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1. Injection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
2. Injection and administration of anesthetic regional blocks (e.q., paracervical, uterosacral, and pudendal) that may be used during minor surgical procedures.

The Gynex Extended Reach Needles are made of 302 instrument grade stainless steel. There are two styles each being 27 gauge and 90mm in length. One is equipped with a standard I hore are the other basing thas a threaded hub. Both are disposable. As is typical for this type of anesthetic needle, the shaft of the needle is dual diameter. That is, the shaft of the needle from the hub to within 5mm of the tip a is larger diameter. This allows for easy estimation of insertion depth during anesthetic administration and prevents over-insertion of needle into deeper tissue levels or spaces.

The provided text is a 510(k) premarket notification for the GYNEX Extended Reach Needle. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information on detailed acceptance criteria or a specific study proving the device meets them in the context of performance metrics like sensitivity, specificity, or reader improvement. This type of regulatory submission for a simple medical device like a needle typically demonstrates safety and effectiveness through comparison to existing devices and compliance with relevant standards, rather than complex performance studies.

Therefore, many of the requested sections about study details, sample sizes, expert qualifications, and ground truth cannot be answered from the provided text.

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

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy. The "Comparison Table" in the document focuses on features for establishing substantial equivalence to the predicate device, not on quantitative performance against specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical performance study with a test set. The validation is based on comparison to an existing predicate device and adherence to manufacturing and materials standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no test set requiring expert ground truth is described.

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

Not applicable, as no test set requiring 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 disposable needle, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a disposable needle, not an algorithm.

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

Not applicable, as no ground truth is established for performance evaluation of this device type in this submission. The "ground truth" for regulatory approval here is primarily based on the predicate device's established safety and efficacy, and compliance with manufacturing and materials standards.

8. The sample size for the training set

Not applicable, as there is no training set for an AI algorithm described.

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

Not applicable, as there is no training set for an AI algorithm described.

Summary of available information:

The provided document describes the GYNEX Extended Reach Needle as a Class II medical device intended for administering regional anesthetic blocks. The regulatory submission (510(k)) aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily the Potocky Needle (K910252) and preamendment devices.

Acceptance Criteria (Implicit via Substantial Equivalence and Standards):

While not explicitly presented as a "table of acceptance criteria" with numerical performance targets, the document establishes implicit acceptance criteria based on:

• Indications for Use: The Gynex needle must be suitable for administering paracervical-pudendal anesthetic, matching the predicate.
• Design: Leuer lock & threaded hub, comparable to predicate.
• Sterilization Method: Supplied sterile and non-pyrogenic via radiation, with a Sterility Assurance Level (SAL) of at least 10⁻⁶. This is a critical safety criterion.
• Dimensions/Sizes: 90mm with a 5mm 27 gauge tip, matching the Potocky predicate.
• Material: 302 Stainless Steel, matching the predicate.
• Manufacturing Standards: Compliance with voluntary standards such as ASTM, GYNEX Corporation Standard Operating Procedures (SOPs), vendor certification/qualification, Quality Systems Regulations (QSR), ISO materials standards, and ISO 9000 series quality regulations. This implies the device must meet specified mechanical properties, biocompatibility, and manufacturing quality.
• Packaging: Individually packaged and labeled, with instructions for inspection and handling to maintain sterility.

Reported Device Performance (Implicit/Feature Comparison):

The "Comparison Table" provides the "reported device performance" in terms of features relative to the predicate:

Note on Sterilization: The "NO & YES" for sterilization indicates that Gynex's radiation sterilization method differs from "Steam Autoclave - reusable" but is equivalent to "Potocky - Supplied sterile - disposable." The FDA found this acceptable for substantial equivalence.

This document serves as a regulatory submission demonstrating substantial equivalence for a medical device, and as such, does not typically include detailed clinical performance studies often associated with diagnostic or AI-driven devices.

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