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The DUTAU-NOVATECH® is intended for rigid bronchoscopy. For use in trachea and bronchi. To be used by qualified surgeons during ENT endoscopic procedures. The DUTAU-NOVATECH® is suitable for use for a patient population greater than 5 years of age.

DUTAU-NOVATECH® is a rigid bronchoscope that consists of a bronchoscope head and replaceable tubes and is fully dismantlable. It is made of medical grade stainless steel. The tracheal tube mounted on the bronchoscope head is inserted into the trachea. The bronchial tube mounted on the bronchoscope head is inserted through the trachea into the bronchi. A telescope and instruments for diagnosis and treatment can be inserted through these tubes into the bronchi (bronchial tube) or the trachea, respectively. To ventilate the patient, the ventilation tube can be connected either to the bronchoscope head or directly to the respective tube. The tubes are colour coded depending on the size and have a scale to measure stenosis. DUTAU-NOVATECH® is supplied unsterile and must be cleaned, disinfected, and sterilized prior to its use.

I am sorry, but the provided text does not contain the detailed information required to fill out the table and answer all the questions comprehensively. The document primarily focuses on establishing substantial equivalence to a predicate device, listing the device description, intended use, indications for use, and a side-by-side comparison of technological characteristics.

Specifically, the following information is not present in the provided text:

• Acceptance Criteria for specific performance metrics (beyond general statements of meeting standards or passing internal protocols).
• Reported Device Performance against explicit acceptance criteria with quantitative results.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details or effect sizes.
• Standalone (algorithm only) performance study details.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document mainly discusses physical and mechanical performance tests for safety and functionality, such as disconnect stability, assembling, compression, tensile, connection stability, plug-in connection, luer lock connection, separation tensile force, atraumatic design, rotational torque, and leakage tests. However, it does not provide specific numerical acceptance criteria or quantitative results for these tests in a format that could be readily presented in the requested table.

The text confirms that "The test results have been checked against the requirements stated in the relevant standard or against the performance of the predicate device," and that "The requirements are fulfilled for all the test samples." This indicates successful testing but lacks the specifics requested.

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For maintaining open the airway, after dilation of the stenosis or resection of the obstruction, in particular in case of:

• Tracheobronchial tumors
• Tracheal stenoses with scarring
• Stenoses following surgical anastomosis, resection or pulmonary transplantation.

The TRACHEOBRONXANE™ DUMON® stents are flexible tracheobronchial tubes made of medical grade silicone, designed to improve patient respiration capacity while acting as trachea or bronchi support. These medical devices are designed to conform to individual anatomies.

Each stent has a specific treatment, to improve the evacuation of mucus in order to limit the risk of obstruction.

A large range of shape, thickness and sizes is available depending on the pathology to be treated, patient intrinsic factor and location of the implantation. Indeed, the TRACHEOBRONXANE™ DUMON® range consists of various models which vary from each other in the following characteristics:

• The stents type: TD, TF, BD, Y, ST corresponding to various profiles made of silicone with different hardness;
• . The dimensions: each profile consists of different sizes in diameter and length;
• The radiopacity: stents can be provided radiopaque or not radiopaque; barium sulfate . is added during the manufacturing process in order to make the stent radiopaque which allows obtaining a better visibility by X-rays radiography.

The TRACHEOBRONXANE™ DUMON® stents have been designed with studs in order to facilitate their anchorage in the trachea or bronchi (on cartilage rings). The number of stud rows is depending on the stent profile and stent final destination (bronchi or trachea).

The TRACHEOBRONXANE™ DUMON® stent holds the respiratory tract open by exerting a radial force.

The Tracheobronxane™ Dumon® device is a medical-grade silicone tracheobronchial tube intended to maintain an open airway after dilation or resection, particularly in cases of tumors, scarring, or post-surgical/transplantation stenoses.

The provided document does not contain a typical acceptance criteria table with reported device performance for an AI/algorithm-based device. Instead, it describes performance data related to the physical and biological characteristics of a medical device (a stent). The assessment is for demonstrating substantial equivalence to a predicate device, not for an AI's diagnostic or predictive capabilities.

However, based on the information provided, we can infer the acceptance criteria and the studies performed to demonstrate equivalence.

Here's an interpretation based on the provided text, framed as acceptance criteria for the device itself (the stent), rather than for an AI:

1. Table of Acceptance Criteria and Reported Device Performance:

• Chemical testing and subsequent risk assessment revealed no systemic toxic effects.
• In-vitro studies on NuSil medical-grade silicones and DUMON® stents passed cytotoxicity tests.
• Chemical testing did not reveal sensitizing or irritating substances; in-vivo studies on NuSil medical-grade silicones passed.
• Devices do not contain substances from DIN EN ISO 10993-11 Annex G; in-vivo studies on NuSil medical-grade silicones revealed no material-mediated pyrogenicity.
• Long history of safe clinical use supports no expectation of systemic toxicity, implantation effects, carcinogenicity, or reproductive/developmental toxicity.
• Due to non-polar nature of silicone, no degradation expected; chemical testing on DUMON® stents revealed no degradation products.
• Chemical testing on DUMON® stents revealed no substances in toxicologically relevant amounts (toxicokinetics). |
  | Mechanical Performance | Fatigue Resistance: Stents maintain performance characteristics after simulating normal usage.
  Weighing: Stents do not absorb or dispose of significant substances.
  Compression: Stents maintain radial performance and required force for compression. | - Specific test procedures performed on brand new, fatigue-stressed, and water-bath stored stents. Data compared. (Implies performance maintained, though specific metrics not given).
• Weighing test performed on water-bath and fatigue-tested stents. (Implies results were acceptable).
• Compression test performed on fatigue-tested stents to examine radial performance. (Implies results were acceptable). |
  | Shelf-Life | 3-year shelf-life demonstrated. | 3 years. (This is a specific claim met). |
  | Sterilization | Supplied sterile. | Steam Sterilization method used, device supplied sterile. (This is a specific claim met). |
  | Equivalence to Predicate | The device is substantially equivalent to the ENDOXANE® predicate device in terms of intended use, indications for use, patient target group, intended user, anatomical sites, environment of use, energy used, materials, principles of operation, and mechanical safety. It maintains the same level of safety and effectiveness. | - Comparison table shows "same" for nearly all categories including intended use, indications, materials, and mechanical safety characteristics.
• The only noted difference is that the proposed device is supplied sterile, while the predicate was non-sterile, which would not negate equivalence. |

2. Sample Size Used for the Test Set and Data Provenance:

The document describes benchmarking performance tests and biocompatibility testing. However, it does not specify "test sets" in the context of an algorithm or AI.

• Biocompatibility Testing: The "samples" would be the device materials (medical-grade silicone, barium sulfate) and the final stents themselves. The exact number of samples for each test (cytotoxicity, sensitization, etc.) is not specified, but standard ISO 10993 testing involves a defined number of replicates/samples. The provenance is internal to the manufacturer (Novatech SA) and involves standard lab testing, not patient data in the sense of retrospective or prospective clinical studies.
• Benchmark Performance Tests (Fatigue, Weighing, Compression): The "samples" are the stents themselves. The number of stents used for these tests (brand new, fatigue-stressed, water-bath treated) is not specified. The provenance is internal laboratory testing by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This device is a physical medical implant (stent), not a diagnostic or AI device that relies on expert interpretation for ground truth establishment. The ground truth for its performance is derived from standardized laboratory tests (biocompatibility, mechanical tests).

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" in the context of expert review or adjudication as would be relevant for an AI/algorithm. Performance is assessed against pre-defined, standardized test methods and criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. This is not an AI-assisted device, so MRMC studies for human readers with and without AI assistance are not relevant or performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• Biocompatibility: Ground truth is established by adherence to ISO 10993-1 standards and the absence of adverse biological reactions in standardized in-vitro and in-vivo tests, as well as a "long history of safe clinical use" for similar materials.
• Mechanical Performance: Ground truth is established by engineering specifications for stent integrity, radial force, and material absorption/disposal, measured through specific mechanical tests (fatigue, weighing, compression).
• Shelf-Life/Sterilization: Ground truth is established by stability testing and validated sterilization methods demonstrating sterility assurance levels.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is a physical medical device, not an AI/algorithm.

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