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The Aspiration/Ovum Pick-Up Aspiration Needles with AQ Coating are used for general irrigation/aspiration and flushing of oocytes from ovarian follicles.

The Ovum Pick-Up Aspiration Needles with AQ coating is used for transvaginal ultrasound or laparoscopic aspiration/flushing of oocves from ovarian follicles. The Aspiration Needles with AQ coating are used for general aspiration and irrigation.

The provided text is a 510(k) summary for Ovum Pick-Up Aspiration Needles with AQ Coating and Aspiration Needles with AQ Coating. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically found in clinical trials for novel devices.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Explanation Based on the Provided Document:

The acceptance criteria for a 510(k) submission like this are primarily about demonstrating substantial equivalence to existing, legally marketed predicate devices. This means showing that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate.

The study proving the device meets these acceptance criteria, as described in the 510(k) summary (Section {0}), is a comparison to predicate devices.

Key Information from the Document Regarding "Acceptance Criteria" (Substantial Equivalence) and "Study" (Comparison to Predicate):

• Predicate Devices: The Ovum Pick-Up Aspiration Needles with AQ Coating and the Aspiration Needles with AQ Coating are deemed substantially equivalent to predicate devices including:

  • Cook OB/GYN Ovum Pick-Up Needles
  • Aspiration Needles (Cook OB/GYN)
  • Hydrophilic Dilators (Cook OB/GYN, Cook Urological)
  • Hydrophilic Catheters (Cook OB/GYN, Cook Urological)

• Basis for Substantial Equivalence (the "Study"): "The Ovum Pick-Up Aspiration Needles with AQ Coating and the Aspiraiton Needles with AQ Coating are substantially equivalent to predicate devices in terms of indications for use, design, and materials of construction." (Section {0})

• Device Description:

  • Ovum Pick-Up Aspiration Needles with AQ coating: "used for transvaginal ultrasound or laparoscopic aspiration/flushing of oocves from ovarian follicles."
  • Aspiration Needles with AQ coating: "used for general aspiration and irrigation."

• Substantial Equivalence Statement: "These devices will be manufactured according to specified controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510(k) substantial equivalence." (Section {0})

This 510(k) submission is a regulatory filing, not a scientific study designed to establish quantitative performance metrics against specific acceptance criteria for a novel technology. It relies on the pre-existing safety and effectiveness of predicate devices.

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