(415 days)
The Pulsair IntelliPuff Non-Contact Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.
The Pulsair Desktop Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.
The Keeler Pulsair Tonometer product family are non-contact tonometers and are used to measure intraocular pressure without contacting the eye to aid with the screening and diagnosis of glaucoma. The product family consists of the Pulsair Intellipuff (Hand Held device) and the Pulsair Desktop which is mounted on a desk. The Pulsair Intellipuff Tonometer has been designed using the same ergonomics as the predicate device described in 510(k) submission K990257 whilst the Pulsair Desktop Tonometer ergonomics have been adapted to suite the Desktop mounted market place. Both products use the same concept of measurement as the predicate device and contain many common components. All of the products consist of an air generation system in the form of a vacuum Diaphragm pump, an air reservoir, a solenoid valve, a light source and an opto-electronic platform which is used for position detection and IOP measurement.
The basic concept of operation is the same. The user positions the instrument close to the patient's cornea using a targeting system. As the user moves the instrument closer to the patient, the reflection off the cornea from the built in light source increases until the predefined firing thresholds on the built in photodiodes have been met. Once this condition has been met, a quantised puff of air is automatically projected toward the patient's cornea. As the cornea flattens due to the force of the puff of air, the light being reflected off of the cornea changes shape which in turn changes the profile of the light being reflected back onto the photodiodes. The rate of change of this reflection is monitored by the photodiodes and converted into intraocular pressure in units of mmHg by the on board microprocessor.
The Keeler Pulsair IntelliPuff and Pulsair Desktop Tonometers are non-contact tonometers used to measure intraocular pressure (IOP) to aid in the screening and diagnosis of glaucoma.
Here's an analysis of their acceptance criteria and the studies conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Pulsair IntelliPuff) | Reported Device Performance (Pulsair Desktop) |
|---|---|---|
| No more than 5% of paired differences between device and Goldmann Tonometer should be outside ±5mmHg tolerance in three IOP ranges (specified by ANSI Z80.10-2003 and ISO 8612:2001). | Paired differences between Intellipuff and Goldmann were within ±5mmHg for over 95% of eyes tested. Readings were not significantly biased relative to Goldmann. | Paired differences between Desktop and Goldmann were within ±5mmHg for over 95% of eyes tested. Readings were not significantly biased relative to Goldmann. |
| Clinical equivalence between Pulsair Intellipuff and Pulsair Desktop. | Paired differences between Desktop and Intellipuff were within ±5mmHg for over 95% of eyes tested. Readings were not significantly biased relative to Intellipuff. | Demonstrated clinical equivalence to Pulsair Intellipuff. |
| Repeatable and comparable measurements (Bench Testing). | Produce repeatable and comparable measurements. | Produce repeatable and comparable measurements. |
2. Sample Size and Data Provenance for Test Set:
- Pulsair IntelliPuff Tonometer: The document does not explicitly state the exact sample size for the "new independent clinical study" used to show design compliance. It only mentions "over 95% of the eyes tested," implying a statistically significant number of eyes were included to meet the 5% tolerance criterion.
- Data Provenance: The study was "new," "independent," and conducted to ISO 8612:2001, which is an international standard. No specific country of origin is mentioned, but the manufacturing location is the UK, suggesting the study likely occurred in Europe or the UK. It was a prospective clinical trial.
- Pulsair Desktop Tonometer: "An additional small scale trial was conducted within a clinical environment on 28 eyes."
- Data Provenance: Conducted within a "clinical environment." No specific country is mentioned, but likely similar to the IntelliPuff. This was also a prospective study.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications for the test sets. However, the ground truth standard was the Goldmann Tonometer, which is considered the "gold standard" for IOP measurement, implying its use by trained clinicians.
4. Adjudication Method for the Test Set:
Not explicitly stated. The studies describe comparing device readings directly to Goldmann Tonometer readings and to each other, but not a consensus-based adjudication process for discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not explicitly mentioned. The studies focus on comparing the device's readings to a "gold standard" (Goldmann Tonometer) or to another version of the device, rather than assessing human reader improvement with or without AI assistance. The device is a measurement instrument, not an AI diagnostic aid requiring human interpretation to improve.
6. Standalone Performance Study (Algorithm Only):
Yes, the described clinical trials for both the Pulsair IntelliPuff and the Pulsair Desktop effectively demonstrate their standalone performance. The devices directly output an IOP measurement, and this output was compared against the Goldmann Tonometer, representing the algorithm's performance without specific human-in-the-loop steps designed to alter the measurement itself. The "IntelliPuff readings tended to fall slightly below the Goldmann readings at IOP's exceeding 30mmHg" is an observation about its standalone performance.
7. Type of Ground Truth Used:
The primary ground truth used was measurements obtained from a Goldmann Tonometer, which is the clinical "gold standard" for intraocular pressure measurement.
8. Sample Size for the Training Set:
The document does not provide information on the sample size used for the training set. It mentions the "algorithm for IOP calculation remains the same" as the predicate Pulsair 3000 and that the software was "sub-contracted for further development" based on a "Product Design Requirements Specification." This implies the algorithm was developed and refined, but the training data specifics are not detailed.
9. How Ground Truth for the Training Set Was Established:
The document does not explicitly detail how the ground truth for the training set (if a distinct training set was used for the algorithm's development) was established. Given the algorithm's continuity from the predicate device (Pulsair 3000), it's implied that it was originally developed and validated against a known standard, likely the Goldmann Tonometer, similar to how the current devices were tested. The development involved functionality and usability improvements rather than a complete re-training of a new core IOP calculation algorithm.
§ 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.