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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 Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.

The Caerus Active System is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) and thermal exchange therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately.

The Caerus Avenue8 device is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy and electronic heat.

The provided text is a 510(k) summary for the Caerus Active System and Avenue8, seeking substantial equivalence to predicate devices. It describes performance data and a clinical study conducted.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that non-clinical performance testing and a clinical study were conducted to verify device performance and satisfy special controls. However, it does not explicitly state specific acceptance criteria values (e.g., "The device must achieve X% pain reduction to be considered effective") and then report the results against those criteria in a tabular format. Instead, it reports outcomes from the clinical study and compliance with standards.

We can infer "performance" from the clinical study's outcome in terms of pain reduction effect.

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

The text describes a clinical study which serves as the "test set" for demonstrating clinical performance.

• Sample Size: 120 patients enrolled.
  • 48 in the Active System (Shortwave Diathermy + Heating Therapy) group.
  • 43 in the SOC group. (Note: The sum of these two groups is 91, not 120. There's a discrepancy in the provided numbers, as 120 is the total. This could imply other groups or just a rounding/reporting discrepancy. Assuming the reported group sizes are correct for the Active System and SOC groups, the remaining 29 participants are unaccounted for in this specific breakdown).
• Data Provenance: Not specified, neither country of origin nor retrospective/prospective. However, a clinical study implies prospective data collection.

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

• This information is not provided in the document. For a clinical study measuring pain, the "ground truth" is typically the patient's self-reported pain score (Mankowski scale in this case), not an expert consensus on interpreting data like images. Therefore, expert consensus in the traditional sense (e.g., radiologists interpreting images) is not applicable here.

4. Adjudication Method for the Test Set

• This information is not applicable as the "ground truth" is patient-reported pain scores, not adjudicated data. There's no mention of an adjudication process for these scores.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This device involves direct patient treatment and pain measurement, not interpretation of data by multiple human readers (e.g., radiologists) with or without AI assistance. The study described is a clinical trial comparing the device's efficacy against standard of care.

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

• This question is not applicable. The device (Active System) is a physical medical device that delivers therapy, not a standalone AI algorithm for diagnosis or interpretation. The clinical study evaluates the device's performance as a treatment.

7. The Type of Ground Truth Used

• The "ground truth" for the clinical study was patient-reported pain assessment scores, specifically using the Mankowski scale, measuring the change from baseline at the end of 2 weeks.

8. The Sample Size for the Training Set

• This information is not applicable or not provided. This document describes a medical device for treatment, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The clinical study serves to validate the device's effectiveness, not to train an algorithm. There is no mention of an algorithm or AI component that would require a training set.

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

• This information is not applicable or not provided as there is no "training set" in the context of an AI/ML algorithm for this 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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The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. It is also indicated for the temporary relief of minor muscle and pain associated with overexertion, strains, sprains and arthritis.

Pulsed electromagnetic field wrap

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a "Pulsed Electromagnetic Field Wrap" and primarily discusses regulatory aspects, indications for use, and general controls provisions. It does not include details on performance studies, test sets, expert qualifications, or comparative effectiveness.

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Adjunctive treatment of musculoskeletal pain

The ActiPatch® device is a pulsed shortwave therapy device. The circuitry consists of low voltage (3 V) digital/analog electronics that control all timing functions to produce the therapeutic radiofrequency (RF) field, where the antenna is placed directly above the therapeutic site. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply, transfers the RF energy to the target tissue as a localized therapy with no far field effects.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: ActiPatch® (K192234)
Intended Use: Adjunctive treatment of musculoskeletal pain

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a typical quantitative format for algorithm performance (e.g., "sensitivity must be > X%, specificity > Y%"). Instead, the substantial equivalence hinges on demonstrating that the ActiPatch is "at least as safe and effective as the predicate ActiPatch (K152432)."

Therefore, the "acceptance criteria" can be inferred from the studies' primary effectiveness endpoints, which consistently aimed to show a statistically significant reduction in pain compared to a control group (either active-treatment or placebo). The device's performance is described by achieving these significant reductions.

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Adjunctive treatment of postoperative pain

The RecoveryRx® device is a pulsed shortwave therapy device. The circuitry consists of low voltage (3 V) digital/analog electronics that control all timing functions to produce the therapeutic radiofrequency (RF) field, where the antenna is placed directly above the therapeutic site. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply, transfers the RF energy to the target tissue as a localized therapy with no far field effects.

The provided text describes the regulatory filing for a medical device called "RecoveryRx®". It is a pulsed shortwave therapy device intended for the adjunctive treatment of postoperative pain. However, the document does not contain acceptance criteria and information about a study proving that the device meets specific acceptance criteria in the context of an AI/Machine Learning (ML) enabled medical device.

Instead, the document details a traditional medical device submission (510(k)) where the manufacturer demonstrates substantial equivalence to predicate devices (ActiBand and Ivivi) by providing:

• Technological characteristics comparison: Showing the RecoveryRx® has similar features and operates on the same principles as the predicate devices.
• Non-clinical performance data: Electrical safety, electromagnetic safety, and biocompatibility testing, demonstrating compliance with relevant standards.
• Clinical data: Results from two randomized, double-blinded, placebo-controlled studies to show effectiveness in reducing postoperative pain, which supports its intended use.

Therefore, I cannot directly answer your prompt, as the requested information (acceptance criteria for AI/ML performance, test set details, expert ground truth, MRMC study, standalone performance, training set details) is specific to AI/ML device validation and is not present in this document. This document describes a physical medical device, not an AI/ML software device.

To answer your prompt, I would need a document that describes the validation of an AI/ML-enabled medical device.

However, I can extract the relevant information from the provided text that describes the clinical studies performed to demonstrate the device's effectiveness, which is analogous to "proving the device meets" its intended therapeutic effect (not an AI/ML performance metric).

Here's a breakdown of what is provided regarding the device's performance validation, interpreted in light of your request:

Study Proving Therapeutic Effect (Not AI/ML Performance)

The document describes two clinical studies to demonstrate the effectiveness of RecoveryRx® in reducing postoperative pain.

1. Acceptance Criteria and Reported Device Performance (Therapeutic Effect)

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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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Adjunctive treatment of musculoskeletal pain related to: (1) plantar fasciitis of the heel; and (2) osteoarthritis of the knee.

The ActiPatch® device is a pulsed shortwave therapy device. The circuitry consists of low voltage (3 V) digital/analog electronics that control all timing functions to produce the therapeutic radiofrequency (RF) field, where the antenna is placed directly above the therapeutic site. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply, transfers the RF energy to the target tissue as a localized therapy with no far field effects.

The provided document is a 510(k) premarket notification for the ActiPatch® device. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness. Therefore, the information provided focuses on comparative performance and safety rather than establishing acceptance criteria as would be seen for a new medical device. The document does not explicitly state "acceptance criteria" but rather presents clinical study results as evidence of comparable safety and effectiveness to predicate devices.

Here's an attempt to extract and organize the requested information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't define explicit "acceptance criteria" in the traditional sense of pre-defined thresholds. Instead, it presents clinical study results to demonstrate effectiveness and safety comparable to predicate devices. The "reported device performance" below summarizes these clinical findings.

• 36% of the treatment group reported a >30% decrease in VAS pain, compared to 9% for the placebo group.
• 18% of the treatment group reported a >30% decrease in total WOMAC pain, compared to 3% for the placebo group.
• 26% of the treatment group stopped pharmacological therapy, whereas 33% of the placebo group started new pharmacological therapy. |
  | Effectiveness - Plantar Fasciitis | Reduction in pain levels (daily morning VAS score) comparable to or better than placebo/no treatment for plantar fasciitis. | Plantar fasciitis study:
• Average reported pain reduction (day 1 AM to day 7 AM VAS) for the treatment group was 40%, compared to 7% for the control group. |
  | Safety | No significant adverse events related to the device. | Osteoarthritis of the knee study: No adverse events were recorded.
  Plantar fasciitis study: Primary safety endpoint was all treatment-related adverse events; the document does not explicitly state if any were recorded but implies a positive safety profile through the "safe and effective as its predicate devices" conclusion. |
  | Usability (OTC Use) | Lay users must understand how to use the device safely and effectively for pain relief in the specified indications. | Usability testing:
• 46 men and women (age >17, wide education levels) demonstrated understanding of indications for use, contraindications, how to turn on, correct placement, and duration of use. |
  | Non-Clinical Performance | Conformity to relevant electrical safety, electromagnetic compatibility, and biocompatibility standards. Performance as intended under anticipated conditions of use regarding output power, pulse characteristics, absorption rates, and electromagnetic fields. | Non-Clinical/Performance Data:
• Conformed to IEC/EN 60601-1-2:2012, IEC 60601-1:2005+A1:2012, EN 60601-1:2006.
• Biocompatibility testing (ISO 10993-10:2010 for sensitization and irritation, ISO 10993-5:2009 for cytotoxicity) showed no evidence of sensitization, irritation, or in vitro cytotoxicity.
• Special controls testing (per October 13, 2015 Final Reclassification Order) demonstrated intended performance, characterizing peak output power, pulse characteristics, duty cycle, average output power, specific absorption rates, and electrical/magnetic fields in a saline gel test load. |

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

• Osteoarthritis of the knee study:
  • Sample size: 66 intent-to-treat patients, with 60 patients completing the four-week study.
  • Data Provenance: Not explicitly stated (e.g., country of origin, specific locations), but described as "double-blind randomized controlled study" implying a prospective design.
• Plantar fasciitis study:
  • Sample size: 70 patients completed the study.
  • Data Provenance: Described as "double-blind, multicenter, randomized, placebo-controlled study," implying a prospective design. Country of origin not specified.
• Usability testing:
  • Sample size: 46 men and women.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but the description ("These subjects demonstrated use...") implies a prospective, interactive study.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of image interpretation or diagnostic accuracy studies. The clinical studies evaluated patient-reported outcomes (VAS and WOMAC scores) and adverse events, which are direct measures from the participants themselves, rather than interpretations by experts.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document describes the clinical studies as "double-blind and placebo-controlled randomized controlled trials." This implies that blinding was used for both participants and researchers/assessors regarding treatment allocation. However, it does not specify an adjudication method for outcome measures like VAS or WOMAC scores, which typically do not require such adjudication as they are direct patient responses. For adverse events, it states "No adverse events were recorded" for the knee study; the method for reviewing or adjudicating AEs in the plantar fasciitis study is not detailed beyond "primary safety endpoint was all treatment-related adverse events."

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 ActiPatch® is a physical medical device for pain relief, not an AI or imaging interpretation device that would typically involve human readers.

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

Not applicable. The ActiPatch® is a physical device, not an algorithm. Its performance is inherent in its physical and electrical characteristics and its interaction with the patient's body. The clinical studies evaluate the device's effect directly on patients.

7. The Type of Ground Truth Used

For the clinical studies, the "ground truth" was primarily based on patient-reported outcomes:

• Pain levels: Measured using validated scales like the Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores.
• Adverse events: Self-reported by patients or observed during the study.

For usability testing, the "ground truth" was established by observing lay user comprehension and ability to perform tasks (turn on, place correctly, understand indications/contraindications).

For non-clinical testing, the "ground truth" was conformance to established engineering and biological standards (e.g., IEC, ISO standards for electrical safety, biocompatibility, and specific power output measurements).

8. The Sample Size for the Training Set

The document does not describe the use of a "training set" as it would for an algorithm or AI model development. The clinical studies described are for evaluating the final device's performance, not for training a model.

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

Not applicable, as no training set was explicitly mentioned or used in the context of algorithm development. The document describes clinical trials and usability studies of a physical medical 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.

Ask a specific question about this device