(14 days)
The Yield Mini Doppler Probe with Broncus® Monitor is intended for use through a bronchoscope to detect blood flow behind airway walls in the tracheobronchial tree.
This premarket notification covers Broncus' Yield Mini Doppler System, which comprises the Yield Mini Doppler Probe and Broncus Monitor. The Mini Doppler System will enable the bronchoscopist to identify vessel-free areas prior to performing transbronchial procedures such as needle aspiration or biopsy.
Acceptance Criteria and Study for Yield™ Mini Doppler System (K090743)
The provided documentation for the Yield™ Mini Doppler System (K090743) is a 510(k) Summary and an FDA clearance letter. These documents attest to the device's substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of a clinical performance trial with specific metrics.
Therefore, much of the requested information regarding specific acceptance criteria, performance metrics, sample sizes, ground truth establishment, and multi-reader studies is not explicitly available in the provided text. The submission focuses on demonstrating safety and equivalence through engineering testing and comparison to existing cleared devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not specify quantitative clinical acceptance criteria or performance metrics such as sensitivity, specificity, or diagnostic accuracy that would be typically found in a clinical performance study for an AI/algorithm-based device. The "acceptance criteria" discussed are primarily related to manufacturing, safety, and functionality.
| Acceptance Criteria Category | Description / Testing Performed | Reported Device Performance |
|---|---|---|
| Mechanical Safety | Performance testing was conducted. | All items tested were within specification tolerances. No failures. |
| Thermal Safety | Performance testing was conducted. | All items tested were within specification tolerances. No failures. |
| Electrical Safety | Performance testing was conducted. | All items tested were within specification tolerances. No failures. |
| Biocompatibility | Performed in accordance with ISO 10993, Biological Evaluation of Medical Devices. | Pass/Meets ISO 10993 requirements. |
| Sterilization | Device is intended to be sterilized using e-beam sterilization. (While not an "acceptance criterion" in the same way, this is a critical aspect of device safety and manufacturing control). | Appropriate sterilization method identified. |
| Functional Equivalence | The Yield Mini Doppler System has the same intended use, methods of introduction, method of operation, and design features as the predicate devices (Exhale Doppler System K010649 and P.D. Access Percutaneous Doppler Vascular Device K973713). The intended use is to detect blood flow behind the airway wall in the tracheobronchial tree. | Determined to be substantially equivalent to predicate devices, implying functional performance is comparable for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "performance testing" but does not detail the nature or sample size of any clinical or in-vitro test set for evaluating the device's ability to detect blood flow. The clearance is based on equivalence to predicate devices and engineering testing.
- Data Provenance: Not applicable, as there's no clinical test set data from patients described. The testing described (mechanical, thermal, electrical safety, biocompatibility) are engineering and laboratory tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. There is no mention of a human-read test set or expert ground truth establishment for a clinical performance evaluation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document does not describe any MRMC study comparing human reader performance with or without AI assistance. This device is a diagnostic tool, not an AI-assisted interpretation product.
6. Standalone Performance Study
- Standalone Performance Study: The document describes "Performance testing of the Yield Mini Doppler System included mechanical, thermal and electrical safety testing." These are standalone engineering tests. However, a standalone clinical performance study (e.g., sensitivity, specificity for detecting blood flow compared to a definitive reference standard in a patient population) that would typically be associated with an AI algorithm's standalone performance is not described. The clearance relies on substantial equivalence to predicate devices.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "Performance Data" mentioned (mechanical, thermal, electrical safety, biocompatibility), the ground truth would be engineering specifications, regulatory standards (e.g., ISO 10993), and safety requirements. For the device's core function of detecting blood flow, while not explicitly detailed, the inherent design and operation are deemed equivalent to previously cleared devices which would have established their ability to detect blood flow. There's no mention of pathology, outcomes data, or expert consensus as ground truth for a clinical efficacy study within this submission.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a Doppler system, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for an AI/machine learning algorithm.
§ 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.