(162 days)
Olympus UM-2R and UM-3R Ultrasonic Probes have been designed for use in conjunction with Olympus Endoscopic Ultrasound System for intraluminal sonographic imaging of the upper airways and tracheobronchial tree.
In routine examination of the upper airways and tracheobronchial tree, there are situations where the physician prefers to perform an intensive examination, observation, and diagnosis of the upper airways and tracheobronchial tree. The conventional type bronchoscopes limit the physician's ability to access certain areas of interest. The UM-2R/UM-3R Ultrasonic Probes, when used with an endoscope offer transendoscopic access to the upper airways and tracheobronchial tree. The 2.4 mm insertion tube of these probes can be advanced through strictures and anatomical ducts. The Olympus Ultrasonic Probes to be used in conjunction with bronchoscopes with a minimum channel size of 2.8 mm. The rotation of the transducer is controlled by a probe driving unit.
The UM-2R and UM-3R probes produce a B-mode scans using the de-aerated water immersion method and offer 360 degree mechanical/radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4 mm and the length is 2050 mm. Both probes incorporate similar design, construction, intended use, and method of operation. The only difference between these two probes is that the UM-2R probe operates at 12 MHz and is compatible with both Olympus EU-M30, EU-M20 and EU-M3 Endoscopic Ultrasound Systems, while the UM-3R probe operates at 20 MHz and is compatible with the EU-M30 and the EU-M20 Endoscopic Ultrasound System.
The provided text describes a 510(k) summary for the Olympus UM-2R/3R Ultrasonic Probes. It primarily focuses on the device's description, intended use, and safety compliance, particularly regarding its extension to bronchial use. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria with detailed performance metrics.
The document states that the probes "meet the requirements of the FDA's 510(k) Diagnostic Ultrasound Guidance for 1993 and 1985," and that "neither ultrasound probe incorporates any significant change in method of operation, material, or design that could affect safety or effectiveness" when compared to predicate devices, except for the expanded intended use. This implies that the device is deemed to meet safety and effectiveness standards, likely by demonstrating substantial equivalence to previously cleared devices. However, explicit performance metrics, such as sensitivity, specificity, accuracy, or any quantitative results from a specific clinical study for the new bronchial indication, are not presented.
Therefore, many of the requested sections regarding a specific study design and results cannot be filled from the provided text.
Here's a breakdown of what can be inferred or directly stated from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantitative metrics. The implicit acceptance criteria are that the device meets existing FDA guidance for diagnostic ultrasound and is substantially equivalent in safety and effectiveness to predicate devices for its new intended use (bronchial imaging).
- Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, effect size) are reported for the device in the provided document.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (Electrical Safety) | Device is designed, manufactured, and tested in compliance. |
| Compliance with FDA 510(k) Diagnostic Ultrasound Guidance (1993, 1985) | Device meets these requirements for ultrasound characteristics. |
| Substantial Equivalence to Predicate Devices (Safety & Effectiveness) | No significant change in method, material, or design affecting safety or effectiveness compared to predicates (except for intended use). |
| Ability to visualize upper airways and tracheobronchial tree via intraluminal sonographic imaging | Device is designed for this purpose, but no performance data is given. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not mentioned. No specific test set or clinical study supporting the new bronchial indication is described.
- Data Provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. No specific ground truth establishment is described for a test set.
4. Adjudication method for the test set:
- Not 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:
- No MRMC study is mentioned. This device is an ultrasonic probe, not an AI-assisted diagnostic tool as described in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (ultrasonic probe), not an algorithm.
7. The type of ground truth used:
- Not mentioned. The document relies on demonstrating substantial equivalence to predicate devices and compliance with existing standards rather than presenting a novel clinical study with a defined ground truth.
8. The sample size for the training set:
- Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety and performance standards for an ultrasonic probe. It does not describe a clinical study with new performance data beyond these regulatory requirements.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.