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510(k) Data Aggregation
(132 days)
ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT
The Aragon Surgical Laparoscopic (L2) Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic laparoscopic procedures where ligation and division of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.
The indications for use include general laparoscopic procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological laparoscopic procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectorny, adhesiolysis, bowel resections, and oophorectomy etc., or any procedure where vessel ligation (cutting and sealing), tissue grasping, and dissection is performed.
The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.
The Aragon Surgical Laparoscopic Instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.
The Aragon Surgical Laparoscopic Instrument(L2) is provided as a sterile, single use device. The device is capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws during open and laparoscopic procedures. The device is designed to be used with the Aragon Surgical RF Generator (K081312) and creates vessel ligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.
Here's an analysis of the provided text regarding the Aragon Surgical Laparoscopic Instrument (L2) and its performance data, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, does not explicitly state specific acceptance criteria in measurable terms (e.g., "burst pressure of X mm Hg," "seal time of Y seconds"). Instead, it broadly states that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices. | "Meets design, safety, and effectiveness criteria." |
| Meets design, safety, and effectiveness criteria for intended use. | "Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical L2 Instrument is substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria." |
| No new issues regarding safety or effectiveness compared to predicate devices. | "Any differences between the Aragon Surgical device and the predicate devices do not raise new issues regarding safety or effectiveness." |
| Effective for vessel ligation (cutting and sealing) up to 7mm vessels. | "The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument." |
| Not effective for tubal sterilization/coagulation. | "The Aragon Surgical Laparoscopic Instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench and pre-clinical evaluations" but does not specify the sample size for any test sets used. The data provenance is not explicitly stated as retrospective or prospective, nor does it detail country of origin, but it can be inferred that these were controlled evaluations conducted by the manufacturer, Aragon Surgical, Inc., presumably in a laboratory or animal setting ("pre-clinical").
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study typically involves human readers (e.g., radiologists) evaluating cases with and without AI assistance to measure the effect size of AI on their performance. The device described here is a surgical instrument, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a surgical instrument, not an algorithm or AI system. Its performance is inherently linked to its physical interaction with tissue and the surgeon's use.
7. Type of Ground Truth Used
The document implies that the ground truth for the "bench and pre-clinical evaluations" would be based on direct measurements of physical properties of vessel seals (e.g., burst pressure, seal integrity) and visual or histological assessment of tissue effects in the pre-clinical (likely animal) models, compared to established predicate devices. However, the exact nature of the ground truth is not explicitly detailed.
8. Sample Size for the Training Set
The document describes "bench and pre-clinical evaluations" for performance data. As this is a physical medical device, not a machine learning algorithm, there is no concept of a "training set" in the traditional sense. The development and testing of such a device involve iterative design, prototyping, and testing, but not the training of an algorithm on a distinct dataset.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" in the context of this device. Therefore, the establishment of ground truth for a training set is not applicable.
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