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BTL-99-OC is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The BTL-99-OC is a non-invasive therapeutic device that produces and delivers magnetic field to induce electrical currents targeting specific regions of the human cerebral cortex. BTL-99-OC consists of a main unit and applicator(s). The main unit consists of a master unit and a generator unit. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information quides the Operator through the entire therapy procedure. The therapeutic parameters are set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device functions with: M1 figure-of-8 coil applicator. The therapy is provided with the applicator attached to the applicator arm. The BTL-99-OC composed of stimulation generator and stimulation coil. The stimulation generator is driven by software, which the operator controls through the GUI and contains a high voltage energy storage capacitor charging and discharging system, a power supply and a microcomputer control system. The software capabilities for administering treatment in the subject device are the comparable to these in the predicate devices. The stimulation coil is composed of a stimulation coil, an air forced cooling system and an applicator holder. The main unit BTL-99-OC with the M1 coil is intended to be used for both - MT threshold estimation and subsequent application of OCD therapy.

The provided text is a 510(k) summary for the BTL-99-OC device, which is a transcranial magnetic stimulation (TMS) system intended as an adjunct treatment for Obsessive-Compulsive Disorder (OCD). The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MagVenture TMS Therapy system - K193006) and a reference device (BTL-995-rTMS - K212723), rather than presenting a performance study with specific acceptance criteria and detailed findings from a clinical trial.

Therefore, the document does NOT contain the information needed to fill out a table of acceptance criteria and reported device performance based on clinical study outcomes, nor does it detail a study structure that includes sample sizes for test sets, data provenance, expert consultation for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The provided text mostly describes:

• The device's intended use and technical characteristics.
• Comparisons of the BTL-99-OC with its predicate and reference devices, primarily focusing on physical and electrical parameters (e.g., magnetic field intensity, coil parameters, electrical safety compliance) to establish technical substantial equivalence.
• Compliance with electrical safety, software lifecycle, and risk management standards (IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971).
• Bench testing results comparing induced fields in a phantom head, showing values are substantially equivalent within a certain range.

In summary, there is no information in the provided document about a clinical study that proves the device meets specific acceptance criteria related to its clinical efficacy or performance in diagnosing/treating OCD. The substantial equivalence is argued based on technological similarities and adherence to safety standards.

Therefore, I cannot populate the requested table or describe the study details as they are not present in this 510(k) summary.

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BTL-899F is indicated to be used for:

• Non-invasive lipolysis (breakdown of fat) of the abdomen.
• Reduction in circumference of the abdomen.
• Non-invasive lipolysis (breakdown of fat) of the thighs.
• Reduction in circumference of the thighs.
• BTL-899F is intended for use with skin types I VI.
• Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I IV.
• Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.

The BTL-899F is a non-invasive therapeutic device.
BTL-899F consists of a main unit and applicators. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device is equipped with an emergency button to terminate the therapy. The two outputs (applicators) of the device enable hands-free simultaneous treatment.

The provided text describes a 510(k) premarket notification for the BTL-899F device, a non-invasive therapeutic device intended for lipolysis and circumference reduction in various body areas. The submission aims to demonstrate substantial equivalence to a predicate device (BTL-899A).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 55 subjects were enrolled in the study. 51 participants attended the final 3-month follow-up. The performance metrics are based on these 51 participants.
• Data Provenance: The document does not explicitly state the country of origin for the data. It is a clinical investigation conducted by BTL Industries Inc., a company with a Marlborough, Massachusetts address. The study design is described as single-arm, open-label, and interventional, indicating it was a prospective study.

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

• Number of Experts: Three independent blinded evaluators were used to assess the pre- and post-treatment images.
• Qualifications of Experts: The document does not specify the qualifications (e.g., radiologist with years of experience) of the evaluators. They are simply referred to as "independent blinded evaluators."

4. Adjudication Method for the Test Set

• The acceptance criterion for image identification was "at least two of three independent blinded evaluators." This implies a 2 out of 3 consensus or similar majority-based adjudication method for image recognition. The exact adjudication method for other observations (e.g., fat thickness measurement, side effect assessment) is not explicitly detailed, but the fat thickness reduction seems to be a measured outcome, not subjected to expert adjudication in the same way.

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 involving human readers assisting with or without AI was not conducted. This study's primary focus was on the device's direct effect on fat thickness and subjective patient outcomes, with independent evaluators assessing before/after images. The device itself is a therapeutic device, not an AI diagnostic tool.

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

• This device is a therapeutic device (electrosurgical cutting and coagulation device) that performs non-invasive lipolysis. It is not an AI algorithm in the context of image analysis or diagnostic support. Therefore, a "standalone algorithm performance" evaluation as typically understood for AI software was not applicable and not performed. The device's performance is driven by its physical application and effect.

7. The Type of Ground Truth Used

• The ground truth for the primary objective (fat thickness reduction) was based on objective measurements (ultrasound).
• For the secondary objectives:
  • Safety was assessed through clinical observation and patient reporting of adverse events.
  • Image evaluation involved a form of expert consensus (at least 2 out of 3 independent blinded evaluators).
  • Patient satisfaction and comfort were based on patient-reported outcomes.

8. The Sample Size for the Training Set

• The document does not describe a separate "training set" in the context of an AI model. The clinical investigation appears to be a single study evaluating the device's performance. The device is a physical therapeutic device, not a software algorithm that would typically undergo a separate training phase with a distinct dataset.

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

• As there is no mention of a separate training set for an AI model, this question is not applicable based on the provided document. The device's validation is based on the clinical investigation described for its performance.

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The BTL-785BNF Handpiece device has the following indications for use: The device is indicated for aesthetic use including facial and neck stimulation or body skin stimulation.

The BTL-785BNF Handpiece is a state-of-the-art electrostimulation device that enables the application of therapy by an electromagnetic field. The subjected device is intended to be used together with a main control unit that is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The BTL-785BNF Handpiece is a specially developed device that can be used with the applicators and the main control unit. The generated electromagnetic field is interact with the tissues of the human body in order to achieve neuro-muscle stimulation. The radiofrequency is providing a low degree of warming to enhance the patient's comfort during the treatment. The BTL-785BNF Handpiece consists of the following main components: BTL-785BNF Handpiece, Single-use application electrodes, Holding arm, Connection cables, Therapy discomfort button.

This document, primarily a 510(k) summary for the BTL-785BNF Handpiece, does not contain information about acceptance criteria for a device's performance in a clinical study, nor does it describe a study that explicitly proves the device meets specific acceptance criteria. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance metrics against pre-defined acceptance criteria from a clinical trial.

However, it does provide information about non-clinical testing performed to establish safety and compliance with relevant standards, which can be thought of as a form of "acceptance criteria" for safety.

Here's a breakdown of the requested information based on the provided text, noting where information is explicitly stated or absent:

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

   • Not explicitly provided in the context of clinical performance. The document states, "A clinical study was not conducted."
   • The document does list compliance with voluntary standards as a form of performance or acceptance criteria for safety. The reported device performance is that it "has been found to comply with applicable medical device safety standards."

   Acceptance Criteria (Safety Standards)	Reported Device Performance (Compliance)
   IEC 60601-1 (Basic safety & essential performance)	Complies
   IEC 60601-1-2 (EMC)	Complies
   IEC 60601-2-10 (Nerve & muscle stimulators)	Complies
   IEC 60601-1-6 (Usability)	Complies
   IEC 62304 (Software life cycle)	Complies
   ISO 14971 (Risk management)	Complies
   ISO 10993-1 (Biological evaluation)	Complies
   ISO 10993-5 (In vitro cytotoxicity)	Complies
   ISO 10993-10 (Irritation & sensitization)	Complies

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

   • Not applicable. The document explicitly states, "A clinical study was not conducted." Therefore, there is no test set in the traditional sense of a clinical trial. The "test set" for substantiating safety and performance was the device itself subjected to non-clinical laboratory testing against international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. No clinical study was conducted. The "ground truth" for the non-clinical tests would be the specifications and requirements of the referenced international safety standards. These do not involve human experts establishing ground truth in the context of interpreting clinical outcomes.

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

   • Not applicable. No clinical study was conducted. Adjudication methods are typically relevant in clinical trials for resolving disagreements among readers or evaluators of clinical data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • No. This document is for a physical medical device (Transcutaneous Electrical Nerve Stimulator) and not an AI-assisted diagnostic or predictive device. Therefore, an MRMC study and AI assistance are not relevant here.

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

   • Not applicable. This device is not an algorithm; it is a physical electrostimulation device.

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

   • For the non-clinical safety and performance aspects, the "ground truth" would be the requirements and specifications outlined in the international consensus standards (e.g., IEC 60601-series, ISO 14971, ISO 10993-series). The device was tested to demonstrate compliance with these standards.

8. The sample size for the training set

   • Not applicable. No clinical study was conducted, and this is not an AI/algorithm-based device that would typically involve a "training set."

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

   • Not applicable. As above, no training set for an AI/algorithm was used or established.

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The BTL-785X device has the following indications for use:

The BTL-785X with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BTL-785X with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785X with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785-4 with BTL-785-4 applicator used with tips BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785X device used with tips BTL-785-4-4, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.

The BTL-785X with BTL-785-7 hands-free applicator used with forehead BTL-785-7-1 and cheek BTL-785-7-2 singleuse electrodes is intended to provide:

• heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

• non-invasive temporary reduction of facial wrinkles

The BTL-785X is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field.

The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785X device comes with five different types of applicators.

The BTL-785X device consists of the following main components:

• microprocessor-driven control unit
• radiofrequency generator
• user interface with 15.6" color touch screen
• applicators for an application of radiofrequency
• exchangeable applicator tips

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided document:

Acceptance Criteria and Device Performance

The core acceptance criterion for the new indication (non-invasive temporary reduction of facial wrinkles) of the BTL-785X with the BTL-785-7 hands-free applicator was based on a statistically significant reduction in wrinkle severity.

Secondary Acceptance Criteria and Device Performance:

Study Details

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

• Sample Size: N = 42 subjects completed all study treatments and follow-up visits.
• Data Provenance: The study was conducted at a "single site." The document does not specify the country of origin, but given the applicant and sponsor are based in Marlborough, Massachusetts, USA, it is likely a US-based study. The study design is classified as "interventional," indicating prospective data collection.

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

• Number of Experts: 3 blinded dermatologists.
• Qualifications: The document identifies them as "blinded dermatologists." Specific years of experience or other additional qualifications are not provided.

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

• The primary efficacy outcome measure required at least 2 out of 3 blinded dermatologists to agree on a statistically significant reduction of at least 1.0 score in the FWES scale. This indicates an adjudication method, where a simple majority (2 out of 3) determined the positive outcome.

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 involving AI assistance for human readers was not conducted. This study focused on the standalone performance of the device in reducing wrinkles, with dermatologists assessing the outcome.

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

• This question is not applicable in the context of the provided document. The device is a radiofrequency system with applicators for therapeutic use, not an AI-driven algorithm for image analysis or diagnosis. The performance related to "non-invasive temporary reduction of facial wrinkles" was evaluated in human subjects.

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

• Expert Consensus: The primary ground truth for wrinkle reduction was established by expert consensus, specifically the assessment of 3 blinded dermatologists using the Fitzpatrick Wrinkle and Elastosis Scale (FWES).
• Outcomes Data: Patient satisfaction and adverse events were also collected as outcomes data.

8. The sample size for the training set:

• The document describes a clinical study to demonstrate the performance, efficacy, and safety of the device for a new indication. This is a validation study (test set), not a training set for an algorithm. Therefore, there is no information about a separate training set.

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

• As mentioned above, there is no description of a training set for an algorithm in this document, so this question is not applicable.

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BTL-094 is indicated to be used for:

• Relief of minor muscle aches and pains.
• Temporary increase in local blood circulation.
• Activation of connective tissue.

The BTL-094 is a non-invasive therapeutic device, which uses acoustic waves in order to stimulate a local biological response in the treated tissue.

The BTL-094 generates extracorporeally induced massage pulses to stimulate a local biological response in the treated tissue. The main source of acoustic waves is a piezo transducer inside the applicator. The energy transfer from the piezo transducer to the treated tissue is realized via coupling pad.

The main unit is equipped with a color touch screen, which considerably simplifies its operation. The onscreen information guides the user step through the entire therapy process. A secondary screen is placed on the applicator for the presentation of the actual state of main therapy parameters. The therapeutic parameters are adjustable via touch-screen, buttons and knob. The user is able to set following therapy parameters: intensity, frequency and number of shocks.

The provided text describes a 510(k) premarket notification for the BTL-094 therapeutic massager, which is a Class I device. The focus of the document is to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than establishing new performance criteria through a clinical study. Therefore, a direct 'acceptance criteria' and 'reported device performance' based on a clinical study for the BTL-094 device itself are not applicable as per the document.

The document explicitly states: "Clinical Testing: Not applicable" on page 5. This indicates that no clinical study was performed or required for this 510(k) submission to assess the device's performance against specific acceptance criteria.

Instead of a clinical study, the submission relies on demonstrating that the BTL-094 device has "technological characteristics" (on pages 6-11) that are substantially equivalent to those of two predicate devices: D-Actor 200 (K173692) and DolorClast® Radial (K220538). The "acceptance criteria" in this context are implicitly that the technological characteristics of the BTL-094 are comparable enough to the predicates that they do not raise new questions of safety or effectiveness.

Here's an analysis based on the information provided, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical study was conducted for the BTL-094 to establish new acceptance criteria and measure its performance against them, a direct table for this is not available in the document. The acceptance for this submission is based on the comparison of the BTL-094's technological characteristics to those of the predicate devices. The table below summarizes key comparative information presented in the document, which serves as the basis for the declaration of substantial equivalence.

Comparison of BTL-094 to Predicate Devices (Basis for Substantial Equivalence)

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

Not Applicable. As stated, "Clinical Testing: Not applicable." No test set of patient data was used for a clinical study to prove the device meets acceptance criteria. The submission relies on non-clinical testing (safety and performance standards, biocompatibility) and a comparison of technological characteristics to existing predicate devices.

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

Not Applicable. No clinical test set requiring expert ground truth establishment was used.

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. The device is a therapeutic massager, not an AI-assisted diagnostic tool.

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

Not Applicable. The device is a physical therapeutic massager, not an algorithm.

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

Not Applicable. No clinical performance study was conducted that would require a ground truth based on patient data. The "ground truth" for this 510(k) submission, in a broad sense, is the demonstration of adherence to recognized safety standards and the established safety and effectiveness profiles of the legally marketed predicate devices through a comparison of technological attributes.

8. The sample size for the training set

Not Applicable. No training set of data was used, as no artificial intelligence or machine learning component is described for this device.

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

Not Applicable. There was no training set mentioned in the provided document.

In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence based on non-clinical testing (compliance with recognized safety and performance standards like IEC 60601 series and ISO 14971/10993 for electrical safety, EMC, usability, and biocompatibility) and a detailed comparison of the device's technological characteristics to those of two legally marketed predicate devices. The absence of clinical testing is explicitly stated, indicating that the FDA determined it was not necessary for this type of device and submission pathway.

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The BTL-785W device has the following indications for use:

The BTL-785W with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BTL-785W with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785W with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The Applicator BTL-785-4 of BTL-785W device used with tips BTL-785-4-1, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostass. The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.

The BTL-785-7 hands-free applicator of BTL-785W used with BTL-785-7-1, BTL-785-7-2, BTL-785-7-3 and BTL-785-7-4, BTL-785-7-5, BTL-785-7-6 single use electrodes is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785W is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field. The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785W device comes with five different types of applicators. The BTL-785W device consists of the following main components: microprocessor-driven control unit, radiofrequency generator, user interface with 15.6" color touch screen, applicators for an application of radiofrequency, exchangeable applicator tips.

The provided document is a 510(k) summary for the BTL-785W device, an electrosurgical cutting and coagulation device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data related to electrical safety and the ability to achieve and maintain superficial skin temperature.

Therefore, the document DOES NOT describe a study that involves ground truth establishment by experts, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance for AI/ML-based medical devices.

Instead, the "Performance Data" section (page 7) details a series of compliance tests against various IEC and ISO standards related to electrical safety, electromagnetic disturbances, biological evaluation, and sterility, and non-clinical performance for the new applicator.

Given the information in the document, it's impossible to fill out the requested table and answer the questions related to AI/ML device testing criteria (sample sizes for test/training sets, expert ground truth, adjudication, MRMC studies, standalone performance), as these types of studies were not conducted or reported for this device.

Here's what can be extracted and inferred from the document based on the prompt's categories, with significant portions marked as 'N/A' due to the nature of the device and testing described:

Acceptance Criteria and Device Performance (Based on provided information)

Detailed Answers to Specific Questions:

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

• (Provided above)

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

• Test set/Study Type: The performance data primarily refers to compliance with safety standards (IEC, ISO) and internal non-clinical testing for the new applicator's ability to achieve and maintain target temperature. This is not a typical "test set" in the context of AI/ML or clinical efficacy studies with human subjects.
• Sample Size: Not specified for any particular test. Compliance with standards typically involves engineering tests, material tests, and functional tests on device prototypes or production units, not a "sample size" of patient data. For the BTL-785-7 applicator, it states "internal tests" were done, but no number of subjects or runs is provided.
• Data Provenance: Not specified. "Internal tests" suggests in-house testing by the manufacturer. Retrospective/prospective is not applicable as this is not a clinical data collection study for performance.

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)

• N/A. This device and its testing do not involve establishing ground truth from expert interpretations of medical images or conditions. The "ground truth" for the performance claims would be objective measurements (e.g., temperature readings, power output, compliance with standard specifications) in a laboratory or bench testing environment.

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

• N/A. Adjudication methods are relevant for subjective human interpretations (e.g., reading medical images) where discrepancies might arise. This is not applicable to the engineering and bench tests described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• N/A. An MRMC study is relevant for AI-assisted diagnostic or interpretative devices. This document describes a radiofrequency device for therapeutic purposes, and no AI component is mentioned.

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

• N/A. This device is hardware for energy delivery, not an algorithm.

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

• Objective Measurements/Standards Compliance. For electrical safety and performance, the "ground truth" is adherence to predefined engineering specifications and regulatory standards (IEC, ISO) and the ability to physically achieve and maintain a certain temperature. This is not a disease diagnosis or outcome that would require expert consensus or pathology.

8. The sample size for the training set

• N/A. The device is not an AI/ML model and therefore does not have a "training set."

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

• N/A. This question is not applicable as there is no training set mentioned or implied for this device.

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BTL-995-rTMS is indicated to be used for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The BTL-995-rTMS is a non-invasive therapeutic device that produces and delivers magnetic field to induce electrical currents targeting specific regions of the human cerebral cortex. BTL-995-rTMS consists of a main unit and applicator(s). The main unit consists of a master unit and a generator unit. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device functions with two applicator types: figure-of-8 coil applicator and circular coil applicator. The therapy is provided with the applicator attached to the applicator arm.

The provided document is a 510(k) Summary for the BTL-995-rTMS device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results and acceptance criteria for algorithmic performance.

Based on the document, here's an analysis of the requested information:

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

The document does not explicitly state acceptance criteria for device performance in the form of metrics (e.g., sensitivity, specificity, accuracy) that would typically be associated with an AI/machine learning device. This is because the device is a therapeutic medical device (rTMS system), not a diagnostic or AI-powered analytical tool. The "performance" discussed primarily relates to electrical safety and electromagnetic compatibility.

• Acceptance Criteria (Implicit from Non-Clinical Testing): Compliance with specific international standards for medical electrical equipment.
• Reported Device Performance:
  • Electrical Safety: Complies with IEC 60601-1
  • Electromagnetic Disturbances: Complies with IEC 60601-1-2
  • Usability: Complies with IEC 60601-1-6
  • Software Life Cycle Processes: Complies with IEC 62304
  • Risk Management: Complies with ISO 14971
  • Biological Evaluation (Cytotoxicity): Complies with ISO 10993-5
  • Biological Evaluation (Irritation & Skin Sensitization): Complies with ISO 10993-10

For the therapeutic parameters, the device reports the following parameters, which are comparable to the predicate device, implying that the device "performs" by delivering these specified outputs:

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

The document explicitly states: "No clinical testing was performed for this device." Therefore, there is no test set, sample size, or data provenance to report in the context of clinical or AI performance. The evaluation was based on non-clinical (bench) testing and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical testing or AI algorithm performance evaluation was conducted, there was no ground truth to establish by experts for a test set.

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

Not applicable. No clinical testing or AI algorithm performance evaluation, so no adjudication method was used for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The BTL-995-rTMS is a therapeutic device, not a diagnostic imaging or AI assistance tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a Repetitive Transcranial Magnetic Stimulation (rTMS) system, a physical medical device, not an AI algorithm. Its function is to deliver magnetic pulses for therapeutic purposes, not to provide an independent diagnosis or analysis.

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

Not applicable in the context of AI/diagnostic evaluation. The "ground truth" for this device's performance is its compliance with safety and performance standards (bench testing) and its ability to deliver the specified therapeutic parameters as designed.

8. The sample size for the training set

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

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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BTL-899A is indicated to be used for:

Non-invasive lipolysis (breakdown of fat) of the abdomen. Reduction in circumference of the abdomen. Non-invasive lipolysis (breakdown of fat) of the thighs. Reduction in circumference of the thighs. BTL-899A is intended for use with skin type I - VI. Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.

The BTL-899A is a non-invasive therapeutic device.

BTL-899A consists of a main unit and applicators. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device is equipped with an emergency button to terminate the therapy. The two outputs (applicators) of the device enable hands-free simultaneous treatment.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the BTL-899A device:

Device: BTL-899A (Non-invasive lipolysis device)

Study Purpose: To demonstrate the effectiveness and safety of the BTL-899A device for non-invasive lipolysis of the upper arms.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size (Test Set/Clinical Study): Forty (40) participants.
• Data Provenance: Not explicitly stated, but the study was conducted by BTL Industries who are based in Marlborough, MA, USA, and the submission is for FDA clearance, implying the study was conducted in a manner acceptable for US regulatory review. The text does not specify if it was retrospective or prospective, but the description of "clinical investigation" with "follow-up intervals" and "participants received treatments" strongly suggests a prospective study.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three (3) independent blinded evaluators.
• Qualifications of Experts: Not specified. (e.g., "Radiologist with X years of experience" is not provided).

4. Adjudication Method for the Test Set

• Adjudication Method: "Correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators had to be reported." This indicates a 2-out-of-3 majority vote method for image recognition.

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

• MRMC Study Done?: No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not conducted or described. This device is a therapeutic device (non-invasive lipolysis), not an AI-powered diagnostic tool assisting human readers. The clinical study evaluated the direct effect of the device on patients.

6. Standalone Performance

• Standalone Performance Done?: Not applicable in the context of this device. This is a therapeutic device, not an AI algorithm whose standalone diagnostic performance would be measured. The primary efficacy endpoint refers to human evaluators assessing the outcome of the device treatment.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the primary efficacy endpoint was established by the consensus of three independent blinded human evaluators (at least 2 out of 3 agreeing) on pre-treatment and 3-month follow-up images, as a proxy for the device's ability to induce lipolysis.
  • For the secondary endpoint of fat thickness reduction, it implies some form of objective measurement (e.g., ultrasound, caliper measurements, or other imaging) that would be considered the ground truth, though the specific method is not detailed.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This document describes the clinical validation study of a physical therapeutic device, not the development or validation of an AI algorithm which typically involves training sets.

9. How Ground Truth for Training Set Was Established

• How Ground Truth Established: Not applicable, as there is no mention of a training set for an AI algorithm.

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BTL-899 FP is indicated to be used for:

• Non-invasive lipolysis (breakdown of fat) of the abdomen.
• Reduction in circumference of the abdomen.
• Non-invasive lipolysis (breakdown of fat) of the thighs.
• Reduction in circumference of the thighs.
• BTL-899 FP is intended for use with skin type I VI.

The BTL-899 FP is a non-invasive therapeutic device. BTL-899 FP consists of a main unit and applicator(s). The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device is equipped with an emergency button to terminate the therapy. The two outputs (applicators) of the device enable hands-free simultaneous treatment by two applicators. The system combines bipolar radiofrequency with electromagnetic stimulation.

Here's a summary of the acceptance criteria and study details for the BTL-899 FP device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for the BTL-899 FP device. Instead, it describes "endpoints" for its clinical studies focusing on safety and efficacy, which can be interpreted as the criteria for demonstrating the device's performance. The performance is compared to what was "previously evidenced" by a predicate device.

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

• Sample Size: 34 subjects with Fitzpatrick Skin Types (FST) IV-VI were recruited.
  • Specific breakdown: 9 subjects with skin type IV, 8 subjects with skin type V, and 8 subjects with skin type VI completed the treatments (25 subjects explicitly mentioned as completing, though 34 recruited).
• Data Provenance: Prospective, clinical investigations conducted in the United States of America.

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

The document does not specify the number or qualifications of experts used to establish a ground truth for the clinical endpoints (fat thickness reduction, circumference reduction, satisfaction, safety). The assessment appears to be based on direct measurements (ultrasound or MRI for fat/circumference) and patient self-reporting (Likert scale, VAS for discomfort and satisfaction). There is no mention of independent expert review of these assessments.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the clinical study results. Measurements appear to be taken directly or reported by subjects, with no indication of a separate expert review or consensus process for conflicting interpretations.

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

No, an MRMC comparative effectiveness study was not explicitly done. The study focused on the performance of the BTL-899 FP device itself, primarily comparing it to "efficacy previously evidenced" by its predicate device (K192224), rather than comparing human readers with and without AI assistance. The BTL-899 FP is a therapeutic device, not an AI diagnostic/interpretive tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable. The BTL-899 FP is a physical therapeutic device with specific operational parameters, not an algorithm, AI, or software that can operate in a standalone manner without human interaction. The "algorithm" in this context refers to the device's internal firmware controlling the treatment, not an AI for interpretation or diagnosis.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established through:

• Objective Measurements: Diagnostic ultrasound or magnetic resonance for fat tissue reduction, and abdominal circumference measurements.
• Patient-Reported Outcomes: 5-point Likert scale questionnaire and 10-point visual analogue scale (VAS) for therapy comfort and subjective satisfaction.
• Observation/Clinical Assessment: Monitoring for adverse reactions (inflammation, post-inflammatory hyperpigmentation, erythema, muscle soreness).

8. The Sample Size for the Training Set

The device is a physical therapeutic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the device's parameters comes from pre-clinical engineering, safety testing, and potentially prior clinical studies that informed the predicate device's efficacy. The document does not describe a training set for an algorithm.

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

As stated above, this question is not applicable as the device is not an AI/ML algorithm requiring a training set with established ground truth labels. The performance of the device's internal control firmware is evaluated through engineering verification and validation against safety and performance standards (e.g., IEC 60601-1, IEC 62304) and confirmed safe and effective via a clinical study with real subjects.

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