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RelieVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence based 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.

RelievRx is an immersive virtual reality (VR) system with preloaded software content on a proprietary hardware platform that delivers automated cognitive behavioral therapy (CBT) and other behavioral methods to patients diagnosed with chronic pain. The VR content is delivered while incorporating CBT to enable diaphragmatic breathing exercises and mindfulness strategies, and is intended to be self-administered, unsupervised in the patient's home while the patient is in a seated position. The device is powered by a rechargeable lithium battery. Each device is intended for a single patient. The medical device is meant for repeated use, does not include non-medical software, and is only effective when treating chronic pain.

It appears there's a misunderstanding in the request. The provided FDA 510(k) clearance letter for RelieVRx (Pico G3) does not contain any information about clinical performance studies, acceptance criteria, sample sizes, expert involvement, or ground truth for the device's efficacy in pain relief.

This 510(k) clearance is specifically for a minor modification – the addition of a Predetermined Change Control Plan (PCCP) to allow future hardware updates (specifically to the VR headset) without requiring a new 510(k) submission, provided these changes adhere to predefined criteria and do not alter the intended use or therapeutic content.

The letter explicitly states:

• "No new nonclinical performance testing was conducted to demonstrate substantial equivalence."
• "The only changes that have been made to the RelieVRx in the current submission are the addition of a Predetermined Change Control Plan to accommodate potential future updates to the device hardware."
• "Please refer to K243417 for a comprehensive description of non-clinical testing that has been completed to validate the device."

Therefore, the information regarding the device's performance in reducing pain and pain interference, and the study that would demonstrate it meets acceptance criteria for its therapeutic effect, would be found in the original 510(k) clearance for the predicate device (K243417), not in this document.

Since the provided document K251519 does not contain the requested information about clinical performance studies, I cannot fill out the requested table or answer most of the questions.

However, I can extract the relevant information from this document regarding the nature of the submission and what it does discuss:

Based on the provided FDA 510(k) Clearance Letter (K251519) for RelieVRx (Pico G3):

This 510(k) does not describe a study proving the device meets acceptance criteria for its direct therapeutic effect on pain. Instead, it's a submission for a Predetermined Change Control Plan (PCCP) to streamline future hardware modifications. Therefore, most of the requested fields related to clinical performance testing cannot be filled from this document.

Here's what can be gathered regarding the purpose of this specific 510(k) and how it addresses a "change":

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: For this specific 510(k), the acceptance criteria are related to the Predetermined Change Control Plan (PCCP). The plan outlines that any future hardware modifications made under the PCCP must:
  • Maintain the same intended use and therapeutic content.
  • Meet predefined acceptance criteria aligned with "Table 6 of the PCCP" (which is not provided in this document). These criteria are for "safety, biocompatibility, and software performance" of the modified configurations.
  • Undergo specified verification and validation protocols (electrical and mechanical testing (IEC 60601-1/11), electromagnetic compatibility (IEC 60601-1-2), environmental and acoustic safety, performance benchmarking).
  • Be clearly communicated to users via updated labeling.
• Reported Device Performance (for this submission): No new clinical performance data is reported as "no new nonclinical performance testing was conducted to demonstrate substantial equivalence." The substantial equivalence claim is based on the subject device being identical to the predicate (K243417) in its intended use, indications, principles of operation, and technological characteristics, with the only change being the addition of the PCCP.

Therefore, a table describing "device performance" in terms of pain relief effectiveness cannot be constructed from this document. The "performance" discussed here is adherence to a change control plan.

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

• Not applicable for this 510(k). This submission did not involve new clinical performance testing on a test set to prove therapeutic efficacy.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable for this 510(k). No clinical ground truth for therapeutic efficacy was established in this submission.

4. Adjudication Method for the Test Set:

• Not applicable for this 510(k).

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

• No, not for this 510(k). This submission focuses on a change control plan, not a comparative effectiveness study for therapeutic outcomes.

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

• No, not for this 510(k). This device is a preloaded VR system for patient self-administration, not an AI algorithm with standalone performance metrics.

7. The Type of Ground Truth Used:

• Not applicable for this 510(k). No new clinical ground truth was established for this submission. The device's foundational efficacy would have been established in the predicate device's clearance (K243417).

8. The Sample Size for the Training Set:

• Not applicable for this 510(k). This submission pertains to a hardware change control plan, not the training of a new therapeutic algorithm.

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

• Not applicable for this 510(k).

Summary of what K251519 is about:
This 510(k) (K251519) is a software modification 510(k), specifically for adding a Predetermined Change Control Plan, not a clinical efficacy study for a new device or significant modification to the therapeutic content. All discussions about performance and validation in this document relate to ensuring that future hardware changes will not adversely affect the device's safety or effectiveness, building upon the substantial equivalence established by its predicate (K243417).

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RelieVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence based 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 interference associated with chronic lower back pain.

RelieVRx is an immersive virtual reality (VR) system with preloaded software content on a proprietary hardware platform that delivers automated cognitive behavioral therapy (CBT) and other behavioral methods to patients diagnosed with chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The VR content is delivered while incorporating CBT to enable diaphragmatic breathing exercises and mindfulness strategies, and is intended to be self-administered, unsupervised in the patient's home while the patient is in a seated position. Each device is intended for single patient use during treatment and can be used on multiple patients over the device lifetime. The medical device does not include nonmedical software and is only effective when treating chronic lower back pain.

Similar to the predicate device, EaseVRx (DEN210014), the Relie VRx device consists of an off-the-shelf VR head-mounted display with added Breathing Amplifier 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. No change is being made to the core RelieVRx program used in the pivotal clinical trial conducted for market authorization; the 8-week theme-based structure, weekly VRexperience structure, and daily session structure is unchanged. Minor changes were made to the content of the 56 VR sessions. Briefly, 46 of 56 VR sessions are unchanged. Of the 10 sessions that have been updated, there were 3 changes to Relaxation/Interoceptive sessions, and 7 changes to Distraction sessions. The 3 Relaxation/Interoceptive sessions include slightly altered minor graphical rendering to improve images. The 7 changes to Distraction sessions include changed background which is dimmer to help to user to achieve the goal of attentional focus (dragonfly). There is no negative impact on safety or effectiveness.

The provided FDA 510(k) summary for RelieVRx (K243417) indicates that clinical testing was NOT performed for this specific submission to demonstrate substantial equivalence. Instead, substantial equivalence was established through the results of nonclinical testing and a comparison of technological characteristics to the predicate device, EaseVRx (DEN210014).

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets them from this document. The document states:

"Clinical Testing
Substantial equivalence of the subject device to the predicate has been established through the results of nonclinical testing."

Since no clinical study was conducted for this specific submission, the subsequent points regarding sample size, data provenance, ground truth, adjudication, MRMC studies, or standalone performance are not applicable based on the provided text.

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VRNT is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence-based 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.

VRNT is an immersive virtual reality (VR) system which delivers behavioral therapy content for the treatment of chronic pain via virtual reality hardware. VRNT is a prescription-use device containing pre-loaded, proprietary content on commercially available VR hardware shown in the figure below. The behavioral content incorporates cognitive behavioral therapy (CBT) skills and other evidence-based behavioral methods.

VRNT uses a virtual reality system called GearVR, consisting of a virtual reality head-mounted display, a hand controller and a smartphone

VRNT is designed to be used in an 8-week treatment program which delivers a multifaceted combination of pain management skills training through a sequence of daily sessions (5 days a week) ranging from 7-27 minutes in length (average of 20 minutes). Similar to multisession behavioral treatment program begins with basic skills and progresses to more advanced skills over the 8 weeks. Initial themes in VRNT are focused on understanding the basic science behind chronic pain and developing rudimentary breathing, bodily awareness and mindfulness, relaxation and interoception skills. Later themes build on these skills; they expand on interoception, add passive distraction and refocusing attention, thought appraisal skills for managing emotion triggers. Finally, the program provides opportunities to practice applying the education and self-regulation skills when faced with actual pain triggers. The treatment content, thus, allows the patient over time to build upon education, skills training and their own experiential learning in a manner that increasingly mimics real-world situations.

Here's a breakdown of the acceptance criteria and study information for the VRNT device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details the clinical study results as evidence of effectiveness but does not explicitly state pre-defined acceptance criteria in a quantitative table format. Instead, it describes the statistical significance and effect sizes achieved.

• 60% of VRNT participants, compared to 30% of controls, achieved clinically meaningful reductions (at least 30%) in pain intensity.
• 47% of VRNT participants compared to 13% of controls achieved ≥50% pain reduction. |
  | Reduction in Pain Interference | - Significantly greater reduction in pain interference at post-treatment than controls (group by time interaction, p = 0.002, g = 0.84; large effect).
• 77% of VRNT participants compared to 53% of controls achieved at least 30% reduction in interference.
• 60% of VRNT participants compared to 30% of controls achieved ≥50% pain interference reduction. |
  | Reduction in Pain Interference (Individual Items) | - Significantly greater improvement in interference with general activity, mood, and sleep (p values: 0.03, 0.0006, 0.001, respectively).
• General Activity: 80% VRNT and 53% control achieved ≥30% reduction; 67% VRNT and 37% control achieved ≥50% reduction.
• Mood: 77% VRNT and 37% control achieved ≥30% reduction; 63% VRNT achieved ≥50% reduction.
• Sleep: 73% VRNT and 30% control achieved ≥30% reduction; 53% VRNT achieved ≥50% reduction. |
  | Safety | - 3% (1/31) of VRNT condition participants reported any adverse events (temporary cybersickness). |

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

The "test set" in this context refers to the clinical trial participants.

• Sample Size: 61 adults.
• Data Provenance: Prospective, randomized clinical trial conducted by the device developer. The country of origin for the data is not explicitly stated.

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

This device is a therapeutic virtual reality system, not a diagnostic or AI-driven image analysis device that requires expert ground truthing of cases. The "ground truth" for its effectiveness is based on patient-reported outcomes (pain intensity and pain interference) as assessed by the Short-Form Brief Pain Inventory (BPI-SF). The validation of these measures is established in the medical community through psychometric studies, not by expert consensus on individual cases for a test set in the way a diagnostic algorithm might be evaluated.

4. Adjudication Method for the Test Set

Not applicable. As this is a therapeutic device evaluated by patient-reported outcomes in a randomized controlled trial, there is no "adjudication method" in the context of expert review of cases (like 2+1 radiology review). The primary outcomes were assessed using a standardized, validated questionnaire (BPI-SF).

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI, where multiple readers evaluate cases with and without AI assistance. The VRNT device is a therapeutic tool, and its effectiveness was evaluated via a randomized controlled clinical trial comparing the device to a control group.

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

The clinical trial is essentially a standalone performance study of the device (which includes the algorithm/software as its core therapeutic component). The "human-in-the-loop" here is the patient using the VR system, not a clinician interacting with an AI output for diagnosis or interpretation. The study evaluates the effectiveness of the VRNT program as a whole, including the software and the patient's interaction with it, without direct real-time human expert intervention to modify its output or efficacy during the treatment sessions.

7. The Type of Ground Truth Used

The ground truth for the clinical effectiveness study was based on patient-reported outcomes (PROs) of pain intensity and pain interference, measured using the Short-Form Brief Pain Inventory (BPI-SF). These are standardized, validated instruments in clinical research for chronic pain. The "ground truth" for an individual patient's pain experience is inherently subjective and best captured directly from the patient using such tools.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning model development. The VRNT device delivers "behavioral therapy content" based on "cognitive behavioral therapy (CBT) skills and other evidence-based behavioral methods." This suggests that the content and therapeutic approach are designed based on established psychological and medical principles, rather than being developed through a machine learning training process on a specific dataset.

If there were any underlying AI components that were "trained," the details are not provided in this regulatory summary. The focus is on the clinical validation of the therapeutic program as a whole.

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

Not applicable, as no training set for a machine learning model is described in this document. The "ground truth" for the therapeutic approach is established through decades of research in CBT and other evidence-based behavioral methods for pain management. The content of the VRNT program is derived from these established principles.

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The Smileyscope System's Therapy Mode is a prescription-use intual reality system intended to provide adjunctive treatment based on guided relaxation and other evidence-based behavioral methods for patients aged 4-1 years who can cooperate and interact with the device at a developmentally appropriate level. The Smileyscope Therapy Mode is intended to temporarily reduce and/or manage pain and temporarily relieve acute procedural with needle procedures (e.g., venipuncture, IV placement, vaccination, port access, subcutaneous injections). The device is not intended to treat anxiety disorders or specific phobias (e.g. trypanophobia).

Smileyscope is an immersive virtual reality (VR) device, consisting of Hardware and Software components. In Smileyscope Therapy mode, the device delivers 3-dimensional virtual reality treatment based on guided relaxation and other evidence-based behavioral methods to temporarily reduce pain and temporarily relieve acute procedural anxiety in individuals undergoing needle procedures. This prescription-use device uses pre-loaded software on a proprietary hardware and software platform to deliver treatment. The Smileyscope device is supplied with a USB charger and USB cable to facilitate charging.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Smileyscope System (Therapy Mode):

Background Note: This document is a 510(k) summary, which often focuses on establishing substantial equivalence to a predicate device rather than presenting a full, detailed clinical study report. Therefore, some specific details about the study methodology (e.g., precise expert qualifications, detailed adjudication methods for ground truth) might not be explicitly stated in this type of summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the "Special Controls" applied to the predicate device, which the Smileyscope Therapy Mode aims to meet, and the "Clinical Performance Testing" results presented.

• Emergency Department study (N=123): Nil adverse effects in treatment arm.
• Outpatient Pathology study (N=129): 3 mild adverse effects in treatment arm.
  Overall, "safe, with no significant adverse effects." Adverse effects were mild (nausea, dizziness, headache, vomiting) and self-limiting. |
  | 2. Patient-contacting components are biocompatible. | Met: Biocompatibility evaluation performed per FDA guidance (ISO 10993-1:2018) for surface-contacting, limited duration (intact skin) components. Tests included Cytotoxicity, Sensitization, Intracutaneous Reactivity. |
  | 3. Software verification, validation, and hazard analysis performed. | Met: Documentation provided for "Minor" Level of Concern software, including requirements, traceability, revision history, V&V, hazard analysis, and cybersecurity. |
  | 4. Electromagnetic compatibility (EMC) and electrical, mechanical, and thermal safety testing performed. | Met: Conformance declared to harmonized standards (e.g., IEC 60950-1, EN 62368-1 for electrical safety; EN 301 489 series, EN 55032/55035 for EMC). |
  | 5. Labeling includes warnings for nausea/motion sickness, discomfort, and summary of clinical testing. | Implied Met: Labeling is listed as a migration measure for identified risks (nausea/motion sickness, discomfort, ineffective treatment, use error). A summary of clinical testing is provided in the 510(k) (and presumably in the actual labeling). |
  | II. Clinical Effectiveness Criteria (from study results): | |
  | Temporarily reduce and/or manage pain (primary effectiveness endpoint). | Met:
• Emergency Department study: Child Self-Rated Pain (Faces Pain Scale-Revised) reduction of -1.78 units with Smileyscope Therapy Mode vs. control (p=0.018).
• Outpatient Pathology study: Child Self-Rated Pain (Faces Pain Scale-Revised) reduction of -1.39 units with Smileyscope Therapy Mode vs. control (p=0.034). |
  | Temporarily relieve acute procedural anxiety (secondary effectiveness endpoint). | Met: Both studies "substantially reduced the secondary endpoint of procedural anxiety." (Specific quantitative results for anxiety are not provided in this summary table). |

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

The "test set" here refers to the subjects in the clinical performance studies.

• Sample Size:

  • Emergency Department study: 123 (64 in Smileyscope Therapy Mode arm, 59 in Control arm).
  • Outpatient Pathology study: 129 (63 in Smileyscope Therapy Mode arm, 66 in Control arm).
  • Combined N = 252 (Enrollment N=254, but treatment group totals 252).

• Data Provenance:

  • Country of Origin: "Outside of the United States only". The specific countries are not mentioned in this summary.
  • Retrospective or Prospective: These were "randomized clinical studies" and referenced as "randomized controlled studies," implying a prospective design. Given that they are published in a peer-reviewed journal and were used for regulatory submission, this is a strong indication of prospective data collection.

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

• The summary does not explicitly state the number of experts or their qualifications for establishing ground truth, as the primary effectiveness endpoint was "Child Self-Rated Pain (Faces Pain Scale-Revised)." This is considered a patient-reported outcome (PRO).
• For the secondary endpoint of "procedural anxiety," again, no specific expert involvement for ground truth is mentioned. Procedural anxiety in children is often assessed using validated scales administered by trained researchers or clinicians, or through observational measures.

4. Adjudication Method for the Test Set

• The summary does not explicitly state an adjudication method (e.g., 2+1, 3+1, none) for the test set. Given that the primary endpoint was child self-rated pain, and the studies were randomized controlled trials, the outcome measure itself (Faces Pain Scale-Revised) is directly reported by the patient. Adjudication of such an endpoint by external experts is generally not performed.
• For other aspects of the study (e.g., adverse event reporting, study protocol adherence), there would have been standard clinical trial monitoring and oversight, but this is not detailed as a "ground truth" adjudication.

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

• No, an MRMC comparative effectiveness study was not done in the context of human readers with vs. without AI assistance.
• This device is a virtual reality behavioral therapy device, not an AI-powered diagnostic or assistive tool for human readers. Its primary function is to deliver therapeutic content directly to the patient to reduce pain and anxiety, rather than to assist a human in interpreting data or making a diagnosis. The studies compared the device's therapeutic effect against a control condition.

6. Standalone Performance (Algorithm Only)

• Yes, in essence, standalone performance was done for the "algorithm only" (the therapeutic virtual reality program). The studies measured the direct effect of the Smileyscope Therapy Mode on patients, where patients interacted solely with the device (software content running on specific hardware) and clinicians administered it.
• There was no "human-in-the-loop" component in the sense of a human interpreting AI output or making decisions based on AI assistance. The human (clinician) used the device as a tool, and the "performance" here refers to the device's therapeutic effect on the patient, which was measured directly in the clinical trials against a control.

7. Type of Ground Truth Used

• The primary ground truth used for effectiveness was patient-reported outcomes (PROs), specifically "Child Self-Rated Pain (Faces Pain Scale-Revised)."
• For safety, reported adverse events were the ground truth.

8. Sample Size for the Training Set

• The document does not mention a training set sample size. Because this device delivers virtual reality behavioral therapy, the "algorithm" is the behavioral therapy program itself, not a machine learning model that requires a separate training set in the typical sense.
• The development of the VR experience and its behavioral techniques would have been informed by existing evidence-based behavioral methods, but this is a different concept than a machine learning training set.

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

• As there's no explicit mention of a machine learning training set in the document, establishing ground truth for such a set is not applicable here.
• The "ground truth" for the device's therapeutic approach is implicitly based on "guided relaxation and other evidence-based behavioral methods" which are established practices in psychology and pain management. The clinical studies then validated if the VR delivery of these methods achieved the intended therapeutic effect.

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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.

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.

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:

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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