(175 days)
The Aragon Surgical RF System is indicated for tissue sealing and division during the performance of abdominal hysterectomy. The instrument can seal vessels up to 7mm. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.
The Aragon Surgical RF System consists of the Aragon Surgical Radiofrequency Energy (RF) Generator and a handheld Instrument, foot pedal, and power coad. The Aragon Surgical Instrument connects to the RF Generator. The Aragon Surgical Instrument is supplied sterile and is intended for single use. The Instrument uses a bipolar design, which means that a return pad is not required for operation. Software is utilized in the operation of the Aragon Surgical RF Generator.
The provided text describes the Aragon Surgical RF System and its 510(k) premarket notification (K081312) but does not contain information regarding specific acceptance criteria for performance metrics or a detailed study proving the device meets particular criteria, such as sensitivity, specificity, accuracy, or any comparative effectiveness data with human readers.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through bench and pre-clinical evaluations.
Here's an analysis based only on the provided text, outlining why certain sections of your request cannot be fulfilled:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The core of the 510(k) submission is to demonstrate substantial equivalence to predicate devices, not necessarily to meet specific, quantifiable performance criteria in a published table. | The document states "Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical System is substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria." However, specific performance metrics (e.g., burst pressure, thermal spread, sealing time) and their corresponding acceptance thresholds are not detailed. It mentions the ability to "seal vessels up to 7mm." |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document mentions "bench and pre-clinical evaluations" but does not provide details on the number of samples, cases, or procedures involved.
- Data Provenance: Not specified. It only states "bench and pre-clinical evaluations." There is no mention of country of origin, or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document does not describe a study involving human experts establishing ground truth for a test set, as might be found in imaging or diagnostic device submissions. The evaluations mentioned are "bench and pre-clinical," implying laboratory and possibly animal studies.
4. Adjudication method for the test set:
- Not applicable/Not specified. As there's no mention of studies involving human readers or interpretation, no adjudication method would be detailed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No. The document does not describe an MRMC comparative effectiveness study. This type of study is common for diagnostic imaging devices where human interpretation is a key component. The Aragon Surgical RF System is an electrosurgical device for tissue sealing and division.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself is a tool used by a surgeon. "Standalone performance" in this context would refer to the device's physical and functional capabilities (e.g., sealing strength, heat generation, division effectiveness). The document generally states that "bench and pre-clinical evaluations" were conducted to demonstrate it "meets design, safety, and effectiveness criteria." However, specific standalone performance metrics and results beyond "can seal vessels up to 7mm" are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For "bench and pre-clinical evaluations," ground truth would likely be established through objective measurements (e.g., burst pressure testing for vessel seals, histological examination for tissue damage/seal integrity, temperature measurements) rather than expert consensus or pathology in the context of clinical expert interpretation.
8. The sample size for the training set:
- Not applicable/Not specified. The term "training set" typically refers to data used to train machine learning algorithms. While "Software is utilized in the operation of the Aragon Surgical RF Generator," the document does not describe the development of an AI algorithm based on a training set. The evaluations focus on the physical performance of the device itself.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, as there is no mention of a training set or AI algorithm development in the provided text.
Summary of Device and Performance Information Available from the Text:
- Device Name: Aragon Surgical RF System
- Indication for Use: Tissue sealing and division during abdominal hysterectomy, specifically sealing vessels up to 7mm.
- Demonstrated Equivalence: Substantially equivalent to predicate devices (LigaSure™ Vessel Sealing System K981916 and LigaSure™ Open Dissector Divider K041587) in terms of design, materials, principle of operation, and product specifications.
- Performance Data: "Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical System is substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria." The capability to "seal vessels up to 7mm" is explicitly mentioned.
- Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, justifying 510(k) clearance.
The document provided is a 510(k) summary focused on regulatory clearance via substantial equivalence, which often does not include the detailed performance study results that would be found in a peer-reviewed publication or a more comprehensive technical report.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.