Search Results

Fetzer Medical Self-retaining Retractors are reusable manual instruments made from stainless steel, aluminum or titanium. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use. Devices are available with the following features: frame type retractors, Ring handle retractors, MIS Port retractor.

AI/ML Overview

The document describes the submission for a medical device called "Fetzer Medical Self-Retaining Retractors" for 510(k) clearance. The device is a self-retaining retractor for neurosurgery.

Here's an analysis of the acceptance criteria and the study used to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Test (Acceptance Criteria Category)	Test Method Summary	Reported Device Performance (Results)
Reprocessing Validation	Verification that devices can be cleaned with provided cleaning steps as per IFU. Contamination of accessible, interior, and exterior surfaces (worst-case) with visible contamination (red blood cells), residual protein, and organisms. Effectiveness evaluated by comparing contamination between control and test instruments. (Acc. ANSI/AAMI ST81 and AAMI TIR 30).	This validation provides evidence that viable microbiological contamination as well as a soil contamination of the "Self-retaining retractors" are removed by the given cleaning and disinfection instructions.
Sterilization Testing	Verification that devices can be sterilized with the provided sterilization procedure described in the IFU. Test specimens contaminated with bioindicators or challenge suspension and tested for sterility after the sterilization process. Part-cycle sterilization performed to assure a SAL of 10^-6.	A reduction of test bacteria was observed and assured showing that contaminated test specimens are free of viable/augmentable bacteria after sterilization.
Biocompatibility Testing	Verification of biocompatibility of all patient-contacting materials according to ISO 10993-1. Devices considered "tissue/bone contacting" with contact duration < 24 hours. Cytotoxic tests (ISO 10993-5) and sensitization/irritation tests (ISO 10993-10) performed for different materials and manufacturing lines.	All tested devices were considered non cytotoxic and they did not cause any skin irritation reaction for the indicated contact duration.
Mechanical Tests	Testing for typical forces to hold a wound open during spinal surgery. Testing load was double to triple the maximum load assumed during surgery.	All devices were able to withstand the required test load without deformation or failure.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state a numerical sample size for the "test set" in the context of device performance testing. Instead, it refers to "representative worst-case instruments" for reprocessing validation and "test specimens" for sterilization. It also performs tests on "all patient contacting materials" for biocompatibility and "all devices" (implied across the product line for mechanical tests).

The data provenance is not specified. It is implied to be internal testing conducted by Fetzer Medical GmbH & Co. KG. No country of origin for the data is explicitly mentioned, nor is it stated whether the data is retrospective or prospective, though it's likely prospective laboratory testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device and study. The ground truth for performance of a mechanical surgical retractor is established through objective engineering and biological testing (e.g., measuring forces, observing bacterial reduction, assessing cytotoxicity), not through expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where subjective human interpretation is involved. For the engineering and biological tests described, the 'results' are objective measurements or observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is being evaluated. The Fetzer Medical Self-Retaining Retractors are mechanical surgical instruments.

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

No, a standalone (algorithm only) performance study was not done. This concept is relevant for AI/ML-driven software as a medical device (SaMD) or diagnostic algorithms. The Fetzer Medical device is a conventional, mechanical surgical tool.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established scientific and engineering principles, and regulatory standards:

For reprocessing and sterilization: Reduction of microbial contamination to acceptable, defined levels (e.g., SAL of 10^-6), and removal of visual and chemical contaminants.
For biocompatibility: Absence of cytotoxic effects, sensitization, or irritation as defined by ISO 10993 standards.
For mechanical tests: Ability to withstand (without deformation or failure) loads at multiples of assumed surgical forces, meeting predetermined engineering specifications.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. The Fetzer Medical device is a mechanical instrument, not an AI/ML device, and therefore does not have a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set for this mechanical device.

Ask a Question

Ask a specific question about this device

Page 1 of 1