(96 days)
The MFA Syringe/Needle Device is a syringe with needle intended for use in aspirating a specimen of fluid or tissue out of the human body for pathologic examination.
The MFA and predicate devices have substantially similar technological characteristics in terms of design and materials. Although there are minor difference in the characteristics of the MFA device and its predicate devices, those differences do not raise new questions of safety or efficacy. MFA differs from some predicates in the range of syringe and needle sizes but is similar to those of other predicates. Compared with the predicates, the MFA Device has a different size and shape of the hub of the needle: the size of the hub is larger and has a larger lumen to allow the collected samples to be picked up and transferred to other containers. In additional, the inner end of the needle that is located in the lumen of the hub has a cover above the opening of the needle to prohibit the collected sample getting up into the lumen of the syringe.
Here's a breakdown of the acceptance criteria and study information for Dr. Li's MFA Syringe with Needle, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Claim | MFA Syringe with Needle Performance |
|---|---|
| Prevention of fluid spreading into syringe lumen (for liquid samples > 50 µl) | Significantly prevented fluid spreading compared to predicate devices. |
| Prevention of solid tissue samples spreading into syringe lumen | Significantly prevented solid tissue spreading compared to predicate devices. |
| Part of the needle penetrating skin is the same as predicate devices | The part of the needle that will penetrate the skin into the body is the same as that of predicate devices; therefore there is no additional risk. |
| Aspirates fluid and tissue samples in a manner equivalent to predicate devices | The MFA device aspirates fluid and tissue samples from the human body in a manner equivalent to that used by the predicate devices. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a numerical sample size of individual tests. The study was described as "using different animal organs and tissues." This implies a qualitative comparison rather than a statistically powered clinical trial.
- Data Provenance: The study was a "non-clinical Device Function Test." It involved "different animal organs and tissues." Therefore, the data provenance is from animal models, not human subjects, and it was a prospective test designed to compare function.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not mentioned. Given it was a non-clinical device function test on animal organs/tissues, a formal adjudication process between experts is unlikely to have been part of this specific test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. This was a non-clinical device function test, not a comparative effectiveness study involving human readers or cases.
- Effect Size of Human Readers Improvement with/without AI: Not applicable, as no human-in-the-loop study was performed, and the device is a medical instrument, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Done
- Standalone Study Done? Yes, in a sense. The described "non-clinical Device Function Test" that compared the MFA device's performance against predicate devices using animal organs/tissues can be considered a standalone performance evaluation of the device itself. It did not involve human users in a clinical context; it focused solely on the device's functional characteristics (fluid and tissue retention).
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was based on direct observation and measurement of the device's functional performance in retaining liquid and solid tissue samples within the hub and preventing them from spreading into the syringe lumen, in experiments miming human procedures on animal organs/tissues. This is best described as experimental observation/measurement of device function.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical medical instrument, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
§ 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).