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The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.

The sam CS Long Duration Ultrasound Device consists of:

• Rechargeable Power Controller and Timer
• Ultrasound Generating Applicators
  Single use disposable accessories
• Ultrasonic Coupling Patch
  The Power Controller can be used to power the Applicator to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches.
  The sam CS Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) premarket notification summary for a medical device (sam CS Long Duration Ultrasound Device). It aims to demonstrate substantial equivalence to a predicate device (sam X1 Long Duration Ultrasound Device, K211513) to gain market clearance from the FDA.

Here's what can be extracted based on your request, highlighting the absence of specific details about acceptance criteria and a detailed study:

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

The document provides a "Substantial Equivalence Summary" (Table 1 on pages 5-6) which compares the subject device (sam CS) to the predicate device (sam X1) across various technical specifications. This table effectively serves as a comparison of performance characteristics, where "Identical" implies the sam CS meets the same reported performance as the sam X1. However, it does not explicitly state pre-defined acceptance criteria (e.g., "Device must achieve X% accuracy," or "Temperature rise must be between Y and Z degrees"). Instead, the acceptance is based on demonstrating equivalence to the predicate device.

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The sam 2.0 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, the local increase in circulation, and the relief of pain associated with limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofascial pain, and shoulder, elbow and ankle tendinopathy).

The sam 2.0 Long Duration Ultrasound Device consists of ultrasound: Power Controller, Cables, Applicators, Coupling Patches. The sam 2.0 Long Duration Ultrasound Device contains firmware for logging usage time. There is no control function of this firmware. The Power Controller and cables can be used to power one or two Applicators simultaneously to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with a onetime use Coupling Patches. The system is intended to apply ultrasonic energy for a long duration (4 hours) to generate deep heat within body tissues. The system is intended for prescription home use after proper instruction from a healthcare professional.

This document is a 510(k) Premarket Notification from ZetrOZ Systems, LLC for their sam 2.0 Long Duration Ultrasound Device. It seeks to demonstrate substantial equivalence to a previously cleared predicate device, K191568. The key aspect of this submission is an expansion of indications for use for an identical device design.

The document states that the substantial equivalence is supported by clinical performance testing which involved a systematic literature review and meta-analysis rather than a new clinical study. This means there is no traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way one would analyze a new AI medical device's performance.

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

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

The document does not present quantitative acceptance criteria in the way one would for a new AI or diagnostic device (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to the predicate device and by providing clinical evidence from published literature supporting the expanded indications.

The 'performance' is described qualitatively as "efficacy of SAM therapy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation." For the expanded indications, it is stated: "the relief of pain associated with limited mobility and function related to the soft tissue injuries that have been clinically validated include knee osteoarthritis, shoulder, elbow and ankle tendinopathy, and chronic myofascial pain."

Given that this is a K-submission for an ultrasound device with expanded indications and not a novel AI/diagnostic device, the table structure won't fit perfectly with typical AI acceptance criteria. The most relevant 'performance' is the equivalency of the device's technical specifications and the clinical efficacy of ultrasound therapy as demonstrated by the literature review.

Table of Device Comparison (as presented in the document to demonstrate equivalence):

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The PainShield MD PLUS is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.

The PainShield MD PLUS is an electrically powered ultrasonic diathermy device intended to relieve pain, muscle spasms, and joint contractures. It is used to apply deep heat to tissues in the body with a transducer/applicator that is incorporated into a bandage-like patch that adheres to the skin.

The PainShield MD PLUS is used to generate continuous wave (CW) ultrasound at 90 kHz, through a reusable applicator/transducer that covers an area of about 6 cm². The small applicators allow treatment of less accessible body parts such as, for example, the heel, the Achilles tendon and the wrist. The device includes the above-mentioned transducers with a cable which connects to a small, rechargeable, battery-powered driver unit and self-adhering patch to apply the transducer on to the skin. The unit is also supplied with a charger used for recharging the battery. Ultrasonic gel is typically not required to be used with the PainShield MD PLUS device. However, for treatment over hairy sites where there might not be adequate sonic coupling between the applicator and the skin, users are instructed to apply standard, FDA-cleared ultrasound gel to the site to improve coupling.

The provided text describes the PainShield MD PLUS device and its substantial equivalence to a predicate device, PainShield MD, but it does not contain information about studies proving the device meets acceptance criteria related to clinical performance or effectiveness.

The document focuses on regulatory compliance through non-clinical testing (electrical safety, EMC, biocompatibility, and software validation) and a comparison of technological characteristics with its predicate device. This type of information is typical for a 510(k) submission where the goal is to demonstrate substantial equivalence, rather than provide new clinical effectiveness data.

Therefore, many of the requested details about acceptance criteria for clinical performance, sample size, ground truth, expert qualifications, and MRMC studies are not available in the provided text.

Here's a breakdown of the information that is available:

Acceptance Criteria and Reported Device Performance

Missing Information (Not found in the provided text)

2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth data is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical test set data is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ultrasonic diathermy device, not an AI-powered diagnostic tool. No human-in-the-loop performance or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical effectiveness, as no such studies are described. For the non-clinical tests (electrical safety, EMC, etc.), the "ground truth" is adherence to the specified international standards.
8. The sample size for the training set: Not applicable as no machine learning/AI model training is described.
9. How the ground truth for the training set was established: Not applicable as no machine learning/AI model training is described.

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The sam X I Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation

The sam X1 Long Duration Ultrasound Device consists of:

• Rechargeable Power Controller and Timer
• Ultrasound Generating Applicators
• Single use disposable accessories
• Ultrasonic Coupling Patch
  The Power Controller can be used to power the Applicator to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches.
  The sam X1 Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware.
  The system is intended for prescription home use to apply ultrasonic energy for a long duration (1 hours) to generate deep heat within body tissues and treat selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

This document is a 510(k) Premarket Notification from ZetrOZ Systems, LLC for their sam X1 Long Duration Ultrasound Device. It seeks to demonstrate substantial equivalence to a predicate device (sam 2.0 Long Duration Ultrasound System, K191568).

The document does not describe an AI/ML-based device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details a physical medical device (an ultrasonic diathermy device) used for therapeutic purposes (deep heat generation for pain relief, muscle spasms, joint contractures, and circulation increase).

Therefore, I cannot provide the information requested in the prompt, as the prompt's questions pertain to acceptance criteria and studies for AI/ML diagnostic devices, such as those that might involve:

1. A table of acceptance criteria and reported device performance (for AI metrics like sensitivity, specificity, AUC).
2. Sample sizes and data provenance for test sets (relevant to AI model validation).
3. Number and qualifications of experts for ground truth establishment (critical for AI imaging diagnostics).
4. Adjudication methods for test sets (common in AI imaging studies).
5. MRMC comparative effectiveness studies (specifically for AI assistance to human readers).
6. Standalone algorithm performance.
7. Types of ground truth (e.g., pathology, outcomes data - often used in AI validation).
8. Training set sample size and ground truth establishment (fundamental to AI development).

The provided text focuses on the physical and functional equivalence of the sam X1 device to its predecessor, particularly noting a smaller battery and a maximum 1-hour treatment duration compared to the predicate's 4 hours. The testing mentioned (power output, treatment time, battery conformance, electrical safety, usability, software, cybersecurity) are standard for medical device hardware and firmware safety and performance, not for AI model validation.

In summary, as the provided document is for a non-AI medical device, the requested information regarding AI acceptance criteria and study design is not applicable and cannot be extracted from the text.

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The sam 2.0 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

The sam 2.0 Long Duration Ultrasound Device consists of:

• Rechargeable Power Controller and Timer
• Ultrasound Generating Applicators
• Applicator Adaptor Cables
  Single use disposable accessories
• Ultrasonic Coupling Patch
  The Power Controller and cables can be used to power one or two Applicators simultaneously to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches.
  The sam 2.0 Long Duration Ultrasound Device contains firmware for logging usage time. There is no control function of this firmware.
  The system is intended for prescription home use to apply ultrasonic energy for a long duration (4 hours) to generate deep heat within body tissues and treat selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ZetrOZ Systems sam 2.0 Long Duration Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device (ZetrOZ Ultrasonic Diathermy Device, K130978) rather than detailing specific, quantified acceptance criteria for novel performance claims. The "comparison" column in the table implicitly indicates where performance is identical or similar to the predicate. Therefore, the acceptance criteria are effectively defined by matching or being similar to the predicate device's established performance specifications.

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The ZTX Ultrasonic Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

The ZTX Ultrasonic Diathermy Device is a prescription use device. The ZTX Device should only be administered and monitored by a licensed healthcare practitioner.

The ZTX Ultrasonic Diathermy Device consists of a ZTX Ultrasound Power Controller and cable which can be used to power one or two ZTX Ultrasound Applicators simultaneously that each generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per ZTX Ultrasound Applicator. The ZTX Ultrasound Applicators are applied with one time use ZTX Ultrasound Coupling Bandages which hold the ZTX Ultrasound Applicators in place during treatment and allow for the transmission of ultrasound into the body. This provides the operator with the ability to use the device hands-free in a single applicator mode of operation that delivers 0.65W at 3MHz or in a dual applicator mode of operation that provides 1.3W at 3MHz. The ZTX Ultrasound Power Controller displays battery and treatment setting information to the operator and provides control of device treatment time. The ZTX Ultrasound Applicator frequency and power settings are not modifiable by the operator. The ZTX ultrasound applicators and coupling bandage allows for the delivery of ultrasonic energy to tissue at one or two locations simultancously, as determined by a physician. The ZTX Ultrasound Power Controller , ZTX Ultrasound Applicators, interconnecting power cable and ZTX Ultrasound Coupling Bandages comprise the entire ZTX treatment system.

The provided text describes the regulatory submission for the ZTX Ultrasonic Diathermy Device, focusing on its substantial equivalence to a predicate device. It details various technical characteristics and performance testing but does not explicitly define acceptance criteria in terms of specific quantitative thresholds or clinical endpoints for a study.

Instead, the submission states that the ZTX device met performance standards and demonstrated substantially equivalent diathermic heating effects and safety profiles to the predicate device. This implies that the 'acceptance criteria' were essentially demonstrating compliance with regulatory standards (21 CFR 1050.10, IEC 60601-1, IEC 60601-1-2) and showing comparable performance to the predicate.

Given this, I will interpret "acceptance criteria" as the performance standards and substantial equivalence claims mentioned, and "reported device performance" as the documented outcomes against those standards and claims.

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

Acceptance Criteria and Device Performance

Study Details:

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

   • Ex vivo bovine muscle model: Sample size not specified. Data provenance: ex vivo, specific country not mentioned.
   • In vivo swine model: Sample size not specified. Data provenance: in vivo, GLP structured, specific country not mentioned.
   • Biocompatibility: Sample size not specified (e.g., number of test articles or subjects). Data provenance: contract laboratory.

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

   • The document describes engineering (bench testing) and animal model studies, not studies involving human experts establishing ground truth for perception or diagnostic tasks. Therefore, this information is not applicable in the context of this device's submission. The "ground truth" for the performance tests would be the measured physical parameters (e.g., temperature changes, power output, safety parameters) and biological responses in the animal model.

3. Adjudication method for the test set:

   • This concept is typically relevant for human-in-the-loop studies involving subjective interpretations (e.g., medical imaging reviews). For the bench and animal model testing described, adjudication in this sense is not applicable. The 'adjudication' would be the scientific interpretation and analysis of the quantitative results by qualified individuals, though no specific multi-expert adjudication process is described.

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

   • No MRMC or human-in-the-loop study with human readers/AI assistance was conducted or mentioned. This information is not applicable as the device is an ultrasonic diathermy device, not an AI-powered diagnostic tool.

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

   • The ZTX device does not contain software or firmware that controls its functionality, nor does it have a microprocessor or CPU. It's a hardware-based therapeutic device. Therefore, a standalone algorithm-only performance study is not applicable. The performance testing described is of the physical device's output and effects.

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

   • Bench testing: Ground truth was based on measurements of physical parameters (e.g., power, frequency, beam characteristics) and diathermic heating effects (temperature changes) in an ex vivo model, compared to established standards and the predicate device's performance.
   • In vivo swine model: Ground truth was based on physiological responses and safety profiles observed in the animal model, compared to the predicate device.
   • Biocompatibility: Ground truth was based on established assays for sensitization and cytotoxicity.

7. The sample size for the training set:

   • The ZTX device is a hardware-based therapeutic device without software, firmware, or AI components that would require a "training set" in the computational sense. Therefore, this question is not applicable. The device was designed and then tested against performance standards and a predicate.

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

   • As there is no "training set" in the context of this device, this question is not applicable.

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The PainShield"M MD diathermy device is intended to apply ultrasounic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.

The PainShield™ MD is an ultrasonic diathermy device used to apply deep heat to tissues in the body with a transducer/applicator that is incorporated into a patch that adheres to the skin, as does a bandage.The PainShield™ MD is used to generate continuous wave ultrasound at 90 kHz, through a reusable applicator/transducer that covers an area of about 6 cm². The small applicator allows treatment of less accessible body parts such as, for example, the heel, the achilles tendon and the wrist. The device includes the above-mentioned transducer, a small, rechargeable, battery-powered driver unit and a cable that connects the driver to the transducer.

The provided text is a summary of safety and effectiveness for a medical device called PainShield™ MD, a 510(k) clearance letter from the FDA, and the indications for use. It primarily focuses on demonstrating substantial equivalence to a predicate device and regulatory compliance.

Crucially, the document DOES NOT contain information regarding acceptance criteria, performance studies with specific statistical outcomes, sample sizes for test or training sets, ground truth establishment, expert qualifications, or details about any comparative effectiveness studies (MRMC) or standalone performance studies.

The "Summary of Safety and Effectiveness" section describes the device, its intended use, and lists several advantages it has over existing devices. It concludes by stating, "The Painshield™ MD complies with the FDA standard for ultrasonic therapy products." This is a general statement of compliance, not a detailed report of performance against specific acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or information about the studies mentioned in your prompt because this information is not present in the provided text.

The text is a regulatory submission about the device, not a scientific study of the device's performance against specific metrics. It focuses on regulatory equivalence and safety assurances.

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The HF54 interferential therapy and premodulated therapy is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain.

Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: Relief of pain joint contractures This can be done using One or two ultrasound applicators. The second ultrasound applicator is optional. Ultrasound therapy, either alone or in combination with interferential therapy or premodulated therapy can be used in a scanned manner (where the therapist moves the applicator) or for specific treatment areas identified in the operator's manual, the applicator can be used in a hands-free manner (where the applicator remains stationary).

An Infrared Therapy Probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or for stand-alone use with an optional external medical grade, isolated power supply. It is used to provide topical heating for: Temporary increases in local blood flow and circulation. Temporary relief of minor muscle and joint aches Temporary relief of pain and stiffness Relaxation of muscles. Temporary relief (or relaxation) of muscle spasms. Temporary relief of minor pain and stiffness associated with arthritis

The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation is a device that provides ultrasonic diathermy, interferential current therapy, and infrared lamp therapy. It can be used with one or two ultrasound applicators, and the ultrasound therapy can be applied in a scanned or hands-free manner. An optional infrared light probe is also available.

The provided 510(k) summary for the Hill Laboratories HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation (K072256) does not describe a study involving a test set, expert adjudication, MRMC comparative effectiveness, or stand-alone algorithm performance in the typical sense of a clinical trial or algorithm validation study for diagnostic devices.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K062256) by affirming compliance with mandatory and consensus standards, and by performing risk analysis for the expanded indication of "hands-free" operation for ultrasound. The "acceptance criteria" here refer to safety thresholds and compliance with established performance standards for similar medical devices.

Here's an breakdown based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a "test set" in the context of clinical data or images. The "tests" mentioned are primarily engineering and electrical safety measurements (e.g., thermal measurements, pulsed output analysis) for the device itself.

• Sample Size: Not applicable in the context of a clinical test set. The measurements were likely performed on a single or a small number of device units.
• Data Provenance: The measurements related to thermal output and standing waves were conducted internally by Hill Laboratories, likely in a laboratory setting. This is a technical validation, not clinical data from patients.

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

Not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, is not described as part of this submission. The "ground truth" for the engineering performance aspects would be the physical laws and measurement standards.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This submission is for an expanded indication for a physical therapy device, focusing on safety and technical equivalence rather than a diagnostic or screening efficacy study involving human readers.

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

Not applicable. This device is a physical therapy equipment, not an AI algorithm for diagnosis or image analysis. Its operation inherently involves a human operator (therapist). The "hands-free" aspect refers to the applicator staying stationary on the patient, but the therapist still monitors the patient.

7. The Type of Ground Truth Used

The "ground truth" here is based on:

• Engineering and physical measurements: For thermal output, acoustic properties (standing waves), and electrical safety.
• Compliance with established standards: Mandatory (21 CFR 1050.10) and consensus standards (IEC 60601 series, UL 60601-1).
• Risk analysis: Identifying potential hazards and mitigation strategies (e.g., operator manual instructions).

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI algorithms described in this submission.

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

Not applicable. As there is no training set, there's no ground truth established for one.

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