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TransferMan® 4m Micromanipulator Indications for Use:

The TransferMan® 4m Micromanipulator is intended for use in assisted reproduction procedures requiring coarse and fine positioning of a microtool under the microscope.

CellTram® Air Microinjector / CellTram® Oil Microinjector / CellTrans® vario Microinjector Indications for Use: The CellTram® Microinjectors are intended for use in Intra-Cytoplasmic Spermatozoa Injection (ICSI) procedures to aspirate and inject sperm into oocytes.

The TransferMan® 4m Micromanipulator is a motorized micromanipulator consisting of a Motor module unit and a Control board that allows the user to precisely control the movement of tools (i.e., microcapillaries) used for Intra-Cytoplasmic Spermatozoa Injection (ICSI) and other In Vitro Fertilization (IVF) procedures. The tool is mounted in a Universal Capillary Holder on the TransferMan® 4m Micromanipulator's Motor module unit that is, itself, mounted to an inverted microscope. The user controls the movements of the tool using a joystick on the Control board. The Motor module unit shifts the position of the tool in response to the joystick motions.

The CellTram Microinjectors are manual piston pumps for holding and transfer of suspension cells (e.g., oocytes and sperms for use in ICSI procedures), used in manual microinjection procedures. Using a movable piston in a cylinder system, the CellTram® Microinjectors generate differences in pressure that are transferred directly to a microcapillary via a connected pressure tube. Depending on the piston movement, material can be aspirated or dispensed. Three versions of the CellTram® Microinjectors will be marketed for use in ICSI procedures, the CellTram® Air, the CellTram® Oil, and the CellTram vario. The three versions differ in the medium used for pressure transmission (air versus oil).

The provided document describes a 510(k) premarket notification for the Eppendorf AG TransferMan® 4m Micromanipulator and CellTram® Microinjectors (Air, Oil, and Vario). It aims to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new acceptance criteria through a study demonstrating novel device performance.

Therefore, the document does not report on a study designed to prove the device meets specific acceptance criteria in the traditional sense of a clinical trial or performance study against predefined metrics for efficacy or diagnostic accuracy. Instead, it focuses on demonstrating that the new devices are substantially equivalent to existing predicate devices based on technological characteristics and established safety standards.

Here's a breakdown based on the information provided, highlighting why certain questions cannot be fully answered in the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence based on technological characteristics, the "acceptance criteria" are primarily related to conforming to existing standards and demonstrating similar functionality to predicate devices. There are no performance metrics stated as "acceptance criteria" with quantitative results from a specific clinical or performance study in the way one might expect for a new diagnostic or interventional device.

2. Sample size used for the test set and the data provenance

This document does not describe a clinical or performance study with a "test set" of patient data in the context of a new diagnostic or prognostic tool. The testing performed is related to engineering verification and validation (e.g., hardware testing, endurance testing, EMC testing) rather than a clinical trial with a patient sample size. Therefore, there is no sample size or data provenance (country of origin, retrospective/prospective) for a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert-established ground truth on patient cases.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. The devices described are mechanical micromanipulators and microinjectors, not AI-powered diagnostic or assistive tools for human readers.

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

Not applicable. These are mechanical devices, not algorithms.

7. The type of ground truth used

The "ground truth" in this context refers to the established standards for safety and performance for similar medical devices and the functional equivalence to predicate devices. This is demonstrated through:

• Compliance with recognized national and international electrical safety and EMC standards (e.g., EN 61326-1, EN 55011, UL 61010-1).
• Hardware testing and endurance testing to ensure mechanical integrity and function.
• Comparison of technological characteristics and intended use with already-marketed predicate devices, which have a history of safe and effective use.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence of new medical devices to existing ones. It relies on standard engineering and safety testing, and direct comparison of technological specifications and intended use against predicates, rather than generating new clinical performance data against specific acceptance criteria for a novel clinical claim.

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