(158 days)
The 5.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5.0 Fr Arndt Endobronchial Blocker is indicated for pediatric populations, in children 1 year and older.
The 9.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 9.0 Fr Arndt Endobronchial Blocker is indicated for adult use only.
The 5.0 Fr Arndt Endobronchial Blocker Set and the 9.0 Fr Arndt Endobronchial Blocker Set are comprised of a blocker catheter with a silicone balloon near the distal end. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. A nylon guide loop at the distal end of the blocker catheter is wrapped around the tip of the bronchoscope and tightened, in order for the bronchoscope to assist in the precise placement of the blocker catheter. An Arndt Multiport Airway Adapter, a proximal straight connector, a suction adapter, and a syringe are also provided with each set.
This document describes the premarket notification for the 5.0 Fr Arndt Endobronchial Blocker Set and the 9.0 Fr Arndt Endobronchial Blocker Set. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study where the device proves it meets acceptance criteria through clinical performance metrics like sensitivity, specificity, etc.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics such as accuracy, sensitivity, specificity, and related study designs (e.g., sample sizes for test/training sets, expert consensus, MRMC studies), cannot be extracted directly from this document. This is a 510(k) submission, which primarily relies on technological characteristics and comparison to legally marketed predicate devices to establish substantial equivalence. Clinical performance studies with human readers or standalone algorithm performance are typically not required for this type of submission unless new questions of safety or effectiveness are raised.
The document does, however, detail various engineering and performance tests conducted to ensure reliable design and functionality of the device itself, rather than its clinical performance in diagnosing or assisting human experts.
Here's an attempt to address your points based on the available information, noting the limitations:
1. A table of acceptance criteria and the reported device performance
The document provides a list of engineering and performance tests with their general acceptance criteria and outcomes. The performance is reported as meeting "established acceptance criteria." Quantitative results are not provided beyond "greater than or equal to" or "do not exhibit signs of leakage or burst."
| Test Type | Acceptance Criteria (General) | Reported Device Performance (General Outcome) |
|---|---|---|
| Tensile Tests (Catheter Shaft, Distal Sideport, Snare-to-Proximal Manifold Bond, Hub-to-Shaft Bond, Pilot Balloon Assembly-to-Manifold) (Zero-Time, Three-Year Accelerated Aged) | Peak load value greater than or equal to established acceptance criteria. | Demonstrated to be greater than or equal to the established acceptance criteria. |
| Analysis of Re-insertion Method of Snare (Zero-Time) | (Performed for characterization only, no specific acceptance criteria stated for performance) | This test was performed for characterization only. |
| Balloon Shear Loading Test (Zero-Time, Three-Year Accelerated Aged) | Test articles do not completely separate from the catheter shaft (both proximal and distal balloon bonds fail, i.e.) or, if the balloon ruptures, not fragment. | The acceptance criteria were met. |
| Pressurization Testing (Zero-Time, Three-Year Accelerated Aged) | Test articles do not exhibit signs of leakage or burst while pressurized. | The acceptance criteria were met. |
| Balloon Inflation Test (Zero-Time, Three-Year Accelerated Aged) | Inflation diameter of the test articles were demonstrated to be greater than the established acceptance criteria. | Demonstrated to be greater than the established acceptance criteria. |
| Balloon Burst Testing (Zero-Time, Three-Year Accelerated Aged) | Minimum failure volume of the test articles were demonstrated to be greater than the established acceptance criteria. | Demonstrated to be greater than the established acceptance criteria. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes device engineering and performance testing (e.g., tensile strength, balloon inflation) on the device itself, not a clinical study involving patients or human data for clinical performance evaluation. Therefore, "test set" in the context of clinical data or patient data is not applicable here. The "test articles" in the engineering tests refer to physical units of the device. The sample sizes for these engineering tests are not specified in the provided text. Data provenance (country of origin, retrospective/prospective) is also not applicable as it's not a clinical study using patient data.
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)
Not applicable. This is not a study requiring expert interpretation or ground truth establishment of clinical findings. The "ground truth" for the engineering tests would be established by validated test methods and physical property standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of clinical findings.
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 applicable. This is not a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (a physical blocker set), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the engineering tests described, the "ground truth" would be the established physical and material properties, and the performance expectations defined by the device's design requirements. These are validated through standard engineering and materials testing methodologies.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI study that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).