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The DEKA PHYSIQ 360 is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs, in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

The PHYSIQ 360 is a diode laser device. The device is provided with:

• Up to 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).
• An LCD control panel with touch-screen technology provides information on the status and settings of the PHYSIQ 360 device to input commands into the system.
• One wavelength, 1060 ±20 nm (infrared)
  The PHYSIQ 360 electrical specifications are: 115-230V~ single phase, 50/60Hz, 1200VA (max)

This document is a 510(k) summary for the DEKA PHYSIQ 360 device, a diode laser intended for non-invasive lipolysis. It focuses on demonstrating substantial equivalence to a predicate device (Sculpsure K171992) rather than presenting a study proving that the device meets specific acceptance criteria related to a diagnostic or AI-driven performance.

Therefore, the requested information, such as acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for a diagnostic device), clinical study data to demonstrate that the device meets these criteria, sample sizes for test sets, expert involvement in ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document.

This document primarily relies on the comparison to a predicate device and non-clinical performance data (electrical safety, EMC, software validation) to demonstrate substantial equivalence, rather than new clinical efficacy or performance studies with specific acceptance criteria that would typically be associated with AI/diagnostic devices.

Here's why the requested information isn't present in this specific type of document:

• Device Type: The DEKA PHYSIQ 360 is a laser for aesthetic use (non-invasive lipolysis). Its clearance is based on demonstrating that it is substantially equivalent to an existing legally marketed predicate device, not on demonstrating a specific diagnostic performance or AI-driven capabilities.
• 510(k) Pathway: The 510(k) premarket notification pathway often relies on comparison to a predicate device and non-clinical testing rather than extensive new clinical studies, especially if the new device has the same technological characteristics and similar indications for use as a cleared predicate.
• "Clinical Performance Data: None": As explicitly stated in the document, no clinical performance data was submitted. This confirms that a study of the type you're asking about (with performance metrics against acceptance criteria) was not part of this submission.
• Focus on Substantial Equivalence: The primary objective of this 510(k) summary is to argue that the DEKA PHYSIQ 360 is "as safe, as effective, and performs as well as the legally marketed predicate device." This is achieved by showing identical or substantially similar technological characteristics and indications for use, and by providing non-clinical safety testing.

In summary, based on the provided document, I cannot fulfill your request for acceptance criteria and a study proving the device meets them, because this type of information is not included in this 510(k) summary for the DEKA PHYSIQ 360.

The document details:

• Non-Clinical Performance Data:
  • Electrical safety and electromagnetic compatibility (EMC) testing based on ANSI AAMI ES60601-1 and IEC 60601-1-2.
  • Software Validation and Verification Testing as per FDA guidance.
  • Additional non-clinical testing per IEC 60601-2-22 and IEC 60825-1.

These non-clinical tests ensure device safety and functionality but are not "performance data" in the sense of diagnostic accuracy or clinical efficacy against specific statistical acceptance criteria for a human performance or AI-driven system.

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Intended Use:

The PHYSIQ device is intended in EMS mode for:

Prevention or retardation of disuse atrophy Maintaining or increasing range of motion Muscle re-education Relaxation of muscle spasms Increasing local blood circulation Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

and in TENS mode for:

Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain

The PHYSIQ is a device provided with 4 handpieces by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.

The PhysiQ consists of :

• an AC/DC power supply unit,
• EMS/TENS driving electronic board
• CPU controller; ●
• user interface with LCD touch screen, . ●
• 4 EMS/TENS handpieces with interconnecting cables ●

EMS or TENS treatment is enabled at the same time on all 4 handpieces. The operator can choose how many handpieces to use and leave the unused ones in the proper holder.

Through the handpieces the electrical energy is delivered to the patient, which repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area.

During TENS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes which are in contact with the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

During EMS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes in contact with the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms, prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.

Handpieces are directly applied on the area to be treated, such as-upper and lower back, abdomen, legs and arms.

The user interface allows to fully control the treatment parameters. The operator can manage Electro Muscle Stimulation (EMS) or Transcutaneous Electrical Nerve Stimulation (TENS) (OFF or ON from 1 to 50, with selection step of 1).

Treatment time can be changed regardless of the suggested one.

The provided text describes a 510(k) premarket notification for the PHYSIQ device, which is a powered muscle stimulator and transcutaneous electrical nerve stimulator. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on non-clinical performance data rather than extensive clinical studies with acceptance criteria based on patient outcomes.

Therefore, the acceptance criteria and study detailed below will focus on the non-clinical performance benchmarks used to establish substantial equivalence with the predicate device, rather than clinical performance metrics typically found in efficacy trials.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the PHYSIQ device are based on demonstrating similar performance characteristics to its predicate device, The InMode System with Tone Applicator (K192249), and compliance with relevant safety standards. The reported device performance aligns with these criteria.

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The physIQ Heart Rhythm and Respiration Module (Version 3.0) is intended for use by a physician or other qualified medical professionals for the calculation of heart rate variability, the detection of atrial fibrillation and determination of respiration rate using ambulatory ECG and triaxial accelerometer data. The physIQ Heart Rhythm and Respiration Module is intended to be integrated by the customer organization into an end-to-end system (biosensor data collection to clinician display).

The physIQ Heart Rhythm and Respiration Module may only be used with FDA-cleared, chest-worn biosensors using "wet electrode" technology that capture single-lead digital ECG data at 125Hz or higher and integrated triaxial accelerometer data at 15Hz or higher and that are recorded in a compatible format for analysis.

The physIQ Heart Rhythm and Respiration Module is for use in adult patients in subacute clinical settings for remote patient monitoring. The physIQ Heart Rhythm and Respiration Module is not for use in patients requiring life-supporting or life-sustaining systems or as ECG or respiration alarm devices.

The physIQ Heart Rhythm and Respiration Module (Version 3.0) is a computerized all-software callable function library in the Python programming language that is designed for calculating heart rate and heart rate variability and for detecting atrial fibrillation and determining respiration rate determined by automated analysis of any single electrocardiogram (ECG) channel collected by commercially-available ECG biosensor devices with triaxial accelerometers. The physlQ Heart Rhythm and Respiration Module (3.0) will be integrated by the customer organization into an end-to-end system (biosensor data collection to clinician display) that makes calls into the product, most typically via a Python middleware script. The "middleware" accesses the source ECG and triaxial accelerometer data from a customer's data collection system, most likely via its own application programming interface (API), and makes calls to the physIQ Heart Rhythm and Respiration Module (3.0) to input ECG and triaxial accelerometer data for processing into the vital sign outputs of the product. These outputs are returned to the middleware, which may insert these results into a downstream monitoring system for clinical use.

The provided text describes the physIQ Heart Rhythm and Respiration Module (Version 3.0) and its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria and detailed study information requested in the prompt.

The document states that "performance testing demonstrates that the physIQ Heart Rhythm and Respiration Module (3.0) meets its intended use and any differences in technological characteristics between the physIQ Heart Rhythm and Respiration Module (3.0) and the predicate device do not raise any new issues and is substantially equivalent to the predicate device."

It also mentions that "Performance testing following guidelines of ANSI/AAMI EC572012: Testing and Reporting Performance Results of Cardiac Rhythm and ST segment Medsurement Algorithms was applied to heart rate variability, and atrial fibrillation algorithms in a previous Traditional 510(k) submission for the physIQ Heart Rhythm and Respiration Module (K183322) predicate device." and that "In this submission, performance of all algorithms including Heartbeat Detector, Heart Rate, Heart Rate Variability, Atrial Fibrillation, and Respiration Rate have been repeated and evaluated using the modified technology. The respiration rate algorithm met its corresponding acceptance criteria and performed comparably to the predicate device."

Based on the provided text, I cannot extract the following information:

• A table of acceptance criteria and the reported device performance. While it mentions that algorithms met acceptance criteria, the specific criteria and reported values are not present.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. (It implies standalone testing as it refers to algorithm performance, but doesn't explicitly state it or provide details).
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

Therefore, I can only provide the information that is explicitly stated or strongly implied from the text:

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

• Not explicitly provided. The document states that the respiration rate algorithm met its corresponding acceptance criteria and performed comparably to the predicate device. However, the specific numerical criteria for heart rate variability, atrial fibrillation, and respiration rate, and the reported performance metrics, are not included in this document.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not specified.

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

• Not specified.

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 mentioned. The document focuses on the algorithm's performance and substantial equivalence, not human-AI collaboration.

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

• Implied yes. The document repeatedly refers to the "performance of all algorithms" and the "physIQ Heart Rhythm and Respiration Module (3.0)" in isolation, suggesting standalone algorithm testing was performed to assess its functionality and accuracy.

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

• Not specified.

8. The sample size for the training set

• Not specified.

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

• Not specified.

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The physIQ Heart Rhythm and Respiration Module (Version 2.0) is intended for use by a physician or other qualified medical professionals for the calculation of heart rate variability, the detection of atrial fibrillation and determination of respiration rate using ambulatory ECG and triaxial accelerometer data. The physIQ Heart Rhythm and Respiration Module supports receiving and analyzing single-lead ECG signals recorded in a compatible format from FDA-cleared ECG biosensor devices using "wet" electrode technology and triaxial accelerometers when assessment of rhythm and respiration rate is desired. The physIQ Heart Rhythm and Respiration Module is for use in adult patients in subacute clinical and nonclinical settings for remote patient monitoring. The physIQ Heart Rhythm and Respiration Module is not for use in patients requiring life-supporting or life-sustaining systems or as ECG or respiration alarm devices.

The physIQ Heart Rhythm and Respiration Module (Version 2.0) is a computerized all-software callable function library in the Python programming language that is designed for calculating heart rate and heart rate variability and for detecting atrial fibrillation and determining respiration rate determined by automated analysis of any single electrocardiogram (ECG) channel collected by commercially-available ECG biosensor devices with triaxial accelerometers. The physIQ Heart Rhythm and Respiration Module will be integrated by the customer organization into an end-to-end system (biosensor data collection to clinician display) that makes calls into the product, most typically via a Python middleware script. The "middleware" accesses the source ECG and triaxial accelerometer data from a customer's data collection system, most likely via its own application programming interface (API), and makes calls to the phys/Q Heart Rhythm and Respiration Module to input ECG and triaxial accelerometer data for processing into the vital sign outputs of the product. These outputs are returned to the middleware, which may insert these results into a downstream monitoring system for clinical use.

The physIQ Heart Rhythm and Respiration Module (Version 2.0) was assessed for its performance in calculating heart rate variability, detecting atrial fibrillation, and determining respiration rate. The study followed guidelines of ANSI/AAMI EC57-2012 for heart rate variability and atrial fibrillation, while respiration rate was evaluated using internal acceptance criteria and comparison to a predicate device due to a lack of FDA-recognized consensus standards.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample size for the test set used for the respiration rate algorithm or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "performance validation was performed using clinical and bench testing."

For heart rate variability and atrial fibrillation, performance testing followed ANSI/AAMI EC57-2012 guidelines in a previous submission (K180234), but the specific sample size and provenance for that previous test are not detailed in this document.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method:

The document does not specify the adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The document does not mention if an MRMC comparative effectiveness study was done or the effect size of human readers' improvement with AI vs. without AI assistance. The device is a "computerized all-software callable function library" and its output is intended for use by medical professionals, suggesting it's an assistive tool, but a comparative effectiveness study with human readers is not detailed.

6. Standalone Performance:

Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted. The "Performance Testing" section states that the device contains "a collection of algorithms intended to be applied to ECG data." The validation was performed on these algorithms, and the results were compared to acceptance criteria.

7. Type of Ground Truth Used:

The type of ground truth used is not explicitly stated. However, for heart rate variability and atrial fibrillation, the reference to ANSI/AAMI EC57-2012 suggests established standards and potentially expert consensus or validated physiological measurements for ground truth. For respiration rate, it was compared to "internal acceptance criteria" and a "predicate device," implying a form of reference standard or clinical gold standard might have been used for the internal criteria.

8. Sample Size for Training Set:

The document does not provide the sample size used for the training set.

9. How Ground Truth for Training Set Was Established:

The document does not provide information on how the ground truth for the training set was established.

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The physlQ Heart Rhythm Module is intended for use by a physician or other qualified medical professionals for the calculation of heart rate and heart rate variability and the detection of atrial fibrillation using ambulatory ECG data. The physlQ Heart Rhythm Module supports receiving and analyzing single-lead ECG signals recorded in a compatible format from FDA-cleared ECG biosensor devices using "wet" electrode technology when assessment of rhythm is desired. The phys\Q Heart Rhythm Module is for use in subacute clinical settings for remote patient monitoring. The physlQ Heart Rhythm Module is not for use in patients requiring or life-sustaining systems or ECG Alam devices.

The physIQ Heart Rhythm Module (Version 1.0) is a computerized all-software callable function library in the Python programming language that is designed for calculating heart rate and heart rate variability and for detecting atrial fibrillation determined by automated analysis of any single electrocardiogram (ECG) channel collected by commercially-available ECG biosensor devices. This Heart Rhythm Module will be integrated by the customer organization into an end-to-end system (biosensor data collection to clinician display) that makes calls into the product, most typically via a Python middleware script. The "middleware" accesses the source ECG data from a customer's data collection system, most likely via its own application programming interface (API), and makes calls to the physIQ Heart Rhythm Module to input ECG for processing into the vital sign outputs of the product. These outputs are returned to the middleware, which may insert these results into a downstream monitoring system for clinical use.

Here's an analysis of the acceptance criteria and supporting studies for the physIQ Heart Rhythm Module (Version 1.0), based on the provided FDA 510(k) document:

phyIQ Heart Rhythm Module (Version 1.0) Acceptance Criteria and Performance

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that "Performance testing following guidelines of ANS/AAMI EC572012: Testing and Reporting Performance Results of Cardiac Rhythm and ST segment Measurement Algorithms has been applied to each of the algorithms. The performance testing results for all algorithms were compared to physIQ's defined acceptance criteria for performance testing. All algorithms met their corresponding acceptance criteria."

However, the specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for each algorithm (Heartbeat Detector, Heart Rate, Heart Rate Variability, and Atrial Fibrillation Detector) are not explicitly detailed in the provided text. Similarly, the exact reported performance metrics (e.g., the achieved sensitivity/specificity values) are also not provided in a summarized table within this document. The document only confirms that "All algorithms met acceptance criteria."

Therefore, an exact table with numerical acceptance criteria and reported performance cannot be generated from the given text.

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

The document states:
"further supportive clinical validation testing of the physIQ Heart Rhythm Module was performed using electrocardiography (ECG) signals captured from ambulatory patients using a wearable single-lead biosensor device which were annotated by medical experts in cardiology."

• Sample Size for Test Set: Not explicitly stated. The document only refers to "ambulatory patients" without specifying the number of patients or the duration/amount of ECG data.
• Data Provenance: The ECG signals were "captured from ambulatory patients" using two commercially available FDA-cleared patches: HealthPatch (K152139) manufactured by VitalConnect Inc. and BodyGuardian (K121197; K151188) manufactured by Preventice Inc. The country of origin of the data is not specified, but the use of FDA-cleared devices typically implies data collected in regions where such devices are marketed, often the US. The data appears to be retrospective, as it was "captured from ambulatory patients" and then annotated.

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

• Number of Experts: Not explicitly stated. The document mentions "medical experts in cardiology."
• Qualifications of Experts: They were described as "medical experts in cardiology." Specific experience level (e.g., "10 years of experience") is not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document only says the data was "annotated by medical experts in cardiology." It does not specify if multiple experts independently annotated and then reached consensus, or if a single expert provided the ground truth, or if a specific adjudication process (like 2+1 or 3+1) was used.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or described in the provided text. The testing focused on the standalone performance of the algorithm against expert annotations.
• Effect Size of Human Improvement with AI Assistance: Not applicable, as no MRMC study was described.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• Standalone Performance: Yes, a standalone performance evaluation was conducted. The document states: "this testing did not use any patch-generated vitals, but instead compared physIQ Heart Rhythm Module outputs to annotations by cardiology experts using ECG captured from two commercially-available patches..." This indicates the algorithm's output was directly compared to the expert-derived ground truth without human intervention in the device's output.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert Consensus (or Expert Annotation). The document explicitly states the ECG signals were "annotated by medical experts in cardiology."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not mentioned in the provided text. The document focuses on the performance testing and clinical validation rather than the development and training details of the algorithms.

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

• Ground Truth for Training Set: Not mentioned in the provided text. As with the training set size, the document does not delve into the methodology for establishing ground truth for any training data used for the algorithms.

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Permanent pacing lead, Model Physique™ is indicated for pacing and sensing of the ventricle and/or atrium of the heart. This lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

Permanent Pacing Lead, Model Physique™

The provided text is a 510(k) clearance letter from the FDA for a medical device: a Permanent Pacing Lead, Model Physique™. This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The letter explicitly states that the device is approved based on its substantial equivalence to a legally marketed predicate device. This means that the FDA reviewed existing data and information for similar devices already on the market and determined that the new device is as safe and effective as those already approved.

Therefore, I cannot provide the requested information from this document. The document's purpose is to grant marketing clearance, not to detail the specific studies and acceptance criteria for product development and validation.

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