(113 days)
The QUANTEL MEDICAL Compact TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:
- Visualization of the interior of the eye and the orbit by A and B scans.
- Axial Length measurement of the eye by ultrasonic means.
- Implanted IOL power calculation, using the Axial Length measurement.
- Measurement of corneal thickness by ultrasonic means.
The Compact TOUCH is an ultrasonic system designed for ophthalmic use. It combines A and B type scans for diagnostic imaging of the eye. The system is composed of a main console controlled by a touch screen. It consists of three probes which plug into the main console; the B-scan probe, the A-scan probe, and a Pachymetry probe.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Compact TOUCH Ophthalmic Ultrasound System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria with quantifiable metrics (e.g., accuracy, precision values) for the device's performance. Instead, it relies on a claim of "substantial equivalence" to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| A-scan Probe Performance | "identical to that used by the predicate, AVISO K051851." |
| Axial Length measurement | (Not explicitly quantified, but implied to be equivalent to predicate) |
| IOL power calculation | (Not explicitly quantified, but implied to be equivalent to predicate based on axial length measurement) |
| B-scan Probe Performance | "identical to that used by the predicate, AVISO K051851." |
| Diagnostic imaging of the eye | (Not explicitly quantified, but implied to be equivalent to predicate) |
| Pachymetry Probe Performance | "identical to that used by the predicate, POCKET K993674." |
| Corneal thickness measurement | (Not explicitly quantified, but implied to be equivalent to predicate) |
| Overall System Performance | "met design specifications and was substantially equivalent to the predicate devices." |
| Safety and Efficacy | "risks and benefits for the Compact TOUCH are argued to be comparable to the predicate devices. We believe that there are no new questions of safety or efficacy raised by the introduction of the Compact TOUCH." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The study described is "Laboratory testing," which suggests it was likely performed in a controlled environment, but the origin of any data used for comparison (if any beyond predicate device specifications) is not mentioned. It is not possible to determine if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The submission states "No Clinical testing is required," meaning there was no human-based evaluation of diagnostic output that would necessitate an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document explicitly states "No Clinical testing is required." Therefore, no assessment of human reader improvement with or without AI assistance was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, in a way. The "Laboratory testing" was performed to verify that the device met design specifications and was substantially equivalent to predicate devices. This type of testing would assess the device's performance directly against established specifications or the performance of other devices, without human-in-the-loop diagnostic interpretation. However, the exact methodology for this testing is not detailed beyond referencing a guidance document.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this submission appears to be based on the design specifications of the Compact TOUCH and the established performance of the predicate devices. The device's components (probes) are explicitly stated to be "identical" to those used in the predicate devices, implying that their performance characteristics are known and accepted.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is an ultrasound system and its probes, not an algorithm that undergoes machine learning training in the context commonly understood today (e.g., AI with neural networks). The "training" in this context would refer to the engineering and validation processes that led to the design specifications of the device and its probes, which are stated to be identical to previously cleared devices.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable in the context of machine learning training data. For a hardware device like this, the "ground truth" for its design and manufacturing would be established through engineering specifications, previous validation studies for the predicate devices, and adherence to relevant industry standards and guidance documents (e.g., "Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers"). The claim of "identical" probes to predicate devices means the extensive testing and validation performed for those original devices serve as the foundation for the current device's performance claims.
§ 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.