(30 days)
The 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 Ophthalmic Ultrasound System is an ultrasonic system for ophthalmology. It is a modification to the COMPACT TOUCH® cleared in K094038. Similar to the previous version of the device, it consists of a base and probes. The Base performs the same calculations and displays as the predicate COMPACT TOUCH®. The A-scan probe for biometry and pachymeter is identical to the predicate while the B-scan probe has an increased transducer frequency of 15 Hz which allows for improved measurement accuracy of ± 0.115 mm.
The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical trial or performance study report. Instead, it is a 510(k) summary for a medical device (COMPACT TOUCH® Ophthalmic Ultrasound System) seeking FDA clearance based on substantial equivalence to an existing predicate device (K094038).
The document focuses on explaining that the new device has the same indications for use and similar technological characteristics to the predicate device, with some minor modifications. The "performance data" section primarily lists compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, usability, and particular requirements for ultrasonic medical diagnostic equipment. It also mentions hardware and software validation activities.
However, I can extract the relevant information regarding the performance improvement stated and the basis for equivalence as outlined in the document.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text for a full "acceptance criteria and study results" breakdown.
Device Name: COMPACT TOUCH® Ophthalmic Ultrasound System
Predicate Device: Quantel Medical Compact Touch (K094038)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the form of specific thresholds (e.g., sensitivity, specificity, accuracy targets) for its diagnostic functions or biometric measurements, as would be typical for a clinical performance study. Instead, the "acceptance criteria" are implied by showing equivalence to the predicate and highlighting an improvement in measurement accuracy for one specific probe.
| Acceptance Criterion (Implied by Equivalence / Improvement) | Reported Device Performance (New Device) |
|---|---|
| B-Scan Probe Measurement Accuracy | Improved to ± 0.115 mm |
| (Predicate Device Performance) | (± 0.2 mm) |
| Safety and Effectiveness | (Not explicitly quantified, but stated as unimpaired despite modifications) |
| Compliance with Consensus Standards | Demonstrated compliance with listed IEC and AAMI ANSI standards |
| Software Validation | Performed, appropriate for Moderate level of concern |
| Electrical Safety | Complies with electrical safety standards (degree of protection changed from BF to B) |
| Electromagnetic Compatibility (EMC) | Complies with EMC standards |
| Usability | Complies with usability standards |
| Indications for Use | Same as predicate device |
| Technological Characteristics | Similar to predicate device (A-scan/pachymeter identical, B-scan frequency increased, other minor changes) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set or test subjects for evaluating the improved measurement accuracy (± 0.115 mm). It states that the improvement is "due to the increase of the frequency of the probe" and that "IEC 60601-2-37 tests have been followed...". This suggests the performance claim for accuracy is likely derived from laboratory testing or phantom measurements, rather than a clinical study on a patient population.
Data provenance (country of origin, retrospective/prospective) and details of the "test set" are not provided, as it seems no clinical human subject test set was used for the accuracy claim or overall equivalence beyond technical standard compliance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since no clinical test set with human subjects is described for evaluating the stated performance improvement, there is no mention of experts being used to establish ground truth in such a context. The evaluation appears to be based on technical specifications and compliance with standards.
4. Adjudication Method for the Test Set
As no clinical test set for human subject performance validation is described, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any assessment of human readers improving with or without AI assistance. This device is an ultrasound system purely for diagnostic imaging and biometric measurement, not an AI-powered diagnostic interpretation tool.
6. Standalone (Algorithm Only) Performance Study
The document describes the device as an "Ophthalmic Ultrasound System" which performs imaging and measurements. It mentions "calculations" and "software revised to accommodate the other device changes". However, there is no standalone algorithm-only performance study described in the context of diagnostic interpretation or classification. The performance discussed relates to the physical measurement capabilities of the ultrasound system.
7. Type of Ground Truth Used
For the improved measurement accuracy of ± 0.115 mm, the ground truth is implicitly derived from technical specifications and calibration procedures of the ultrasound system, likely using phantoms or reference standards in a laboratory setting, rather than expert consensus, pathology, or outcomes data from human subjects. The primary "ground truth" for the overall device's safety and effectiveness in the context of this 510(k) is its substantial equivalence to the predicate device, which itself would have undergone its own validation.
8. Sample Size for the Training Set
This document pertains to a hardware device with associated software for measurement and display. It is not an AI/Machine Learning device that undergoes a "training" process with a large dataset. Therefore, there is no training set sample size mentioned.
9. How the Ground Truth for the Training Set Was Established
As it is not an AI/Machine Learning device, there is no training set and consequently no ground truth establishment process for a training set mentioned.
§ 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.