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The PowrSyringe Aspirator is a piston syringe to inject fluids into, or aspirate fluids from, the body.

The PowrSyringe Aspirator is a single use manual hand-held general-purpose piston syringe with handles to inject fluids into, or aspirate fluid from. The PowrSyringe Aspirator handles allow the user to pull the plunger back within the barrel when the user squeezes the handles. Users may open the PowrSyringe Aspirator's handles to inject fluids back into the barrel.

The PowrSyringe Aspirator safety features include:

• Clear barrel for visualization of air bubbles.
• Minimum dead space between the plunger and barrel with the handles are fully squeezed.
• Handle design to prevent the plunger from being pulled out of the barrel during aspiration.

The provided document is a 510(k) Premarket Notification for the PowrSyringe Aspirator, a piston syringe.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not applicable. The document states "Clinical testing: Not applicable." The performance testing mentioned is non-clinical. For non-clinical performance testing, the sample size is not specified in the provided text.
• Data Provenance: Not applicable, as no clinical human data was used for testing. The testing was non-clinical.

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

• Not applicable. There was no clinical testing involving human data and therefore no ground truth established by experts in this context.

4. Adjudication method for the test set:

• Not applicable. No clinical testing or expert adjudication was performed.

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. This device is a manual piston syringe, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

• No. This device is a physical, manual piston syringe, not an algorithm.

7. The type of ground truth used:

• For the non-clinical performance testing, the ground truth would be based on engineering specifications, physical measurements, and functional requirements for a piston syringe, validated against established industry standards and the predicate devices' performance. The document doesn't explicitly state the specific "type" but implies objective physical and functional criteria.

8. The sample size for the training set:

• Not applicable. This device is a physical medical device, not an AI algorithm that requires a training set.

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

• Not applicable. As above, this is not an AI algorithm.

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The PowrSyringe Monitor is a piston syringe to inject fluids and monitor the pressure of that fluid including use in inflation and discography.

The PowrSyringe Monitor is a single use manual hand-held piston syringe with handles and a pressure gauge to inject fluids and monitor the pressure of that fluid including use in inflation and discography. The PowrSyringe Monitor handles allow the user to push the plunger into the barrel when the user squeezes the handles. Users may open the PowrSyringe Monitor's handles to aspirate fluid back into the barrel.

The PowrSyringe Monitor safety features include:

• Clear barrel for visualization of air bubbles.
• Minimum dead space between the plunger and barrel with the handles are fully squeezed.
• Handle design to prevent the plunger from being pulled out of the barrel during aspiration.

The provided text details a 510(k) submission for the "PowrSyringe Monitor," a piston syringe. However, it explicitly states that "Clinical testing is not applicable" for this device. Therefore, a study proving the device meets acceptance criteria, as typically understood in a clinical trial context with performance metrics, ground truth, and statistical analysis, was not conducted or required for this submission.

The acceptance criteria described for this device are focused on substantial equivalence to predicate devices through non-clinical (bench and animal) performance testing and demonstrating that it "does not introduce any new safety risks."

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable for clinical testing as none was performed. For non-clinical (bench and animal) testing, the sample sizes are not specified in the provided summary.
• Data Provenance: Not applicable for clinical testing. For non-clinical testing, the provenance is not specified.

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

• Not applicable as clinical testing with human experts for ground truth was not performed.

4. Adjudication method for the test set

• Not applicable as clinical testing was not performed.

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. This device is a manual piston syringe, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is a manual piston syringe, not an algorithm.

7. The type of ground truth used

• Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be established by engineering specifications, validated test methods, and direct measurement of physical properties and performance during bench and animal testing.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model that requires a training set.

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

• Not applicable.

In summary, the provided document relates to a 510(k) submission for a medical device (a syringe) where substantial equivalence was demonstrated through non-clinical testing, and clinical testing was deemed unnecessary. Therefore, the questions related to clinical study design, performance metrics, and AI/ML model validation are not applicable in this context.

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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:

1. 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.

2. 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."

3. 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.

4. 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.

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. This device is a manual piston syringe, not an AI-powered diagnostic tool. The concept of "human readers" and "AI assistance" doesn't apply.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

7. 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.

8. The sample size for the training set: Not applicable, as this device doesn't involve machine learning or a "training set."

9. 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.

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