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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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The NAI-5 Micromanipulator Set enables coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures.

The NAI-5 Micromanipulator Set enables coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures. The NAI-5 Micromanipulator Set consists of motor driven coarse manipulators that enable coarse movement operation and oil hydraulic micromanipulators that enable fine movement operation.

The provided document is a 510(k) summary for the NAI-5 Micromanipulator Set. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific, quantifiable clinical performance acceptance criteria with a dedicated study involving human subjects or AI algorithms.

Therefore, many of the requested categories regarding acceptance criteria, study design, expert involvement, and comparative effectiveness (which are more relevant to AI/diagnostic device approvals) are not applicable to this 510(k) notification for a micromanipulator set.

However, I can extract the information that is present and indicate where requested information is not available or not relevant to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

For this micromanipulator set, "acceptance criteria" are embodied by the technical specifications and intended use being substantially equivalent to the predicate devices. There are no explicit, quantifiable clinical performance metrics or thresholds defined as "acceptance criteria" in the context of a clinical study in this document. The "performance" is demonstrated by the device's physical and functional specifications.

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

• Not Applicable. This device is a physical micromanipulator. A 510(k) submission for this type of device typically relies on engineering specifications, bench testing, and comparison to predicate devices, rather than a "test set" of clinical data or images.

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

• Not Applicable. No ground truth for a "test set" of clinical data was established for this device, as it's a physical instrument and not an AI or diagnostic tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or associated adjudication methods are described for this physical device.

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. This is a physical laboratory instrument, not an AI-assisted diagnostic or imaging system involving "human readers" or AI assistance.

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

• Not Applicable. This device is a physical micromanipulator; there is no standalone algorithm to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. As a physical instrument, the "ground truth" for its function relies on its engineering specifications and the ability to perform its mechanical tasks accurately, which would be verified through bench testing and quality control during manufacturing, not through clinical ground truth data like pathology or outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is a physical device, not an AI algorithm.

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

• Not Applicable. There is no training set for this device.

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The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure.

The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure.

The IM-11 Pneumatic Microinjector is a manually operated pneumatically actuated screw driven microinjector incorporating coarse and fine control knobs. The coarse control knob is used to perform coarse movement operation while the fine control knob is used to perform fine movement operation. It is easy to use simply by turning the control knob clockwise for injection and counterclockwise for aspiration.

The IM-11 Pneumatic Microinjector is a component part of a micromanipulator system.

The provided text is a 510(k) summary for the Narishige IM-11 Pneumatic Microinjector. It focuses on establishing substantial equivalence to a predicate device, the IM-9C Pneumatic Injector, rather than presenting a study demonstrating the device meets specific acceptance criteria for performance.

Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in the provided document. The document primarily relies on a comparison of technological characteristics and intended use to claim substantial equivalence.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided. The document does not define specific quantitative acceptance criteria for the IM-11. Instead, it compares the IM-11's technological characteristics to those of its predicate device, the IM-9C, implying that performance is acceptable if these characteristics are similar or improved.

Note: The IM-11's maximum operating range (40mm) is less than the IM-9C (53mm), but this is not presented as a deficiency, likely because the combined coarse and fine controls offer sufficient precision and range for ICSI procedures. The larger syringe volume and the more convenient pressure relief valve (lever vs. plug) are presented as improvements or at least not negatively impacting safety/effectiveness.

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

Not applicable/Not provided. This document does not describe a clinical study with a test set of data. The assessment is based on a technical comparison of the device itself and its predicate.

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

Not applicable/Not provided. No "test set" or "ground truth" using human experts is described in this document.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No test set or expert adjudication is described.

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. This device is a pneumatic microinjector, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

Not applicable. This is a mechanical device, not an algorithm. Therefore, a standalone algorithm performance study is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The submission does not define a "ground truth" as it would for a diagnostic or AI device. Instead, the "truth" is established by comparing the technological characteristics and documented performance/safety of the predicate device.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is a medical device for physical manipulation, not an AI/algorithm.

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

Not applicable. There is no training set mentioned.

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