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The PMD-200 with the Nociception Level (NOL) Index is indicated for use in a clinical setting that requires assessment of changes in nociception levels in adult patients under general anesthesia receiving opioid or opioid-sparing analgesia as part of their care.

The PMD-200 should be used as an adjunct to clinical judgment. Clinical judgment should always be used when interpreting the NOL index in conjunction with other available clinical and vital signs.

The PMD-200 (device) is a nociception monitoring system which assists assessment of anaesthetized patient's physiological response to noxious stimuli and helps tailor analgesic administration to the patient's actual response to painful stimuli. The device provides quantification of the patient's response to noxious stimuli with the nociception level index (NOL).

The PMD-200 system consists of 4 main components:

• Monitor acquisition and display of physiological raw data signals and NOL . index and trend graph.
• . Software includes two main components:
  • Calculation of the NOL index based on physiological parameters extracted from raw data signals.
• O User interface displays physiological raw data signals, NOL index and trend graph.
• Finger probe -includes the following sensors: .
  • Photoplethysmogram (PPG or Pleth) o
  • · Thermistor for peripheral temperature (TMP)
  • · A 3-axis accelerometer for movement (ACC or Movement).
  • Connectors for the Galvanic skin response sensor (GSR or Conductance)
• Single use sensor (connected to the finger probe) includes the following sensor: . o Bio-impedance Galvanic skin response sensor (GSR or Conductance)

The NOL index is a relative, non-linear measure with a range of 0-100, where 0 represents no pain /nociceptive response and 100 represents extreme pain/nociceptive response. The NOL index and trend are intended to support clinical decisions concerning the administration of analgesic medications.

Here's a breakdown of the acceptance criteria and study information for the Medasense Biometrics Ltd. PMD-200, based on the provided text:

PMD-200 Acceptance Criteria and Performance Studies

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the algorithm's performance are primarily detailed in the "Algorithm Verification" and "Algorithm Validation" sections. The device met all specified acceptance criteria.

Algorithm Verification Results (Table 1 from text):

Algorithm Validation Phase I Results (Table 2 from text):

Algorithm Validation Phase II (Sub-group Analysis) (Table 3 from text):
All subgroups (Female, Male, Age 65, BMI 18-25, BMI 25-30, BMI > 30, Remifentanil, Fentanyl, Desflurane, Sevoflurane, Propofol, ASA I, ASA II, ASA III) passed all 7 tests.

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

The document describes three main types of studies for evaluating the PMD-200.

• Algorithm Verification: A multinational, multi-center dataset was used. The specific number of patients or data points for this dataset is not explicitly stated, but it covered a wide range of patient demographics and anesthetic drugs.
• Algorithm Validation: A separate multinational, multi-center dataset was used, distinct from the verification and training datasets.
  • Phase I Validation: The exact number of patients or data points for Phase I validation is not explicitly stated for all tests; however, the sub-group analysis (Phase II) indicates that each sub-group contained at least 40 patients.
  • Phase II Validation (Sub-group Analysis): The dataset used for Phase II combined both the verification and validation datasets.
    • Female: 75 patients (retrospective study mentions 483 data points)
    • Male: 75 patients (retrospective study mentions 219 data points)
    • Age 65: 48 patients (retrospective study mentions 217 data points)
    • BMI 18-25: 39 patients
    • BMI 25-30: 45 patients
    • BMI > 30: 45 patients
    • Remifentanil: 55 patients (retrospective study mentions 265 data points)
    • Fentanyl: 67 patients (retrospective study mentions 395 data points)
    • Desflurane: 155 data points (from retrospective study)
    • Sevoflurane: 354 data points (from retrospective study)
    • Propofol: 173 data points (from retrospective study)
    • ASA I: 112 data points (from retrospective study)
    • ASA II: 418 data points (from retrospective study)
    • ASA III: 91 data points (from retrospective study)
• NOL Retrospective Clinical Validation Study: This study used a database comprising 500 adult patients with 702 data points total across all subgroups (summing N data points in the table), collected retrospectively between January 2015 to December 2020.
  • Provenance: This multi-center dataset included data from:
    • HMR, Montreal, Canada (datasets: CINAAMON, NOLGYN, Remi-Trach)
    • Shaare Zedek Medical Center, Jerusalem, Israel (dataset: Abdomi-NOL)
    • Leiden University Medical Center, Leiden, the Netherlands (datasets: NOLA, SOLAR)
    • University of Vermont Medical Center, Larner College of Medicine, Burlington, Vermont (Observational study)
    • Cleveland Clinic Foundation, Cleveland, USA (Fentanyl pilot study)

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

The document does not explicitly state the number of experts used to establish ground truth for the algorithm verification or validation datasets, nor does it specify their qualifications. The ground truth appears to be based on observed physiological responses to stimuli during anesthesia (e.g., intubation, incision) as recorded during surgical procedures.

For the human factors testing, the following was mentioned:

• Usability validation study in Israel: 18 participants representative of intended users.
• Usability validation study in Boulder, Colorado: Fifteen (15) US licensed anesthesiologists and CRNAs. Both are considered professional users with extensive clinical training.

4. Adjudication Method for the Test Set

The document does not describe a formal expert adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the physiological responses. The ground truth appears to be derived from the timing and nature of clinical events (e.g., intubation, incision) which are considered noxious stimuli. The retrospective study mentions "manual and automated data review" for excluding patients with incomplete records, which suggests some level of data quality assessment but not necessarily expert consensus on event labeling.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. without AI Assistance

The document does not describe an MRMC study comparing human readers with and without AI assistance. Instead, it presents two clinical outcome studies (Abdomi-NOL and SOLAR) that compare NOL-guided analgesia (which implicitly means human clinicians using the PMD-200 for guidance) against standard of care monitoring (human clinicians using traditional methods like blood pressure and heart rate).

Effect Size (from Abdomi-NOL and SOLAR studies comparing NOL-guided vs. SOC):

• Abdomi-NOL Study:
  • Median postoperative pain scores (NRS scale) at 60 minutes in PACU: 3 (NOL-guided) vs. 5 (SOC). Actual difference: 1.6 (95% CI 0.5-2.7). Corrected for sex distribution: 1.9 (95% CI 0.7-3.0).
  • Median postoperative pain scores (NRS scale) at 90 minutes in PACU: 3 (NOL-guided) vs. 5 (SOC). Actual difference: 1.3 (95% CI 0.3-2.3). Corrected for sex distribution: 1.5 (95% CI 0.5-2.6).
  • These reductions represent 30-33% improvement on the 11-point NRS scale.
• SOLAR Study:
  • Median postoperative pain scores (NRS scale) during the first 90 minutes of PACU stay: 3.2 (NOL-guided) vs. 4.8 (control group). Actual difference: 1.6 (95% CI 0.5-2.7).
  • Increased ACTH and cortisol levels (stress hormones) were 1.5 to 2-fold greater in the standard care group compared to the NOL-guided group.

These studies demonstrate an improvement in patient outcomes (reduced postoperative pain) when clinicians use the NOL index as an adjunct, but they do not isolate the improvement of human reader performance itself.

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

Yes, standalone performance (algorithm only) was assessed.

The "Algorithm Verification," "Algorithm Validation" (Phase I and II), and "NOL Retrospective Clinical Validation Study" sections describe the standalone performance of the PMD-200 algorithm. These studies evaluate the algorithm's ability to correctly identify and predict nociception based on its input physiological data, independent of direct clinician intervention. The metrics like AUC, sensitivity, specificity, and accuracy are measures of the algorithm's standalone diagnostic performance.

7. The Type of Ground Truth Used

The ground truth for both the algorithm verification, validation activities, and the retrospective study primarily relies on the occurrence of specific noxious stimuli during surgical procedures.

Examples of ground truth events indicating nociception include:

• Intubation (TP1)
• Incision/trocar placement (TP2)
• Periods of "no noxious stimulus" or "no nociception reported" (TNP)

These events represent discrete points in time during surgery where a nociceptive response is expected (or not expected), allowing for the classification of the PMD-200's NOL index against these clinical events.

8. The Sample Size for the Training Set

The document explicitly states that the recordings used for verification were not used in the training dataset, and similarly, validation data was unique, i.e., not used for training the algorithm or for verification purposes.

However, the specific sample size for the training set is not provided in the given text.

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

While the document states that the system has a training dataset, it does not explicitly describe how the ground truth for the training set was established. It can be inferred that it would follow a similar methodology to the verification and validation datasets, likely based on recorded physiological responses to known noxious and non-noxious stimuli during general anesthesia, as observed in surgical procedures.

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Interferential Current Mode: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post surgical and post traumatic pain.

Neuromuscular Stimulator Mode: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post surgical stimulation of calf muscles to prevent venous thrombosis.

The PMD-2000 Interferential Stimulator is a battery or AC wall adapter powered device intended for clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The PMD-2000 is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The PMD-2000 incorporates the following features:

• Two independent stimulation channels, which provide true interferential current and neuromuscular stimulation.
• Continuous or pulsed stimulation. Various sweep and ramp times.
• Adjustable amplitude and frequency.
• Fifteen preset therapy protocols.
• Pause button to allow temporary suspension of treatment and a resume button to allow the resumption of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes its countdown and the amplitude (intensity) is reset to zero.
• Easy to connect, easy to handle, patient lead wire/cable assembly with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes.
• Timed therapy sessions.
• Double A (AA) battery system accommodates standard alkaline, NiCad and Nickel Metal Hydride batteries.
• The PMD-2000 user interface incorporates a 16 character (8x2) Liquid Crystal Display (LCD) and tactile switches for menu navigation.

Here's a breakdown of the acceptance criteria and study information for the PMD-2000 Interferential Stimulator, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a quantitative manner for specific performance metrics (e.g., "output frequency must be within +/- X%"). Instead, the acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to a legally marketed predicate device (CS3101 Interferential Stimulator) through qualitative and comparative bench testing.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify a numerical sample size for the test set used in a clinical study. Instead, it mentions "Bench testing was performed on the marketed device and the PMD-2000." This indicates that the comparison was likely done on a limited number of physical units of both the PMD-2000 and the predicate device (CS3101).
• Data Provenance: The data provenance is from bench testing. No information is provided regarding country of origin or whether it was retrospective or prospective, as it was a technical comparison of device outputs, not patient data.

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

This information is not provided in the document. The "ground truth" for this device's performance seems to be established by physical measurements and comparisons against the known operational characteristics of the predicate device, rather than expert interpretation of complex data (like medical images).

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Given that the evaluation was based on bench testing of device outputs, there would be no need for an adjudication method involving human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done.
• This device is an electrical stimulator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this product.

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

• Yes, a standalone performance assessment was done in the form of bench testing. The document states: "Bench testing was performed on the marketed device and the PMD-2000 and the therapy output and performance characteristics for both units was substantially equivalent." This constitutes a standalone evaluation of the device's functional output without human interaction in the loop determining its primary effectiveness.

7. The Type of Ground Truth Used

The ground truth used for assessing the PMD-2000's performance was the measured therapy output and performance characteristics of the legally marketed predicate device (CS3101 Interferential Stimulator). Essentially, the predicate device defined the acceptable "truth" for output waveform, frequency, amplitude, etc., which the PMD-2000 had to match or be substantially equivalent to.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The PMD-2000 is an electrical stimulator and is not described as involving machine learning or AI algorithms that would require a "training set" in the conventional sense. Its design and functions are based on established biophysical principles of electrical stimulation.

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

This information is not applicable and therefore not provided, as there is no mention of a "training set" for an AI model.

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