(178 days)
Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal stenlization or tubal coagulation for sterilization procedures and should not be used for these procedures.
These devices are bipolar forceps design for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. They are constructed of stainless steel, a nylon coating, and a non-stick tip. The devices are provided non-sterile and must be autoclaved prior to use.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
Important Note: The provided text only describes a 510(k) summary for a medical device (Stingray Electrosurgical Forceps). A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, not necessarily detailed performance criteria or clinical efficacy studies as would be required for a novel device or a PMA. The information requested in the prompt, such as acceptance criteria table with reported performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, are not present in the provided document.
Therefore, the following response will indicate where the requested information is absent.
Acceptance Criteria and Study Details for Stingray Electrosurgical Forceps (K123478)
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Not Specified | Validated through twenty (20) sterilization cycles. Additional limit testing to forty (40) sterilization cycles showed no degradation observed. |
| Coagulation Efficacy | Not Specified | "Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch." (This describes the mechanism, not specific performance metrics or acceptance criteria). |
| Biocompatibility | Not Specified | Not explicitly mentioned but generally implied by use of "stainless steel, a nylon coating, and a non-stick tip." |
| Sterilization Efficacy | Not Specified | "Substantial changes to the Instructions for Use are proposed within this submission including a change of steam sterilization method and an update to the cleaning/reprocessing instructions." (This indicates a change in method, not acceptance criteria for sterilization efficacy itself). |
| Useful Lifetime | Not Specified | Estimated to be two (2) years. Validated through twenty (20) sterilization cycles (exceeds estimated amount of cycles for a single device in two years). |
Explanation: The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K083162) and changes to instructions for use, particularly sterilization and cleaning. It does not provide explicit, quantitative acceptance criteria for device performance or a detailed study demonstrating that these criteria have been met in the format typically seen for novel product performance. The "reported device performance" in the table above is derived from statements about validation and testing mentioned in the document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions validation through "twenty (20) sterilization cycles" and "forty (40) sterilization cycles" for an unspecified number of devices, which relates to the device's durability rather than a clinical test set.
- Data Provenance: Not specified. The description of testing (sterilization cycles) suggests laboratory-based validation, not clinical data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not specified. The provided text describes engineering/technical validation (sterilization cycles), not a study requiring expert-established ground truth.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. The validation described (sterilization cycles) does not involve adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The device is an electrosurgical forceps, a surgical instrument. MRMC studies are typically performed for diagnostic imaging or AI-assisted diagnostic devices to assess how AI affects human interpretation. This type of study is not relevant or described for this device.
- Effect Size of Human Reader Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: No. This device is a manual surgical instrument. The concept of an "algorithm only" or "standalone" performance without human-in-the-loop is not applicable to an electrosurgical forceps.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for clinical ground truth. The "ground truth" implied by the testing described relates to the physical integrity and continued functionality of the device after repeated sterilization, determined by engineering assessments, not expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. This device does not involve a "training set" in the context of machine learning or AI models.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable/not specified. This concept is not relevant to the described device or the 510(k) submission.
§ 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.