(100 days)
The Quantel Medical ABSOLU is intended to be used for:
-Axial Length measurement of the eye by ultrasonic means;
-Implanted IOL power calculation, using the Axial Length measurement;
- Visualization of the interior of the eye and the orbit by A and B scans.
The ABSOLU is a high definition multifunction ophthalmic ultrasound system used for the following intended use:
- -Axial Length measurement of the eye by ultrasonic means;
- Implanted IOL power calculation, using the axial length measurements; -
- Visualization of the interior of the eve and the orbit by A and B scans. -
The Quantel Medical ABSOLU device is intended for axial length measurement of the eye, implanted IOL power calculation using axial length measurements, and visualization of the interior of the eye and orbit via A and B scans. The performance data and acceptance criteria are outlined below, primarily focusing on safety and compliance with recognized standards rather than specific diagnostic accuracy metrics of a standalone AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with AAMI ANSI ES60601-1:2005 + Corr. 1:2006+Corr. 2:2007+A1:2012 (Medical electrical equipment-Part 1: General requirements for basic safety and essential performance). |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014 (Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests). |
| Usability | Complies with IEC 60601-1-6:2010+A1:2013 (Medical electrical equipment-Part 1-6: General requirements for safety-Collateral Standard Usability). This is supported by the improved, more intuitive user interface. |
| Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment | Complies with IEC 60601-2-37: "Ed2 + AM1 with 60601-1 (ed.3), AM1 with correc 1 & correc 2 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment". This specifically addresses performance of the B-scan probes. |
| Hardware and Software Validation | Hardware and software validation activities were performed to ensure the device performs as intended. Software documentation appropriate for the Moderate level of concern was provided. |
| Technological Changes (e.g., B-scan probe improvements, frequency changes) | The 20 MHz annular B-scan probe technology increases depth of field by 70%, allowing simultaneous examination of vitreous, retina, and orbit pathologies without compromising image quality. The 15 MHz B-scan probe offers superior resolution and improved measurement accuracy compared to the previous 10 MHz version, with a focal point change from 25 mm to 24 mm. These changes do not affect safety or performance. |
| Measurement Accuracy (Axial Length, IOL power calculation) | Improved with the 15 MHz B-scan probe due to increased frequency. (No specific quantitative metric provided in the document for comparison against a threshold.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes tests performed for regulatory compliance (safety, EMC, usability, and ultrasonic equipment safety standards) and validation of technological changes. It does not mention a specific "test set" in the context of clinical data for diagnostic or measurement accuracy of a standalone AI algorithm. The performance data refers to instrumental performance, safety, and functional validation against standards for the device as a whole and its components (probes, software). Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not available in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document, as the evaluations described are primarily for device safety, EMC, usability, and technical performance against engineering standards, not a clinical diagnostic performance study with expert-adjudicated ground truth.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided in the document, as the evaluations described are for device safety and technical performance, not for clinical diagnostic performance adjudicated by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is present in the document. The device is an ultrasound system with specific measurement and visualization capabilities, and the performance data focuses on its compliance with operational, safety, and technical standards, rather than an AI-driven diagnostic accuracy study comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not describe a standalone performance study for an AI algorithm without human intervention. The ABSOLU is described as an "ultrasonic pulsed echo imaging system" intended for use by "trained medical personnel" where "the use of the different parameters of the ABSOLU® and the predicate device are under control of the physician for the different phases of the diagnostic." This strongly suggests a human-in-the-loop system, not a standalone AI.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not detail specific "ground truth" for clinical diagnostic or measurement accuracy in the context of expert consensus, pathology, or outcomes data. The "performance data" mentioned pertains to compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, usability, and ultrasonic medical device safety. These standards serve as the "ground truth" for the device's technical and safety performance.
8. Sample Size for the Training Set
No information regarding a training set sample size is provided. The document outlines a regulatory submission for an ultrasound imaging system, not an AI algorithm that typically requires a large training dataset for its development. The "software" mentioned as being revised is general device software, not an AI component trained on data.
9. How the Ground Truth for the Training Set Was Established
Since no training set for an AI algorithm is mentioned, there is no information on how ground truth for such a set was established.
§ 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.