(77 days)
The Medtronic Magellan™ Ratio Dispenser Kit including tip is intended to assist the user in simultaneously delivering two non-homogenous liquids to the same treatment area(s).
The Magellan Ratio Dispenser Kit consists of the following components: 12 cc legally marketed disposable piston syringe 1, 1 cc legally marketed disposable piston syringe 1, Dispenser Handle 1, Plunger clip 1, Dual channel tip (spray or cannula) 1, Two medicine cups.
The provided text is a 510(k) summary for the Medtronic Magellan™ Ratio Dispenser Kit. It explicitly states that performance data supporting the safety and effectiveness of the device is included in the submission but does not detail the acceptance criteria or the specific study that proves the device meets those criteria.
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the provided text.
- Reported Device Performance: Not explicitly stated in the provided text. The document broadly states "Performance data that supports the safety and Effectiveness of the use of Magellan Ratio Dispenser Kit is included in the submission." without providing any specifics.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
- Number of Experts: Not applicable, as no ground truth establishment is described for a test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Not applicable, as no test set evaluation with adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Study Conducted: No MRMC study is mentioned.
- Effect Size: Not applicable.
6. Standalone Performance Study (Algorithm Only):
- Study Conducted: This device is a physical medical device (syringe dispenser kit), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable. The performance data would relate to the physical and functional aspects of the dispenser.
7. Type of Ground Truth Used:
- Not applicable, as the document refers to performance data for a physical device, not an AI algorithm requiring ground truth in the typical sense (e.g., expert consensus, pathology for diagnostic tasks). Performance data for such a device would likely involve measurements of dispensing accuracy, consistency, ease of use, material compatibility, etc.
8. Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Summary of Missing Information:
The provided 510(k) summary is a high-level overview. It declares that performance data exists and supports the substantial equivalence claim but does not provide any specifics regarding:
- The actual performance criteria the device was intended to meet.
- The results of any performance testing in quantitative terms.
- Details about the studies conducted (e.g., design, sample sizes, methodology, data sources).
To obtain this detailed information, one would typically need to review the full 510(k) submission document, which is generally not publicly available in its entirety but summarized in documents like this. The 510(k) summary is designed to provide just enough information to support the substantial equivalence claim without revealing proprietary details of the tests.
§ 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).