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510(k) Data Aggregation
(31 days)
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
| Acceptance Criteria Category | Reported Device Performance | Comments from Text |
|---|---|---|
| Equivalence in Indications for Use | "Substantial equivalence is based on equivalence in indications for use..." | The device is a "piston syringe to inject fluids and monitor the pressure of that fluid including use in inflation and discography," which is deemed equivalent to predicate devices. |
| Equivalence in Intended Use | "Substantial equivalence is based on equivalence in...intended use..." | Same as above. |
| Equivalence in Patient Contact | "Substantial equivalence is based on equivalence in...patient contact..." | Not specifically detailed, but implied to be similar to predicate devices. |
| Equivalence in Materials | "Substantial equivalence is based on equivalence in...materials..." | Not specifically detailed, but implied to be similar to predicate devices. |
| Equivalence in Design | "Substantial equivalence is based on equivalence in...design..." | Key design features mentioned: clear barrel, minimum dead space, handle design to prevent plunger pull-out. Implied to be equivalent to predicate. |
| Equivalence in Function | "Substantial equivalence is based on equivalence in...function..." | Function: "inject fluids and monitor the pressure." Implied to be equivalent to predicate. |
| Equivalence in Performance (Non-Clinical) | "Bench and animal performance testing to confirm functionality in the intended use and equivalence to predicate device is included." | Specific performance metrics from these tests are not provided in the summary. |
| Equivalence in Sterilization | "Substantial equivalence is based on equivalence in...sterilization..." | Not specifically detailed, but implied to be similar to predicate devices. |
| Equivalence in Safety | "Substantial equivalence is based on equivalence in...safety." Also, "does not introduce any new safety risks." | Safety features mentioned: clear barrel, minimum dead space, handle design. Implied to be equivalent or better in safety than predicate. |
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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