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The Saf-T-Syringe is a sterile, single-use, disposable safety syringe with an auto-retracting needle is intended for injection of insulin subcutaneously. The retractable needle withdraws into plunger body after completion of injection and reduces the risk of accidental needle sticks injuries during use.

The Saf-T-Syringe is a sterile, single-use, disposable, safety syringe with an auto-retracting needle and is intended for injection of allergy testing fluid and tuberculin. The retractable needle withdraws into plunger body after completion of injection and reduces the risk of accidental needle sticks injuries during use.

The Saf-T-Syringe is a sterile, single-use, disposable, safety syringe with an auto-retracting needle and is intended for withdrawal of fluids and injection of fluids below the surface of the skin. The retractable needle withdraws into plunger body after completion of injection and reduces the risk of accidental needle sticks injuries during use.

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This document is a 510(k) premarket notification decision letter from the FDA for several Saf-T-Syringe products. It does not contain information about acceptance criteria or a study proving device performance against acceptance criteria. The document only states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given text.

The information I would need to answer your request would typically be found in a Premarket Approval (PMA) application, a De Novo request, or detailed clinical study reports, which are not part of this 510(k) notification.

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The Saf-T-Syringe's primary intended use is to provide a safe, accurate and reliable method of injecting medication into a patient. The syringe is available in a 3cc, 5cc and 10cc with various needle sizes. The needle automatically withdraws and prevents accidental needle sticks.
3cc, 5cc, and 10cc Syringes are available for: Prescription Use

The Saf-T-Syringe is a 3cc, 5cc, and 10cc, sterile, non-toxic, non-pyrogenic, disposable, one-hand operated, passively activated, automatic retraction, plunger type, Anti-Stick syringe with a unique, dedicated luer-lock hypodermic needle, as detailed within this submission and in relevant patents. The syringe includes an interchangeable needle; 18 gauge to 25 gauge and lengths of 5/8", 1" and 1-1/2".
The primary intended use of the device is to administer safe and accurate subcutaneous and intramuscular injections. Its secondary intended use is to retract and contain the contaminated needle after injection which renders the syringe inoperable for reuse, while not introducing any additional steps to the one-handed operating method, for the purpose of aiding in the prevention of accidental needle stick injuries.

Here's an analysis of the provided text regarding the Saf-T-Syringe, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Summary for a medical device (a safety syringe). These documents primarily focus on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing direct clinical effectiveness through rigorous outcome studies. Therefore, many of the requested categories for AI/software-based devices (like MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of submission. The "acceptance criteria" here are geared towards demonstrating safety, performance, and equivalence, not necessarily diagnostic accuracy or clinical improvement in the way an AI algorithm might be evaluated.

Description of Acceptance Criteria and Supporting Study for Saf-T-Syringe

This 510(k) summary for the Saf-T-Syringe focuses on demonstrating substantial equivalence to predicate devices (POP-N-LOCK SYRINGE/VANISHPOINT™ SYRINGE and BD INTEGRA™ Syringe). The "acceptance criteria" can be inferred from the tests and standards the device claims to meet for safety and basic functionality, rather than specific performance metrics (e.g., sensitivity, specificity) often associated with diagnostic or AI devices. The "study" described is a series of tests to ensure biocompatibility and sterility, and an assertion of equivalence in design and function.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Specific sample sizes for the sterility and biocompatibility tests are not provided in this summary. The summary states that tests were performed according to the mentioned standards.
• Data Provenance: The data provenance is internal testing performed by Safety Medical International, Incorporated, referencing established international and FDA standards. The nature of these tests (e.g., benchtop, lab-based) implies controlled experimental conditions rather than human clinical data in the sense of retrospective/prospective clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This question is not applicable in the traditional sense of diagnostic AI or image analysis. The "ground truth" for sterility and biocompatibility is established by adherence to validated testing methodologies and their respective endpoints as defined in international standards (e.g., absence of microbial growth for sterility, specific cellular responses for cytotoxicity). There isn't a panel of "experts" interpreting a dataset for a diagnostic outcome.

4. Adjudication Method for the Test Set

• This question is not applicable. The assessment for sterility and biocompatibility follows clear, pre-defined protocols and quantitative/qualitative endpoints without the need for an adjudication method typically used for subjective interpretations (like radiology reads).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not the purpose of a 510(k) submission for a safety syringe. The submission focuses on the device itself meeting safety and performance standards, and demonstrating physical and functional equivalence to existing devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. The Saf-T-Syringe is a physical medical device, not a software algorithm. Its "performance" is inherent in its physical and mechanical function, which is assessed through bench testing and adherence to standards, not via a standalone algorithm evaluation.

7. The Type of Ground Truth Used

• The "ground truth" for this device's safety and performance is based on established scientific and regulatory standards for sterility (e.g., no viable microorganisms detected after sterilization) and biocompatibility (e.g., absence of toxicity, irritation, sensitization as per ISO 10993). For substantial equivalence, the "ground truth" is a direct comparison of the device's technological characteristics and intended use against legally marketed predicate devices.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of a physical medical device like a syringe. This concept applies to machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable. As there is no training set for a physical device, there's no ground truth to establish for it.

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