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510(k) Data Aggregation
(383 days)
NON-CONTACT TONOMETER, MODEL FT-1000
The NON-CONTACT TONOMETER FT-1000 is indicated for the measurement of intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.
The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure of the human eye.
The provided text describes a 510(k) premarket notification for the TOMEY NON-CONTACT TONOMETER FT-1000. This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics of the new device itself.
Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, expert qualifications, and detailed performance metrics cannot be found in the provided text. The document's purpose is to demonstrate that the new device is as safe and effective as a legally marketed predicate, not to report on an independent clinical trial meeting specific quantitative acceptance criteria for the new device's performance.
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of specific acceptance criteria in the quantitative sense (e.g., "sensitivity must be > X%, specificity > Y%"). Instead, it relies on a comparison table to establish equivalence in technical characteristics and indication for use with the predicate device.
| Feature | Predicate Device (CANON TONOMETER TX-F) | TOMEY NON-CONTACT TONOMETER FT-1000 | "Acceptance" (Equivalence Claim) |
|---|---|---|---|
| Device Type | Non-contact (air-puff) type | Same as TX-F | Equivalent |
| Indication for Use | For measurement of intraocular pressure. | For measurement of intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma. | Equivalent (expanded for screening/diagnosis) |
| Measurable Range | 0 to 60 mmHg (auto shifting) | 0 to 60 mmHg (manual changing) | Equivalent (range) |
| Measuring Increment | 1 mmHg | Same as TX-F | Equivalent |
| Measuring Unit | mmHg | mmHg / hPa | Equivalent (with added unit) |
| Operation Distance | 11.3mm | 11.0mm | Similar |
| Safety Mechanism | Software Controlled Stopper | Software Controlled Stopper (Same as TX-F), Touch Sensor | Equivalent (with added feature) |
| Memory | Max. 10 measurements for each eye | Same as TX-F | Equivalent |
| Data Output | RS232C | Same as TX-F | Equivalent |
| Power-saving | Available | Same as TX-F | Equivalent |
| Printer | Thermal line printer | Same as TX-F | Equivalent |
| Chin Rest | Power assisted | Same as TX-F | Equivalent |
| Power Supply | AC100-240V, 50/60Hz, 0.4-0.8A, Approx.80VA | AC100-240V, 50/60Hz, 85-110VA | Similar |
2. Sample size used for the test set and the data provenance:
The provided text does not include information on a specific test set, its sample size, or data provenance for proving the device's performance against defined acceptance criteria. The submission focuses on technical and functional comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available in the provided document. As no specific test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided document.
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 available and is not relevant to this submission, which is for a standalone measurement device rather than an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device described is a standalone measurement device (a tonometer) that measures intraocular pressure. Its performance is inherent to the device itself. The primary "study" presented is the comparison to the predicate device, demonstrating that its technical characteristics and function are substantially equivalent. The 510(k) process often relies on such comparisons rather than new, large-scale clinical trials if substantial equivalence can be demonstrated through technical and functional grounds.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" in the diagnostic sense (e.g., for sensitivity/specificity) is not explicitly addressed as no diagnostic performance study of the new device is detailed. For a measurement device like a tonometer, the "truth" would typically relate to the accuracy and precision of its IOP measurements compared to a gold standard tonometry method (e.g., Goldmann applanation tonometry) if a clinical study were performed to establish these. However, this level of detail for a new study is not present. The submission relies on the predicate's established performance as a reference.
8. The sample size for the training set:
This information is not available. The device is an electro-mechanical measurement device, and the concept of a "training set" in the context of an algorithm or AI model does not apply here.
9. How the ground truth for the training set was established:
This information is not available for the reason stated in point 8.
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