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The Marz Blossom Syringe Assist device is intended to be used to assist the clinician in the delivery of sterile saline to fill temporary, removable tissue expanders in accordance with the best judgment of the clinician. Specifically, the Marz Blossom Syringe Assist device is indicated for assisting the clinician in delivery of sterile saline into the surgically placed sub-dermal temporary, removable tissue expander.

1. The Marz controller is a battery operated device that is used to assist the clinician in delivering sterile saline into a surgically placed sub-dermal temporary, removable tissue expander. The Marz Blossom Syringe Assist device includes a battery powered controller to provide a regulated method for delivery of a specific volume of saline at a specific rate. The Marz Medical Blossom Syringe Assist Device consists of a re-useable controller with an integrated syringe cradle for holding a 10cc syringe, firmware, LED displays, an external pressure sensor, and is battery powered by three 1.5V, AA batteries (LR6 designation).
2. Supplied with the controller in a kit are the following components: Single use, sterile 10cc luer lock piston syringe, transfer set with proximal connection to the controller, and saline reservoir including distal connections to the inflation port of the expander, or via an infusion needle. All connections are luer lock compatible. The fluid path is clear that allows for visual inspection of the content.

The Marz Blossom Syringe Assist Device is a battery-operated device designed to assist clinicians in delivering sterile saline to fill temporary, removable tissue expanders. It includes a controller with an integrated syringe cradle for a 10cc syringe, firmware, LED displays, an external pressure sensor, and is powered by AA batteries. The device also comes with single-use, sterile 10cc luer lock piston syringes, a transfer set, and a saline reservoir.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not explicitly state the specific number of devices or components used as a "sample size" for each individual test. It consistently uses terms like "all units," "The devices," "The unit," and "units" when referring to the items tested. This suggests that the testing was conducted on a sufficient number of samples to demonstrate compliance with the criteria, likely following internal quality control procedures.

Data Provenance: The studies were conducted internally by Marz Medical, Inc. based on the report titles (e.g., MRZ-TR-881). The text does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's a pre-market notification, the data would typically be derived from prospective testing conducted during the device's development and validation.

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

This information is not applicable to this device and its testing. The Marz Blossom Syringe Assist Device is a mechanical/electronic medical device. Its performance criteria are based on engineering specifications, physical measurements (e.g., fluid delivery, force, pressure), software functionality, and compliance with recognized standards (e.g., ISTA, EMC, IEC). It does not involve interpretation of medical images or patient data that would require "experts" to establish a "ground truth" in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons mentioned in point 3. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of data (e.g., medical imaging) where discrepancies between expert readers need to be resolved to establish ground truth. The testing for the Marz Blossom Syringe Assist Device involves objective, measurable physical and functional parameters.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images) where the aim is to assess the impact of a device (like AI) on human performance. The Marz Blossom Syringe Assist Device is an assistive, mechanical device with objective performance metrics, not a diagnostic one requiring human interpretation of medical cases.

There was a "Thumb Force Test Report" (MRZ-TR-883) and "Comparative Product Analysis and System Forces and Pressures" which compared the device's force/pressure profile to manual approaches and predicate devices. However, these are engineering comparisons of physical characteristics, not an MRMC study assessing human reader performance.

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

The device itself is an "assist device" for a clinician. While its component tests (e.g., software verification, performance verification, fault conditions, EMC, IEC standards) evaluate the device's inherent functionality without direct human interaction during the test execution, the device's intended use is always "to assist the clinician." Therefore, the performance tests primarily focus on the device's standalone mechanical and electronic capabilities to fulfill its assistive role. There isn't a stated performance metric that evaluates the algorithm's performance in isolation from the physical device.

7. The Type of Ground Truth Used:

For this device, the "ground truth" is defined by:

• Engineering Specifications: Specific parameters for fluid delivery volume, rate, force, pressure, and software functionality that the device was designed to meet.
• Regulatory Standards: Compliance with recognized industry standards (e.g., IEC 60601, FCC Part 15, ISTA 2A) that define acceptable levels of safety and performance.
• Predicate Device Comparison: Establishing substantial equivalence by demonstrating similar or improved performance characteristics (e.g., force/pressure) compared to a legally marketed predicate device.

It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic medical device would be.

8. The Sample Size for the Training Set:

This information is not applicable to this device. As a mechanical/electronic assistive device, it does not employ machine learning or AI algorithms that require a "training set" of data in the conventional sense. The firmware and software are likely developed and validated through traditional software engineering methods, not data-driven machine learning.

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

This information is not applicable for the same reason as point 8; no training set in the machine learning context is mentioned or implied for this device. The "ground truth" for its development would be its design requirements, functional specifications, and compliance with engineering principles and standards.

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