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--- The TMD™ 0.5ml Safety Syringe (FA18 Series 0.5ml) is intended for injection of fluids into the body after the aspiration of fluid.

--- The TMD™ 0.5ml Insulin Safety Syringe (FA58 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin.

--- The TMD™ 0.5ml Tuberculin Safety Syringe (FA78 Series Tuberculin) is intended intra-dermal of Tuberculin.

All the three syringes above incorporate a safety feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.

The TMD 1 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin / FA78 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.

Please provide me with the content of the "Input" in a machine-readable format. The current format is an image, and I need the text to effectively answer your request.

Once you provide the content, I will analyze the FDA 510(k) submission to extract the requested information about acceptance criteria and study details.

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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.

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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

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.

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Not Found

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the TMD™ Safety Syringe. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot extract the requested information from the provided text.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This indicates that the device's approval is based on substantial equivalence to a predicate device, not on meeting specific acceptance criteria proven by a new clinical study.

Therefore, I cannot populate the table or answer the specific questions about a study, as that information is not present in this document.

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