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It is intended to inject fluids into the body or withdraw blood for medical purposes. After injection, the needle tube will be retracted into the barrel when the safety features are manually activated to minimize the risk of accidental sharps injury.

Safety Sterile Syringes is a sterile device consisting of a calibrated barrel, plunger, piston, push button, retraction cylinder, sealing ring, spring and a needle. It is made of plastic, stainless steel and silicone materials. Safety Sterile Syringes have two types: Type F and type D. Type F is a syringe with a fixed needle. Type D is a syringe with a detachable needle. The detachable needle is secured by rotating it through the front needle hub into the back needle hub located on the syringe. Safety Sterile Syringes is using plunger to fill syringe as well as discharge the fluid. After use, by continuing to press the push-button down to depress the plunger all of the way within the barrel, the safety mechanism will be triggered, then the needle tube, needle hub and retraction cylinder will be retracted into the barrel completely under the force of the spring to minimize the risk of accidental sharps injury. Product is delivered sterilization process is validated according to EN ISO 11135. This is a single-use device. Safety Sterile Syringes is intended to be used in professional healthcare facility/hospital and transport environment.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "VeriSafe Safety sterile syringes." This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing a specific clinical study with acceptance criteria in the same way one might for a novel diagnostic or therapeutic AI device.

Therefore, the requested information elements related to AI/algorithm performance, ground truth establishment for AI, sample sizes for test/training sets in an AI context, expert qualifications, and MRMC studies are not directly applicable to this submission. This document describes bench testing verifying physical and material properties of a medical device (a syringe).

However, I can extract the relevant "acceptance criteria" (standards and tests) and how the device "meets" them based on the provided summary.

1. Table of Acceptance Criteria and Reported Device Performance

• Seal strength, dye penetration, and sterility tests performed and met criteria. |
  | Shelf-Life (ASTM F1980-16) | - 3 years (validated using accelerated aging) |

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

• Test Set Sample Size: Not specified in terms of specific number of units tested for each standard. The document states "The bench testing performed verifies that the performance of the subject device is substantially equivalent..." implying tests were conducted on representative samples of the device as required by the listed ISO and ASTM standards.
• Data Provenance: The device manufacturer is Promisemed Hangzhou Meditech Co., Ltd. in Hangzhou, Zhejiang, China. The tests cited are international standards (ISO, ASTM, USP), indicating the testing was conducted to these globally recognized specifications. The document doesn't explicitly state if the testing was performed retrospectively or prospectively, but standard device testing for 510(k) submissions is typically conducted during product development and validation, and is inherently "prospective" in relation to the submission itself.

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)

This section is Not Applicable (N/A). The "ground truth" here is defined by performance against established international consensus standards (e.g., ISO, ASTM, USP) for physical, chemical, and biological properties of a medical device (syringe), not by expert clinical judgment or interpretation of data. The standards themselves are developed by committees of experts, but this is not what is typically asked for in terms of "ground truth" for a device's performance in a clinical or AI context.

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

This section is Not Applicable (N/A). Performance is measured objectively against the criteria defined by the listed standards, not through adjudication by multiple human reviewers.

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

This section is Not Applicable (N/A). This device is a sterile safety syringe and does not involve AI or human "readers" in the context of its function or assessment for this submission.

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

This section is Not Applicable (N/A). This device is a sterile safety syringe and does not involve an algorithm.

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

The "ground truth" for this device's performance is the objective criteria and acceptable limits defined within the cited international consensus standards (ISO 7886-1, ISO 9626, ISO 7864, ISO 23908, ISO 10993 series, ISO 11135, ASTM F1980-16, ASTM D4169-16, ASTM F88/F88-15, ASTM F1929-15, USP, USP42-NF37, USP, USP38-NF33_C71). These standards specify the test methods and the performance thresholds that the device must meet to be considered compliant and safe/effective.

8. The sample size for the training set

This section is Not Applicable (N/A). There is no AI model involved, therefore no training set.

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

This section is Not Applicable (N/A). There is no AI model involved, therefore no training set or ground truth establishment for it.

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