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To be utilized through a flexible endoscope or the superDimension system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.

The superDimension® Triple Needle Cytology Brush is designed to obtain tissue samples for biopsy from endobronchial lesions, peripheral lung nodules, or lung masses. The superDimension® Triple Needle Cytology Brush is an endoscopic catheter comprised of an outer Ethylene Tetrafluoroethylene (ETFE) sheathing and an inner catheter assembly. The inner catheter assembly consists of a thumb ring at the proximal end and a twisted wire shaft to connect to the distal end. The distal end terminates in three connected brushes available in two lengths: 10 mm and 15mm. The brushes have sharpened ends, referred to as needle-tipped, that can be used to rough up tissue to obtain a sample of tissue or cells. When the catheter is inserted into a channel such as a bronchoscope or superDimension Extended Working Channel (EWC) with the distal brush in a retracted position inside the outer sheath. When the catheter is in position, the brushes can be extended into the tissue to obtain tissue samples by advancing the proximal thumb ring. When the physician believes that an adequate sample has been taken, the brushes are retracted back into the sheath and then the entire catheter is withdrawn from the channel The superDimension® Triple Needle Cytology Brush is for standard tissue analysis. similar to currently marketed cytology brushes except that it has three smaller brushes in place of one larger brush.

The provided text describes the 510(k) summary for the Covidien SuperDimension® Triple Needle Cytology Brush. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria with specific numerical thresholds for performance metrics. Instead, it states that the device "met the required specifications for the completed tests and performed similarly to the predicate devices." The performance evaluation is based on demonstrating substantial equivalence to predicate devices, rather than achieving pre-defined quantitative performance targets.

However, based on the described "Performance Data," we can infer the categories of performance evaluated:

• Catheter tensile strength
• Dimensional accuracy
• Ability to simulate use cases
• Trackability | Met required specifications; similar to predicate devices. |
  | Durability/Stability| - Shelf life (per ASTM F1980-07, ASTM F2096-11, and ASTM F88-09)
• Distribution integrity (per ASTM D4169-09) | Met required specifications; similar to predicate devices. |
  | Sterilization | - Sterility (per ISO 11135-1) | Met required specifications; similar to predicate devices. |
  | Biocompatibility | - Cytotoxicity, irritation, sensitization (per ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10) | Met required specifications; similar to predicate devices. |
  | Functional (In Vivo)| - Ability to collect tissue specimens
• Safety (no adverse events/complications in the animal model) | Demonstrated tissue collection and safety in a porcine model; similar to predicate devices. |

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

The document mentions "In-vitro and in-vivo testing" was performed, but does not specify the sample sizes used for these tests. For the in-vivo testing, it was conducted "in a porcine model," indicating an animal study, not human data. The data provenance is described as:

• In-vitro testing: Laboratory-based, likely conducted by the manufacturer.
• In-vivo testing: Porcine model (animal study).

There is no mention of human retrospective or prospective data for the performance evaluation.

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

This information is not provided in the document. Given that the testing involved in-vitro and in-vivo (animal model) studies, the "ground truth" would likely be established through objective measurements (for in-vitro tests) and pathological examination of collected animal tissue, possibly by veterinarians or animal pathologists. However, the specific number and qualifications of experts are not stated.

4. Adjudication Method for the Test Set:

This information is not provided. As the testing primarily involved objective measurements and animal studies, a formal adjudication method for human consensus on ground truth (like 2+1 or 3+1) would not be applicable in the absence of human clinical data or expert evaluation of test results.

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 comparative effectiveness study was done, nor is there any mention of AI assistance in this context. The device described is a physical medical instrument (cytology brush), not an AI-powered diagnostic or assistive tool.

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

This question is not applicable as the device is a physical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Based on the described testing:

• For in-vitro tests, the ground truth would be based on objective physical and material measurements against established engineering specifications and industry standards.
• For in-vivo testing in a porcine model, the ground truth for tissue collection would likely be pathological examination of collected animal tissue samples to confirm the presence and adequacy of collected cells/tissue. Safety would be assessed through observation and potentially post-mortem examination.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical instrument, and there is no mention of an algorithm or AI model that requires a training set.

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

This information is not applicable as there is no training set mentioned for this physical device.

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