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The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The DT-100 infrared thermometer can be used by consumers in household environment.

The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The operation principle is based on infrared sensor technology. IR sensor can put out different signal when measuring the different object temperature or body temperature. An ASIC can turn the signal from IR sensor to a digital value and display it by LCD. The DT-100 noncontact infrared thermometer can measure body temperature at maximum 40cm between patient and product. The thermometer stores temperature measurement value up to 30, a user can compare prior measurement value and uses an alkaline battery AAA type for operation.

Here's a breakdown of the acceptance criteria and study information for the DT-100 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The exact sample size for the clinical test set is not explicitly stated. The text mentions "all participants" in reference to repeatability, suggesting a cohort of individuals.

• Provenance: The clinical investigation was conducted at Yonsei University Severance Hospital, Republic of Korea. The study was prospective as it involved a clinical investigation to evaluate the device's accuracy and repeatability.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. It states that the clinical investigation was conducted at an "Accredited by IRB" hospital, implying ethical oversight and likely involvement of medical professionals in the data collection process. However, the exact method for determining "ground truth" temperature (e.g., comparison to rectal thermometer, other validated method) is not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "clinical bias" and "clinical repeatability" were calculated based on the measurements obtained during the clinical investigation, implying a direct comparison to a reference standard rather than an adjudicated interpretation of results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. This device is a thermometer, and the evaluation focuses on its accuracy and repeatability against a reference, not on how it assists human readers in interpreting images or data.

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

Yes, a standalone performance study was done for the device. The clinical accuracy and repeatability validation test reports, which are part of the listed performance testing, would reflect the device's intrinsic performance. The clinical investigation directly assessed the device's ability to measure temperature.

7. Type of Ground Truth Used

The type of ground truth used was likely a clinical reference standard for temperature measurement, against which the DT-100's readings were compared. While not explicitly stated, in a clinical thermometer validation, this typically involves a highly accurate and validated method (e.g., rectal thermometer, or another established core body temperature measurement technique) as the "truth." The document mentions that the clinical bias and repeatability were evaluated against requirements of the ASTM E1965-98 standard, which specifies reference thermometry.

8. Sample Size for the Training Set

The document does not provide information about a training set since this is a medical device (thermometer) and not a machine learning/AI algorithm that requires a separate training phase. The discussion focuses on the validation of the device's performance through clinical and bench testing.

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

Not applicable as there is no mention of a training set for this device.

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The CRI Zmachine is a single-channel, EEG acquisition and analysis system, designed for use in the home or clinical environments. This device is intended to be used by qualified healthcare practitioners to monitor the wake and sleep states of adult patients and as an adjunct to their diagnosis of sleep disorders.

The CRI Zmachine is a battery-operated, single-channel, EEG acquisition and analysis system. The Zmachine system includes the Zmachine device, disposable EEG sensor cable, and a wall charger. The device operates on data from the differential-mastoid EEG channel to determine the wake and sleep states of the patient every 30 seconds.

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

Zmachine® Acceptance Criteria and Performance Study

The Zmachine® is a single-channel EEG acquisition and analysis system designed to monitor wake and sleep states in adult patients and as an adjunct to the diagnosis of sleep disorders. Its performance was evaluated against human scoring consensus.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: 99 subjects.
• Data Provenance: Not explicitly stated, but implied to be from a clinical study where polysomnographic (PSG) data was acquired. The location (country) is not specified. The study was prospective in the sense that the Zmachine data was acquired simultaneously with PSG data for the purpose of the study.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: At least two (2) certified polysomnographic technologists per PSG record (3 records scored by 2, 16 records scored by 3, and 80 records scored by 4 technologists).
• Qualifications: Certified polysomnographic technologists. No specific experience level (e.g., "10 years of experience") is mentioned.

4. Adjudication Method for Test Set

The adjudication method used was a consensus of human scorers. Specifically:

• 3 records were scored by 2 technologists.
• 16 records were scored by 3 technologists.
• 80 records were scored by 4 technologists.
  The consensus was then used as the ground truth.

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

No, an MRMC comparative effectiveness study examining the effect size of human readers improving with AI vs. without AI assistance was not conducted or reported. The study focused on the standalone performance of the Zmachine algorithm against human consensus.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The performance metrics (specificity, sensitivity, and Kappa agreement) directly reflect the Zmachine algorithm's ability to determine wake/sleep states without human intervention, compared to the expert ground truth.

7. Type of Ground Truth Used

The ground truth used was expert consensus based on visual sleep scoring rules (Rechtschaffen & Kales R&K, 1968) of polysomnographic (PSG) data.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. It only describes the clinical study for performance testing.

9. How Ground Truth for Training Set Was Established

The document does not provide details on how the ground truth for the training set was established. It describes the Zmachine's EEG analysis methodology as a "Proprietary adaptive algorithm using time and frequency domain features," but offers no information regarding its development or the data used for training.

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1. Acute Hepatic Encephalopathy: The BioLogic-DT System is indicatd for the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure.
2. Drug Overdose and Poisonings: The BioLogic-DT System is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal, such as acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents, antimicrobials, theophylline, herbicides, and insecticides.

Not Found

This document is a 510(k) clearance letter for the BioLogic-DT® System, which means it's a device that has been deemed substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on demonstrating equivalence rather than extensive clinical studies that would establish acceptance criteria and performance against those criteria in the same way a Premarket Approval (PMA) would.

Therefore, the provided document does not contain the detailed information requested regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert qualifications as it pertains to a direct performance study of the BioLogic-DT® System itself. The letter focuses on regulatory clearance based on substantial equivalence.

Here's an analysis based on the information provided and what is missing for each point:

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

• Information in document: Not present. The 510(k) clearance letter doesn't include performance data or acceptance criteria for the BioLogic-DT® System. It simply states that the device is "substantially equivalent" to predicate devices. The "Indications for Use" describe what the device is intended for, but not specific performance metrics or thresholds.
• Missing: Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, removal rates for toxins, etc.) and the predefined acceptance criteria for these metrics.

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

• Information in document: Not present. The document does not describe any specific clinical test set, its size, or its provenance.
• Missing: Details on a test set, including its size, whether it was retrospective or prospective, and its geographic origin.

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)

• Information in document: Not present. Since no test set is described, there's no mention of experts establishing ground truth.
• Missing: Information about experts, their number, and their qualifications.

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

• Information in document: Not present. No test set is described.
• Missing: Description of any adjudication method.

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

• Information in document: Not present. This document does not describe any MRMC studies, nor does it refer to an AI component for the device. The BioLogic-DT System appears to be a medical device for treatment (acute hepatic encephalopathy, drug overdose/poisonings), not an diagnostic AI tool.
• Missing: Any information related to MRMC studies or AI assistance.

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

• Information in document: Not present. The device is a treatment system, not an algorithm, so this concept is not applicable here.
• Missing: Not applicable for this type of device.

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

• Information in document: Not present. No study or ground truth is described.
• Missing: Information about ground truth.

8. The sample size for the training set

• Information in document: Not present. No training set is described.
• Missing: Sample size for a training set.

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

• Information in document: Not present. No training set or ground truth described.
• Missing: Method for establishing ground truth for a training set.

Summary:

The provided document is a 510(k) clearance letter, which signifies that the BioLogic-DT® System has been found "substantially equivalent" to a legally marketed predicate device. This regulatory pathway primarily focuses on demonstrating that a new device is as safe and effective as an already cleared device, without requiring extensive de novo clinical trials to prove device performance against specific, novel acceptance criteria.

Therefore, the detailed information requested about acceptance criteria, study design, sample sizes, ground truth establishment, and expert qualifications is typically found in design validation documentation, clinical study reports, or a Premarket Approval (PMA) submission, none of which are present in this 510(k) clearance letter. The letter confirms the device's clearance for marketing based on equivalence, not necessarily on a detailed performance study as would be required for innovative, high-risk devices.

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1. Acute Hepatic Encephalopathy: The BioLogic-DT System is indicated for the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure.
2. Drug Overdose and Poisonings: The BioLogic-DT System is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal, such as acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents, antimicrobials, theophylline, herbicides, and insecticides.

The BioLogic-DT System is a sorbent regenerated detoxification system consisting of the BioLogic-DT Machine and the single use BioLogic-DT-1000-TK (Treatment Kit). In many ways, it is similar to a standard hemodialysis machine in that blood is removed from the body, passed through a cellulosic dialyzer, and returned to the body. Within the dialyzer, diffusion causes many chemicals and toxins to pass from the dialysate surrounding the membranes. Depending on the binding characteristics of the sorbents in suspension in the dialysate, some chemicals remain at low concentration in the dialysate, and are therefore efficiently removed from the blood, while others reach concentrations similar to blood, and are therefore not removed from the blood. Like existing single-access dialysis systems, the BioLogic-DT System alternately withdraws and returns blood through a single-lumen catheter. Unlike standard dialysis machines, which use roller pumps to pass blood through the membranes, the DT applies an alternating pressure/ vacuum cycle to the sorbent suspension causing the alternating expansion and compression of the dialyzer's parallel plate cellulosic membranes. This expansion and compression of the membranes is used to pump blood through the system.

An improvement in software of the DT-1000 System mixes the sorbents before prime, obviating the need for the operator to shake the bag.

This document (K984546) describes a 510(k) submission for the BioLogic-DT System, an improved version of a sorbent-based blood treatment system. The improvements primarily concern a software change to automatically mix the sorbent suspension during device setup. The study focuses on this specific change and its impact on the device's performance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 7 repetitions of the DT System setup with automatic mixing.
• Data Provenance: Retrospective, internally generated by HemoCleanse Inc. The study described is non-clinical performance data.

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

• Not applicable for this type of non-clinical, performance-based study. The ground truth (clogging or free flow) was an observable physical outcome.

4. Adjudication Method for the Test Set

• Not applicable. The outcome was a direct observation of the device's physical performance (clogging vs. free flow).

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

• No, a MRMC comparative effectiveness study was not done. The study was a non-clinical evaluation of a device function.

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

• Yes, this was a standalone performance evaluation of the device's new automatic mixing function. The "algorithm" here refers to the software change that automated the mixing process. The study directly assessed the device's ability to mix the sorbent and prevent clogging without human intervention during the mixing step.

7. The Type of Ground Truth Used

• Direct Observational Outcome: The ground truth was the direct observation of "sorbent flow freely through the dialyzer" or "sorbent clogging."

8. The Sample Size for the Training Set

• The document does not explicitly mention a training set. The "software change" was implemented, and then its performance was tested with 7 repetitions. It's implied that any development and internal testing prior to this documented study would have involved some form of iterative development, but a formal "training set" in the machine learning sense is not described.

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

• As a formal "training set" is not explicitly mentioned, there's no information on how its ground truth would have been established. The development of the software change likely involved engineering and design principles, with internal validation steps rather than a distinct "training set" with ground truth in the context of supervised learning. The previous method's 1 out of 4 (25%) clogging rate served as a baseline or justification for the need for improvement.

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