Search Results

The Arcpoint™ pulmonary needle is utilized through a flexible endoscope or with the superDimension™ navigation system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.

The Arcpoint™ pulmonary needle is an endobronchial biopsy needle that consists of a pulmonary needle and a stylet. The pulmonary needle is intended to retrieve tissue specimens from lungs during an endobronchial lung biopsy procedure. The product is used either through a flexible endoscope or in conjunction with the superDimension™ navigation system's extended working channel. The pulmonary needle is comprised of an outer polymeric shaft with stainless steel braid reinforcement and an inner polymeric shaft with a stainless steel needle attached. The needle and device shaft are visible under fluoroscopy. The proximal end consists of handle connected to the outer shaft and a needle plunger with luer-lock fitting connected to the inner shaft. The pulmonary needle features a positive stop retraction/extension design which is controlled by sliding of the inner shaft via the needle plunger. When retracted, the needle stays within the outer shaft. The needle protrudes 8.0 mm from the outer shaft when fully extended. This design provides protection during passage in a working channel and allows accurate and quick release when the needle is at the targeted site. The luer-lock fitting allows connection to a standard luer-lock syringe for applying suction to the inner shaft to aspirate cell specimens. A stylet comes pre-inserted in the pulmonary needle which provides additional rigidity to the needle shaft and may help prevent unwanted tissue capture during passage to the targeted site. Use of the stylet is optional at physicians' discretion. The product is packaged in a Tyvek pouch and is sterilized with ethylene oxide. The product package contains the pulmonary needle and stylet.

The document provided is a 510(k) summary for the Arcpoint™ pulmonary needle, a medical device intended for retrieving tissue specimens from lungs. The information required to describe the acceptance criteria and the study that proves the device meets those criteria is primarily found in Section 7, "Performance Data," particularly the "Animal Study Data" subsection.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not explicitly state the number of animals or specific procedures conducted within the porcine model study. It mentions the study was conducted "in a porcine model."
• Data Provenance: The study was a "preclinical study" conducted "in a porcine model." This indicates an ex-vivo/in-vivo animal study, not human data. The country of origin is not specified but is implicitly associated with the applicant, Covidien LLC, located in Plymouth, MN, USA. The study is prospective in nature, as it was conducted to evaluate the performance of a new device.

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

• Number of Experts: Three physicians.
• Qualifications of Experts: Two pulmonologists and one thoracic surgeon.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for establishing ground truth from the experts' assessments. It states that "All acceptance criteria were met," implying a consensus or individual assessment against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is an animal study comparing the performance of the device to a predicate device, focusing on safety and effectiveness endpoints rather than human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The Arcpoint™ pulmonary needle is a physical medical device (biopsy needle), not an algorithm or AI software. Therefore, an "algorithm only" or "standalone" performance study in the context of AI does not apply. The performance evaluation was focused on the device's physical and functional capabilities.

7. The Type of Ground Truth Used

The ground truth for the animal study was established through direct observation and measurement of physiological and pathological outcomes in the porcine model. This includes:

• Incidence of pneumothorax.
• Incidence of intraoperative bleeding.
• Incidence of bleeding/hemorrhage at necropsy.
• Pathological findings (trauma/tissue injury).
  The assessment of these outcomes would have been performed by the three physicians and other research personnel involved in the preclinical study.

8. The Sample Size for the Training Set

This question is not applicable. The Arcpoint™ pulmonary needle is a physical medical device. It does not employ machine learning or AI models that require a "training set."

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

This question is not applicable, as there is no training set for a physical medical device.

Ask a specific question about this device