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Sunkingdom Ophthalmic Ultrasound Examination Instrument can be used in ophthalmology clinical application under A(A-scan echography), P(Pachymetry) and B(B-scan echography) operation modes. A-scan echography applies to axial length measurement, including anterior chamber depth, crystal thickness, vitreous length; Pachymetry applies to corneal thickness measurement; and B-scan echography applies to ocular ultrasound imaging.

The device should be operated by doctors or appropriately-trained healthcare professional and should be used in hospitals or large clinics. It is prohibited to use the device on patients with active ocular inflammatory lesions (such as acute conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis etc);and this device cannot be used on fetuses.

Sunkingdom Ophthalmic Ultrasound Examination Instrument, models SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P is an ultrasound imaging system intended for use in ophthalmic applications.

Model SK-3000A with A, P, B probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length), corneal thickness and to ocular ultrasound imaging.

Model SK-3000B with A, B probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length) and to ocular ultrasound imaging.

Model SK-3000C with B probe is used to ocular ultrasound imaging.

Model SK-2000AP with A, P probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length) and corneal thickness.

Model SK-2000A with A probe is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length).

Model SK-2000P with P probe is used to biometric measurement of corneal thickness.

Among them, the 10 MHz A probe transmits ultrasound wave into eye tissue, and measure the duration of the acoustic pulse from the A probe to anterior chamber, lens and vitreum and back to the A probe. This mode is mainly used for biometric measurement axial length, which including anterior chamber depth, lens thickness, vitreous depth of eyes.

The 10 MHz B probe transmits ultrasound wave into eye tissue, and to form a sectional echogram by means of the brightness of echogenic dots. This mode is mainly used for ocular ultrasound imaging.

The 20 MHz Pachymeter probe is to get the thickness of corneal by measurement of the time interval between the anterior and posterior interface reflection waves of cornea. This mode is mainly used for biometric measurement of corneal thickness.

All probes can work independently, and record patient data and connect to a video printer to print image report. It also can work with computer which has the software installed to manage patient record.

This device must be used by trained and qualified medical personnel.

Contraindication: Patients with active ocular inflammatory lesions (such as acute conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis, iridocyclitis etc) and the fetal cannot use the device.

The provided text details a 510(k) premarket notification for the Sunkingdom Ophthalmic Ultrasound Examination Instrument. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study or a study directly measuring performance against predefined metrics.

Therefore, many of the requested details about acceptance criteria, clinical study methodology, sample sizes, expert involvement, and ground truth establishment are explicitly stated as "Not applicable" or are not present in this type of regulatory submission.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence based on:

1. Same intended use/indications for use.
2. Similar technological characteristics and operating principles.
3. Compliance with recognized performance standards for electrical safety, electromagnetic compatibility, biocompatibility, and acoustic output.

The "Performance Data" section primarily describes pre-clinical testing to ensure safety and functionality, not clinical efficacy or diagnostic accuracy.

Table of "Acceptance Criteria" and "Reported Device Performance" (as inferred from the substantial equivalence argument):

Study Details (as related to clinical performance)

The document explicitly states "Clinical testing: Not applicable." This means no clinical study (human subject study) was conducted or deemed necessary for this 510(k) submission to demonstrate the device meets acceptance criteria related to diagnostic performance or clinical outcomes. The basis for clearance is substantial equivalence to legally marketed predicate devices through engineering and non-clinical performance testing.

Therefore, the following points cannot be answered from the provided text:

1. Sample sizes used for the test set and the data provenance: Not applicable as no clinical test set was used for performance evaluation that would necessitate these details.
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 ultrasound imaging instrument, not an AI-assisted diagnostic tool for image interpretation.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical performance study since none was done. The "ground truth" for the non-clinical tests would be the established scientific principles and measured values from calibrated equipment.
7. The sample size for the training set: Not applicable as a clinical training set is not mentioned for this type of device and submission.
8. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission successfully demonstrated substantial equivalence based on a comparison of intended use, technological characteristics, and compliance with recognized safety and performance standards for medical devices, rather than a clinical performance study with specific acceptance criteria.

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