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The MICROPERIMETER MP-3 and MICROPERIMETER MP-3 Type S are indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry Visual rehabilitation

The modified NIDEK Microperimeter MP-3 type S measure the visual sensitivity of a specified area on the fundus and captures color fundus images. The fundus image overlaid with the retinal sensitivity mapping is displayed on the screen for fundusimage-correlated evaluation. With reference to the Microperimeter MP-3, cleared with K152729, a rehabilitation function and the capability to performs exams in scotopic environments (only MP-3 type S) have been added.

Visual sensitivity mapping function
Visual sensitivity mapping can be displayed using static perimetry principle.
Stimuli and a fixation target are displayed by the built-in LCD projector. While focusing on the fixation target, the response button to indicate that they saw a stimulus projected at the location and light intensity specified by the internal measurement program or the operator. The patient's response signals are computed by the device and measurement results are displayed on the LCD.

Fixation function
The MicroperimeterMP-3 can measure fixation and determine the preferred retinal locus, simply by having the patient fixate on a target. Any change in fixation can be compared pre- and post-treatment because the patiently tracked during microperimetry.

Fundus photography function
Auto alignment is performed while observing on the LCD, the front of the patient's eye illumination LED (infrared light). After the alignment is roughly complete, the mode automatically changes to the fundus observation mode. The fundus of the patient's eye is illumination LED (infrared light). After alignment and focusing are automatically performed on the fight from the xenon flash lamp is emitted on the fundus. The light reflected from the fundus is captured by the built-in color CCD camera for fundus image capture.

Visual rehabilitation
Visual rehabilitation is a collective name of Fundus-related microperimetry, Feedback exam, They are used to support the fixation training for patient.
Feedback exam: similar function with the Fixation exam. The same as those in Fixation exam, Feedback exam, and Fixation exam, and differ only in the following characteristics: in the Feedback exam, a sound is heard and the appearance of the fixation target changes when the patient's vision inside the circle specified by the operator (TRL Trained[tarqet] Retinal Locus, which the patient cannot see).

The provided text does not contain detailed information about specific acceptance criteria for performance, nor does it describe a study that explicitly proves the device meets such criteria with quantitative results.

Instead, the document primarily focuses on regulatory approval (510(k) summary) and establishes substantial equivalence to a predicate device. It states that the device has undergone non-clinical testing to verify its functions and performance requirements and compliance with applicable international standards. However, it does not provide the specific performance metrics (e.g., sensitivity, specificity, accuracy) that would constitute "acceptance criteria" in the context of diagnostic device validation.

Here's a breakdown of what is and isn't present, addressing your numbered points:

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

• Not provided. The document states that "performance tests... demonstrate that the subject device is effective and performs as well as the predicate device" but does not define specific acceptance criteria (e.g., minimum accuracy percentages, sensitivity/specificity thresholds) or report quantitative performance metrics for the device or its predicate.

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

• Not provided. The document mentions "non-clinical testing" but does not describe a clinical test set, its sample size, or data provenance.

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. Since no clinical test set or diagnostic efficacy study is detailed, there's no mention of experts establishing ground truth for such a test.

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

• Not applicable/Not provided.

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 provided. This document does not describe AI assistance or MRMC studies. The device itself is a Microperimeter and Ophthalmic Camera, not an AI-driven diagnostic system in the sense of assisting human readers.

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

• Not applicable/Not provided in the context of diagnostic performance. The device is a diagnostic tool, and its "standalone" performance would likely refer to its ability to measure visual sensitivity and capture images, which are assessed through engineering and design validation, not typically through standalone diagnostic accuracy studies described in this type of summary.

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

• Not provided/Not explicitly applicable. For a device acting as a measurement tool (microperimeter) and an imaging device (ophthalmic camera), ground truth during its development and validation would primarily relate to the accuracy of its measurements against known standards or the fidelity of its image capture. The document states "We have verified and validated that the Microperimeter MP-3 meets its functions and performance requirements," implying internal validation against engineering specifications and applicable standards, but not a "ground truth" derived from clinical diagnostic outcomes.

8. The sample size for the training set

• Not applicable/Not provided. The device is not described as an AI/machine learning system that requires a "training set."

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

• Not applicable/Not provided.

Summary of what is present regarding "acceptance criteria" and "study":

The core of the documentation provided is a 510(k) Summary for a medical device (Microperimeter MP-3, Microperimeter MP-3 Type S). A 510(k) submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific clinical acceptance criteria in the same way a PMA (Premarket Approval) would require.

• Acceptance Criteria (Implied): The implied acceptance criteria are that the device performs "as well as the predicate device" and complies with relevant international standards.

  • "Effective and performs as well as the predicate device." (from section "Non-Clinical and/or Clinical Tests Summary & Conclusions").
  • Compliance with international standards: IEC 60601-1-2, ISO 15004-1, ANSI Z80.36, ISO 12866, ISO 10940, IEC 62366-1, and IEC 62304 (for software). These standards address safety, performance, and usability aspects. The document states, "The results demonstrate that the subject device complies with applicable international standards... and it is safe as the predicate device."

• Study Proving Acceptance Criteria: The "study" mentioned is non-clinical testing (bench testing, software verification and validation).

  • Type of Study: Non-clinical testing, including bench testing and software verification and validation.
  • Purpose: To "verify and validate that the Microperimeter MP-3 meets its functions and performance requirements, and complies with applicable international standards."
  • Clinical Data: The document explicitly states "Clinical Summary: Not Applicable," indicating no new clinical studies were conducted for this 510(k) submission to demonstrate performance in a patient population. Substantial equivalence relies on the known performance and safety profile of the predicate device and the demonstration that the new device's differences do not raise new questions of safety or efficacy.

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