(96 days)
The Applanation Tonometer HT-5000 is a manual device intended to measure an intraocular pressure by applanation to aid in the diagnosis of glaucoma.
The Applanation Tonometer HT-5000 is 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 Applanation Tonometer HT-5000 is an active medical device, powered by AAA batteries. The device can be used in conjunction with slit lamp microscopes which are commercially available. Components of the tonometer contains applanation tonometer main body, weight bars, connection arms and measuring prisms.
The provided text describes the Huvitz Applanation Tonometer HT-5000, a manual device for measuring intraocular pressure (IOP). The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing studies proving the device meets clinical acceptance criteria for an AI/ML algorithm.
Therefore, many of the requested items related to AI/ML study design (such as human reader improvement with AI assistance, MRMC studies, ground truth establishment for AI training, etc.) are not applicable to this specific device and the information provided. This document describes a traditional medical device (a tonometer) and its physical and electrical performance, not an AI/ML diagnostic or assistive tool.
However, I can extract information related to the acceptance criteria and performance testing conducted for this manual measurement device.
Here's the breakdown of the information available in the provided text:
Device: Huvitz Applanation Tonometer HT-5000
Type of Device: Manual Applanation Tonometer (non-AI/ML device)
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this manual tonometer are primarily defined by adherence to recognized standards and comparative performance with a predicate device, focusing on physical measurement accuracy and safety.
| Acceptance Criteria Category | Specific Criteria (Standard/Tolerance) | Reported Device Performance (HT-5000) | Notes |
|---|---|---|---|
| Measurement Deviation/Accuracy | 0.49mN or 1.5% of measurement value, whichever is greater (Same as predicate) | Met the specified tolerance; provided reliable and repeatable IOP measurements within the provided IOP range. | Bench testing involved two experimenters measuring six different weight values 10 times in three devices. One investigator also compared accuracy against predicate devices. |
| Measurement Range | Predicate: 5-65 mmHg | 3-75 mmHg | HT-5000 has a wider measurement range. The manufacturer states this difference doesn't affect safety, effectiveness, or intended use. |
| Electrical Safety | IEC 60601-1, Edition 3.2 | All necessary safety testing conducted; demonstrated substantial equivalence to predicate device. | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2, Edition 4.1 | All necessary safety testing conducted; demonstrated substantial equivalence to predicate device. | |
| Ophthalmic Instruments General Requirements | ISO 15004-1:2020 | All necessary safety testing conducted; demonstrated substantial equivalence to predicate device. | |
| Disinfection/Cleaning Validation | FDA guidance 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling' | Proposed disinfection/cleaning procedure and disinfectants do not affect damage of mechanical characteristics, degradation of performance characteristics, or degradation of biological characteristics during the defined period. | |
| Biocompatibility | ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021 | Considered non-cytotoxic, non-sensitizer, and doesn't cause ocular irritant based on Vitro-Cytotoxicity, Skin Sensitization, and Ocular Irritation tests. | Patient contact part is the front surface of measuring prisms. Contact time ≤ 30 seconds. |
| Software Verification | IEC 62304:2015 | Software verified against design requirements. | The device contains software for numerical display. |
| Performance Testing Standard | ANSI Z80.10-2014, Ophthalmic Instruments Tonometer | All necessary verification testing conducted; demonstrated substantial equivalence to predicate device in terms of performance and effectiveness. | |
| Tonometer Prism Shelf-Life | Predicate: Recommend not used when > 2 years old | Recommend using for 2 years after first use in normal conditions, or replaced after 600 cycles of disinfection with dilute bleach in 10 minutes. | Manufacturer states effectiveness and safety verified in reliability test despite slight difference. |
Study Details (Performance Testing)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: "six different weight values for 10 times in three devices." This indicates 60 measurements per device (6 weights * 10 repetitions), across 3 devices, totaling 180 measurements for the primary bench testing. Additionally, "one investigator measured each weight values in 3 devices and predicate devices" for comparative accuracy.
- Data Provenance: Not explicitly stated, but implied to be laboratory bench testing conducted by the manufacturer, Huvitz Co., Ltd. (Republic of Korea). The data is retrospective in the context of the 510(k) submission, meaning it was collected prior to submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a manual measurement device, not an AI/ML diagnostic tool requiring expert ground truth in the same way. The "ground truth" for the performance testing was established by applying "known pressures" via calibration bars, verified using the calibration procedure described in ISO 8612:2009, and comparing the device's readings against these known values.
- The bench testing was conducted by "two different experimenters" and "one investigator." Their specific qualifications are not detailed, beyond being capable of performing these technical measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the context of this device's performance testing. The "ground truth" is physical calibration weights/pressures, not human interpretation requiring adjudication. Performance was assessed by comparing measurements against these known values.
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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 is a manual medical device, not an AI-powered one. No human-in-the-loop AI assistance is described or claimed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The device itself is the "standalone" unit for measurement. Its performance was assessed independently against physical standards and compared to a predicate device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For performance testing, the ground truth was known physical forces/pressures applied using calibrated equipment (calibration bars), referencing "known pressures covering the measurement range." This is a metrological ground truth.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense.
- For the device's internal calibration during manufacturing, "known pressures covering the measurement range are applied to the measurement arm using a calibration arm using calibration bars." This is a factory calibration procedure, not an AI training process.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above. For factory calibration, "ground truth" is established by certified physical standards.
§ 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.