(23 days)
To measure thickness of the cornea in the human eye using ultrasound energy.
Not Found
The provided text is a 510(k) summary for the POD Pac-20m Corneal Pachymeter System, dated March 21, 2003. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and study results for device performance.
Therefore, much of the requested information cannot be extracted directly from this document.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document states that the technological characteristics are "the same as those for the predicate device except for the models of some of the components, and the user interface." It also mentions that the acoustic output is "similar to that of predicate devices and below the preamendment levels." However, specific acceptance criteria for measurement accuracy, precision, or other performance metrics for the POD Pac-20m are not provided, nor are detailed reported performance values. The clearance is based on substantial equivalence, implying that its performance is expected to be comparable to the predicate, but no specific performance data is given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. The document does not describe any specific clinical or performance test set, its sample size, or data provenance. The 510(k) summary is for substantial equivalence and does not include details of a clinical study for the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be extracted. As no specific clinical or performance test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. No test set is described, so no adjudication method is mentioned.
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
- Cannot be extracted. This device is an "Ultrasonic Corneal Pachymeter," which is an imaging and measurement device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be extracted directly, but inferred as "yes" in practice. As a measurement device for corneal thickness, its primary function is standalone measurement. The document doesn't explicitly describe a "standalone performance study" in the context of an algorithm, but the device's intended use is to directly measure thickness, which inherently implies its standalone function. No performance metrics are provided to quantify this, however.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be extracted. No ground truth establishment is described in this document.
8. The sample size for the training set
- Cannot be extracted. This document describes an ultrasonic measurement device, not an AI/machine learning algorithm. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established
- Cannot be extracted. As there's no training set, there's no ground truth establishment for it mentioned.
Summary of available information from the document related to device validation:
The document relies on substantial equivalence to a previously cleared predicate device, the Quantel "Pocket" Ultrasonic Pachymeter (K993674), and the classified device described in 21CFR892.1560 "Ultrasonic Pulsed Echo Imaging System," for its clearance.
The key points for substantial equivalence are:
- Same intended use: To measure the thickness of the cornea.
- Same technological characteristics: Except for models of some components and the user interface.
- Same patient-contact materials.
- Similar acoustic output: Below pre-amendment levels.
The FDA's letter mentions a condition that "prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G." This is a post-market requirement for validation, not part of the pre-market submission detailed in this summary.
§ 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.