Search Results

The Stryker SERFAS 90-S Max electrosurgical probe is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle, and wrist.

The Stryker SERFAS 90-S Max electrosurgical probe (hereafter referred to as "Proposed device") is an accessory to the SERFAS Energy System, marketed through K041810 and K160050, and the Crossfire Arthroscopy System, marketed through K071859, which is intended for resection, ablation, and coagulation of soft tissue via radiofrequency (RF) ablation. RF ablation probes are the main tool used in most arthroscopic procedures for the removal of tissue and the coagulation of bleeding vessels. The Proposed device is a disposable single-use electrosurgical device provided sterile via Ethylene Oxide sterilization.

The provided text describes a 510(k) premarket notification for a medical device, the Stryker® SERFAS 90-S Max Electrosurgical Probe. The document focuses on demonstrating substantial equivalence to a predicate device through performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document lists several performance tests and states that the device "Pass"ed each one. While specific numerical acceptance criteria are not explicitly detailed in the table, the "Description" column implies the criteria (e.g., "Determines if a probe can last its full lifetime without failure," "Determines if the probe tip can withstand normal and side force"). The reported device performance is "Pass" for all tests.

2. Sample sized used for the test set and the data provenance:

The document mentions "Bench performance testing" but does not specify the sample size used for each test. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The tests described are primarily physical/mechanical performance tests, not clinical evaluations that would typically involve expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided as the tests are objective physical/mechanical measurements, not subjective evaluations requiring adjudication.

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:

This is not applicable to this device. The Stryker® SERFAS 90-S Max Electrosurgical Probe is a physical electro-surgical instrument, not an AI-powered diagnostic or assistive tool for human "readers" (e.g., radiologists). Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable to this device, as it is a physical surgical probe, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the performance tests listed, the "ground truth" would be established by engineering specifications, physical measurements against those specifications, and comparison to the predicate/reference device's performance (e.g., for thermal damage). It's not a ground truth derived from expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic devices.

8. The sample size for the training set:

This is not applicable. This document describes a physical medical device and its performance testing, not an AI/algorithm-based device that would require training data.

9. How the ground truth for the training set was established:

This is not applicable for the same reason as point 8.

Ask a specific question about this device