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The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

The Aragon Surgical LapCap is a single-use device used during laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate dome housing containing a pass-through port for introduction of a standard Veress needle and a vacuum port for attachment to a standard hospital vacuum line.

The provided text does not contain any information about acceptance criteria or a study proving device performance.

The document is a 510(k) summary and the FDA's clearance letter for the Aragon Surgical LapCap. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies or pre-defined acceptance criteria for the new device's efficacy or accuracy.

Therefore, I cannot populate the requested table and information points as the source material does not contain the necessary details.

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The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

The Aragon Surgical LapCap is a single-use device used during laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate dome housing containing a pass-through port for introduction of a standard Veress needle and a vacuum port for attachment to a standard hospital vacuum line.

This 510(k) summary does not contain the detailed information necessary to answer all parts of your request. It's a premarket notification for a medical device (Aragon Surgical LapCap) seeking substantial equivalence to existing devices. Therefore, it focuses on comparing the new device's intended use and technological characteristics to predicates, rather than presenting a detailed study with acceptance criteria and specific performance metrics in the way you've outlined.

Specifically, the document does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or details on how ground truth was established for such a set.
• Information on the number or qualifications of experts, or adjudication methods for a test set.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of AI improvement.
• Results from a standalone algorithm (AI) performance study.
• Details on the sample size for a training set or how ground truth was established for it.

The document is a regulatory submission for a physical medical device (a laparoscopic insufflator accessory), not an AI/software device whose performance would typically be evaluated against such criteria. The "study" mentioned here is a demonstration of substantial equivalence to predicate devices based on intended use and technological characteristics, rather than a clinical performance study with specific quantitative acceptance criteria of the kind usually seen for algorithmic diagnostics.

Therefore, I cannot populate the requested table and information based on the provided text. The document's purpose is to demonstrate that the device is "substantially equivalent" to already approved devices, meaning it doesn't raise new questions of safety and effectiveness, not to prove performance against specific numerical targets.

Ask a specific question about this device