(113 days)
The Stryker SERFAS 90-S 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 Electrosurgical Probe (hereafter referred to as "Proposed device") is an accessory to the SERFAS Energy System, marketed through K041810, 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.
This document describes the Stryker SERFAS 90-S Electrosurgical Probe and its substantial equivalence to a predicate device. The information provided is primarily focused on demonstrating that the new device does not introduce new safety or effectiveness concerns compared to its predecessor.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly "Pass" for all tests, indicating the device met the internal design specifications and applicable performance standards.
| Test Name | Description | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Aggressive Use | Determines if a probe can last its full lifetime without failure while being subjected to an extended activation period on tissue at the highest power setting. | Pass | Pass |
| Tip Cantilever | Determines if the probe tip can withstand the normal, side, and back force required to permanently deform the lumen. | Pass | Pass |
| Electrode Bend | Verifies the electrode can withstand a 7lb force for a worst-case scenario. | Pass | Pass |
| Thermal Expansion (Heat) Test | Verifies that the SERFAS probe tip assembly does not experience thermal expansion capable of causing catastrophic failure when subject to excessive heat. | Pass | Pass |
| Leak | Verifies the condition of the ceramic-outer lumen assembly and the condition of the suction clamp of all styles of Stryker and non-Stryker RF ablation probes. | Pass | Pass |
| System Compatibility | Verifies that the electrosurgical probe is compatible with Stryker's legally marketed consoles. | Pass | Pass |
| Biocompatibility | Assessed in accordance with ISO 10993-1:2009 and related collateral standards for patient contacting materials. (Implicitly "Pass" as it contributes to substantial equivalence) | Pass | Pass |
| Sterilization | Assessed in accordance with ISO 11135:2014 and ISO 10993-7 for sterilization residuals. (Implicitly "Pass" as it contributes to substantial equivalence) | Pass | Pass |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for each "Test Name" listed (e.g., how many probes were subjected to the Aggressive Use test). It also does not provide details on data provenance (e.g., country of origin, retrospective or prospective data) as these are non-clinical (bench) tests rather than clinical studies with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. These were non-clinical bench tests performed against design specifications and industry standards, not assessments requiring expert interpretation of clinical ground truth.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against defined criteria (e.g., pass/fail for mechanical stress, leak detection). There is no mention of an adjudication method typical for subjective clinical assessments.
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
No. This document describes a medical device (electrosurgical probe), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests are the internal design specifications of the device and applicable performance standards (e.g., ISO standards for biocompatibility and sterilization). The goal was to demonstrate that the device met these engineering and regulatory requirements.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device that requires a training set.
§ 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.