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MD-2300S Ultrasonic A/B Scanner for Ophthalmology is intended for ophthalmological ultrasonic diagnosis and AL biometric measurement.

The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure.

The device should be operated by trained medical staff.

Patients with eyelid trauma and severe eye infection are prohibited from using B-Scan; and patients and cornea trauma are prohibited from using A-Biometric scan.

The A-biometric scan should be used cautiously on patients without independent behavior abilities or who are highly sensitive to contacting measurements, whose ineffective cooperation may result in inaccurate measurements,

MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging instrument specialized in ophthalmological diagnosis. It consists of a main unit, a power adaptor, a 10MHz B-Scan probe, a 20MHz B-Probe, a 10MHz A-Probe, a footswitch, a keyboard and a mouse.

MD-2300S includes two most popular operation modes for ophthalmological clinical diagnosis: B-mode ultrasonic section imaging and A-mode axial biometric parameter measurement.

The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure.

The part of B-mode uses 10MHz and 20MHz mechanical sector-scan probes for scanning. It acquires echo signal through ultrasonic pulse transmitting and receiving circuits; and converts it into digital information to save in FIFO; the data information of each echo line is transmitted to the embedded board through USB port. The application software running on Windows XPE platform realizes real time display, saving and case report generation for images of eye tissue.

The part of A-mode uses 10MHz A-biometric probe for A-mode scanning. It acquires echo signal through ultrasonic pulse transmitting and receiving circuits; and converts it into digital information to save in FIFO; the data information of each echo line is transmitted to the embedded board through USB port. Based on the interface reflection of ultrasound wave in three different tissues of anterior chamber, lens and vitreous body, the application software running on Windows XPE platform measures the transmitting time of ultrasound wave in different tissues and then calculates distances of each segment according to the acoustic velocity of different tissues to get the axial length and generates case report of A-biometry automatically, thus provides parameters for intraocular lens implantation operation.

This document describes the premarket notification (510(k)) for the MD-2300S Ultrasonic A/B Scanner for Ophthalmology. The information provided primarily focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study with explicit acceptance criteria and statistical performance metrics for novel AI algorithms.

Here's a breakdown of the requested information based on the provided text, recognizing that some of the questions may not be fully applicable to this type of submission which is focused on substantial equivalence for a medical device rather than an AI/ML algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in the typical sense of a target performance threshold for a new AI algorithm. Instead, it demonstrates the device's technical specifications and clinical utility are substantially equivalent to predicate devices. The "performance" is described in terms of technical characteristics and observational clinical findings.

2. Sample Sizes Used for the Test Set and Data Provenance

• B-Mode Test Set:
  • Sample Size: "randomly outpatients and inpatients that need to make B-mode ultrasonic examination" (no specific number provided). The selection aimed to cover "typical cases of ultrasonic diagnosis for ophthalmology."
  • Data Provenance: Prospective (implied by "make ultrasonic inspection") clinical validation study conducted at Tianjin Eye Hospital, China.
• A-Mode Test Set:
  • Sample Size: "50 eyes randomly from outpatients and inpatients that need to measure axial length (AL)."
  • Data Provenance: Prospective clinical validation study conducted at Tianjin Eye Hospital, China. Patients' sex and age were not restricted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• B-Mode: "Clinical doctors validate the intended use according to the image quality of B-Scan on orbit and intraocular tissues." The number and specific qualifications of these "clinical doctors" are not stated.
• A-Mode: The ground truth for A-mode measurements was established by comparing measurements from the MD-2300S against a predicate device, the ODM-2100 Ultrasonic A/B Scanner for Ophthalmology. This implies the predicate device's measurements served as the reference. The operators for both devices are described as "expected user representatives," implying trained medical staff, but specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• B-Mode: Not explicitly stated as a formal adjudication process. The text indicates "Clinical doctors validate the intended use according to the image quality." This suggests a qualitative assessment by medical professionals.
• A-Mode: "The statistical processing results for AL measuring data with Bland-Altman statistical method should have no obvious difference." This is a statistical method for assessing agreement between two different methods of measurement, rather than a formal expert adjudication of ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size of how much human readers improve with AI vs without AI assistance

This document describes the premarket notification for a diagnostic ultrasound system, not an AI/ML device assisting human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted or reported in this submission. The "clinical effectiveness validation" was about the device's inherent diagnostic capabilities.

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

This is not an AI/ML algorithm. The device, an ultrasonic scanner, performs measurements (A-mode) and generates images (B-mode) in a standalone capacity. Operators (human-in-the-loop) are required to use the device. The A-mode's automated measurement of AL and IOL calculation is a function of the device, validated against another device's measurements. The B-mode image quality is validated by clinical doctors' assessment.

7. The Type of Ground Truth Used

• B-Mode: Expert consensus/clinical assessment based on qualitative evaluation of image quality by "Clinical doctors."
• A-Mode: Comparison against a legally marketed predicate device (ODM-2100 Ultrasonic A/B Scanner for Ophthalmology) using the Bland-Altman statistical method to assess agreement. This acts as a reference standard for the AL measurement. Pathology or outcomes data are not mentioned as ground truth sources.

8. The Sample Size for the Training Set

This submission does not discuss an AI algorithm or a "training set." The device is a traditional medical imaging device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set or AI algorithm in this submission.

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