(13 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transesophageal, Transrectal, Transvaginal, Transurethral, Gastrointestinal tract, biliary, pancreatic duct and the surrounding Organs, Intraluminal ultrasound for upper airways and tracheobronchial tree, Urinary tract, Female reproductive tract, 3D imaging.
The OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER makes a endoscopic ultrasound imaging system used to acquire and to display high-resolution and high-penetration, real-time ultrasound B-mode 2D and 3D images.
The provided document is a 510(k) summary for the OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER, cleared in 2004. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. As such, it does not contain acceptance criteria in the usual sense of performance metrics or a study demonstrating the device meets those criteria.
Instead, the document primarily focuses on establishing substantial equivalence to existing predicate devices. This is a regulatory pathway where the new device is shown to be as safe and effective as a device already on the market (the predicate device). The "study" here is essentially the demonstration of similar technological characteristics and intended uses.
Therefore, many of the requested categories cannot be populated from the provided text because they relate to performance studies and ground truth establishment, which are typically not part of a 510(k) submission that relies on substantial equivalence.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance
No explicit acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) are reported in this 510(k) summary.
The primary "acceptance criterion" for a 510(k) submission is establishing substantial equivalence to a legally marketed predicate device. This is demonstrated by showing:
- Same intended use as the predicate.
- Same technological characteristics as the predicate OR different technological characteristics that do not raise new questions of safety and effectiveness, and are demonstrated to be as safe and effective as the predicate.
In this case, the document states: "Technological Characteristics of this device is identical to the predicated devices identified in item C." and the intended uses are largely carried over from the predicate (K011886) with some new additions (indicated by 'E').
Explanation for Non-Applicable Sections:
Since this is a 510(k) summary focused on substantial equivalence rather than a clinical performance study with quantitative metrics, the following sections are not applicable or cannot be extracted from this document:
- Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described. The "test" is the comparison to predicate devices, not a clinical study to generate performance metrics.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for a test set is established or required for a substantial equivalence determination based on identical technological characteristics and similar intended use.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is an ultrasound system, not an AI or imaging assistance device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance study generating such data is described.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 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.