(29 days)
The TMD™ 1ml Safety Syringe (FA11 Series 1ml) is designed as an anti-stick svringe to reduce the risk of sharps injuries and the potential for syringe reuse. It is a single use, disposable and manual retractable safety syringe that is intended for injection of fluids into the body after the aspiration of fluid.
The TMD™ 1ml Insulin Safety Syringe (FA51 Series U-100 Insulin) 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 use for subcutaneous injection of Insulin
The TMD 1ml Tuberculin Safety Syringe (FA71 Series Tuberculin) 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 to use for the three types of injection(subcutaneous, intra-dermal and intra-muscular) of Tuberculin.
The TMD 1ml Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Insulin / FA71 Series Tuberculin) is a single use, sterile, disposable syringes that is designed to reduce the risk of sharps injuries. The insulin syringe has scale lines in insulin units. The Tuberculin syringe has scale lines of Tuberculin.
The provided document is a 510(k) Summary for a medical device (TMD™ 1ml Safety Syringe). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically seen in clinical trials for new technologies.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies, and detailed ground truth establishment is not available in this type of regulatory submission.
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." (Section 7)
- "Additional performance data was conducted to demonstrate the compliance with ISO8537 (Insulin Syringes) specification." (Section 7)
- The comparison table (Section 9) focuses on technological characteristics rather than specific performance outcomes against predefined acceptance criteria for clinical efficacy.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document as specific quantifiable acceptance criteria and corresponding device performance metrics (e.g., success rate of the safety mechanism in preventing needlestick injuries in a controlled user study) are not detailed. The document generally states that performance data was generated and demonstrated equivalence to predicate devices and compliance with ISO8537.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "Performance data has been generated" but does not detail the number of units tested or the methodology.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The manufacturer is based in Taiwan, and the submission is to the US FDA, but the origin or nature of the performance data is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. This type of information is typically relevant for diagnostic devices where subjective interpretation (e.g., by radiologists) is being evaluated against a ground truth. For a safety syringe, performance data would likely involve engineering tests, biomechanical tests, and possibly simulated use tests, not expert consensus on "ground truth" labels.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not specified. Similar to point 3, adjudication methods are used for resolving disagreements in expert interpretations for diagnostic accuracy, which is not the primary focus for a safety syringe's performance data.
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. MRMC studies and "human improvement with AI" are relevant for AI-powered diagnostic or assistive technologies. This device is a manual safety syringe, not an AI system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This question is for AI algorithms. The device is a physical safety syringe.
7. The type of ground truth used
Not applicable/Not specified in detail. For a safety syringe, "ground truth" would relate to objective measurements of mechanical function, sterility, biocompatibility, and possibly the actual successful activation of the safety mechanism in simulated use. The document broadly refers to "compliance with the design control requirement and appropriate standards" and ISO8537.
8. The sample size for the training set
Not applicable/Not specified. Training sets are relevant for machine learning algorithms. This is a physical device without an AI component.
9. How the ground truth for the training set was established
Not applicable.
§ 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).