Search Results

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.

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

The document explicitly states: "Clinical testing was not necessary to support substantial equivalence of the sam CS device." This implies that no specific "test set" of patient data was used for a clinical performance study of the sam CS device itself. The data provenance of the predecessor device (sam X1) is not provided in this document.

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 with a specific test set was conducted for the sam CS device.

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

Not applicable, as no clinical testing with a specific test set was conducted for the sam CS device.

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 ultrasound diathermy device, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned or performed.

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

This refers to an "algorithm only" performance, often relevant for AI/software devices. While the device does have firmware, it is for control functions like timing and battery level, not for diagnostic or therapeutic algorithms that would require standalone performance evaluation in the context of an "algorithm." The device's primary function is physical energy delivery.

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

Not applicable, as no clinical testing with a specific test set was conducted for the sam CS device. The "ground truth" for the device's technical specifications is established through engineering and physical measurements against recognized standards (e.g., IEC standards).

8. The sample size for the training set

Not applicable, as no machine learning / AI model was trained for the device's primary function.

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

Not applicable, as no machine learning / AI model was trained for the device's primary function.

In summary:

This 510(k) submission for the "sam CS Long Duration Ultrasound Device" focuses on demonstrating substantial equivalence to an already cleared predicate device ("sam X1 Long Duration Ultrasound Device"). The argument is that since the sam CS device has identical technical specifications and a similar intended use (a subset of the predicate's indications), it poses no new questions of safety or effectiveness. Therefore, clinical performance data and detailed studies on acceptance criteria, test sets, or ground truth were deemed "not necessary" for this particular submission. The "acceptance criteria" here are implicitly that the device's technical characteristics and performance match those of the predicate device.

Ask a specific question about this device

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):

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

This submission relies on a systematic literature review and meta-analysis to support the expanded indications, not a new clinical trial with a defined "test set" sample size. Therefore, there isn't a single "sample size" for a test set in the traditional sense.

• Sample Size: Not applicable as a new test set was not generated. The evidence comes from accumulated studies in the literature.
• Data Provenance: The systematic literature review was conducted using databases such as PubMed, EBSCOhost, Academic Search Complete, Google Scholar, and ClinicalTrials.gov. This implies global data sources, reflecting a diverse range of studies published in scientific literature. The studies themselves would have their own provenance (e.g., country of origin, retrospective/prospective design), but these details are not provided for the individual studies included in the review. The review itself is retrospective.

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

• This question is not applicable as this submission is for an ultrasound therapy device and relies on clinical efficacy from published literature, not on expert adjudication of diagnostic images or interpretations to establish ground truth for a test set. There's no mention of experts involved in reviewing the literature for the purpose of establishing a "ground truth" for a device performance test. The "ground truth" is implied by the clinical outcomes reported in the accumulated scientific literature on SAM treatment.

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

• This question is not applicable as there was no new "test set" and no image-based diagnostic task requiring adjudication. The evidence comes from a systematic literature review and meta-analysis of clinical studies.

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

• This question is not applicable. The device is an ultrasound therapy device, not an AI-assisted diagnostic or imaging interpretation tool that would involve human readers or MRMC studies.

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

• This question is not applicable. The device is a therapeutic ultrasound device, not an algorithm.

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

• The "ground truth" for the expanded indications for this therapeutic device is based on outcomes data from various clinical studies summarized in the systematic literature review. These outcomes relate to "the relief of pain, the relief of muscle spasms, the treatment of joint contractures, the local increase in circulation," and specifically for the expanded indications, "relief of pain associated with limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofafascial pain, and shoulder, elbow and ankle tendinopathy)." The efficacy is based on the therapeutic effect reported in the aggregated clinical literature.

8. The sample size for the training set

• This question is not applicable. The device is not an AI algorithm requiring a training set. The clinical evidence is derived from existing scientific literature.

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

• This question is not applicable. The device is not an AI algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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

• Test Set Sample Size: Not explicitly mentioned for specific performance tests.
• Data Provenance:
  • Preclinical Testing: "Third party testing of the electronics" and "Third party testing of the device" for electrical safety and home use standards. "Bench testing experiments" for diathermic heating effects on an ex vivo bovine muscle model. This implies lab-based, controlled testing. There is no mention of country of origin, but given the FDA submission, it's likely testing was done in accredited labs that meet international standards.
  • Clinical Testing: "Usability data, human factors studies, and literature was provided to support the home use label." This suggests that prospective studies focusing on usability and human factors were conducted, but specific sample sizes and data provenance (e.g., country of origin) are not detailed within this summary. It might also refer to literature reviews of similar devices or general human factors principles. The document is submitted to the US FDA, so any data provided would need to be acceptable to the US regulatory body.

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

Not applicable. The reported studies (bench testing, electrical safety, usability/human factors) do not involve expert interpretation or subjective ground truth establishment in the way, for example, a diagnostic image analysis algorithm would. The "ground truth" for electrical safety and performance standards is defined by the standards themselves and objective measurements. For diathermic heating effects, it would be measured temperature changes. For usability, it would involve direct observation and user feedback rather than expert consensus on a 'truth'.

4. Adjudication method for the test set

Not applicable for the types of studies mentioned. These are objective measures against standards or physical phenomena, not subjective assessments requiring adjudication.

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

No MRMC comparative effectiveness study was done or mentioned. This device is an ultrasound therapy system, not a diagnostic imaging AI.

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

A standalone performance assessment was effectively done for the physical and electrical characteristics of the device through preclinical bench testing and compliance with standards. The device itself operates independently to generate ultrasonic energy. The "home use" indication implies it's designed for use by the patient, meaning it's largely standalone in its therapeutic application, though prescribed by a physician. The firmware is for logging, not for diagnostic or control functions, so there isn't an "AI" component in the traditional sense to evaluate.

7. The type of ground truth used

• Preclinical Testing (Electrical Safety, Performance Standards): The ground truth is defined by the international and national standards (e.g., IEC 60601 series, 21 CFR 1050.10) and objective physical measurements (e.g., temperature, power output) on the device and an ex vivo model.
• Clinical Testing (Usability/Human Factors): The ground truth for usability would be user performance, feedback, and adherence to safety protocols, evaluated against human factors guidelines.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a training set. The firmware mentioned is for logging usage time, not for learning or decision-making.

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

Not applicable, as no training set was used for an AI/ML component.

Ask a specific question about this device