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These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.
These devices are used for I.C.S.I. (Intra cytoplasmic sperm injection)

The holding and injection pipettes were made from 30µl borosilicate glass capillary tubes, 78mm in length and with inner and outer diameters of 0.69 and 0.97mm respectively. The glass pipettes were obtained by drawing thin-walled glass capillary tubes using a horizontal microelectrode puller. The holding pipette was cut and firepolished on a microforge to obtain an outer diamter of 50um and an inner diameter of 20um. To prepare the injection pipette, the pulled capillary was opened on a microgriner to an outer diameter of 7um and an inner diameter of 5um; the bevel angle was 45°. This grinding step required ~3 minutes. The whetstone of the grinder was humidified by a slow water drip during the procedure. The microforge was then used to make a sharp spike on the injection piepette and to bend the edge of the holding and injection pipettes to an angle of ~35° to facilitate the injection procedure in the Petri dish.

This is a 510(k) summary for Prodimed Microinjection Pipettes, which are manual tools used in assisted reproduction. This type of device is not an AI/ML device, so many of the requested categories are not applicable.

Here's a breakdown based on the provided text, indicating where information is not available or not applicable for this type of medical device submission.

Acceptance Criteria and Device Performance Study

The primary acceptance criteria for this type of device, as implied by the 510(k) submission, revolve around its substantial equivalence to existing, legally marketed predicate devices. This means demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness.

The document describes the device's functional and physical characteristics rather than performance metrics from a clinical study. The "study" proving acceptance criteria is effectively the demonstration of these characteristics and their similarity to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

• Material composition and physical properties are safe and effective for the intended use and similar to predicates.
• Performance (Function) specifications met.
• Sterility and biocompatibility.
• Manufacturing Quality. | Micro-Injection Pipettes: Made from borosilicate glass capillary tubes. Holding pipette: outer diameter 50um, inner diameter 20um. Injection pipette: outer diameter 7um, inner diameter 5um; bevel angle 45°. Spike present.
  Holding Pipettes: Made from borosilicate glass capillary tubes.
  Material: Borosilicate Glass (Boron Oxide, Sodium Oxide).
  Performance (Function): "Clear view and full control of the sperm for precision manipulation." "Bevel equipped with a short, sharp spike for easy, non-traumatising penetration of the oocyte." "Effective prehension by the holding pipettes to avoid rotation of the oocyte during the micro-injection."
  Quality and Security: "Manufactured according to ISO 9001 and EN 46001 standards." "Routine performance of tests with revelation of biological indicators, search for endotoxins and embryotoxicity tests." "Guaranteed sterility of pipettes." |
  | Safety and Effectiveness: No new questions of safety or effectiveness raised by differences from predicates. | The FDA letter explicitly states, "we have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This is the ultimate "acceptance" for a 510(k) submission, confirming that no new safety or effectiveness concerns were identified. |

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

Not applicable. This is a 510(k) for a physical medical device (pipettes), not an AI/ML device that would involve a "test set" in the computational sense. The submission relies on characterizing the device's physical properties, materials, and manufacturing processes, and demonstrating substantial equivalence to predicate devices, rather than statistical performance on a test dataset.

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

Not applicable. There is no "ground truth" establishment in the context of an AI/ML model for this type of device. The ground truth for device safety and effectiveness is established through adherence to manufacturing standards, material specifications, and comparison to legally marketed predicate devices used in clinical practice. The FDA review team acts as the expert body determining substantial equivalence.

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

Not applicable. There is no "test set" or image/data adjudication process for this type of medical device submission.

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 not an AI-assisted device. It is a manual microtool.

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

Not applicable. This is not an algorithm.

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

Not applicable in the AI/ML sense. The "ground truth" for the acceptance of this device is its demonstrated substantial equivalence to legally marketed predicate devices, established through:

• Verification of its physical and functional characteristics.
• Confirmation that its materials (borosilicate glass) are safe and commonly used in similar applications.
• Adherence to quality manufacturing standards (ISO 9001 and EN 46001).
• Performance of biological indicator tests, endotoxin testing, and embryotoxicity tests.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and therefore no "training set."

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

Not applicable.

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