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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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