Search Results

Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.

Cardiac stabilization and positioning devices are specially designed devices used in minimally invasive cardiac surgery for coronary artery bypass grafting. The devices offer a retraction as well as a stabilizing function to control the movement of the beating heart. The cardiac stabilization and positioning devices consist of a combination of one or more of the following components: tissue stabilizer, heart positioner, and sternum retractor blades.

The provided text describes a 510(k) submission for "Reprocessed Cardiac Stabilization and Positioning Devices" (K070034). This submission focuses on demonstrating substantial equivalence to predicate devices for reprocessed medical instruments, rather than a novel AI or diagnostic device. As such, the typical acceptance criteria and study designs relating to AI performance (e.g., sensitivity, specificity, reader studies, ground truth establishment) are not applicable.

Instead, the submission details how the reprocessed device meets performance standards to be considered safe and effective, and equivalent to the original predicate devices.

Here's an analysis of the provided text based on your request, highlighting why some aspects are not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific sample sizes for each test (biocompatibility, reprocessing validation, etc.). It states that "Each individual Cardiac Stabilization and Positioning Device is tested for appropriate function of its components." This implies testing on multiple reprocessed units.

• Test Set Size: Not explicitly stated as a single "test set" in the context of an AI study.
• Data Provenance: N/A for this type of device. The "data" here refers to bench and laboratory testing results of the reprocessed devices themselves, not patient data.

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

This concept is not applicable here. Ground truth in the context of medical device reprocessing refers to validated standards for cleanliness, sterility, functional integrity, and biocompatibility, not expert interpretation of images or clinical data. No "experts" in the sense of clinical reviewers are mentioned for establishing ground truth on these performance tests.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are relevant for studies involving human interpretation or subjective assessments. The tests described are objective, laboratory-based performance tests with predefined pass/fail criteria based on engineering and regulatory standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The device in question is a reprocessed surgical instrument.

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

N/A. This is an AI-specific concept. The "algorithm" here is the reprocessing procedure, and its performance is assessed via the various validations listed (biocompatibility, sterilization, function, etc.).

7. The Type of Ground Truth Used

The "ground truth" for the reprocessed device is established by:

• Validated Standards: For biocompatibility, sterility, and packaging.
• Original Device Specifications/Performance: For functional equivalence, ensuring the reprocessed device performs "as originally intended" and identically to the predicate device.
• Regulatory Requirements: For decontamination and overall safety/effectiveness.

8. The Sample Size for the Training Set

N/A. There is no "training set" in the context of reprocessed medical instruments. This term is specific to machine learning and AI algorithms.

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

N/A, as there is no training set.

Ask a specific question about this device