Search Results

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).

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device