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The ISEN-Goggles with Data Viewer are used in the assessment of nystagmus by measuring, displaying, and analyzing eye movements.

This device consists of patient eye goggles ("ISEN-Goggles"), previously cleared under K152727, and a software application for data visualization and analysis ("Data Viewer").

The ISEN-Goggles have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USB port to facilitate transfer of data captured and stored in the device's SD-type memory.

The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for nearsimultaneous viewing of the video images from both eyes on the attached LCD screen.

The Data Viewer software retrieves data from the goggles, displays it, performs analysis functions, and exports customizable reports. It includes a patient database.

The provided text from the 510(k) notification for the ISEN-Goggles with Data Viewer (K163270) specifically states:

"No clinical testing is included in this 510(k)."

Therefore, based on the provided document, the following points cannot be addressed as no study was presented to prove the device meets acceptance criteria.

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available.
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 available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
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: Not available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as no clinical testing was performed for the algorithm component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
8. The sample size for the training set: Not applicable, as no clinical testing was performed for the algorithm component.
9. How the ground truth for the training set was established: Not applicable, as no clinical testing was performed for the algorithm component.

The 510(k) submission primarily relies on non-clinical testing and substantial equivalence to a predicate device (ICS Impulse System Model 1085, K151504). The non-clinical testing included:

• Electrical safety testing: IEC 60601-1
• Electromagnetic compatibility testing: IEC 60601-1-2
• Lamp safety: IEC 62471
• FCC regulations: 47 CFR Part 15
• Battery testing: IEC 62133
• Biocompatibility testing: ISO 10993
• Hardware and software verification and validation.

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The ISEN-Goggles are used to record and visually display movements of the eyes including nystagmus.

This device consists of patient eye goggles with an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USB port to facilitate transfer of data captured and stored in the device's SD-type memory.

The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for nearsimultaneous viewing of the video images from both eyes on the attached LCD screen.

This document is a 510(k) premarket notification for a medical device called "ISEN-Goggles". The purpose of this notification is to demonstrate that the ISEN-Goggles are substantially equivalent to a legally marketed predicate device. As such, it does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical trial might.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ICS Medical VEMR, K972631) by comparing similar technical characteristics and intended use.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in the typical sense of a clinical or performance study. Its primary goal is to show equivalence. The "performance" is implicitly demonstrated by the comparison to the predicate device in functionality.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There is no clinical test set or data described in this 510(k) submission. The document explicitly states: "No clinical testing is included in this 510(k)."

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 testing or test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical testing or test set 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

Not applicable. The device described, "ISEN-Goggles," is an IR/Video Eye Movement Viewer/Recorder, not explicitly an AI-driven image analysis or diagnostic tool that would typically undergo an MRMC study for improved human reader performance. No such study is mentioned or implied.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as the device is not an algorithm for standalone performance. It's a tool to view and record eye movements, which a human operator then interprets.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical testing is described.

8. The sample size for the training set

Not applicable, as no algorithm training or clinical data is mentioned for this purpose.

9. How the ground truth for the training set was established

Not applicable, as no algorithm training or clinical data is mentioned.

Summary of what the document DOES provide regarding "acceptance":

The "acceptance criteria" in the context of this 510(k) are implicitly focused on demonstrating substantial equivalence to the predicate device, K972631. This is achieved by:

• Matching Intended Use/Indications for Use: Both the ISEN-Goggles and the predicate device are used to "record and visually display movements of the eyes including nystagmus."
• Technological Comparison (Table 5-1): The document provides a detailed comparison of features, highlighting similarities (e.g., goggles with IR sensitive video cameras, IR LEDs) and explaining differences (e.g., miniaturization, combined components, energy source) as not affecting substantial equivalence.
• Non-clinical Testing: This type of testing serves as "acceptance criteria" for safety and performance under various standards.
  • Tests Performed:
    • Electrical safety: IEC 60601-1
    • Electromagnetic compatibility: IEC 60601-1-2
    • Lamp safety: IEC 62471
    • FCC regulations: 47 CFR Part 15
    • Battery testing: IEC 62133
    • Biocompatibility: ISO 10993
    • Hardware and software verification and validation.
  • Reported Device Performance: The document states that these tests were "completed," implying successful conformance to the respective standards. The specific performance values or pass/fail criteria for each test are not detailed in this summary, but the successful completion is a form of "acceptance criteria met."

In essence, for a 510(k) submission, "acceptance" largely means demonstrating that the new device is as safe and effective as a legally marketed predicate, primarily through technical and non-clinical data, rather than extensive clinical efficacy studies comparing it against a 'gold standard' for a particular diagnostic outcome.

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