(232 days)
The OLCR Pachymeter Pachy-01 SL is a device used with slit-lamp systems to measure corneal thickness. The OLCR Pachy-01 SL includes the functional capability to perform calculations of residual stroma thickness and correction to intraocular pressure values from user input.
The Haag-Streit OLCR Pachymeter Pachy-01 SL is a device used with slit-lamp biomicroscopes to measure corneal thickness without eye contact. The Pachymeter is an add-on to Haag-Streit slit-lamps, including the BC 900, and those of other manufacturers marketed in the US. The Haag-Streit slit lamp and pachymeter provide ophthalmology specialists with the means of performing ocular measurements without contact, anesthesia, and external indentation of the ocular surface. The Haag-Streit pachymeter system allows for instantaneous, precise/reproducible and real time measurements.
The OLCR Pachymeter consists of a base unit, a light-delivery instrument and a user touch pad. The Pachymeter's Base unit generates a computer-controlled laser/light signal that is delivered through a fiber-optic coupler cable and emitted from a light-delivery instrument attached to the slit-lamp biomicroscope. The instrument emits light in the visible and infrared spectral regions within limit values specified by the ISO standard for ophthalmic instruments, ISO EN 15004. The instrument provides two laser exit locations; a location for the axial aiming laser and the measuring laser and a location for the lower aiming laser. The OLCR Pachymeter functions and assessment are user-controlled by means of a touch screen pad.
Here's a breakdown of the acceptance criteria and the study details for the KO30393 OLCR Pachymeter, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in a tabulated format with specific thresholds before the study. Instead, it describes the demonstration of accuracy and precision as the measures used to show substantial equivalence. The reported performance is presented as the device successfully demonstrating these qualities.
Table 1: Acceptance Criteria (Implied) and Reported Device Performance
| Implied Acceptance Criteria (Demonstrated) | Reported Device Performance |
|---|---|
| Accuracy | Demonstrated in lab tests by measuring accepted calibration standards and glass check rods using 9 pachymeters mounted on 5 different biomicroscope slit lamp systems. The measured accuracies of the 9 pachymeters documented accuracy under laboratory conditions. |
| Precision/Reproducibility | Demonstrated in lab tests by measuring accepted calibration standards and glass check rods using 9 pachymeters mounted on 5 different biomicroscope slit lamp systems. Demonstrated in clinical studies (in-vivo) by measuring the central corneal thickness of 3 healthy individuals over 5 consecutive measurements using 5 OLCR pachymeters mounted on 5 different slit lamps. The studies documented the precision or variability of in-vivo human measurements. |
Study Details
Here's a breakdown of the study characteristics based on the provided text:
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Sample size used for the test set and the data provenance:
- Lab Tests:
- Pachymeters: 9 different OLCR pachymeters.
- Slit Lamp Systems: 5 different biomicroscope slit lamp systems.
- Measurement Objects: Accepted calibration standards and glass check rods.
- Clinical Studies (In-vivo):
- Subjects: 3 healthy individuals.
- Pachymeters: 5 OLCR pachymeters.
- Slit Lamp Systems: 5 different slit lamps.
- Measurements per Subject: 5 consecutive measurements for central corneal thickness.
- Data Provenance: The document does not specify the country of origin for the data. Given the submitter's address (Koeniz, Bern, Switzerland), it's highly likely the studies were conducted in Switzerland or within Europe, but this is not explicitly stated. The studies appear to be prospective as they were conducted to demonstrate performance.
- Lab Tests:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly mention experts used to establish ground truth for the test set.
- For the lab tests, the ground truth was "accepted calibration standards and glass check rods," implying objective physical standards rather than expert interpretation.
- For the clinical studies, "central corneal thickness" was measured, which is an objective physiological parameter.
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Adjudication method for the test set:
- None explicitly mentioned. The measurements appear to be objective readings from the device against physical standards or direct physiological measurements, not requiring expert adjudication for ground truth.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a diagnostic measurement tool (a pachymeter) and the study focuses on its inherent accuracy and precision, not on human reader performance or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The lab tests and the in-vivo measurements are designed to assess the device's intrinsic performance (accuracy and precision) when measuring corneal thickness. While a human operator uses the device, the performance being evaluated is that of the pachymeter itself in generating measurements, not the operator's diagnostic ability with or without the device. The "Pachymeter's performance conforms to the voluntary standard (IEC EN 60825-1) for class I laser devices," further suggesting an evaluation of the device's standalone technical capabilities.
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The type of ground truth used:
- Lab Tests: Objective physical standards (accepted calibration standards and glass check rods).
- Clinical Studies (In-vivo): Direct physiological measurements of central corneal thickness.
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The sample size for the training set:
- The document does not mention a separate "training set" for the device. The studies described are performance validation studies, not machine learning model training.
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How the ground truth for the training set was established:
- Not applicable, as a training set is not mentioned or implied for this type of device and study.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.