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

The Nidek Model NT-4000 non-contact tonometer optically detects the momentary state of the cornea (applanated by air pressure) and measures intraocular pressure without touching the cornea.

The Model NT-4000 is comprised of main unit and a measuring unit that are provided on a base unit. Each unit contains the following components:

MAIN UNIT: A screen, control panel, and joystick are provided on this unit. .
MEASURING UNIT: The air nozzle and photo-detector are provided on this unit. .
BASE UNIT: The chinrest and a printer are provided on this unit. .

The Model NT-4000 has the following features:

1. Auto Alignment Mode: When the measuring unit approaches the center of the pupil in this mode, the instrument automatically performs alignment in the up, down, left, and right directions, and focuses in the back and forth directions. The measurement then starts automatically.
1. Automatic Puff Control (APC) Function: The intraocular pressure measurement can be performed with the air pressure as low as possible. When the measurement range is set to "APC 40" or "APC 60", in the first measurement, the automatic shut-off function (which is to stop puffing air as soon as the light reflected from the cornea is detected) activates in order to eliminate excessive puffing. In the subsequent measurement, the APC function activates to perform the measurement with the minimum air pressure based on the former measurement data. As the patient's eye is protected from excessive air pressure, the patient's comfort level increases and continuous measurement can be performed smoothly.
1. Pulse Synchronized Intraocular Pressure Measurement: In addition to the standard IOP measurement mode, the intraocular pressure measurement can be performed in synchronization with an arbitrary position of the pulse signal that is obtained by the detector in the forehead rest. When the signals of the pulse and the completion of the alignment are detected simultaneously, the pulse synchronized IOP measurement is executed. It is possible to select the point of a pulse (i.e., either peak, middle, or bottom) to which measurement will be synchronized.

AI/ML Overview

The provided document describes the Nidek Non-Contact Tonometer Model NT-4000 and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study information requested.

The document focuses on:

Device Description: What the NT-4000 is and its features.
Intended Use: Measurement of intraocular pressure.
Technological Characteristics Comparison: A table comparing the NT-4000 to its predicate (NT-1000) highlighting similar functions and minor differences.
Performance Data (General): States that the device was tested against specific electrical safety, electromagnetic compatibility, and ophthalmic instrument standards (EN 60601-1, EN 60601-1-2, EN 60601-1-4, ISO 15004, JIS T7312) and "was found to meet all requirements."
Conclusion: The device is equivalent to the predicate in intended use, technological characteristics, safety, and effectiveness.
FDA Clearance Letter: Confirmation of 510(k) clearance based on substantial equivalence.

Therefore, I cannot populate most of the requested fields because the necessary detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement is not present in the provided text.

Here's what can be extracted and what cannot:

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (As stated in Document)
Compliance with EN 60601-1 (Electrical Safety)	"was found to meet all requirements of both standards."
Compliance with EN 60601-1-2 (Electromagnetic Compatibility)	"was found to meet all requirements of both standards."
Compliance with EN 60601-1-4 (Programmable Electrical Medical Systems)	"was found to meet all requirements of the standard."
Compliance with ISO 15004 (Test Requirements and Test Methods for Ophthalmic Instruments)	"was found to meet all requirements of the standards."
Compliance with JIS T7312 (Test Requirements and Test Methods for Ophthalmic Instruments - Japan)	"was found to meet all requirements of the standards."
Substantial equivalence to predicate device (Nidek Model NT-1000)	"demonstrated through its evaluation...that the device is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness."

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Provided. The document only mentions general compliance with standards, not specific clinical or performance test data on a patient/sample cohort.
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)
- Information Not Provided. No mention of experts for ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Provided. No details on any specific test set or adjudication.
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
- Information Not Provided. This device is a non-contact tonometer for measuring IOP, not an AI-assisted diagnostic imaging device that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Information Not Provided. The device is a measurement instrument, not an algorithm in the sense of AI or software-only evaluation. Its "standalone" performance is implied by its ability to measure IOP.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information Not Provided. For a tonometer, "ground truth" would ideally be a gold standard IOP measurement device (e.g., Goldmann applanation tonometer). This is not specified, but the device's accuracy is likely compared against such a standard during its development or validation as implied by "meets all requirements of the standards."
The sample size for the training set
- Information Not Provided. Not applicable for this type of device, which relies on physical measurement principles rather than machine learning training sets.
How the ground truth for the training set was established
- Information Not Provided. Not applicable for this type of device.

Summary

Regulation Number and Section

§ 886.1930 Tonometer and accessories.

(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.