(70 days)
This device is used to record and visually display movements of the eyes including nystagmus.
The VEMR™ Eye Movement Recorder is used to observe or record eye movements on a video monitor or video recording tape respectively. This device consists of: patient eye goggles, a video image splitter/power-supply, a video tape cassette recorder (VCR) video monitor console, and a remote control accessory. There is also a built-in microphone in the eye goggles to provide simultaneous voice recording's on a video recording tape. The patient eye goggles are an opaque, facially worn device fitted with tiny video cameras, infrared light emitting diodes (LED's), and a microphone. The diodes illuminate the eyes for video cameras that produce video signals. These signals are processed by the image processor that essentially allows for simultaneous viewing the video images of both eyes on the video screen. The microphone allows for recording of voices to help document events recorded on video tape. The remote control accessory provides remote control of the various functions (e.g. play, record etc.) on the VCR/video monitor console.
The provided document describes the ICS VEMR™ Eye Movement Recorder, a device used to observe and record eye movements. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of accuracy or efficacy for its intended use.
Instead, the document details:
- Substantial Equivalence: The device is deemed substantially equivalent to the House InfraRed/Video Electronystagmograph System.
- Description of the Device: Components and basic function.
- Intended Use: To record and visually display movements of the eyes including nystagmus.
- Technological Similarities and Differences to Predicate Device: A comparison table.
- Non-Clinical Tests: These tests focus on safety and electromagnetic compatibility, not clinical performance for its stated intended use.
Therefore, many of the requested sections regarding acceptance criteria and performance studies cannot be filled from the provided text.
Here's an analysis of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (if available) | Reported Device Performance |
|---|---|---|
| Safety (Biocompatibility) | MEM Elution Cytotoxicity Test | Meets requirements. |
| Primary Skin Irritation Test on Rabbits | Not considered an irritant. | |
| Safety (Electrical) | UL-544/42 (dielectric withstand) | Meets requirements. |
| UL-544/46 (leakage current) | Meets requirements. | |
| Safety (Radiation) | Max irradiance (ACGIH TLV) | Approx. 1/270 of recommended TLV. |
| Max radiance (ACGIH TLV) | Approx. 1/1700 of recommended TLV. | |
| Electromagnetic Compatibility (EMI) | CISPR 11 B (EN55011) Conducted Emissions | Passed. |
| CISPR 11 A (EN55011) Radiated Emissions | Passed. | |
| Military Standard 461 RE 101 Magnetic Emissions | Passed. | |
| ENV 50140 (IEC 1000-4-3) Radiated Susceptibility Test | Passed. | |
| EN 61000-4-2 Electrostatic Discharge Test | Passed. | |
| EN 61000-4-4 Transient Susceptibility Test | Passed. | |
| EN 61000-4-5 Surge Immunity Test | Passed. | |
| Clinical Performance (Accuracy/Efficacy for Intended Use) | Not specified or reported. | Not specified or reported. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. The document describes non-clinical safety and electromagnetic compatibility (EMC) tests, not performance studies on human subjects.
- Data Provenance: Not applicable for clinical performance. The non-clinical tests were likely conducted in a lab environment (e.g., GLP regulations for cytotoxicity and irritation tests, specific test facilities for EMI).
- Retrospective or Prospective: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no clinical performance study with expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical performance study requiring adjudication is described.
5. 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 MRMC study was done. The device does not perform any analyses or measurements; it is a recorder/viewer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone performance study of an algorithm was done. The device is explicitly stated as a "stand-alone device that only permits viewing of the eyes and recording their movements on video tape. Our device does not perform any analyses or measurements of the images."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no clinical performance study requiring ground truth is described.
8. The sample size for the training set
- Not applicable as there is no mention of an algorithm or AI that would require a training set.
9. How the ground truth for the training set was established
- Not applicable as there is no mention of an algorithm or AI.
Conclusion:
The 510(k) submission for the ICS VEMR™ Eye Movement Recorder focuses on demonstrating substantial equivalence to a predicate device and proving safety and electromagnetic compatibility through non-clinical testing. It explicitly states that the device "does not perfom any analyses or measurements of the images," thus negating the need for clinical performance studies related to diagnostic accuracy, a typical requirement for AI/algorithm-driven devices. The acceptance criteria and "study" are primarily related to safety, electrical standards, and EMC, where the device "passed" or "meets the requirements" or "is not considered an irritant," etc.
§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).