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EaseVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidencebased behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.

Device Description

EaseVRx is an immersive virtual reality (VR) system which delivers 3-D VR treatment that incorporates principles of cognitive behavioral therapy (CBT), other behavioral methods, and mindfulness strategies to treat patients diagnosed with chronic pain. It is a prescription-use device which uses preloaded software content on a proprietary hardware platform to deliver treatment. The EaseVRx device, shown in the figures below, consists of an off-the-shelf VR head-mounted display (Figure 1) with added Breathing Amplifier (Figure 2) and AppliedVR developed software. The Breathing Amplifier is a mechanical attachment added to the commercially available headset which enables diaphragmatic breathing exercises designed to enhance the user's engagement by amplifying the user's exhalation into the on-board microphone. The device is also marketed with an optional hand-held controller to aid in navigating the user interface.

AI/ML Overview

Acceptance Criteria and Device Performance for EaseVRx

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for device performance. However, based on the identified risks and special controls, and the clinical study outcomes presented as evidence of effectiveness, the implicit acceptance criteria are related to:

Clinical effectiveness: Demonstrating a clinically meaningful and statistically significant reduction in pain intensity and pain interference (activity, mood, sleep, stress).
Safety: Acceptable adverse event profile with temporary, resolvable events.
Technical Compliance: Meeting relevant electrical, biocompatibility, and software standards.

Here's a table summarizing the implicit performance criteria and the reported device performance, derived from the clinical study results:

Acceptance Criterion (Implicit)	Reported Device Performance (EaseVRx Group)
Clinical Effectiveness:
1. Reduction in Pain Intensity: Clinically meaningful (>=30%) and statistically significant reduction in average pain intensity.	66% of EaseVRx participants achieved >30% reduction in pain intensity. 46% achieved >50% pain reduction. Average reduction: 41.6%. Statistically significant difference observed compared to sham (p-value for Condition effect is (b)(4)).
2. Reduction in Pain Interference with Activity: Clinically meaningful (>=30%) and statistically significant reduction in pain interference with activity.	71% of EaseVRx participants achieved >30% reduction in pain interference with activity. 56% achieved >50% reduction. Average reduction: 48.9%. Statistically significant difference observed compared to sham (p-value for Condition effect is (b)(4)).
3. Reduction in Pain Interference with Mood: Clinically meaningful (>=30%) and statistically significant reduction in pain interference with mood.	74% of EaseVRx participants achieved >30% reduction in pain interference with mood. 60% achieved >50% reduction. Average reduction: 55.7%. Statistically significant difference observed compared to sham (p-value for Condition effect is (b)(4)).
4. Reduction in Pain Interference with Sleep: Clinically meaningful (>=30%) and statistically significant reduction in pain interference with sleep.	70% of EaseVRx participants achieved >30% reduction in pain interference with sleep. 60% achieved >50% reduction. Average reduction: 51.7%. A statistically significant difference (condition effect p-value is (b)(4)) was observed compared to sham.
5. Reduction in Pain Interference with Stress: Clinically meaningful (>=30%) and statistically significant reduction in pain interference with stress.	76% of EaseVRx participants achieved >30% reduction in pain interference with stress. 63% achieved >50% reduction. Average reduction: 57.0%. Statistically significant difference observed compared to sham (p-value for Condition effect is (b)(4)).
Early Resolution/Temporary Adverse Events: Adverse events (e.g., nausea, motion sickness, discomfort) should be temporary and resolve with discontinuation or adjustment of the device. No serious adverse events.	9.7% of EaseVRx group reported nausea and motion sickness. 20.8% reported discomfort with the headset. All reported adverse events were common and expected for VR devices, temporary, and resolved by discontinuing use or adjusting the device. No device-related serious adverse events were observed.
Biocompatibility: Patient-contacting components must be demonstrated to be biocompatible (though in this case, data was not evaluated due to history of safe use and low cumulative contact).	Biocompatibility data was not evaluated for EaseVRx, as the materials have a history of safe use in medical devices, total cumulative contact duration is low, and manufacturing complies with Quality System Regulations.
Electromagnetic Compatibility & Electrical Safety: Device must comply with relevant safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133).	Device was tested and demonstrated compliance with IEC 60601-1:2005 (Modified), IEC 60601-1-2:2014, IEC 60601-1-11:2015, and IEC 62133 Edition 2.0 2012-12 for battery.
Software Verification, Validation, and Hazard Analysis: Software should operate as described in specifications, with identified hazards addressed through V&V testing.	Sponsor provided documentation for software and firmware with a "Minor" Level of Concern. Hazard analysis performed and V&V testing addressed potential hazards with satisfactory results. Documentation described software, firmware, requirements, traceability, revision history, and cybersecurity.
Labeling Compliance: Labeling must meet 21 CFR Part 801.109, provide instructions, safety warnings (nausea, discomfort), and a summary of clinical testing.	User Manual meets requirements of 21 CFR Part 801.109. It includes instructions, appropriate warnings/precautions, and outlines cleaning methods. Provides information on safety and effectiveness. (The document states "The labeling provides information to users describing the clinical data showing the safety and effectiveness...").

2. Sample Size and Data Provenance

Sample Size (Test Set): 188 subjects (patients with chronic low back pain, age 18 and older).
- Treatment group: (b)(4) participants (derived from percentages, e.g., for pain intensity 66% of 188 = approximately 124, 41% of 188 = approximately 77. The specific group counts are redacted as (b)(4) in the table but the percentages confirm a distribution of the 188 subjects between the groups.)
- Sham group: (b)(4) participants.
Data Provenance: The document does not explicitly state the country of origin. It describes a "single-cohort, double-blinded... randomized clinical trial." This implies a prospective data collection, initiated for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

Ground Truth for Clinical Study: No external experts were used to establish the "ground truth" for the primary clinical effectiveness endpoints. The ground truth was patient-reported outcomes (PROs) using standardized scales. Therefore, no information on the number or qualifications of experts for ground truthing is applicable here. The primary endpoints were measured using the Defense and Veterans Pain Rating Scale (DVPRS), which is a self-assessment tool.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Since the primary endpoints were patient-reported outcomes (DVPRS scores), there was no need for expert adjudication. The study collected direct patient responses.

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

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without AI assistance for tasks like image interpretation. EaseVRx is a behavioral therapy device, and its primary endpoints are patient-reported pain and pain interference, not diagnostic accuracy involving expert readers.
Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance: Not applicable in the traditional sense of an "algorithm only" performance study. EaseVRx is an interactive virtual reality system designed for human-in-the-loop use. Its effectiveness relies on the patient's engagement with the software content and the behavioral therapy it delivers. The clinical study did evaluate the device's performance in a standalone manner relative to a sham control, demonstrating the direct effect of the EaseVRx therapeutic program on patient outcomes when used as intended by the patient. However, this is not a "standalone algorithm" performance in the context of, for example, an AI diagnostic algorithm, where the algorithm provides an output without human intervention.

7. Type of Ground Truth Used

Ground Truth Type: Patient-Reported Outcomes (PROs).
- The primary effectiveness endpoints (average pain intensity and pain interference on activity, mood, sleep, and stress) were measured using the Defense and Veterans Pain Rating Scale (DVPRS).
- Secondary endpoints also included PROs such as Patient's Global Impression of Change (PGIC), PROMIS physical function, PROMIS sleep disturbance, Pain Self-Efficacy Questionnaire (PSEQ-2), Pain Catastrophizing Scale (PSCS-4), Chronic Pain Acceptance Questionnaire (CPAQ-8), Patient satisfaction, and Positive and Negative Affect Scale (PANAS).

8. Sample Size for the Training Set

Training Set Sample Size: The document refers to the clinical trial as an evaluation study for the device's effectiveness. It does not describe a separate "training set" for the device's software algorithm in the context of an AI/machine learning development pipeline. EaseVRx delivers preloaded software content based on established therapeutic principles (CBT, behavioral methods, mindfulness). The device's content is "designed to minimize triggers of emotional distress and motion sickness, as well as to induce relaxation and activation of the parasympathetic nervous system." This suggests content designed by experts, rather than an algorithm trained on patient data. Therefore, the concept of a separate "training set" for an AI model that could be assessed independently is not directly addressed or implied by the provided text.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. As discussed above, the document does not describe the development of an adaptive AI algorithm that would require a ground truth-labeled training set. The device utilizes preloaded, expert-designed therapeutic content.

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