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The ODM-1000A/P intended used for ophthalmology to accurately measure the axial length (AL), anterior chamber depth (ACD), lens thickness (LT), and corneal thickness (CT).

The ODM-1000A intended used for ophthalmology to accurately measure the axial length (AL), anterior chamber depth (ACD), lens thickness (LT).

The ODM-1000P intended used for ophthalmology to accurately measure the corneal thickness (CT).

Ultrasound Imaging of the Eye Axial biometric parameter measurement of the Eye

ODM-1000 A/P Biometer is an ultrasonic measuring instrument of pulse reflection. It contains two independent units: A-Mode Axis Biometric Parameter Measuring Unit and P-Mode Corneal Thickness Measuring Unit. It can be selected by user to configure:

ODM-1000A Ultrasonic A-Biometer (only for axial A biometry)

ODM-1000P Pachymeter (only for corneal thickness measurement)

The A-Biometer consists of a 10MHz A-probe and biometric unit. The axial biometry is the measurement for anterior chamber depth (ACD), lens thickness (LENS), vitreous length (VITR) and axial length (AL).

Corneal thickness Pachymeter consists of a 20MHz-pachymetric probe and the measuring unit. It is on the basis of the measurement of time interval between the anterior and post interface reflection wave to get the thickness of the cornea.

The ODM-1000A/P includes A-mode axial biometric parameter measurement and P-mode Corneal thickness measurement. Users can switch between these two modes through keyboard.

In A-mode, the 10MHz transducer transmits ultrasound into eye tissue and receives its echo reflected back by anterior chamber, lens and vitreum. Each length and their sum (AL) are calculated by measuring the time spent in different parts.

In P-mode, the 20MHz transducer transmits ultrasound into eye tissue and receives its echo reflected back by the anterior and post interface reflection pulse of the cornea, and then measure the time interval between two reflection pulse to get the thickness of the cornea.

The provided 510(k) summary for the ODM-1000A/P Ultrasonic Biometer/Pachymeter for Ophthalmology does not contain specific acceptance criteria or a detailed clinical study demonstrating that the device meets such criteria.

Instead, it states that the device is "equivalent in safety and efficacy to the legally marketed predicate device" based on non-clinical tests and the assertion that a clinical test is "Not required."

Therefore, I cannot provide the requested information in the format specified, as the necessary details are absent from the document.

However, I can extract the information that is present regarding performance and predicate devices:

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

This information is not provided in the document. The submission relies on establishing substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria and then showing the device meets them through testing.

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

• Sample Size: Not applicable, as no clinical test set is described.
• Data Provenance: Not applicable, as no clinical test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set requiring expert ground truth establishment is described.

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

Not applicable, as no clinical test set 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:

Not applicable. This device is an ultrasonic biometer/pachymeter, not an AI-assisted diagnostic tool for image interpretation by human readers. Therefore, an MRMC study related to AI assistance is not relevant to this specific device.

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

The device itself is a measurement tool. Its "standalone performance" is implied by its design and the non-clinical tests performed. It doesn't have an "algorithm only" component in the sense of AI for image interpretation separate from a human, but rather directly measures biological parameters. The submission states "Not required" for clinical tests, implying that standalone performance was deemed sufficient by comparison to the predicate.

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

Not applicable, as no clinical study or ground truth establishment process is detailed in the document. The "ground truth" for the device's function would inherently be the physical dimensions it is designed to measure (axial length, anterior chamber depth, lens thickness, corneal thickness), but how this "ground truth" was established for testing purposes is not described.

8. The sample size for the training set:

Not applicable. This device is an ultrasonic measurement instrument, not a machine learning or AI algorithm that requires a separate training set.

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

Not applicable, as no training set is described for this type of device.

Summary of available information related to performance:

The document states that the ODM-1000A/P device's performance relies on its technological characteristics and non-clinical tests for safety and electromagnetic compatibility (EMC).

• Non-clinical tests performed:
  • Safety Test (IEC 60601-1, Tested by TÜV)
  • EMC Test Report (IEC 60601-1-2, Tested by TÜV)
  • Acoustic output Test (FDA Guidance Document)
  • Biological Safety Test (ISO 10993, Tested by TÜV)

The conclusion drawn from these tests, and the assertion that clinical tests are not required, is that the device is "equivalent in safety and efficacy to the legally marketed predicate device" (Micro Medical Devices' PalmScan AP2000/A2000/P2000 Devices, K043287). This strategy is typical for a 510(k) submission seeking substantial equivalence rather than demonstrating de novo performance against specific clinical acceptance criteria.

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