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The SnareLok Bone Marrow Biopsy Needle is intended for harvesting bone and/or bone marrow specimens.

The biopsy instrument is a sterile disposable device which features a cannula assembly containing an outer cannula with an inner spiral snare tube at the distal tip. The device has a handle with a snare lever that can be rotated 180° to engage the snare when a biopsy sample needs to be taken. Finally the device has a stationary stylet to prevent coring during advancement, and a stylet cap which mates to the handle. Three sizes are available; 8, 11 and 13 gauge needles. The 8 and 11 gauge needles are sold in 4" and 6" lengths and have a tip configuration identical to the geometry of the existing Medical Device Technologies Manan Bone and Bone Marrow Biopsy Needle. The 13 gauge needles are sold in 2" and 3" lengths and have a less tapered tip configuration identical to a bone marrow needle currently manufactured by Ranfac.

The provided text is a 510(k) summary for the SnareLok Bone Marrow Biopsy Needle. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's characteristics and intended use. The document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot populate the requested table or answer the specific questions below based on the provided input.

Here's a breakdown of why the information is missing and an explanation of the type of information typically found in such studies:

• Acceptance Criteria and Device Performance: The document describes the device and its intended use but does not present any quantitative performance metrics (e.g., successful biopsy retrieval rates, tissue integrity scores, time to complete procedure) or associated acceptance criteria.
• Sample Size and Data Provenance: Without a study being mentioned, there's no information on sample sizes, country of origin, or whether it was retrospective or prospective.
• Experts and Ground Truth: There's no mention of experts or the establishment of ground truth as no performance study is described.
• Adjudication Method: Not applicable as no study is mentioned.
• MRMC Comparative Effectiveness Study: Not applicable. This type of study is more common for imaging-based diagnostic AI devices where human reader performance is compared with and without AI assistance. The SnareLok is a mechanical biopsy needle.
• Standalone Performance: Not applicable as no performance study is mentioned.
• Type of Ground Truth: Not applicable.
• Training Set Sample Size and Ground Truth Establishment: Not applicable as this device is a physical instrument, not an AI/software device that would require training data.

General Explanation of What Would Be Included in a Performance Study for a Biopsy Needle (if it were present):

If a performance study for a biopsy needle were included, it would typically involve:

1. Acceptance Criteria: Predetermined thresholds for various performance metrics, such as:
   • Specimen Adequacy Rate: The percentage of retrieved samples that are deemed sufficient for diagnosis by a pathologist. (e.g., >= 95%)
   • Specimen Length/Integrity: Average length of retrieved core samples and subjective grading of fragmentation. (e.g., average length >= X mm, = 98%)
   • Ease of Use/Handling: Often assessed qualitatively through surgeon feedback.
   • Complication Rates: Incidence of adverse events (e.g., hemorrhage, infection, pain). (e.g.,

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