(18 days)
The instrument is used for measuring the axial length, anterior chamber depth and lens thickness of the eye. It also is used for calculating the optical power of the IOL to be implanted during cataract surgery.
The AccuSonic A-Scan device is designed as a biometer, which uses pulsed echo ultrasound to measure the axial length, and the location of other structures of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a one-dimensional display of returning pulse echoes, with positive peaks to indicate the location of ocular structures. The distance between peaks can be measured.
The provided 510(k) summary for the AccuSonic A-Scan device primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations.
This submission is for an ultrasound biometer, a physical device that measures ocular structures. It precedes the widespread use and regulatory requirements for AI/ML-driven medical devices. Therefore, the information typically found in such reports (like sample size for test/training sets, ground truth establishment for AI, MRMC studies, etc.) is not applicable in this context. The 510(k) process for devices like this primarily relies on performance specifications, safety testing, and comparison to already cleared devices.
Here's a breakdown of the requested information based on the provided document and the limitations of an A-scan biometer submission from 2003:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in a single table as would be expected for a modern AI/ML device study. Instead, the "performance" is implicitly tied to its "substantially equivalent" claim to predicate devices. For an A-scan biometer, key performance aspects would relate to accuracy, precision, and reproducibility of measurements (axial length, anterior chamber depth, lens thickness). These are typically verified through internal testing and comparison to reference standards or predicate devices.
| Acceptance Criteria (Inferred from device type) | Reported Device Performance (Inferred from Substantial Equivalence) |
|---|---|
| Ability to accurately measure axial length of the eye | Demonstrated to be comparable to legally marketed predicate devices (e.g., Accutome Advent AB, Teknar Ophthasonic A-Scan, DGH 3000A A-Scan) |
| Ability to accurately measure anterior chamber depth | Demonstrated to be comparable to legally marketed predicate devices |
| Ability to accurately measure lens thickness | Demonstrated to be comparable to legally marketed predicate devices |
| Ability to function for IOL power calculation | Demonstrated to be comparable to legally marketed predicate devices |
| Safety and effectiveness for indicated uses | Assessed to be safe and effective for indicated uses, similar to predicate devices |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided: The document does not describe a clinical "test set" in the context of an AI/ML algorithm. For a physical device like an A-scan, performance is typically validated through engineering tests, phantom studies, and comparison to predicate devices, rather than a separate clinical test set to evaluate an algorithm's output. Clinical validation might involve a small number of patients, but this is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: Ground truth in the context of algorithmic performance is not relevant for this device's submission. The "ground truth" for an A-scan biometer's measurements would be the actual physical dimensions of the structures being measured, verified by precise physical standards or other highly accurate measurement methods, not expert consensus on image interpretation.
4. Adjudication method for the test set
- Not Applicable / Not Provided: Adjudication methods are typically employed in studies where human interpretation or labeling of data is involved, especially for AI/ML model training or evaluation. This is not
relevant to the performance evaluation described for the AccuSonic A-Scan.
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
- No: This is a submission for a physical diagnostic ultrasound device (biometer), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: There is no "algorithm only" performance reported in the context of AI for this device. The device itself is the standalone measurement system. Its performance is its ability to accurately measure ocular dimensions.
7. The type of ground truth used
- Inferred: Physical/Reference Standards: For an A-scan biometer, the ground truth would typically be established by:
- High-precision physical phantoms: Known dimensions are measured by the device and compared to the phantom's actual dimensions.
- Comparison to highly accurate predicate devices: Measurements obtained by the new device are compared to those from an already validated predicate device on the same subjects or phantoms.
- Cadaveric eyes or animal eyes: In some cases, direct measurements on excised eyes could serve as ground truth.
These methods ensure the device's measurements correlate accurately with physical reality.
8. The sample size for the training set
- Not Applicable / Not Provided: This device is not an AI/ML algorithm, so it doesn't have a "training set" in that sense. The device's design and calibration are based on engineering principles and physical laws of ultrasound.
9. How the ground truth for the training set was established
- Not Applicable: As there is no AI/ML training set, the concept of establishing ground truth for it is not relevant.
In summary: The provided document is a 510(k) summary for a traditional medical device (ultrasound biometer) from 2003. Its primary purpose is to show "substantial equivalence" to existing cleared devices rather than providing detailed performance metrics from an AI/ML study. Therefore, many of the requested categories related to AI/ML device evaluation are not applicable or not explicitly detailed in this type of regulatory submission. The performance is assessed based on the device's ability to produce measurements comparable to those of already cleared predicate devices.
§ 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.