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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):

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Sunkingdom Applanation Tonometer is a manual device intended for measurement of intraocular pressure by applanation (applying a small flat disk to the cornea) to aid in the diagnosis of glaucoma.

Sunkingdom SK-R, SJ-T, SK-Q are applanation tonometers, which are indicated for measurement of intraocular pressure (IOP). Intraocular pressure (IOP) is a very important physiological parameter and has always been an indispensable part of the diagnosis and treatment of ophthalmology, especially for glaucoma.

The operation principle is based on Goldmann applanation method, which is considered as the gold standard for measuring intraocular pressure. Therefore the applanation tonometer plays an important role in the diagnosis and treatment of ophthalmic diseases.

Sunkingdom series of Applanation tonometer are active medical devices powered by 3V button battery. In practice, it provides two ways to read the measured intraocular pressure value, one from the dial indicator in mmHg unit, the other from the LCD display in mmHg and KPa units. It is used in conjunction with a slit lamp, and the only difference among the SK- R, SK-T, SK-Q is the connection part. Each model differs from each other depending on the type of slit lamp to be used with it as shown in the figure below. All the other technical specifications are the same for these three models.

Model SK-Q is especially for the slit lamp with a large head size that cannot be configured for SK-R. Model SK-R can be left on the slit lamp permanently. It is fixed to the microscope on a mounting base and can be rotated in front of the microscope for examination. Model SK-T is mounted on the guide plate over the slit lamp axis for measurement purposes.

Components of the tonometer include applanation tonometer main body, Connection mechanical parts and screws, calibration rod, and applanation prism.

The provided text describes a medical device, the Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q, and its substantial equivalence determination by the FDA. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information on the specific acceptance criteria for device performance or a comprehensive study report with the level of detail requested in your prompt.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that the testing was carried out in accordance with ANSI Z80.10-2014, Ophthalmic Instruments-Tonometer. This standard would define the specific acceptance criteria for performance (e.g., accuracy, repeatability). However, the document does not explicitly list those criteria or the detailed reported performance data against them. It only states that the devices "are in compliance with above FDA recognized standards."

Detailed Breakdown of Missing and Available Information:

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

• Sample Size: The document mentions "3 devices" were used for performance testing. For verification bench testing, it states an "experimenter measured each weight value for 10 times and by 2 experimenters measured 3 weight values for 2 times in 3 devices." This refers to specific test procedures and not necessarily a clinical test set in the traditional sense of patient data.
• Data Provenance: Not specified. The performance testing appears to be bench testing conducted by the manufacturer.

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

• This information is not provided. The performance testing described is bench testing against known physical forces/weights, not a clinical study involving experts establishing ground truth for patient outcomes.

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

• This information is not applicable/not provided as there is no human-involved "test set" or clinical study described in the provided text that would require adjudication.

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

• This information is not provided. The device is an applanation tonometer, a measurement instrument. There is no mention of AI assistance or human reader involvement in the context of improving diagnostic effectiveness.

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

• This information is not applicable. The device is a manual tonometer that requires a human operator for its use. It's not an automated diagnostic algorithm.

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

• For the performance testing, the "ground truth" was established by known physical forces/weights applied using a balance system, as described in the calibration section and performance testing details. The principle is based on the Goldmann method's physics.

8. The sample size for the training set

• This information is not applicable/not provided. The device is a mechanical/electronic measurement instrument based on physical principles, not a machine learning or AI-driven system that requires a "training set."

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

• This information is not applicable/not provided for the reasons mentioned in point 8.

In summary, the provided FDA document focuses on demonstrating substantial equivalence through comparison with a predicate device and compliance with recognized safety and performance standards for a medical measurement instrument. It lacks the detailed clinical study information and specific performance metrics often associated with AI-driven diagnostic devices or devices requiring human expert interpretation that your prompt implies. The "performance data" section primarily highlights biocompatibility, electrical safety, EMC, and a brief description of bench testing for measuring force.

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The Chongqing Sunkingdom Slit Lamp LS-1A, LS-1B are AC --- powered slit lamp Biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

Sunkingdom slit lamp LS-1A, LS-1B are an AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affects the structural properties of the anterior eye segment. An AC-powered Slit lamp Bio-microscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. Components: The optical body, movement mechanism, illumination system, portable handle, power supply.

The given text is a 510(k) Pre-market Notification for the Sunkingdom Slit Lamp LS-1A, LS-1B. It details the device's technical characteristics and performance testing conducted to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The document primarily relies on demonstrating compliance with relevant industry standards and showing that the proposed device's performance characteristics are comparable to or better than the predicate device. The acceptance criteria are implicitly defined by these standards and the comparison table.

Study Information:

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

   • The document does not explicitly state a "test set" in the context of clinical data for performance evaluation. The performance data provided is primarily from bench testing and compliance with standardized tests (Biocompatibility, Electrical safety, EMC, Performance testing according to ISO 10939, Light Hazard Protection according to ISO 15004-2).
   • For biocompatibility, the tests were conducted with specific samples (e.g., "Chinrest pat and Forehead band extract," "rabbitskin," "guinea pig," "L-929 cells").
   • The data provenance is not specified beyond the tests being conducted on the "Sunkingdom Slit Lamp LS-1A, LS-1B" and under recognized FDA standards and Good Laboratory Practice (21 CFR 58). This suggests the tests were carried out by the manufacturer or a contracted lab. There's no indication of retrospective or prospective human clinical data.

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

   • This question is not applicable as the study did not involve human expert interpretation of clinical cases to establish ground truth. The "ground truth" for the performance claims were objective measurements and adherence to technical specifications and international standards.

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

   • Not applicable, as no human adjudication of clinical cases was performed.

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:

   • No MRMC comparative effectiveness study was done. This device is a traditional medical instrument (slit lamp biomicroscope), not an AI-powered diagnostic tool.

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

   • Not applicable, as this is a medical device for direct human use in eye examination, not an algorithm.

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

   • The ground truth is established by objective measurements against engineering specifications and compliance with international standards for medical device safety and performance (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety/EMC, ISO 10939 for slit lamps, ISO 15004-2 for light hazard).

7. The sample size for the training set:

   • Not applicable. This device does not use an AI component requiring a training set.

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

   • Not applicable. This device does not use an AI component or a training set.

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