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510(k) Data Aggregation
(76 days)
The Estech Cobra Surgical System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
The Estech Cobra Surgical System is a family of devices including RF Ablation Probes, with either a malleable or flexible shafts, used in conjunction with the Cobra Electrosurgical Unit (ESU) and other accessories, including the Estech Cobra Bipolar Recording Electrode. The System is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedures.
This device (Estech Cobra Surgical System) is an electrosurgical device, and the submission is a 510(k) premarket notification for an amendment to the existing device. The information provided heavily focuses on regulatory comparisons to predicate devices rather than a detailed clinical study for acceptance criteria.
Based on the provided text, the "acceptance criteria" for this amendment are primarily based on substantial equivalence to existing predicate devices.
Here's an analysis of the provided text in relation to your questions, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied to be substantial equivalence to predicate devices in terms of intended use, technology, design, and materials, and satisfactory preclinical performance data for any modifications. Specific numerical performance metrics (e.g., coagulation depth, lesion size) are not explicitly stated as "acceptance criteria" in a table format with corresponding reported performance, as would be typical for a new device's clinical study.
| Acceptance Criteria Category | Reported Device Performance Assessment in Submission |
|---|---|
| Substantial Equivalence (General) | The XL version of the Estech Cobra Surgical System is substantially equivalent in intended use, technology, design and materials to the predicate device. |
| The Estech Cobra Surgical Probe is substantially equivalent in intended use, technology, design and materials to the predicate system. | |
| The Estech Cobra Bipolar Recording Electrode is substantially equivalent to the surgical console. | |
| Biocompatibility | No biocompatibility data is necessary since the materials in the modified ablation probes (XL and Surgical Probe) are identical to those in the ablation probes described in the predicate 510(k)s. |
| Preclinical Performance - XL Version | Preclinical performance data is supplied to demonstrate that the XL version of the cooled probe meets pertinent specifications as the predicate version. |
| Preclinical Performance - Surgical Probe | No performance data is necessary for the Estech Cobra Surgical Probe since it is identical in design and manufacture to the predicate device. |
| Preclinical Performance - Bipolar Recording Electrode | Preclinical performance data is supplied to demonstrate that the Estech Cobra Bipolar Recording Electrode operates as intended. |
| Compliance with Standards | Additionally, Estech certifies that the accessories are in compliance with the pertinent standard for electrosurgical devices, AAMI HF-18. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" with human subjects or a specific sample size for a study proving acceptance criteria. The performance data mentioned is "preclinical performance data." This usually refers to bench testing or animal studies.
- Sample Size: Not specified for preclinical performance tests.
- Data Provenance: "Preclinical performance data" implies laboratory or animal testing, not human clinical trials. No country of origin for such data is specified, but it would typically be conducted by the manufacturer or a contract research organization. The context suggests that the submission is from the US, implying data generated or submitted to the US FDA.
- Retrospective or Prospective: Not applicable as it's not a clinical study involving patients. Preclinical data would be generated prospectively as part of the validation process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Since the described data is "preclinical performance data" and not a clinical study with a human "test set" requiring ground truth established by experts, this section is not applicable.
4. Adjudication Method for the Test Set
Not applicable, as there is no described clinical "test set" requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The device is a surgical tool, not an imaging or diagnostic device that typically undergoes MRMC studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical surgical device, not an algorithm.
7. Type of Ground Truth Used
For the preclinical data provided, the "ground truth" would be established by:
- Engineering specifications: Performance of the device (e.g., power output, temperature control, lesion size) compared against predefined engineering targets derived from the predicate device's performance.
- Compliance with standards: Meeting the requirements of AAMI HF-18.
- Predicate device performance: The "ground truth" for the new XL version is the established performance characteristics and safety profile of the predicate device.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm. There's no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical electrosurgical device.
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