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The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle is a single-use aspiration needle comprised of a 304 stainless steel (SS) cannula with a molded plastic Acrylonitrile Butadiene Styrene (ABS) handle, and a 304 stainless steel stylet with a molded plastic (ABS) handle which mates with the cannula handle when the stylet is inserted through the cannula. The distal end of the cannula is threaded and has vent holes for bone marrow aspirate recovery. The needle will be offered in 8G and 13G sizes. It will also be offered in an open tip configuration as well as a closed tip configuration. The Arthrex Vortex™ Threaded Bone Marrow Recovery Needle can be hammered or twisted into the bone to access the marrow. A standard syringe (not included) will be attached to the Luer-lock portion of the ABS handle and negative pressure is applied to withdraw the bone marrow aspirate. The device can be used anywhere bone marrow aspirate can be collected such as the iliac crest, vertebral bodies, femur, humerus and/or the calcaneus. The threaded the portion on the distal end of the cannula will allow for precise depth control of the device while performing the aspiration.

AI/ML Overview

The document does not describe the acceptance criteria and study for an AI/ML powered device. Instead, it is a 510(k) premarket notification for a medical device called the "Arthrex Vortex™ Threaded Bone Marrow Recovery Needle." This device is a manual instrument for aspirating bone marrow and does not involve AI or machine learning. Therefore, the requested information (acceptance criteria for AI, sample size for AI test set, expert qualifications for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, and training set details) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (Ranfac Bone Marrow Aspiration Needle) through comparison of design, materials, indications for use, and mechanical performance testing.

However, I can extract the general performance data presented, which serves to demonstrate the device meets its intended function, analogous to "acceptance criteria" for a non-AI device.

Here's the information extracted from the provided text, structured to best fit your request, but acknowledging the device type:

Device: Arthrex Vortex™ Threaded Bone Marrow Recovery Needle
Intended Use: Aspiration of bone marrow.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from testing)	Reported Device Performance (Arthrex Vortex™ Threaded Bone Marrow Recovery Needle)	Predicate Device Performance (Ranfac Bone Marrow Aspiration Needle)
Functional Performance:
No visible signs of leakage or disassembly during aspiration	No instances of leakage/clogging observed when aspirating the test solution.	No instances of leakage/clogging observed when aspirating the test solution.
No signs of deformation or prevention of aspiration capabilities after hammer insertion	No failures observed during hammer insertion testing. No signs of mechanical deformation or prevention of aspiration capabilities after hammer insertion testing.	No failures observed during hammer insertion testing. No signs of mechanical deformation or prevention of aspiration capabilities after hammer insertion testing.
Material Safety & Sterility:
No material mediated pyrogenicity	No evidence of material mediated pyrogenicity (performed on a comparable device).	Not explicitly stated for predicate in comparison table, but assumed predicate would meet similar standards.
Bacterial endotoxin levels meet standards	Meets 20 EU/device for routine monitoring of sterile products (in accordance with AAMI ST72 2019).	Not explicitly stated for predicate in comparison table.
Biocompatibility in accordance with ISO 10993-1:2018	Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Implantation, and Material Characterization testing performed in accordance with ISO 10993-1:2018. (Implies successful completion for clearance).	Not explicitly stated for predicate in comparison table, but assumed predicate would meet similar standards.
Sterility Assurance Level (SAL)	10-6 (Gamma Irradiation)	10-6 (Ethylene Oxide Gas)
Shelf Life	5 years	5 years
Single Use	Yes	Yes

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

The document does not explicitly state the "sample size" in terms of the number of tested devices or "test set" for the performance testing (e.g., how many needles were subjected to hammer insertion). It mentions "testing on the proposed device and predicate (K131157)" so a comparison was made.

Sample Size: Not explicitly stated as a number of devices tested for each performance criterion (e.g., 10 needles for hammer insertion).
Data Provenance: The studies were conducted by Arthrex Inc. as part of their 510(k) submission. The data is prospective in the sense that the studies were performed specifically for this submission to characterize the device's performance. The country of origin for the data is not specified, but Arthrex Inc. is based in Naples, Florida, USA.

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

Not applicable. This device is a manual surgical instrument, not an AI/ML product that requires ground truth establishment by experts for performance evaluation. Performance is assessed through mechanical and material testing.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or decision-making process for the "test set" that would require adjudication. Performance is measured objectively through physical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is relevant for diagnostic or image-based AI devices where human readers' performance with and without AI assistance is compared. This device is a bone marrow aspiration needle.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a manual surgical instrument with no algorithm or AI component.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. For this mechanical device, "ground truth" equates to the objective outcomes of physical and material tests (e.g., "no leakage," "no deformation," "material biocompatibility").

8. The Sample Size for the Training Set

Not applicable. This device does not use an AI/ML model, so there is no "training set."

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

Not applicable. This device does not use an AI/ML model, so there is no "training set" or "ground truth for the training set."

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