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The I-Style Bone Marrow Aspiration Needle with T-Handle consists of a 15G and 18G needle with a triple sharpened atraumatic tip stylet of corresponding size all made of AISI 304 Stainless steel. The needle has an ergonomic grip at whose base a Luer-Lock cone in fitted. The innovative element of the needle is a removable spacer, which indicates the depths the tip can reach. Using a depth stopper, easy adjustment of the needle length, making it easier to reach the tissue to be examined.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (I-Style Bone Marrow Aspiration Needle with T-Handle) seeking clearance for market, not a study report detailing performance against acceptance criteria with patient data. Therefore, many of the requested elements about clinical studies, sample sizes, expert ground truth, and comparative effectiveness (MRMC) cannot be found in this document.

However, I can extract information related to the device's technical characteristics and the types of verification and validation testing performed.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Test	Reported Device Performance
Biocompatibility Tests:	Met testing requirements and found acceptable.
Cytotoxicity Test	Met testing requirements and found acceptable.
Intracutaneous Reactivity Test	Met testing requirements and found acceptable.
Performance Tests:	Met testing requirements and found acceptable.
Fastening and perforation of the stylet tip on the needle entry point	Met testing requirements and found acceptable.
Easiness of insertion of the cannula in the sampling area	Met testing requirements and found acceptable.
Capacity testing on the needle handle	Met testing requirements and found acceptable.
Easiness and manageability of the adjustable spacer	Met testing requirements and found acceptable.
Adequacy of the Luer-Lock connector and twisting capacity of the syringe for bone marrow aspiration	Met testing requirements and found acceptable.
Inspection quantity control of the collected sample	Met testing requirements and found acceptable.
Substantial Equivalence to Predicate Device	Concluded to be substantially equivalent.

2. Sample size used for the test set and the data provenance:

Not provided. This document details engineering and biocompatibility testing, not a clinical study involving a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/provided. The tests described are laboratory-based and do not involve human experts establishing ground truth for patient data.

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

Not applicable/provided. No clinical test set.

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:

No, an MRMC study was not done. This describes a medical device (needle), not an AI algorithm for diagnosis or interpretation that would involve human readers.

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

Not applicable/provided. This is a physical medical device, not an algorithm.

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

For the biocompatibility tests: Likely validated laboratory standards for cytotoxicity and intracutaneous reactivity.
For the performance tests: Likely engineering specifications and functional requirements for features like stylet fastening, insertion ease, handle capacity, spacer adjustability, Luer-Lock adequacy, and sample collection inspection. The "ground truth" would be whether the device performed as designed and met the pre-defined engineering and safety specifications.
No clinical ground truth (like pathology or outcomes data) was used in the context of a patient-based study.

8. The sample size for the training set:

Not applicable/provided. This document does not describe an AI/ML device with a "training set."

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

Not applicable/provided. As above, no training set.

Summary based on the document:

This 510(k) summary focuses on demonstrating the substantial equivalence of the I-Style Bone Marrow Aspiration Needle with T-Handle to existing predicate devices. This is achieved through:

Technological Characteristics Comparison: Showing the new device has similar characteristics to the predicate, with minor design changes (T-Handle vs. Quick Stylet locking handle).
Biocompatibility Testing: Materials used were evaluated and found acceptable.
Performance Testing: Several functional aspects of the needle were tested (e.g., stylet fastening, insertion ease, handle capacity, spacer manageability, Luer-Lock adequacy, sample inspection) and found acceptable against unstated internal requirements.

The document states that "All materials used... were evaluated through biological qualification safety tests" and "I-Style Bone Marrow Aspiration Needle with T-Handle has been tested for the following performance tests." It concludes that the materials "have met the testing requirements and were found to be acceptable for the intended use," leading to the overall conclusion of substantial equivalence.

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