(111 days)
The REAL Immersive System is an immersive virtual reality and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of virtual environments and full presence tracked avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a seated position in a clinical environment and prescribed and supervised by a medical professional trained in rehabilitation therapy.
REAL Immersive System is a digital hardware and software medical device platform using a combination of virtual environments and full presence tracked avatars for visual feedback. It is designed for use in healthcare and focusing on physical and neuro rehabilitation. The use of the device is intended to be in a clinical environment supervised by a medical professional trained in rehabilitation therapy.
REAL Immersive System contains the following components:
- . All-in-One HMD with Software Application
- . HMD Controller
- Wireless Transmitter Module (WTM or Large Sensor) .
- Wireless Sensor Module (WSM or Small Sensor) .
- . Tablet with Software Application
- . Sensor Charger (charging station)
- Router ●
- Router Battery ●
- Sensor Bands .
The provided text is a 510(k) premarket notification letter for the Penumbra REAL Immersive System. This type of FDA submission seeks to establish substantial equivalence to a legally marketed predicate device, rather than proving novel claims or establishing new general acceptance criteria through a full clinical trial. Therefore, the document does not describe specific acceptance criteria a device must meet in a traditional sense, nor does it present a study that proves the device meets those criteria for novel claims.
Instead, the submission demonstrates that the REAL Immersive System is substantially equivalent to a predicate device (MindMotion Pro) based on:
- Similar intended use.
- Similar technological characteristics.
- Non-clinical performance data (biocompatibility, electrical safety/EMC, software verification & validation, bench-top performance) that shows the device functions as intended and does not raise new questions of safety or effectiveness compared to the predicate.
Given this context, I will address your request by interpreting "acceptance criteria" as the types of testing and successful results deemed sufficient by the FDA for establishing substantial equivalence for this type of device, as outlined in the provided 510(k) summary. "Reported device performance" will refer to the summary of results presented.
Here's an analysis based on the provided document:
1. Table of "Acceptance Criteria" (interpreted as required testing categories for 510(k) SE) and Reported Device Performance
| Acceptance Criteria Category (Testing Type) | Reported Device Performance (Summary of Results) |
|---|---|
| Biocompatibility Testing | "non-clinical testing has not found the REAL Immersive System to be biologically incompatible according to ISO 10993 requirements." Tests performed: Cytotoxicity, Irritation, Sensitization. |
| Electrical Safety and EMC Testing | "The system complies with the requirements of ANSI/AAMI 60601-1:2005, IEC 60601-1-2:2014, 60601-1-6:2010, and IEC 62366:2007. REAL Immersive System also underwent FCC testing and is FCC certified." |
| Software Verification and Validation | "Software verification and validation testing and documentation was provided... The software for this device was considered as a 'moderate' level of concern." Implies successful V&V for this classification. |
| Bench-Top Performance (Design Verification) | "All tests passed successfully." Tests included: Packaging, Battery performance, HMD and Sensor Accuracy, Simulated Use, and Usability Interface Summative. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical trial with a defined test set of patient data. The "test set" here refers to the device itself undergoing various engineering and biological safety tests. The document does not specify a numerical sample size for components tested, but rather indicates that the required tests were performed on "the device."
- Data Provenance: The data is generated internally by Penumbra, Inc. through their engineering and quality control processes to ensure compliance with relevant standards. It is not patient or clinical data in this context. The provenance is therefore the device manufacturer's internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. The ground truth for these types of engineering and biocompatibility tests is adherence to established international and national standards (e.g., ISO 10993, ANSI/AAMI 60601-1, IEC 60601-1-2, FCC). There isn't a "ground truth" established by human experts in the sense of clinical annotations or pathological diagnoses for this type of submission.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus-building among multiple human evaluators, typically in clinical studies, to establish ground truth or assess outcomes. These are not relevant for demonstrating compliance with engineering and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this 510(k) submission. The document explicitly states: "No clinical study was conducted as bench testing was determined sufficient for verification and validation purposes."
- Effect size: Therefore, there is no reported effect size for human readers improving with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not directly applicable in the terms usually associated with AI/ML algorithms. The REAL Immersive System is essentially an "algorithm only" system in the sense that its software processes inputs and provides outputs. The performance here is evaluated against its functional specifications and compliance with standards, not generally as a standalone diagnostic or interpretative AI performance for clinical decision-making. The system's performance is demonstrated through the verification and validation (V&V) of its software.
7. The Type of Ground Truth Used
- The "ground truth" for the various tests conducted is defined by compliance with established industry standards and regulatory requirements.
- For biocompatibility: ISO 10993-1.
- For electrical safety/EMC: ANSI/AAMI 60601-1, IEC 60601-1-2, 60601-1-6, IEC 62366, FCC regulations.
- For software: FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- For bench-top performance: Manufacturer's internal design specifications and functional requirements.
8. The Sample Size for the Training Set
- Not applicable. This device is not described as utilizing machine learning or AI that requires a "training set" of data in the common sense for deriving algorithms or predictions. The software is developed using traditional engineering principles and verified against its specifications.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set."
In summary, the provided document is a 510(k) notification focused on demonstrating substantial equivalence through non-clinical performance data and compliance with established standards, not a report on a clinical study with traditional acceptance criteria for diagnostic accuracy or clinical outcomes.
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.