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The I-Style Bone Marrow Aspiration Needle with T-Handle is intended for aspiration of bone marrow.

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.

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:

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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The I-Style Bone Marrow Aspiration Needle is to be used for the aspiration of bone marrow.
The I-Style Bone Marrow Aspiration Needle is intended for Aspiration of Bone Marrow.

The I-Style Bone Marrow Aspiration Needle consists of an 8ga - 15ga needle and a triple sharpened atraumatic tip stylet of corresponding size. The needle is manufactured in lengths upto 2" with an adjustable depth stopper and graduated scale which allow for the adjustment of the penetration length of the needle. A luer lock connection is provided in the molded needle handle to allow aspiration of bone marrow or blood by use of a standard surgical syringe. The needle will be provided as sterile, single use, disposable device. They will be packaged individually or included in Bone Marrow Biopsy Tray.

The provided document describes the K061570 submission for the I-Style Bone Marrow Aspiration Needle. This is a 510(k) summary, which generally involves demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with acceptance criteria and a device performance study as one might see for novel high-risk devices or software as a medical device (SaMD).

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a "Summary of Tests performed to prove the substantial equivalence of the Aspiration Needles with the predicate device." This is a comparison-based assessment rather than a performance study against predefined numerical benchmarks.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "testing requirements" and "materials ... evaluated through biological qualification safety tests" and tests done to prove substantial equivalence. These are likely bench tests and material characterization, not patient-based clinical studies with a 'test set' of clinical data in the traditional sense.
• Data Provenance: Not explicitly stated. Given the nature of the device (a bone marrow aspiration needle) and the types of tests mentioned (biocompatibility, flow rate, bonding strength), the "data" would be generated from laboratory and bench testing, not clinical data from a specific country or collected retrospectively/prospectively from patients.

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

• Number of Experts: Not applicable. For this type of device and submission, there is no mention or requirement for experts to establish a "ground truth" for a test set in the context of clinical data interpretation (e.g., from images). The evaluation is based on engineering and material performance specifications.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in the context of medical image interpretation or clinical outcome assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data. The I-Style Bone Marrow Aspiration Needle is a mechanical device, not an AI or diagnostic tool.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical medical instrument. The "tests" performed were for material safety and equivalence to a predicate device's mechanical characteristics.

7. Type of Ground Truth Used

• Type of Ground Truth: For the "tests" performed, the ground truth would be based on established material specifications, engineering requirements, and performance data of the predicate device. For biocompatibility, established biological safety standards serve as the ground truth. For flow rate and bonding strength, the measured values are compared directly to the predicate device's characteristics. There's no "expert consensus," "pathology," or "outcomes data" ground truth in this context.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.

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

• Ground Truth for Training Set: Not applicable, as there is no training set mentioned or relevant for this device.

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