(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal - OB/GYN
Laparoscopic
Intraoperative (abdominal organs and vascular)
Abdominal
Small Organ (breast, thyroid, testicle)
Trans-vaginal
Trans-rectal
Musculo-skeletal (conventional)
Musculo-skeletal (superficial)
Neonatal Cephalic
Pediatric
Cardiac-(adult and pediatric)
Trans-esophageal (non-cardiac)
Peripheral Vessel
Other
- Gastrointestinal tract and the surrounding Organs
- The airways and tracheobronchial tree
The EU-C60 is a general purpose, compact, software-controlled, diagnostic ultrasound system. The EU-C60 has compatibility with SonoSite transducers (such as abdominal or intracavital transducers) and Olympus Ultrasound videoscope. Its function is to acquire ultrasound data and display it on a monitor in several modes. ( 2D, Color Power Doppler, PowerMap™ Directional Color Power Doppler, or in a combination of modes.) The EU-C60 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes. The GF-UC160P-OL5/GF-UCT160-OL5 give the operator the ability to perform Endocopic Ultrasound(EUS) guided fine needle aspiration(FNA).
The provided text is a 510(k) Premarket Notification from the FDA for the Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center. This document's primary purpose is to demonstrate substantial equivalence to previously marketed devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner that a clinical trial for a novel AI algorithm would.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in this type of regulatory submission. The document focuses on demonstrating that the new device performs within the expected parameters of existing, legally marketed ultrasound systems.
Here's an analysis of what can be extracted and what is missing:
1. Table of acceptance criteria and reported device performance:
The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) as would be found in a performance study for an AI device. Instead, the "performance" is implicitly demonstrated by stating that the device "operates identically to the predicate devices" and "complies with the standards listed below."
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Intended Use Equivalence | The device's intended uses are substantially equivalent to those of the predicate devices. |
| Technological Characteristics Equivalence | "This device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves… Sound waves are reflected back to the transducer and converted to electric signals, which are processed and displayed as images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis." |
| "Technological Characteristics of this device is identical to the predicated devices identified in item 3." | |
| Design Standards Compliance | "The EU-C60 is designed to comply with the standards listed below: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, CISPR11." |
| Material Biocompatibility | "The material of Balloon3 is a new patient-contacting material. The biocompatibility test reports of the new material show that the new material is safe for its intended use." |
2. Sample size used for the test set and the data provenance:
- Not provided. This document is not a clinical study report with a test set of patient data. The "study" here refers to the process of demonstrating substantial equivalence, which primarily involves comparing the device's technical specifications and intended uses to those of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of an external test set with ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process is described.
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:
- Not conducted/applicable. This is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not conducted/applicable. This is a diagnostic ultrasound system, not an algorithm, and the concept of "standalone performance" in the AI sense does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" in this context is the performance and safety profiles of the predicate devices and compliance with established medical device standards.
8. The sample size for the training set:
- Not applicable. This document describes a medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. See above.
In summary:
This document is a regulatory submission demonstrating substantial equivalence for a physical medical device (an ultrasound system). It leverages comparison to existing, legally marketed predicate devices and compliance with relevant safety and performance standards. It does not contain information about clinical performance studies with specific acceptance criteria, test sets, or ground truths as would be expected for an AI-based diagnostic tool.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.