FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Focus VNG/ENG is a PC-based system, which consist of software modules for installation on a PC, an isolation transformer, a hardware platform, a mains adapter, stimulation devices and recording devices.

The stimulation and recording devices are connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required.

AI/ML Overview

The provided 510(k) summary for the Focus VNG/ENG type 1068 does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the way one might expect for a new AI/ML-based device.

Instead, this submission leverages the substantial equivalence pathway, common for traditional medical devices. This means the device's "effectiveness" is primarily demonstrated by its similarity to a legally marketed predicate device (ICS Medical CHARTR ENG/VNG Diagnostic System, K991497) and its compliance with relevant safety standards.

Therefore, many of the requested sections below will indicate "Not applicable" or "Not provided in this document" because the nature of the submission does not involve a performance study against specific, quantified acceptance criteria for an AI algorithm.

Here's a breakdown based on the available information:

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Effectiveness: The device is "substantially equivalent" to a legally marketed predicate device (ICS Medical CHARTR ENG/VNG Diagnostic System, K991497). The predicate device is "of a technology type that is available and accepted in the market."	The Focus VNG/ENG performs the same intended function: measuring, recording, and displaying involuntary movements (nystagmus) of the eyeball, similar to the predicate. The submission indicates the device's effectiveness relies on its similarity and established market acceptance of this technology type.
Safety: Compliance with relevant medical device safety standards.	- EN 60601-1:1990, UL 60601-1:2003, CAN/CSA-C22.2 NO 601.1-90:1990 (Medical Electrical Equipment. Part 1: General requirements for safety)

EN 60601-1-1:2001 (Medical Electrical Equipment. Part 1: General requirements for safety. 1. Collateral standard: Safety requirements for medical electrical systems)
EN 60601-1-2:2001 (Medical Electrical Equipment. Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests)
EN 60601-2-40:1998 (Medical electrical equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment)
ISO 9001:2000 (Quality Management Systems – Requirements)
ISO13485:2003 (Quality management systems Requirements for regulatory purposes) |
| Technological Characteristics: Key components and interfaces are comparable or offer improvements over the predicate in a way that doesn't raise new safety or effectiveness questions. | Differs from predicate (CHARTR ENG/VNG) in:
External hardware platform with USB interface: (Predicate has built-in hardware, integrated in computer)
Software: (No specific performance difference described, assumed to perform similarly)
Video goggles: (Not detailed, but implies recording/stimulation mechanism is comparable) |

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided in this document. This submission is based on substantial equivalence to a predicate device, not on a clinical performance study with a test set of patient data to evaluate algorithmic performance. The effectiveness is inferred from the predicate's established performance and the new device's comparable design and intended use.

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 / Not provided in this document. No "ground truth" establishment for a test set is described, as it's not an AI/ML performance study.

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

Not applicable / Not provided in this document. No test set or adjudication method 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 / Not done. This is not an AI-assisted diagnostic device, but a measurement and recording device for a physiological signal. No MRMC study or human reader improvement with AI assistance is mentioned.

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

Not applicable / Not done. This device is a complete system (hardware and software) intended for use by a clinician, not a standalone algorithm. Its effectiveness is based on its function as a nystagmograph, not as an AI algorithm.

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

Not applicable / Not provided in this document. As it's not a performance study of an AI algorithm, no specific ground truth for performance evaluation is described. The "ground truth" for its function as a nystagmograph is implicitly the established medical understanding of involuntary eye movements and the ability of such devices to measure them.

8. The sample size for the training set:

Not applicable / Not provided in this document. This is a hardware and software system, not an AI/ML model that requires a training set.

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

Not applicable / Not provided in this document. No training set or ground truth establishment for a training set is described.

Summary

Regulation Number and Section

§ 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).