(23 days)
The TMD™ Safety Syringe (FA14 Series 10ml/FA15 Series 20ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of fluids into or withdraw from the body.
The TMD™ Safety Syringe (FA14 Series 10ml/FA15 Series 20ml) is a sterile, single use and disposable, 10 ml & 20ml piston syringe, provided with or without needle in various product configurations. The TMD™ Safety Syringe (FA14 Series 10ml/FA15 Series 20ml) is similar in appearance, size, materials, operation, and purpose to other conventional single use, sterile, disposable syringes.
The provided document is a 510(k) Summary for a medical device called the TMD™ Safety Syringe. It describes the device, its intended use, and compares it to a legally marketed predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically found for diagnostic algorithms or AI-driven systems.
The document states: "Performance data has been generated in compliance with the design control requirement and appropriate standards. The result demonstrated equivalent to the predicate devices." This implies that the device was tested against existing standards for syringes and found to perform comparably to previously approved devices. However, the specific acceptance criteria, study details, and data provenance are not elaborated in the summary.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "demonstrated equivalent to the predicate devices." (Specific quantitative performance metrics are not provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is a physical medical device (syringe), not a diagnostic algorithm requiring expert ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device and study description.
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 is a syringe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a syringe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For physical devices like syringes, "ground truth" would typically refer to adherence to engineering standards (e.g., ISO standards for sterility, fluid flow, burst pressure, material compatibility, safety mechanism activation). The document broadly states "compliance with the design control requirement and appropriate standards," implying such testing was done, but doesn't detail it.
8. The sample size for the training set
- Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This is a physical device, not a machine learning model.
§ 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).