative testing, but not an AI training set.

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

• As explained in point 8, the device does not employ an AI/machine learning algorithm in the sense that would require a "training set" with ground truth data for model learning. Thus, this question is not applicable.

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BTL-703 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of 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 BTL-703 is comprised of a device unit and applicator that deliver radiofrequency energy to the targeted tissue. The device is designed to enable hands-free treatment. Easyto-use color touch screen allows for maximum operator comfort. The main unit is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office. The BTL-703 consists of the following main components: microprocessor-driven control unit, high-frequency energy generator, user interface with 15,6" HD touch screen, four-point applicator.

The acceptance criteria and study information for the BTL-703 device, based on the provided FDA 510(k) summary, are described below.

Please note: This document focuses on the regulatory submission information. For medical devices like the BTL-703 (Shortwave Diathermy), the "performance" in the context of a 510(k) submission primarily refers to meeting safety and fundamental operational requirements and demonstrating substantial equivalence to a predicate device. It typically does not involve the same kind of clinical trial efficacy metrics (sensitivity, specificity, etc.) as AI/software devices. The "acceptance criteria" here are therefore related to safety standards and the ability to achieve a therapeutic temperature range.

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1-2: Collateral standard: Electromagnetic Disturbance – Requirements and tests (Complied)
• IEC 62304: Medical device software – Software life cycle processes (Complied)
• ISO 14971: Medical devices - Application of risk management to medical devices (Complied)
• ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (Complied)
• ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (Complied)
• ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization (Complied) |
  | Ablity to achieve therapeutic temperature | The device should be able to maintain a therapeutic temperature range in vivo (in relevant body tissues). Specific target: approximately 40-45°C. | The study confirmed the ability of the BTL-703 device to maintain the temperature in the range of approx. 40-45°C in vivo. |
  | Substantial Equivalence | Demonstration that the technological characteristics and indications for use are substantially equivalent to a legally marketed predicate device (K120093, BTL Elite), raising no new safety or effectiveness questions. | Comparison table provided showing similar indications for use, principle of action, clinical use, electrical protection, user interface, firmware control, type of energy, working frequency (27.12 MHz), therapy time (1-30 min), hands-free application, stop remote control, and applicator contact monitor. Differences (e.g., no pulsed mode, negative pressure applicator fixation, thermal stabilization system) were determined not to raise new safety or effectiveness questions. |

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

• Test Set (Animal Study): The document only mentions a "study in porcine model" for demonstrating temperature maintenance. It does not provide the specific sample size (number of animals or test points) used in this model.
• Data Provenance: The animal study was conducted in a porcine model. The country of origin for the data is not specified. This was a prospective study designed to specifically evaluate the device's ability to maintain temperature in vivo.

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

Not applicable. The "ground truth" for the animal study was objective temperature measurement, not a subjective assessment by human experts.

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

Not applicable. The animal study involved direct physical measurements (temperature), not subjective interpretations requiring 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. The BTL-703 is a physical therapy device that applies heat, not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance improvements are not relevant in this context.

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

Not applicable. The BTL-703 is a physical medical device, not a software algorithm or AI.

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

• For the animal study: The ground truth was based on objective temperature measurements within the porcine model.
• For demonstrating substantial equivalence: The ground truth was based on adherence to established medical device safety standards (e.g., IEC, ISO) and comparison of technical specifications and indications for use with the predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that sense. The non-clinical testing involved rigorous testing against established standards.

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

Not applicable (as it's not an AI/ML device with a training set). The "ground truth" for the non-clinical testing was established by internationally recognized and harmonized medical device safety and performance standards.

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To generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.

The ViaTherm BOOST Diathermy System is a single-patient reusable device designed to be self-administered in the home by a non-technical, adult operator. Diathermy is the controlled production of "deep heating" beneath the skin in the subcutaneous tissues, deep muscles and joints for therapeutic purposes. The ViaTherm BOOST Diathermy System is a portable diathermy heat therapy system that uses a shortwave radiofrequency signal to provide diathermic heating of tissue. The ViaTherm BOOST Diathermy System consists of five (5) components: Power generator, Heat applicator garment, Battery charging cable, Velcro extender strap, Cotton pad. Electronic circuitry in the power generator components generates a radiofrequency (RF) signal at a frequency of 13.56 Megahertz (MHz). The radiofrequency signal is delivered to the heat applicator garment that uses induction coil (magnetic field) technology to produce electromagnetic fields external to the applicator. This energy is converted into heat by electromagnetically resistant body tissues. The power generator consists of a battery pack, voltage regulators, a power control and analogue sensor module, and an RF generator. A shielded 1/4" cable with 50 Ohms impedance connects the power generator to the heat applicator garment. The electrode consists of two flat spirals incorporated into the applicator garment. The spirals are each tuned to 50 Ohms. The power from the generator is split and sent to the two spirals, one of which is driven 180 degrees out of phase from the other.

The ViaTherm BOOST Diathermy System is a shortwave diathermy device intended to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.

Here's an analysis of the acceptance criteria and supporting study information:

1. Acceptance Criteria and Device Performance

The primary performance criterion for the ViaTherm BOOST Diathermy System, as implied by comparison to its predicate device (Selicor D100), is its ability to raise tissue temperature.

Note on Acceptance Criteria: The document describes the ViaTherm BOOST Diathermy System as "as safe and effective as the predicate device" and that "Performance data demonstrate that the BOOST Diathermy System is as safe and effective as predicate device." While a specific, quantitative acceptance criterion (e.g., minimum 4°C rise within a certain time frame) is not explicitly stated as such for the new device, the comparison to the predicate's thermal performance (4°C rise at 20 minutes) strongly implies that demonstrating a similar or acceptable thermal performance was a key criterion for the new device (achieving 4°C rise at 25 minutes). Other criteria relate to specifications and safety standards compliance.

2. Sample Size and Data Provenance

• Sample Size for Test Set:
  • Phantom Test: Not specified as a number of samples, but "temperature testing was performed in a muscle/bone phantom". This refers to a simulated tissue environment, not human subjects.
  • Clinical Test: Nine healthy subjects.
• Data Provenance: Not explicitly stated, but the clinical test involved "healthy subjects" and was performed by the submitting company (ViaTherm Therapeutics, LLC) to support market clearance in the US, suggesting the study was likely conducted domestically (US) and prospectively for the purpose of this submission. The document explicitly mentions "clinical test in nine healthy subjects was performed and the temperatures of tissue at the surface, 1cm and 2cm were measured."

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This device is not an AI/imaging device requiring expert interpretation of results for ground truth. It's a therapeutic device with performance measured by physical parameters (temperature rise). Therefore, this section is not applicable. The "ground truth" for its performance is objective temperature measurements.

4. Adjudication Method (Test Set)

Not applicable as the "test set" involves objective temperature measurements in a phantom and healthy volunteers, not subjective human assessments requiring adjudication.

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

No. This device is a therapeutic diathermy system, not an imaging or diagnostic device that would typically undergo an MRMC study for comparative effectiveness of human readers with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted.

• Phantom Study: "Temperature testing was performed in a muscle/bone phantom to assess the temperature rise in simulated tissue."
• Clinical Study: "A clinical test in nine healthy subjects was performed and the temperatures of tissue at the surface, 1cm and 2cm were measured."
  These tests directly measure the device's ability to generate heat in simulated and live tissue, without human intervention in the device's core function.

7. Type of Ground Truth Used

• Objective Measurements: For the phantom study and the clinical study, the ground truth was objective temperature measurements at specific depths (surface, 1cm, 2cm) within the simulated tissue and healthy human tissue.

8. Sample Size for Training Set

This device is not an AI/machine learning device that requires a "training set" in the conventional sense. Its function is based on physical principles of radiofrequency heating. Therefore, this section is not applicable.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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The ProMedTek Model C1400 Shortwave Diathermy device 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
4. Increasing blood flow to tissues in the treatment area.

The ProMedTek C1400 shortwave diathermy device operates at 27.12 MHz. It provides traditional shortwave diathermy using an inductive drum or soft-rubber electrodes. The unit offers both continuous or pulsed modes of operation with a variety of frequencies and pulse widths to choose from. An easy-to-use LCD Touch Screen guides the user through setup. A Patient Safety Pull-Cord allows the patient to stop all output. The base of the ProMedTek C1400 is a sturdy cart with large locking wheels that allows the ProMedTek C1400 to be moved easily around the clinic and supports the arm and drum applicator during treatment.

The provided document is a 510(k) summary for the ProMedTek Model C1400 Shortwave Diathermy Device. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through technological comparison and compliance with relevant standards, rather than extensive clinical studies or AI-driven performance evaluations.

Given the nature of this submission for a shortwave diathermy device, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically understood for AI/ML-driven diagnostic devices (e.g., sensitivity, specificity, clinical endpoints) are not directly applicable in the same way. Instead, "acceptance criteria" here refer to meeting regulatory standards and demonstrating comparable performance to the predicate device through technical and safety testing.

Therefore, many of the requested numbered items for AI/ML device studies will not be present or directly relevant to this document. I will extract what information is available and indicate when a specific point is not applicable.

Acceptance Criteria and Study for ProMedTek Model C1400 Shortwave Diathermy Device

This device is a shortwave diathermy device, which primarily relies on established physical principles for deep tissue heating, rather than diagnostic algorithms or AI/ML. The "acceptance criteria" for this type of device in a 510(k) submission generally revolve around safety, electrical performance, and functional equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable as this device is a physical therapy device (shortwave diathermy) and not an AI/ML diagnostic or predictive device that would typically involve a "test set" of patient data in this context. The "testing" referred to is primarily electrical, safety, and functional conformance to standards and predicate device specifications.

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 applicable. Ground truth experts are typically required for interpreting complex diagnostic images or patient data to validate AI/ML algorithms. This device's function is therapeutic deep heating, and its safety and efficacy are evaluated through engineering tests and comparison to predicate devices, not by expert interpretation of patient outcomes in a diagnostic "test set" validation.

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

This information is not applicable. Adjudication methods are specific to conflict resolution in expert ground truth establishment for diagnostic or predictive tasks, not for the type of device being reviewed here.

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 applicable. MRMC studies are used to assess the impact of AI on human reader performance for diagnostic tasks. This device is not an AI-assisted diagnostic tool.

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

This information is not applicable. This device is not an algorithm-only diagnostic or predictive tool. It is a physical therapy device operated by a human.

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

This information is not applicable in the context of typical AI/ML device validation. The "ground truth" for this device's performance is established by:

• Compliance with recognized electrical safety and EMC standards (IEC 60601-1, -1-2, -2-3).
• Demonstrating functional equivalence to a legally marketed predicate device (Auto Therm 390), meaning it operates in the same way and produces the same therapeutic effects, which have been previously deemed safe and effective.
• Software verification and validation ensuring the control systems function as intended.

8. The sample size for the training set

This information is not applicable. This device does not use an AI/ML algorithm that requires a "training set" of data.

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

This information is not applicable. This device does not involve a training set or associated ground truth.

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Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffness, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.

Generally accepted indications for use:

o Pain Relief

• o Contractures
• o Reduce Muscle Spasm
• o Localized increase Blood Flow
• o Chronic Inflammatory Conditions
• o Bursitis
• o Decrease Joint Stiffness
• o Tenosynovitis
• o Synovitis
• o Chronic Inflammatory Pelvic Disease

ThermoPro is a shortwave diathermy device for use in applying therapeutic deep heat for selected medical conditions by applying electromagnetic energy in the radio frequency band of 27.12 MHz. The ThermoPro is a device with a metal enclosure that includes a display touchscreen. The device also features an applicator that is a standard monode electrode. The applicator is connected to the device housing, where an electronic power module drives electromagnetic energy into applicator. This electromagnetic energy is generated using a sine wave synthesizer in combination with a RF power amplifier. The energy can be applied either in constant wave mode or in pulsed mode.

This document describes the design and performance characteristics of the ThermoPro shortwave diathermy device, manufactured by Zimmer MedizinSysteme GmbH. The device is intended for applying therapeutic deep heat in body tissues for the treatment of various medical conditions.

Based on the provided information, much of the requested detail regarding acceptance criteria linked to a specific study demonstrating device performance (especially in a clinical or AI-assisted context) is not present. The document focuses on regulatory submission for a 510(k) clearance, which primarily establishes substantial equivalence to a predicate device rather than presenting novel clinical study results with acceptance criteria.

However, I can extract information related to technical characteristics and compliance with recognized standards, which serve as a form of "acceptance criteria" for regulatory clearance based on substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document does not present "acceptance criteria" in the typical sense of a clinical trial (e.g., x% sensitivity/specificity), but rather technical specifications and compliance with international standards. The "performance" is implicitly demonstrated by meeting these technical specifications and by substantial equivalence to the predicate 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 in the document. The submission is for a 510(k) premarket notification, which relies heavily on demonstrating substantial equivalence to an existing device through technical and performance characteristic comparisons and compliance with relevant standards, rather than new clinical trials with patient-based test sets. The tests mentioned are for safety and performance against standards, not typically clinical efficacy with a "test set" of patients.

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. As noted above, the submission primarily focuses on technical equivalence and compliance with standards, not on deriving ground truth from human experts for a performance evaluation in a clinical setting.

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

This information is not provided. Not applicable in the context of the presented regulatory submission which lacks a clinical test set requiring expert 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

This information is not provided. The device is a physical therapy device (shortwave diathermy), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.

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

This is not applicable. The ThermoPro is a physical therapy device, not an algorithm. Its performance is evaluated through its physical and electrical characteristics and its ability to safely deliver energy according to its specifications.

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

This information is not explicitly stated in terms of clinical ground truth. For the technical aspects, the "ground truth" would be established by the specifications of the predicate device (Intelect SWD 100) and the requirements of the international standards (e.g., IEC 60601 series, ISO 14971). The device's "performance" is its ability to meet these engineering and safety specifications.

8. The sample size for the training set

This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.

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

This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.

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Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:

• · Relieves pain
• · Increases the extensibility of collagen tissues
• · Decreases joint stiffness
• · Relieves muscle spasm
• Increases local blood flow

Megapulse Shortwave Diathermy system is indicated for use in the following conditions or applications:

• · Disorders of the musculoskeletal system
  • o Muscle spasm
  • o Joint stiffness
  • o Joint contractures
• · Chronic inflammatory or infective conditions
  • o Tenosynovitis
  • o Bursitis
  • o Synovitis
  • o Chronic inflammatory pelvic diseases

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer, along with the device's indications for use. It primarily focuses on the regulatory approval of the "Megapulse III Shortwave Diathermy" device based on substantial equivalence to existing devices.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods. It does not present data from a study proving the device meets specific performance criteria.

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

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The SW-Therm, Model ST 1001, is intended to deliver energy in the radio band of 27.12 MHz to provide deep heating therapeatic 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:

I ) 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.

Not Found

This document is an FDA 510(k) clearance letter for a medical device (SW-Therm, Model ST1001), not a study report. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily focuses on the regulatory clearance process and confirms that the device is substantially equivalent to legally marketed predicate devices, subject to general controls. It does not detail specific performance studies, acceptance criteria, or methodological aspects like sample sizes, ground truth establishment, or expert qualifications.

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The Biofusionary Bebe System is indicated to be used to generate deep heat within body tissues for treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

The Biofusionary Bebe is used for diathermic heating of tissue. The Biofusionary Bebe hand piece tip is comprised of a coil shaped antenna which directs the flow of current parallel to the tissue surface, without contacting the tissue surface, thereby directing the magnetic component of the electromagnetic energy into tissue to result in the formation of eddy currents in tissue. These eddy currents encounter resistance, leading to localized heating.

This 510(k) premarket notification describes the Biofusionary Bebe System, a shortwave diathermy device intended for generating deep heat within body tissues to treat conditions like pain, muscle spasms, and joint contractures. The submission primarily focuses on establishing substantial equivalence to a predicate device (Chattanooga Group-Intelect SWD 100, K083433) rather than a standalone clinical study for therapeutic effectiveness.

Here's an analysis of the acceptance criteria and supporting studies, to the extent provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't present a formalized table of acceptance criteria with specific quantitative targets for clinical outcomes. Instead, it relies on demonstrating that the device meets product specifications and performs comparably to the predicate device in terms of heating capabilities and safety.

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

• Heating Characterization Studies (Benchtop): Phantoms and ex vivo porcine skin tissue were used. No specific sample sizes for these tests are provided.
• In Vivo Studies: "in vivo studies on rats" were conducted. No specific sample size is provided.
• Clinical Studies: "two clinical studies completed to further determine feasibility and safety and effectiveness." No specific sample size is provided for these. The document states they were "feasibility and safety and effectiveness" studies, implying they might not be large-scale effectiveness trials.
• Usability Study: "naive users were first instructed to review the User Manual and protocols for use of the device, followed by actual use of the device in a mock setting." No specific sample size for users is provided.

Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the description of "clinical studies," they were likely prospective.

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

Not applicable for this type of device and submission. The "ground truth" for heating capabilities was derived from instrument measurements (temperature probes in phantoms/tissue). For usability, direct observation and questioning of users served as the assessment method. For safety, compliance with engineering standards (IEEE 95.1-2005) was the basis.

4. Adjudication Method for the Test Set

Not applicable. The testing described involves objective measurements (temperature, electromagnetic field levels) or direct observation/feedback in the usability study, rather than expert adjudication of interpretations.

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 a shortwave diathermy system, a therapeutic medical device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant in this context.

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

Not applicable. This device is not an AI algorithm. It's a hardware-based therapeutic device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Heating Capabilities: Measured temperature readings within phantoms and ex vivo porcine tissue. This is an objective, instrument-based "ground truth."
• Usability: User feedback and direct observation of user interaction with the device and manual.
• Safety: Compliance with established engineering and safety standards (e.g., IEEE 95.1-2005).
• Clinical Studies (Feasibility, Safety, Effectiveness): The document does not explicitly detail the ground truth or endpoints for the "two clinical studies." However, for diathermy devices, effectiveness would typically be gauged by physiological measurements (e.g., actual tissue temperature increases in vivo) and potentially patient-reported outcomes for pain relief or improved function, monitored for safety endpoints like adverse events. The document only states they were "to further determine feasibility and safety and effectiveness."

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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