(89 days)
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.
| Characteristic | Acceptance Criteria (Predicate Device Specifications) | Reported Device Performance (NAI-5 Micromanipulator Set) |
|---|---|---|
| Type of manipulator | Coarse only (MM-89) AND Fine only (MMO-202ND) | Coarse and fine |
| Type of control | Motorized control (MM-89) AND Oil Hydraulic control (MMO-202ND) | Motorized and Oil Hydraulic control |
| Configuration | Coarse Drive Unit, Coarse Control Unit, Power Supply (MM-89) AND Fine Drive Unit, Fine Control Unit (MMO-202ND) | Coarse and Fine Drive Units, Coarse and Fine Control Units, and Power Supply |
| Identification of each axis | X-axis, Y-axis, and Z-axis (coarse only for MM-89; fine only for MMO-202ND) | X-axis, Y-axis, and Z-axis (coarse and fine) |
| Movement Range of each axis | Coarse: 22mm (MM-89) AND Fine: 10mm (MMO-202ND) | Coarse: 22mm; Fine: 10mm |
| Dimensions of Drive Unit | W80 x D116 x H142mm (MM-89) AND W40 x D46 x H87mm (MMO-202ND) | W57 x D138 x H94mm (Coarse and fine combined) |
| Dimensions of Motorized Control Unit | W70 x D100 x H120mm (MM-89) | W70 x D100 x H120mm |
| Dimensions of Hydraulic Control Unit | W165 x D80 x H175mm (MMO-202ND) | W65 x D180 x H175mm |
| Dimensions of Power Supply | W125 x D105 x H85mm (MM-89) | W125 x D105 x H85mm |
| Intended Use | Helps coarse positioning of a microtool under the microscope and is used in assisted reproduction procedures (MM-89) AND Helps fine positioning of a microtool under the microscope and is used in assisted reproduction procedures (MMO-202ND) | Enables coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures. |
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.
§ 884.6150 Assisted reproduction micromanipulators and microinjectors.
(a)
Identification. Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.