(58 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Trans-rectal
Trans-urethral
Trans-esoph. (non-Card.)
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.
Intraluminal ultrasound for upper airways and tracheobronchial tree
3-D Imaging
The combination of the XEU-M60A Endoscopic Ultrasound Center, UM-2R/3R Ultrasonic Probes, UM-DP12/20-25R Ultrasonic Probes, GF-UM130 Ultrasonic Gastrovideoscope, GF-UM160 Ultrasonic Gastrovideoscope, XGF-UM180 Ultrasonic Gastrovideoscope, GF-UE160-AL5 Uftrasonic Gastrovideoscope, GF-UC140P-AL5 Ultrasonic Gastrovideoscope, and GF-UCT140-AL5 Ultrasonic Gastrovideoscope enables the acquisition and display of high-resolution and high-penetration, real-time ultrasound B-mode endoscopic images,
This is a premarket notification (510(k)) for the Olympus XEU-M60A Endoscopic Ultrasound Center and associated ultrasonic probes and gastrovideoscopes. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to establish new acceptance criteria. Therefore, the document does not contain acceptance criteria or study results in the typical sense of a de novo clinical trial for a novel device.
The submission focuses on comparing the new device's technical characteristics and intended use to existing, cleared devices.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
The provided document, a 510(k) submission, does not specify explicit acceptance criteria (e.g., minimum sensitivity, specificity, accuracy) for device performance or present a table of such criteria against reported performance. This type of information is typically reserved for clinical trials designed to prove safety and effectiveness for novel devices, or for performance studies of AI/ML-enabled devices that introduce new diagnostic capabilities.
For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is assessed by confirming that the new device operates similarly and performs as expected for its intended use, aligning with the performance of the predicate devices. The document implies that the device works by stating: "The XEU-M60A Endoscopic Ultrasound Center operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set with a specific sample size, data provenance, or retrospective/prospective design. This information is generally found in clinical performance studies, which are not typically part of a 510(k) that relies on substantial equivalence for an established technology.
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)
Since there is no described clinical test set, there is no mention of experts used to establish ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As there is no described clinical test set, there is no information on an adjudication method.
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
The document does not describe an MRMC comparative effectiveness study. This device is a diagnostic ultrasound system and associated components, not an AI/ML-enabled device, and therefore this type of study showing human readers' improvement with AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an algorithm without human intervention, which is relevant for AI/ML devices. The XEU-M60A is a diagnostic ultrasound system, not an AI/ML algorithm, so a "standalone algorithm" performance study is not applicable or discussed. The device's performance is inherently tied to human operation and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As there is no described clinical test set, there is no information on the type of ground truth used. The submission relies on the established performance of the predicate devices.
8. The sample size for the training set
The document does not refer to a training set. This is typically applicable for AI/ML devices, where a model is trained on a specific dataset. This device is a traditional diagnostic ultrasound system.
9. How the ground truth for the training set was established
As there is no described training set, there is no information on how its ground truth would have been established.
Summary of what the document implies about meeting acceptance criteria:
The "acceptance criteria" in the context of this 510(k) submission are met by demonstrating that the Olympus XEU-M60A Endoscopic Ultrasound Center and its associated ultrasonic probes and gastrovideoscopes are substantially equivalent to legally marketed predicate devices.
Study/Evidence that proves the device meets the acceptance criteria (Substantial Equivalence):
The document explicitly states:
- Identical Mode of Operation: "The XEU-M60A Endoscopic Ultrasound Center operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body."
- Identical Technological Characteristics: "Technological Characteristics of this device is identical to the predicate devices identified in item 3."
- Predicate Device Comparison: The submission includes a table of predicate devices for comparison (listed in Section 3, titled "Predicate Device Information"). For both the Ultrasound System and Ultrasonic Gastrovideoscopes and Probes, specific predicate devices with control numbers (K-numbers) are cited.
- XEU-M60A Endoscopic Ultrasound Center is compared to EU-M60 (K043275) and EU-C60 (K010591).
- Various Ultrasonic Probes and Gastrovideoscopes (UM-2R/3R, UM-DP12/20-25R, GF-UM130, GF-UM160, XGF-UM180, GF-UE160-AL5, GF-UC140P-AL5, GF-UCT140-AL5) are compared to their respective previously cleared versions, often citing multiple K-numbers. For some, like UM-DP12/20-25R, it's mentioned that Olympus determined no new 510(k) was required for device changes based on earlier clearances.
- Indications for Use: The document outlines the intended uses (e.g., Transrectal, Transurethral, Transesophageal, Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree, 3-D Imaging) in sections 4.3.1 through 4.3.9, noting which are "new indications" (N) but implying they fall within the scope of predicate devices or generally accepted ultrasound diagnostic capabilities. The new indications appear to be for specific anatomical sites (e.g., Trans-rectal, Trans-urethral, Trans-esoph. (non-Card.) and "Other" (e.g., Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree), and 3-D Imaging capabilities.
In essence, the "study" demonstrating the device meets "acceptance criteria" here is the analysis of substantial equivalence conducted by Olympus and reviewed by the FDA, concluding that the new device has the same technological characteristics and intended use, or minor differences that do not raise new questions of safety or effectiveness, as its predicates. No independent clinical performance study data would typically be presented in such a 510(k) unless a new indication or technology significantly deviated from predicates.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.