(255 days)
The Quantel Medical POCKET Ultrasonic Pachymeter is intended to be used for the measurement of corneal thickness which is required for some types of corneal surgery.
The POCKET is a small, hand-held ultrasonic Ophthalmic Pachymeter that uses the principles of sonar (pulsed ultrasound) to measure corneal thickness. The device allows the operator to pre-plan a series of measurements on the surface of the cornea, to go automatically from one to the other while making the measurements, and then to present the results of the measurements as thickness over an area of the eye.
The provided document describes the Quantel Medical S.A. "Pocket" Ultrasonic Pachymeter, a device for measuring corneal thickness. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed acceptance criteria or a comprehensive study report for the device's performance.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety standards (IEC 601-1 and 601-1-2) | The POCKET has passed all tests for IEC 601-1 and 601-1-2. |
| Accuracy | Accuracy tests done by an outside laboratory. (Specific values or pass/fail criteria are not provided in this document). |
| Transducer output emissions | Output emissions done by an outside laboratory. (Specific values or pass/fail criteria are not provided). |
| Software validation | Undergone extensive validation testing. (Details of validation testing and results are not provided). |
| Equivalence in safety and efficacy to predicate devices | Concluded to be equivalent in safety and efficacy based on non-clinical tests and the predicate devices' history of "Billed in I OCREF assos and in Europe for several years and has not had reported problems." (No direct comparative clinical study with specific metrics is mentioned). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Since the POCKET uses the same technology as existing devices, clinical tests are Billed in I OCREF assos and in Europe for several years and has not had reported problems."
This indicates that new clinical tests with a defined test set were not conducted for the "Pocket" device. Instead, the submission relies on the established performance and safety record of predicate devices already on the market. Therefore, there is no specified sample size for a test set for this device, and no new data provenance is reported.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no new clinical tests were performed for the "Pocket" device, no experts were used to establish ground truth for a new test set. The claim of safety and efficacy is based on the performance of predicate devices over several years.
4. Adjudication Method for the Test Set
As no new clinical tests were performed, there was no adjudication method applied to a new test set for the "Pocket" device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted. The submission does not present any data on human reader improvement with or without AI assistance, as it is a standalone pachymeter and not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an ultrasonic pachymeter, which is inherently a standalone measurement device. The performance data focuses on non-clinical tests (IEC standards, accuracy, output emissions, software validation) and equivalence to predicate devices, implying its standalone performance is being asserted. However, a formal "standalone study" with a defined protocol and performance metrics against a gold standard for the "Pocket" device itself (beyond general accuracy tests) is not described in detail.
7. Type of Ground Truth Used
For the non-clinical tests, the ground truth would be established by:
- IEC standards: Compliance with predefined test protocols and specifications for electrical safety and electromagnetic compatibility.
- Accuracy tests: Likely comparison against a known standard or calibrated reference for thickness measurement.
- Transducer output emissions: Measurement against regulatory limits for ultrasound output.
- Software validation: Verification against software requirements and design specifications.
For the equivalence claim, the "ground truth" is implied by the historical performance and lack of reported problems with the predicate devices in Europe and other regions. This is not a direct "ground truth" for the "Pocket" device's clinical measurements but rather an reliance on the established safety and efficacy of similar technology.
8. Sample Size for the Training Set
There is no mention of a training set in the context of an algorithm or machine learning model. This device is a measurement instrument based on established ultrasonic technology, not a learning-based artificial intelligence system.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.