<GENX> SINGLE LUMEN SIDEPORT NEEDLE by <GENX> INTL., INC.

The basic design is a single stainless steel needle tubing of 32 cm in exposed length, with a grounded point. It is attached to a hub of polycarbonate designed especially for this purpose. The outer diameter of the outer needle tube maybe 16 or 17gauge, 17 being more desirable.

Attached to the hub are two lengths of tubing. One is attached to the rear of the needles, which allows the occytes to be aspirated into a collection test tube, and the second length is attached to the flush port on the side. This second port is attached to a syringe, which allows the operator to inject media into the follicle to allow "flushing"

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device, the Single Lumen Sideport Needle. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through studies that meet specific acceptance criteria as you've outlined. Therefore, much of the information you requested regarding acceptance criteria, study details, and performance metrics is not typically present in this kind of regulatory filing.

Here's what can be inferred and what cannot be provided based on the given text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to general controls and special controls (though specific special controls aren't detailed, only that they exist for assisted reproduction needles).
Reported Device Performance: Not provided in terms of quantitative clinical or analytical performance. The document describes the device's intended use and design but does not report on its performance against specific clinical outcomes or statistical targets.

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

Sample Size for Test Set: Not applicable. There is no mention of a "test set" in the context of a performance study with human subjects or analytical samples. This is a premarket notification based on substantial equivalence.
Data Provenance: Not applicable. No performance data from clinical or analytical studies is presented.

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

Not applicable. There is no mention of a "test set" requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study would be used to assess the effectiveness of the device in a clinical setting, often comparing human performance with and without an AI-assisted device. This document does not describe such a study.

6. Standalone Performance Study (Algorithm Only):

No, a standalone performance study was not done. The device described is a physical medical instrument (needle) and does not involve an algorithm.

7. Type of Ground Truth Used:

Not applicable. There is no test set or performance study where ground truth would be established.

8. Sample Size for the Training Set:

Not applicable. There is no mention of a "training set," as this device is a physical instrument, not an AI or software algorithm that would require training data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Key Information from the Document (Relevant to Substantial Equivalence):

Device Name: Single Lumen Sideport Needle
Classification Name: Assisted Reproduction Needle
Intended Use: "Used to obtain oocytes from the body"
Design: Single stainless steel needle tubing (32 cm exposed length, grounded point, 16 or 17 gauge), polycarbonate hub, two tubing lengths (one for aspiration, one for flushing).
Sterilization: Gamma Irradiated (2.5 Mrad, SAL: 10^-6) in accordance with ANSI / AAMI / ISO 11137-1994 Standards.
Predicate Devices: The submission claims substantial equivalence to "several products currently marketed in the US." (Details expected in Section 2, which is not provided here).
Regulatory Status: Cleared through 510(k) as Class II device, Procode 85 MQE, CFR# 884.6100.

In summary, the provided text is a 510(k) summary, which is a premarket notification for substantial equivalence, not a report on an efficacy or effectiveness study. Therefore, the specific details requested about acceptance criteria and study design are not found within this type of document.

Summary

Regulation Number and Section

§ 884.6100 Assisted reproduction needles.

(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).