(71 days)
The Stryker Silverglide Bipolar Forceps Reusable Cable and Stryker Silverglide Bipolar Forceps Disposable Cable are intended to transfer electrosurgical power to bipolar forceps from an electrosurgical generator.
The Stryker Silverglide Bipolar Forceps Reusable Cable is an electrosurgical accessory designed to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. The cable is designed to fit standard bipolar forceps and generator connectors. The Silverglide Surgical Bipolar Forceps Reusable Cable is supplied non-sterile. It must be steam sterilized before use.
The Stryker Silverglide Bipolar Forceps Disposable Cable is an electrosurgical accessory designed to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. The cable is designed to fit standard bipolar forceps and generator connectors. The Silverglide Surgical Bipolar Forceps Disposable Cables is supplied sterile, and is a single-patient use device.
Here's an analysis of the provided information regarding the acceptance criteria and supporting study for the Stryker Silverglide Bipolar Forceps Cables:
This document is a 510(k) summary for a medical device. In the context of 510(k) submissions, the "acceptance criteria" and "study" are typically focused on demonstrating substantial equivalence to a predicate device, rather than proving a specific performance metric against a predefined numerical acceptance criterion. The "study" largely consists of a comparison and justification of equivalence to existing devices.
Therefore, many of the requested fields related to a traditional performance study (e.g., sample size, number of experts, adjudication methods, MRMC studies, standalone performance with specific metrics, ground truth establishment for training sets) are not applicable in this type of submission. The focus is on design, materials, indications for use, and technological characteristics being sufficiently similar to a legally marketed predicate.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use: Must be the same or similar to predicate devices. | "The Stryker Silverglide Bipolar Forceps Reusable Cable and the Stryker Silverglide Bipolar Forceps Disposable Cable have the same intended use as the Techno Instruments (Pvt) Ltd. Reusable Bipolar Forceps Cable and the Modern Medical Equipment Mfg. Ltd. Disposable Bipolar Forceps Cable." |
| Technological Characteristics: Must be sufficiently similar to predicate devices. | ". . . the same technological characteristics, the same operating principles and have similar performance characteristics." |
| Safety and Effectiveness: Must be deemed as safe and effective as predicate devices. | "Based upon the comparison to the predicate devices, the Stryker Silverglide Bipolar Forceps Reusable Cable and the Stryker Silverglide Bipolar Forceps Disposable Cable are substantially equivalent to legally marketed devices." |
Detailed breakdown of other requested information:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This is a 510(k) submission seeking substantial equivalence based on comparison to predicate devices, not a clinical performance study with a test set of data. The "test" is an analytical comparison of device features and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. No ground truth for a test set was established in the traditional sense. The "ground truth" for substantial equivalence is the regulatory status and characteristics of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or expert adjudication process as described.
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
- Not Applicable. This device is a cable for electrosurgical forceps, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device (cable), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is the established regulatory clearance and performance characteristics of the predicate devices. The new device's characteristics (intended use, technological characteristics, operating principles, and performance characteristics) are compared to these existing, legally marketed devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. Not an AI/ML device.
§ 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.