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510(k) Data Aggregation
(267 days)
The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual Illuminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.
The Spetzler™ Malis® Dual Illuminating Bipolar Forceps are sterile, single-use devices for use in electrosurgery. The forceps are a bayonet style and incorporates a twin pin cord in the proximal end for connection to a bipolar electrosurgical generator via a generic twin pin, female socket receptacle cord set. A fiberoptic cable is bonded to each tine and mates to a proprietary connector at the proximal end. The connector mates with an adaptor that is inserted in the illumination port of an endoscopic ligthsource.
The provided text describes a 510(k) summary for the Spetzler™ Malis® Dual Illuminating Bipolar Forceps and details non-clinical testing performed to establish substantial equivalence to a predicate device. It does not contain information about an AI/ML device, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone algorithm performance study. Therefore, several requested sections cannot be filled from the given text.
Here's the information extracted and organized based on your request, with "N/A" for unavailable data:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate device and the reference device, aiming for "equivalent" performance.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (Subject Device) |
|---|---|---|
| Non-Stick Coagulation Events (Primary Function) | ≥ 500+ events (equivalent to predicate) | 500+ |
| Illumination Output (Non-Stick Coagulation Testing) | N/A (Predicate did not have illumination) | 200-204 mW |
| Beef Liver Steady State Temperature Rise over Ambient (after 30 min. exposure) | < 110% of Reference Scope AND < 10 degrees F (equivalent to reference) | 4 degrees F |
| Device Output [mW] MAX (Illumination Transmission Levels) | < Reference Scope (Telescope) | 220 mW |
| Device Output [mW] AVG (Illumination Transmission Levels) | < Reference Scope (Telescope) | 207 mW |
| Tip Temperature [°F] MAX | < 110% of Reference Scope (Telescope) | 186 °F |
| Tip Temperature [°F] AVG | < 110% of Reference Scope (Telescope) | 164.5 °F |
| Electrical Safety | Conformity to IEC 60601-1, -1-2, -2-2 | Performed and presumed compliant |
2. Sample Sizes Used for the Test Set and Data Provenance
- Non-Stick Coagulation: Not explicitly stated, but "500+" events recorded for both subject and predicate devices, implying a significant number of trials.
- Beef Liver Temperature Rise: Not explicitly stated, but "6pc sample" is mentioned for Average Device Output and Average Tip Temperature, suggesting at least 6 samples were tested for these specific metrics related to illumination.
- Data Provenance: The devices were tested in a "bench test" setting by internal and independent laboratories. The document does not specify the country of origin of the data or if it was retrospective or prospective, as it's a bench study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
N/A. This was a non-clinical bench testing study, not a study involving human interpretation or ground truth established by experts.
4. Adjudication Method for the Test Set
N/A. Not applicable for non-clinical bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
N/A. No MRMC study was conducted, as this is not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. Not applicable, as this is not an AI/ML device. The testing described is for the physical device's performance characteristics.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on direct physical measurements and observations during bench testing, compared against the performance of a legally marketed predicate device and a reference device, and against established safety standards (IEC standards).
- Non-Stick Coagulation: Performance compared to the predicate device (Spetzler™ Malis® Standard Bipolar Forceps K121426) under specific COAG settings.
- Illumination Output/Temperature: Performance compared to a reference device (Karl Storz Xenon Light Source and Telescope K962595) and specific temperature increase thresholds.
- Electrical Safety: Conformance to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
8. The Sample Size for the Training Set
N/A. Not applicable, as this is not an AI/ML device and no training set was used.
9. How the Ground Truth for the Training Set Was Established
N/A. Not applicable.
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