(36 days)
The Applanation Tonometer AT-1 is indicated to measure intraocular pressure for use as an aid in glaucoma screening and diagnosis.
The device consists of a pressurizing force control unit, tonometer tip (hereinafter referred to as measuring prism), section connected to a slit lamp microscope, and accessories. The measuring prism requires disinfection. The device is available in two models according to the difference in the method of connecting to a slit lamp microscope, while the pressurizing force control unit and measuring prism are the same for the two models. Each model includes no electrical elements. The device is set up to a dedicated support on the slit lamp, and used together with a commercially available slit lamp microscope. The pressurizing force control unit of the device incorporates a measurement dial that indicates pressurizing force, including a pressurizing force control knob, and a prism holder to mount the measuring prism. Also, the pressurizing force control unit includes a connector for mounting a check weight holder to check the pressurizing force of the device. The product is a manual medical device.
The provided text describes a 510(k) premarket notification for the Applanation Tonometer AT-1, seeking to demonstrate its substantial equivalence to a predicate device, the HAAG-STREIT APPLANATION TONOMETER AT 900.
The document primarily focuses on a comparison of device characteristics and technical specifications rather than providing details of a clinical study or performance data in the context of acceptance criteria and device performance as typically understood for an AI/ML powered device.
Based on the provided text, a comprehensive answer to your request regarding acceptance criteria and a study proving the device meets them, particularly for an AI/ML enabled device, cannot be fully provided because this document pertains to a manual medical device, an Applanation Tonometer, not an AI/ML system.
Here's an attempt to address the points based on the available information, noting where information is missing due to the nature of the device (manual tonometer vs. AI/ML system):
Acceptance Criteria and Device Performance for Applanation Tonometer AT-1
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and adherence to the ISO standard. The "performance" in this context refers to the device's technical specifications and its ability to measure intraocular pressure accurately and repeatably, aligning with established standards for tonometers.
| Criteria | Predicate Device (HAAG-STREIT AT900) | New Device (Applanation Tonometer AT-1) | Comments on Meeting Criteria |
|---|---|---|---|
| Type | Manual contact Tonometer | Manual contact Tonometer | Equivalent |
| Indication | Intraocular Pressure (IOP) measurement | Intraocular Pressure (IOP) measurement, aid in glaucoma screening and diagnosis | Equivalent, extended clarity on use as aid |
| Design | Slit lamp mounted, Manual dial | Slit lamp mounted, Manual dial | Equivalent |
| Prism Material | PMMA | PMMA | Equivalent |
| Measurement Range | 0 – 80mmHg | 0 – 80mmHg | Equivalent |
| Measurement Method | Applanation | Applanation | Equivalent |
| Measurement Technique | Direct reading of IOP in mmHg (0.2gf/1.96mN per division) | Direct reading of IOP in mmHg (0.2gf/1.96mN per division) | Equivalent |
| Applanation Circle Diameter | 3.06mm | 3.06mm | Equivalent |
| Calibration | Maintenance and calibration required | Maintenance and calibration required | Equivalent |
| Measurement Accuracy | ±1.5 % of the nominal value or ±0.49 mN, whichever is greater | ±1.5 % of the nominal value or ±0.49 mN, whichever is greater | Equivalent. This appears to be the acceptance criteria for accuracy. The document states the device has this accuracy. |
| Repeatability | ≤0.50mN | ≤0.50mN | Equivalent. This appears to be the acceptance criteria for repeatability. The document states the device has this repeatability. |
| Reverse Span | 0.49mN | 0.49mN | Equivalent |
| Applanation Circle Diameter | 3.06mm ± 0.02mm | 3.06mm ± 0.02mm | Equivalent. This is a technical specification and implicitly an acceptance criterion. |
| Applanation Area | 7.354 mm² | 7.354 mm² | Equivalent |
Study Proving Device Meets Acceptance Criteria:
The document states that the performance of the Applanation Tonometer AT-1 was tested in accordance with ISO 8612:2009 - Ophthalmic Instruments - Tonometers, Annex A.2. This standard outlines the specific tests and procedures for evaluating tonometers, including their accuracy and repeatability. The statement "Performance of the Applanation Tonometer AT-1 was tested in accordance with ISO 8612:2009-Ophtalmic Instrument-Tonometers, Annex A.2" implies that the device passed these tests and therefore meets the specified performance criteria (accuracy and repeatability).
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. As this is a physical medical device and not an AI/ML system analyzing data, the concept of a "test set" in the sense of a dataset for an algorithm is not directly applicable. The testing would involve physical measurements and calibration against known standards. The document does not specify the number of devices or measurements performed for this performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable/provided. Ground truth, in the context of an AI/ML system's diagnostic output, would be established by expert review. For a tonometer, the "ground truth" for calibration and performance testing is established by precision engineering measurements and adherence to metrological standards outlined in the ISO standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are relevant for subjective interpretations of images or data by human experts, typical in AI/ML performance studies. For a physical device measuring a quantifiable parameter, performance is assessed through objective, reproducible measurements according to established metrological protocols.
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 applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This device is a manual tonometer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This device is a manual tonometer, meaning it inherently requires human operation. There is no "algorithm only" component to test independently.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the performance testing of the tonometer, the "ground truth" for accuracy and repeatability is based on metrological standards and calibrated reference instruments (e.g., standard weights and measuring devices) as defined by ISO 8612:2009. It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
This information is not applicable. This is a physical, manual medical device. It does not use machine learning, and therefore there is no "training set" in the context of AI/ML algorithm development.
9. How the ground truth for the training set was established:
This information is not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.
§ 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.