(218 days)
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
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Measurement Range | 0-80mmHg | The proposed device has a wider measurement range than the predicate (5-65mmHg). This is noted as taking "professional's practice requirement into account and provides better practical applications for use." |
| Measurement Deviation | 0.49 mN or 1.5% of measurement value, whichever is the greater | This matches the predicate device. |
| Biocompatibility | Extract of applied sample (MVLV48 LENTILLE) is not cytotoxic. Polar and non-polar extracts do not have to be classified as a skin sensitizer. Meets requirements of ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006. | Specific acceptance limits for cytotoxicity, irritation, and sensitization are not explicitly stated, but compliance with ISO standards confirms acceptable performance. |
| Electrical Safety | Complies with ANSI AAMI IEC60601-1-2:2014, ANSI AAMIES 60601-1:2005, and ISO 15004-1:2006. | Specific limits for electrical safety are not provided, but compliance with recognized standards implies accepted performance. |
| Electromagnetic Compatibility (EMC) | Complies with ANSI AAMI IEC60601-1-2:2014, ANSI AAMIES 60601-1:2005, and ISO 15004-1:2006. | Specific limits for EMC are not provided, but compliance with recognized standards implies accepted performance. |
| Functional Performance (e.g., accuracy against known pressures) | "Verification bench testing using a balance system was carried to verify the measuring force, and conducted by an experimenter to measured each weight value for 10 times and by 2 experimenter to measured 3 weight values for 2 times in 3 devices. The testing was carried out in accordance with ANSI Z80.10-2014, Ophthalmic Instruments-Tonometer." | The document states compliance with ANSI Z80.10-2014, but does not provide the specific performance results (e.g., actual measured force vs. known force values, or the mean deviation and standard deviation against the Goldmann reference) that would demonstrate meeting the standard's accuracy requirements. It only describes the method of verification. |
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.
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.