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

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.

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.

Ask a specific question about this device

The Stryker Crossfire System is intended for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip. The Crossfire System provides abrasion, resection, debridement and removal of bone and soft tissue through its shaver blade; and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels, through its electrosurgical probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

The Stryker Crossfire System consists of a console, footswitch, shaver handpiece and two possible disposable attachments (RF probe and shaver blade).

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This document is a 510(k) summary for the Stryker Crossfire System, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through a study with acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the given text.

The document primarily states:

• Product Description: The Stryker Crossfire System consists of a console, footswitch, shaver handpiece, and two disposable attachments (RF probe and shaver blade).
• Indications for Use: Intended for orthopedic and arthroscopic procedures in various joints for abrasion, resection, debridement, bone and soft tissue removal (shaver blade), and ablation, coagulation, hemostasis of soft tissue and blood vessels (electrosurgical probe).
• Contraindications: Electrosurgical probe should not be used with nonconductive irrigants or in patients with pacemakers/electronic implants.
• Voluntary Safety and Performance Standards: The system conforms to numerous IEC, ISO, and EN standards.
• Predicate Devices: Stryker CORE (K032303), SERFAS Energy (K041810), and Total Performance Shaver (K973195) Systems.
• Substantial Equivalence: Claimed due to same intended use and no new questions of safety and effectiveness compared to predicate devices.

The FDA's letter confirms the substantial equivalence determination but does not detail specific performance studies.

Ask a specific question about this device