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The Synthes Bone Marrow Aspiration (BMA) Syringe is intended for aspiration of bone marrow, autologous blood, plasma, or other body fluids.

The syringe consists of a calibrated hollow barrel and a moveable plunger. At the distal end of the syringe there is a male connector nozzle for fitting the female connector (hub) of a single lumen needle. The syringe can be used for withdrawing body fluids.

The provided text is a 510(k) summary for the Synthes (USA) Bone Marrow Aspiration (BMA) Syringe. It focuses on demonstrating "substantial equivalence" to predicate devices, a regulatory pathway under the FDA. For medical devices pursuing this pathway, the "acceptance criteria" and "study" described in your request are typically not present in the same way as for novel devices undergoing rigorous performance validation. Instead, the focus is on showing similarity in design, materials, and intended use to existing, legally marketed devices.

Therefore, the specific information requested about acceptance criteria and study details (like sample size, ground truth, expert opinions, MRMC studies, standalone performance) for an AI/device performance validation does not apply directly to this 510(k) submission for a non-AI, piston syringe device.

Here's how to address your points based on the provided text's context:

1. A table of acceptance criteria and the reported device performance

• Not Applicable in the traditional sense for this 510(k). The provided text does not define specific performance acceptance criteria for the Synthes BMA Syringe beyond meeting the functional requirements expected of a "Piston Syringe" (21 CFR §888.5860) and demonstrating "substantial equivalence" to predicate devices.
• Implicit acceptance criteria: The device must function as a syringe for "aspiration of bone marrow, autologous blood, plasma, or other body fluids" reliably and safely, consistent with its classification and the performance of its predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This 510(k) summary does not describe a clinical performance study with a "test set" in the context of AI or advanced diagnostic devices. "Substantial equivalence" is typically demonstrated through engineering analyses, bench testing, and comparison to predicate devices, not large-scale clinical trials with defined test sets for performance metrics like sensitivity/specificity.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment by experts for a test set is mentioned or required for this type of device's 510(k) submission.

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

• Not Applicable. No adjudication method for a test set is mentioned.

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

• Not Applicable. An MRMC study is not relevant for a simple piston syringe. This device is not an AI-powered diagnostic or interpretive tool.

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

• Not Applicable. The device is a physical syringe, not an algorithm.

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

• Not Applicable. Ground truth (in the sense of a medical outcome for comparison) is not a concept applied in this 510(k) submission. Device performance is assessed based on engineering specifications and intended function.

8. The sample size for the training set

• Not Applicable. There is no "training set" for this device, as it is not an AI/machine learning product.

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

• Not Applicable. No training set or associated ground truth establishment is relevant to this 510(k) submission.

Summary based on the provided 510(k) document:

The 510(k) summary for the Synthes (USA) Bone Marrow Aspiration (BMA) Syringe demonstrates "substantial equivalence" to legally marketed predicate devices, not by meeting specific performance acceptance criteria from a clinical study, but by showing that its design, materials, and intended use are similar to existing devices. The key "acceptance criteria" here is the regulatory determination by the FDA that the device is "substantially equivalent" to its predicates based on the submitted documentation, allowing it to be marketed. This regulatory pathway does not typically involve the types of studies or performance metrics you've inquired about, which are more common for novel or AI-driven diagnostic devices.

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