(32 days)
The PowrSyringe Injector is a piston syringe to inject fluids into, or aspirate fluids from, the body including use in angiography.
The PowrSyringe Injector is a single use manual hand-held piston syringe with handles to inject fluids into, or aspirate fluid from, the body including use in angiography. The PowrSyringe Injector handles allow the user to push the blunger into the barrel when the user squeezes the handles. Users may open the PowrSyringe Injector's handles to aspirate fluid back into the barrel.
The PowrSyringe Injector safety features include:
- Clear barrel for visualization of air bubbles. a
- I Minimum dead space between the plunger and barrel with the handles are fully squeezed.
- 트 Handle design to prevent the plunger from being pulled out of the barrel during aspiration.
Despite the request for reporting acceptance criteria and study details, the provided text does not contain any information about a study that proves the device meets specific acceptance criteria.
The document is a 510(k) summary for a medical device called "PowrSyringe Injector," which is a piston syringe. The key takeaway from the document regarding performance is that the device demonstrates substantial equivalence to predicate devices through non-clinical testing. This means it's compared to already legally marketed devices and shown to be similar in terms of function and safety, rather than undergoing a study to meet novel acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or expert involvement because this information is not present in the provided text.
Here's a breakdown of why each requested point cannot be addressed:
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A table of acceptance criteria and the reported device performance: No specific quantitative acceptance criteria or reported performance metrics are mentioned for the PowrSyringe Injector in the context of a "study" to prove its performance. The document only states that "Bench and animal performance testing to confirm functionality in the intended use and equivalence to predicate device is included." This implies comparative testing, not testing against predefined, quantifiable acceptance criteria.
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Sample sizes used for the test set and the data provenance: No test set sample sizes are provided. The only "data" mentioned is from "Bench and animal performance testing," without details on the number of units tested. Data provenance is not specified beyond "Non-Clinical Testing."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no mention of a clinical or standalone study with a "test set" requiring ground truth establishment, this information is absent.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there's no test set or expert evaluation described.
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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. This device is a manual piston syringe, not an AI-powered diagnostic tool. The concept of "human readers" and "AI assistance" doesn't apply.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study generating "ground truth" is described. The "ground truth" for substantial equivalence would generally be the performance and safety profiles of the predicate devices.
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The sample size for the training set: Not applicable, as this device doesn't involve machine learning or a "training set."
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How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided document focuses on demonstrating substantial equivalence through non-clinical testing against predicate devices, which is a different regulatory pathway than providing detailed performance studies against specific acceptance criteria for a novel device or AI product.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).