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The Wallace Dual Lumen Oocyte Recovery System is a sterile, single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

The Wallace Dual Lumen Oocyte Recovery System consists of a 33 cm dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source. The Wallace Dual Lumen Oocyte Recovery System is available in 16 or 17-gauge color-coded sizes (16G-Blue and 17G-Red). The needles are available in three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.

The provided text is a 510(k) summary for a medical device (Wallace Dual Lumen Oocyte Recovery System) and does not contain information about studies related to AI or algorithm performance. The content focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of physical attributes, such as needle size, biocompatibility, stability, shelf life, and mechanical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove a device meets criteria in the context of AI/algorithm performance, as these details are not present in the given document.

The document indicates that the device is a sterile, single-use system for ultrasonic-guided transvaginal collection of oocytes and does not mention any AI or software components.

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The Wallace Dual Lumen Oocyte Recovery System in a sterile single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

The Wallace Dual Lumen Oocyte Recovery System consists of a dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source.

The Wallace Dual Lumen Oocyte Recovery System consists of a 17 gauge needle that is 33 cm long, and three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.

Based on the provided text, the device in question is the Wallace Dual Lumen Oocyte Recovery System, an ovulation retrieval needle. The document does not describe a study involving an AI/algorithmic device or human readers. Instead, it details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested sections (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set ground truth establishment) are not applicable as they pertain to the evaluation of an AI or algorithm, which is not the subject of this 510(k) summary.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance for the Wallace Dual Lumen Oocyte Recovery System

The device under review is an assisted reproduction needle, not an AI or algorithm. The acceptance criteria and performance data provided relate to the physical and biological characteristics of the device to demonstrate its safety and effectiveness, primarily through comparison to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various non-clinical performance tests and their acceptance criteria (implicitly met as the conclusion states the device passed all testing).

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

• Sample Size: Not explicitly stated for each test (e.g., number of needles tested for mechanical performance, number of packages for integrity). However, the methods refer to standard test procedures (e.g., ISO, ASTM), which typically define sample sizes.
• Data Provenance: The document describes non-clinical laboratory testing of the device itself, not human clinical data or imaging data. Therefore, concepts like country of origin or retrospective/prospective are not applicable.

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

• Not Applicable. This device is a physical medical instrument, not an AI/algorithmic software. "Ground truth" in this context refers to the defined scientific and engineering standards and methods for assessing the device's physical, chemical, and biological properties, which are established by standard organizations (e.g., ISO, ASTM, USP) and verified by qualified laboratory personnel.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical performance testing of a physical device, there is no "adjudication" of expert opinions in the sense of image interpretation. Test results are objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is not an AI/algorithmic device or diagnostic tool. An MRMC study would be irrelevant.

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

• Not Applicable. This is a physical medical device. "Standalone performance" in this context refers to the device's ability to meet its specifications independently, which is what the non-clinical performance testing aimed to demonstrate.

7. The Type of Ground Truth Used

• Defined Standards and Measurable Performance Metrics: The "ground truth" for this device's performance is based on established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP) for sterility, biocompatibility, mechanical properties, and packaging integrity. Tests evaluate quantitative and qualitative measures directly against these benchmarks (e.g., specific thresholds for endotoxin, percentage of embryo development, strength limits, leak absence).

8. The Sample Size for the Training Set

• Not Applicable. This refers to an AI/algorithmic device, not a physical medical instrument. There is no concept of a "training set" for the type of evaluation described.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. Again, this is for AI/algorithmic development. The "ground truth" for evaluating this physical device is established through adherence to recognized industrial and medical device testing standards and protocols.

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