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The SafeStep™ Safety Dental Cartridge Injector is a sterile, single use disposable injector barrel assembly and a reusable plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges and existing screw-on dental needles for injection of anesthetic solution in oral tissues. The SafeStep™ Safety Dental Cartridge Injector aids in the prevention of needle stick injuries. The SafeStep™ Safety Dental Cartridge Injector incorporates a needle retraction and re-advancing mechanism which may be operated with one hand.

The SafeStep™ Safety Dental Cartridge Syringe consists of a single-use, disposable aspirating syringe-type injector with a separate re-usable plunger assembly indicated for the use in delivering dental anesthetics. The SafeStep™ Safety Dental Cartridge Syringe incorporates a needle safety mechanism that can be activated with one hand.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SafeStep™ Safety Dental Cartridge Injector:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The study is described as a "simulated use clinical study."
• Data Provenance: The study was conducted by "MDC Research Ltd." The text does not specify the country of origin of the data or the participants, nor does it explicitly state if the data was retrospective or prospective. Given it's a "simulated use clinical study," it would inherently be prospective in nature, as new data would be generated.

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

• Number of Experts: Not explicitly stated. The study involved "evaluator preference," implying multiple evaluators, but their number and specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The text mentions "evaluator preference" and a comparison of performance, but it doesn't describe the process of resolving discrepancies or establishing a consensus "ground truth" if multiple evaluators were involved.

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

• No Multi-Reader Multi-Case (MRMC) Study was performed. This device is a manual medical device (a dental cartridge injector), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable. The study compared the device's performance to a predicate device in a simulated clinical setting.

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

• No Standalone (algorithm only) study was done. This is a physical medical device. The "simulated use clinical study" inherently involved humans interacting with the device, making it an "algorithm with human-in-the-loop performance" in a metaphorical sense, as the device's mechanism (the "algorithm") is activated and operated by a user.

7. The Type of Ground Truth Used

The "ground truth" for the simulated use clinical study revolved around:

• Observed Safety Outcomes: Zero prevalence of sharp injuries and zero failures of the protection feature that could lead to sharps injury. This is based on direct observation and recording within the simulation.
• Performance Equivalency and Evaluator Preference: This would be based on subjective and objective assessments made by the evaluators/participants of the simulated use study, comparing the device to the predicate.

8. The Sample Size for the Training Set

• Not Applicable. This device is a mechanical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. Design and functional testing would have been done during its development, but these are not "training sets."

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

• Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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A properly placed MDC Safe Step Safety Blood Collection Needle System incorporates a retractable needle safety mechanism to minimize needle stick injuries when used to access a vein to obtain blood samples.

The Safe Step Safety Blood Collection Needle System consists of four separate components: a blood collection needle assembly; an evacuated tube adapter; a front protective cap; and a rear protective cap.

The Safe Step Safery Blood Collection Needle System is a standard Blood Collection Needle System with the additional feature of a retractable needle. The needle safety mechanism can be activated by lifting the thumb pad (located on the rear piece of the tube adapter) upwards and forward, relative to the two finger tabs on the tube adapter front piece, after removing the last blood sample tube.

After needle retraction, the device is disposed of according to routine procedure in a sharps container.

The provided text describes a traditional medical device (a blood collection needle system) and its regulatory clearance process, not an AI/ML-driven device. Therefore, many of the requested elements pertaining to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment for AI, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable or mentioned in this document.

However, I can extract information related to the device's acceptance criteria and how "performance data" proved it met them, based on the provided text.

Acceptance Criteria and Device Performance for Safe Step Safety Blood Collection Needle System

The "Safe Step Safety Blood Collection Needle System" is a blood collection needle system with an added safety feature: a retractable needle mechanism designed to minimize needle stick injuries.

The document indicates that the device's acceptance was based on demonstrating substantial equivalence to a predicate device and meeting functional requirements and specifications.

1. Table of Acceptance Criteria and Reported Device Performance

• Providing vein access for blood specimen collection using an evacuated blood collection tube.
• Incorporating a safety feature to cover the needle after use. | - "The Safe Step Safety Blood Collection Needle System is substantially equivalent to other Blood Collection Needle Systems currently in commercial distribution by BioPlexus, Inc. in terms of the intended use as a Blood Collection Needle System, providing vein access for the purpose of obtaining blood specimens using an evacuated blood collection tube, and the incorporation of a safety feature to cover the needle after use." (Section 10.5)
• The device incorporates "a retractable needle safety mechanism to minimize needle stick injuries when used to access a vein to obtain blood samples." (Section 10.6) |
  | Technological Characteristics | Similar to the predicate device (Bio-Plexus, Inc. Punctur-Guard Blood Collection Needle System) in terms of:
• Providing vein access to collect blood specimens.
• Including a user-activated feature to cover the needle after use.
• Differences in physical appearance and materials not affecting relative safety or effectiveness. | - "The Safe Step Safety Blood Collection Needle System has the same technological characteristics as the Punctur-Guard Blood Collection Needle System. Both devices provide vein access to collect blood specimens and include a user activated feature to cover the needle after use." (Section 10.7)
• "Differences that exist between these systems relating to physical appearance and materials do not affect the relative safety or effectiveness of the devices." (Section 10.5) |
  | Functional Requirements & Specifications | The device must meet its defined functional requirements and specifications. (Specific functional details are not provided in the summary, but are implied.) | - "Performance data indicate that the Safe Step Safety Blood Collection Needle System meets the functional requirements and specifications of this device." (Section 10.8) (Note: The specific performance data, test methods, or quantified results are not detailed in this summary document.) |

Since this is a medical device clearance and not an AI/ML device, the following points are not applicable or the information is not provided in the document:

2. Sample size used for the test set and the data provenance: Not applicable; this is for a physical device, not an AI model. Performance data is only vaguely mentioned as being present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; ground truth in the AI sense is not relevant here. The "ground truth" for this device would be its ability to perform its mechanical function (retraction, blood collection) reliably, which would be measured through engineering performance tests.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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