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Prism is a neurofeedback software device intended for relaxation and stress reduction through the use of EEG biofeedback. The device is indicated as an adjunctive treatment of symptoms associated with posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.

Prism is a software as medical device, to be prescribed for treatment of patients with PTSD by clinicians as adjunct to standard of care. Prism is a software device running on a laptop that uses EEG signal input from an EEG device (g.Nautilos PRO (K171669)). Prism therapy consists of 15, 30-minute sessions and optional periodic refresher sessions. During a session, the patient is connected to 8 or more EEG channels and views an interactive audio/visual interface.

Acceptance Criteria and Device Performance Study for Prism Device

The Prism device is a neurofeedback software device intended for relaxation and stress reduction through the use of EEG biofeedback, specifically indicated as an adjunctive treatment for symptoms associated with Posttraumatic Stress Disorder (PTSD). The acceptance criteria for its effectiveness were defined by the primary performance measure of a prospective, single-arm, open-label, unblinded study.

The primary effectiveness hypothesis was that from baseline to the 3-month follow-up, at least 50% of study participants would experience a response to the treatment, defined as a 6-point reduction in the Clinician Administered PTSD Scale (CAPS-5) score from baseline.

1. Acceptance Criteria and Reported Device Performance

Table: Acceptance Criteria and Reported Device Performance

• 54.55% of participants showed a ≥10-point reduction in CAPS-5 at 3 months follow-up.
• 50.00% of participants showed a ≥13-point reduction in CAPS-5 at 3 months follow-up. |

Safety Acceptance Criteria (Implicit):
The pre-specified safety goals of the study were met, indicating an acceptable safety profile. This would implicitly mean that the incidence and severity of adverse events were within acceptable clinical limits for the target population and device type.

2. Sample Size and Data Provenance

• Test Set (Clinical Study Participants):

  • Screened: 101 subjects
  • Full Analysis Dataset: 79 subjects
  • Efficacy Analysis Set: 66 subjects (This is the primary sample size for evaluating the effectiveness against the acceptance criteria).
  • Per-Protocol Analysis Set: 63 subjects

• Data Provenance: The study was a prospective, single-arm, open-label, unblinded study. It was conducted at 4 sites outside the United States (OUS) in Israel and one US site. This indicates a combination of Israeli and US data.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish ground truth for the test set. However, it mentions:

• Diagnosis of PTSD: Established according to the DSM-5 criteria and CAPS-5.
• Clinician assessments: Performed and documented by the investigator or qualified and trained designee.

This implies that the ground truth for PTSD diagnosis and symptom severity (CAPS-5 scores) was established by licensed healthcare professionals (investigators or their designees) who were qualified to administer and interpret DSM-5 and CAPS-5. While specific qualifications (e.g., "radiologist with 10 years of experience") are not provided, "qualified and trained designee" suggests adherence to clinical standards for diagnostic assessment.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the initial PTSD diagnosis or CAPS-5 scoring. The assessments were performed by the "investigator or qualified and trained designee." This implies that the initial assessment by a single qualified professional served as the ground truth.

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

There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study described is a single-arm clinical study evaluating the device's adjunctive efficacy.

6. Standalone (Algorithm Only) Performance

The study evaluates the Prism software in conjunction with an EEG device (g.Nautilos PRO) as an adjunctive treatment for PTSD. Therefore, this is not a study of standalone algorithm performance without human-in-the-loop, as the device provides visual feedback to the patient to aid in learning to control EEG activity, and it is used under the direction of a healthcare professional.

7. Type of Ground Truth Used

The ground truth for effectiveness was based on:

• Clinical Assessments: Clinician Administered PTSD Scale (CAPS-5) scores. CAPS-5 is a structured interview administered by a trained clinician and is considered the gold standard for PTSD diagnosis and severity assessment.
• Self-Report Questionnaires: (Secondary measures, not primary ground truth for the acceptance criteria) PTSD Checklist for DSM-5 (PCL-5), Emotion Regulation Questionnaire (ERQ), Patient Health Questionnaire (PHQ-9), Clinical Global Impression (CGI).

8. Sample Size for the Training Set

The document does not provide information regarding the training set size or how the device's algorithms were trained. The provided text describes the clinical study for device validation, not the development or training phase of the software.

9. How Ground Truth for Training Set was Established

As information on the training set is not provided, the method for establishing its ground truth is also not described in this document.

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The WR19 System is intended for prescription use in a health care facility or clinical research environment to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.

The WR19 System requires operation by a healthcare professional familiar with EEG.

The WR19 System acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), accelerometer, photic sensor, external trigger signals and video.

The WR19 System is primarily intended to acquire, transmit, display and store EEG and optionally do so for auxiliary signals. WR19 headset is designed to perform Routine or Outpatient EEG using 19 dry signal electrodes and 1 dedicated dry ground/driven-right-leg (DRL) electrode, adjusted and placed to comply with the 10-20 EEG system.

The device consists of the following components:

• . Headset
• Electrodes (affixed to the underside of the headset) ●
• Charger
• Charging cable .
• Software ●
  • Headset firmware -
  • Client application -
  • Data center application

Here is an analysis of the acceptance criteria and supporting study for the WR19 System, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a single, clear format as might be desired for a device performance study. Instead, it describes performance testing outcomes and comparisons to a predicate device. The primary performance criteria are implicitly related to the ability of the WR19 System to acquire EEG signals comparably to a legally marketed predicate device (XLTEK EMU40EX) and meet established electrical and safety standards.

Here's an attempt to synthesize the acceptance criteria and stated performance based on the "510(k) Summary" and "PERFORMANCE DATA" sections, particularly "8. CLINICAL PERFORMANCE TESTING":

Study Details

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

   • Test Set Sample Size: 7 subjects.
     • 2 cohorts: EEG patients and healthy volunteers.
     • Recording durations: 15-30 minutes for 2 subjects (EEG patients and healthy volunteers) and 2 hours for 3 healthy volunteers.
   • Data Provenance: The study was conducted "at a United States hospital." This indicates prospective data collection for this specific study.

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

   • The document does not specify the number of experts used to establish ground truth or their qualifications. The phrase "qualitative waveform comparisons" suggests expert review, but details are absent.

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

   • The document does not describe any specific adjudication method for the test set.

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. This was not an MRMC comparative effectiveness study involving AI assistance for human readers. The study compared the signal quality of the WR19 System (which is an EEG acquisition device) to another EEG acquisition device. There is no mention of AI in the context of improving human reader performance.

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

   • Yes, in essence, but not in the context of an "AI algorithm." The "standalone" performance here refers to the device's ability to acquire and produce EEG signals. The clinical performance testing ("8. CLINICAL PERFORMANCE TESTING") evaluates the device's inherent signal quality and functionality (e.g., contact quality detection feature, various auxiliary signals). This is a standalone evaluation of the device's performance characteristics.

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

   • The "ground truth" for the clinical performance study was established by comparing the WR19 System's EEG signals to those obtained from a "common EEG device cleared in K163163 - XLTEK EMU40EX." This implies a comparison to an established, legally marketed predicate device's output considered to be the standard for EEG signal quality. The evaluation metrics included "qualitative waveform comparisons, Likert scoring, and spectral correlation and SNR comparisons." This suggests expert qualitative review and quantitative signal analysis relative to the predicate.

7. The sample size for the training set:

   • The document does not mention a training set in the context of the clinical performance study. The WR19 System is an EEG acquisition device, not a diagnostic AI algorithm that typically requires a large training dataset. The software components are described as firmware, client application, and data center application, performing functions like presenting waveforms, controlling sessions, and standard EEG transformations (filters, montages), not complex pattern recognition that would necessitate a traditional "training set."

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

   • Not applicable as no training set (in the AI/machine learning sense) is described for the clinical performance study.

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