(329 days)
Electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.
The device consists of grasping jaws connected to a handle. The handle has finger loops integrated into it to allow the physician to easily manipulate the device for electrosurgical coagulation including the sealing of vessels. The overall length of the device is nine (9) inches. The device will be available in three distinct jaw configurations. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad.
The provided text describes the 510(k) summary for the Gyrus OPEN FORCEPS, a Class II medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study to prove meeting those criteria for a novel algorithm or AI device.
Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert involvement, and ground truth establishment is not available in the provided document, as it pertains to a different type of device approval process.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific quantitative acceptance criteria are not explicitly stated in the document. | The study indicates the device is "safe and effective and conforms to its Intended Use." |
| Substantial equivalence to predicate devices K000496, K981916, and K010010 in: | |
| - Design | "similar in construction" |
| - Component materials | "similar in component materials" |
| - Function | Not explicitly stated but implied by substantial equivalence |
| - Intended Use | "similar to the predicate devices" |
| Preclinical laboratory data and bench test data provide verification that the device is safe and effective. | Not specified in detail. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. The document states "Preclinical laboratory data and bench test data," but does not provide specific sample sizes for these tests.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). These would typically be relevant for clinical data, which is not described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not mentioned. The study referenced "Preclinical laboratory data and bench test data" for a physical device, not an AI or diagnostic algorithm requiring expert-established ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not mentioned. This is not relevant for a device demonstrating substantial equivalence through bench and preclinical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, which the Gyrus OPEN FORCEPS is not.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. The device is a physical electrosurgical instrument; there is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "Preclinical laboratory data and bench test data," the ground truth would likely be established by engineering specifications, physical measurements, and performance standards for electrosurgical devices (e.g., tissue impedance, temperature profiles, vessel seal integrity). Specific details are not provided.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is a physical instrument, not an AI/ML model that undergoes a "training set" phase.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. (See #8)
Summary of Device and Approval Process:
The K024286 submission for the Gyrus OPEN FORCEPS is for a physical electrosurgical instrument. The approval is based on demonstrating substantial equivalence to existing predicate devices (K000496, K981916, K010010). This means the device is considered safe and effective because its design, materials, function, and indications for use are similar to devices already on the market. The "study" mentioned consists of "Preclinical laboratory data and bench test data" to verify safety and effectiveness, but it is not detailed in the provided documents. The 510(k) process for such devices typically relies heavily on engineering and performance testing against established standards, rather than large-scale clinical trials or expert-adjudicated performance metrics common for AI/diagnostic tools.
§ 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.