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510(k) Data Aggregation
(90 days)
The Applanation Tonometer AT-2 is intended 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 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 a calibrator to check the pressurizing force of the device. The product is a manual medical device.
This document (K182491 510(k) Summary) describes the Applanation Tonometer AT-2 and its substantial equivalence to the predicate device, Haag-Streit AT900. It does not contain information about a study proving the device meets acceptance criteria in the typical sense of a clinical trial or a machine learning performance study with a test set, training set, or ground truth established by experts.
Instead, the "acceptance criteria" here refer to technical specifications and performance characteristics, and the "study" is a performance test conducted according to an international standard.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document compares the new device (AT-2) to the predicate device (AT900) based on shared technical specifications. The "acceptance criteria" can be inferred to be alignment with these specifications, particularly the "Measurement accuracy" and "Repeatability" from the predicate.
| Criteria | Predicate Device (Haag-Streit AT900) | New Device (Applanation Tonometer AT-2) | Acceptance Performance (AT-2) |
|---|---|---|---|
| Measurement Range | 0 – 80mmHg | 0 – 80mmHg | Met (same as predicate) |
| One scale unit | 1.96mN | 1.96mN | Met (same as predicate) |
| Measurement accuracy | ± 1.5 % of the nominal value or ± 0.49 mN, whichever is greater | (Not explicitly stated for AT-2, but performance testing according to ISO 8612:2009 implies meeting relevant standard thresholds) | Assumed to be met by ISO 8612 testing |
| Repeatability | $\leq$ 0.50mN | (Not explicitly stated for AT-2, but performance testing according to ISO 8612:2009 implies meeting relevant standard thresholds) | Assumed to be met by ISO 8612 testing |
| Reverse span | 0.49mN | (Not explicitly stated for AT-2) | Assumed to be met by ISO 8612 testing |
| Applanation circle diameter | 3.06mm | 3.06mm ± 0.02mm | Met (within tolerance) |
| Applanation area | (Not specified for predicate) | 7.354 mm³ | (This is a design specification for the new device) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device submission for a physical tonometer, not a study involving patient data or a test set in the context of an algorithm's performance. The "performance testing" refers to mechanical and physical characteristics of the device itself.
3. 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. There is no test set or ground truth established by experts in the context of clinical data for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process is described.
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
Not applicable. This device is not an AI-powered diagnostic tool, and no MRMC study of human readers is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual medical device with no standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance is tied to metrological standards for measurement accuracy and repeatability, as defined by ISO 8612:2009.
8. The sample size for the training set
Not applicable. This device does not use machine learning, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use machine learning, so there is no training set or ground truth established for it.
Summary of "Study" Information:
The "study" cited to demonstrate the device meets acceptance criteria is:
- Performance Testing: "Performance of the Applanation Tonometer AT-2 was tested in accordance with ISO 8612:2009-Ophtalmic Instrument-Tonometers, Annex A.2."
This ISO standard outlines the requirements and test methods for applanation tonometers, ensuring they meet specified accuracy and repeatability thresholds. The success of this testing (implied by the conclusion of substantial equivalence) indicates the device's technical performance. No clinical data, patient studies, or expert evaluations of algorithm performance are described in this 510(k) summary.
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