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The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.

The SECUREGARD is a sterile, single-use, disposable hypodermic syringe with sharps injury and reuse prevention features. It is manufactured in sizes of 0.5, 1, 2, 2.5, 3, 5, 10 and 20 mL volume.

The provided document is about the SECUREGARD® Retractable Safety Syringe and describes its safety and effectiveness. However, it does not contain acceptance criteria or details of a study that proves the device meets specific acceptance criteria in the format requested.

The document is a 510(k) summary (K012121) from October 24, 2201, which primarily focuses on demonstrating substantial equivalence to a predicate device (SOLOGARD® Locking Plus Syringe).

Here's what can be extracted and why other requested information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance:

Critique: These are more descriptive statements of functionality rather than quantitative "acceptance criteria" with specific thresholds (e.g., "95% of users can activate safety feature within X seconds" or "needle fully retracted in Y% of uses").

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. The document states that the safety and effectiveness were "demonstrated" but does not specify how (e.g., in a formal study) or the sample size, data provenance, or study design.

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 provided. This type of information is not relevant for a mechanical device like a syringe and is not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not provided. Not applicable as no formal expert adjudication process is described for this type of device.

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 device is a retractable safety syringe, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI performance metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the functional claims, the "ground truth" implicitly relies on direct observation or testing of the syringe's physical operation by undefined evaluators. There is no mention of pathology, expert consensus, or outcomes data in the context of proving the safety features.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for an AI model.

In summary: The provided text is a regulatory submission for a medical device (syringe) focused on demonstrating substantial equivalence to a legally marketed predicate. It reports on the device's functional characteristics related to safety (sharps injury and reuse prevention) but lacks the detailed experimental design, acceptance criteria, and performance metrics typically found in a study report for more complex diagnostic or AI-driven devices.

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These syringes are intended for use by health care professionals for general purpose fluid aspiration/injection. The devices contain a piston locking mechanism which aids in the prevention of the accidental reuse of the syringe.

The SOLOGARD® LOCKING PLUS Syringe is a sterile, single-use, disposable hypodermic syringe with a plunger locking feature to prevent the accidental reuse of the syringe. It is manufactured in sizes of 1, 2.5, 3, 5, & 10 ml and is supplied with a G29 x ½" or G29 x 5/8" needle.

This document is a 510(k) summary for the SOLOGARD® LOCKING PLUS Syringe with Needle. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested items, such as multi-reader multi-case studies, expert ground truth, and separate training/test sets, are not applicable to this type of regulatory submission for this device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define acceptance criteria in terms of numerical performance metrics. Instead, the "acceptance criteria" for a 510(k) submission are met by demonstrating substantial equivalence to predicate devices. The reported "performance" is that the device is deemed equivalent.

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

• Not Applicable. This 510(k) summary does not describe a "test set" in the context of a performance study for the device's efficacy. The submission focuses on design comparison and intended use equivalence rather than a study with a test set of samples.

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

• Not Applicable. No experts were used for establishing ground truth in a clinical study as described in this document. The equivalence determination is based on a review of device design specifications and intended use by the FDA.

4. Adjudication Method for the Test Set:

• Not Applicable. There was no "test set" and thus no adjudication method employed as part of a performance study described here.

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 device is a manual hypodermic syringe, not an AI-powered system or diagnostic imaging device. No MRMC studies were conducted or relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used:

• Not Applicable / Not Explicitly Stated. For a 510(k) for a device like a syringe, the "ground truth" for showing safety and effectiveness is primarily established through:
  • Predicate Device Comparison: The established safety and effectiveness of legally marketed predicate devices.
  • Engineering/Design Specifications: The design's ability to perform its intended function (e.g., fluid aspiration/injection, locking mechanism integrity). These are usually supported by internal testing data, but such data is not detailed in this summary.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is not an algorithm or an AI/ML-based device.

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

• Not Applicable. No training set was used.

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