Search Results

The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the plunger can be locked for self-locking.

The provided text describes a 510(k) premarket notification for a medical device: Sterile Auto-Disable Syringes with/without Needle for Single Use. The FDA clearance letter indicates that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (Safety Auto-Disable Syringe with Needle (Auto-Lock), K143497).

However, the provided document does not contain information related to a study proving the device meets acceptance criteria for an AI/ML-driven medical device. The document is a regulatory submission for a physical medical device (syringes) and details its physical, material, and performance characteristics compared to a predicate device.

Specifically, the document discusses:

• Device Description: The physical components and mechanism of the auto-disable syringe.
• Indications for Use: Aspiration of fluids and fluid injections.
• Comparison to Predicate Device: Detailed table comparing features like indications for use, product code, regulation number, class, principle of operation, safety features, intended user, environment of use, syringe volume, nozzle type, lubricant, barrel transparency, graduations legibility, needle length, needle gauge, configuration of the tip, needle hub, single use, performance specifications, sterilization, SAL, materials, pyrogenicity, biocompatibility, and labeling.
• Performance Data: Lists various tests conducted to demonstrate the physical device's safety and bio-compatibility, such as biocompatibility testing (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogens, Hemolysis, Particulate Matter), sterilization validation, shipping and shelf-life testing, and performance testing against ISO standards (ISO 7864, ISO 9626, ISO 80369-7, ISO 7886-4, ISO 7886-1).

None of the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device is present in this documentation. The questions about sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment are relevant to AI/ML device evaluations, but not to the type of device described in this 510(k) submission.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance and validation using the provided text. The document is about the substantial equivalence of a physical syringe, not a software or AI/ML product.

Ask a specific question about this device

The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.

The provided document is a 510(k) summary for a medical device (Sterile Auto-Disable Syringes with/without Needle for Single Use). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, the document does not contain the specific details about acceptance criteria and the comprehensive study results to prove that the device meets those criteria, as requested in your prompt regarding a typical device performance study.

The prompt asks for details like:

1. A table of acceptance criteria and the reported device performance: This is not provided in a summarized table format for specific performance metrics.
2. Sample sizes used for the test set and the data provenance: Not specified for each test.
3. Number of experts used to establish the ground truth... and their qualifications: Not applicable as this is a physical medical device, not an AI/diagnostic software.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance: The document describes performance testing for the device itself (standalone in a physical sense), but not algorithm standalone performance.
7. Type of ground truth used: For physical device testing, ground truth refers to established standard measurements and specifications (e.g., ISO standards).
8. Sample size for the training set: Not applicable (not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding performance and testing:

The Section "VII Performance Testing" lists the types of tests conducted:

• Biocompatibility testing:
  • Classification: Externally Communicating Device, Blood Path Indirect, Limited Contact (.
  • Acceptance Criteria/Reported Performance: It states "Conforms to ISO 10993" and "Non-pyrogenic" but does not provide specific numerical outcomes or detailed acceptance criteria for each sub-test.
• Sterilization, Shipping and shelf-life:
  • Tests conducted: EO sterilization validation per ISO11135:2014, Pyrogen testing per USP , EO residuals per ISO 10993-7, Simulated shipping per ASTM D4169, Sterile Barrier Package testing (Seal Strength ASTM F88/F88M-2015, Bubble leak testing ASTM D3078-02(2013), Dye Penetration ASTM F1929-2015).
  • Acceptance Criteria/Reported Performance: "Shelf life of 5 years validated using FDA recognized standards ASTM F1980-16." It implies compliance with these standards, but doesn't offer specific data points or "acceptance criteria met" statements for each.
• Performance testing:
  • Tests conducted according to: ISO 7864:2016, ISO 9626:2016, ISO 80369-7:2016, ISO 7886-4:2018, ISO 7886-1:2017.
  • Acceptance Criteria/Reported Performance: The comparison table (Table 5-1) under "Performance specifications" states: "Complies with ISO 7864, ISO 7886-1, ISO 7886-4." This indicates the device passed these standards, which inherently include acceptance criteria for parameters like syringe dimensions, fluid leakage, plunger force, auto-disable features, etc. However, the exact specific criteria and the numerical results are not detailed in this summary.

In summary, based only on the provided text, I cannot construct the detailed table and answer all points of your prompt because the 510(k) summary provides a high-level overview of the types of tests performed and the standards met, rather than detailed acceptance criteria and specific reported performance metrics for each test. The document confirms that testing was done to demonstrate compliance with relevant international standards, which is typical for a 510(k) submission showing substantial equivalence for a physical device.

Ask a specific question about this device

The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.

The provided text describes a 510(k) premarket notification for a medical device called "Sterile Auto-Disable Syringes with/without Needle for Single Use." The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. The information details the device, its intended use, and a comparison to the predicate, along with performance testing conducted.

Here's an analysis of the provided text in relation to your request for acceptance criteria and the study proving the device meets them:

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

The document does not explicitly state "acceptance criteria" with numerical targets in a tabular format as you might expect for a specific performance metric (e.g., "accuracy > 90%"). Instead, it states that the device's performance "complies with" or "conforms to" various ISO standards. For medical devices like syringes, these standards themselves define the performance requirements and test methods. Therefore, the "acceptance criteria" are implicitly the requirements set forth by these international standards, and the "reported device performance" is that the device meets those standards.

Below is a table constructed from the "Performance testing" section, indicating the relevant standards as acceptance criteria and the reported performance as compliance with these standards.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any of the performance tests.
The document does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). These details are typically found in the full test reports, which are summarized here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device and study. The testing for a syringe involves physical, chemical, and biological performance against standardized criteria, not interpretation by human experts to establish a "ground truth" like in imaging or diagnostic studies. The "ground truth" is defined by the parameters and thresholds in the ISO and ASTM standards themselves.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) when establishing ground truth for subjective assessments. Since this study relies on objective performance against defined standards, there's no need for adjudication.

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 is not applicable. An MRMC study is relevant for diagnostic or AI-assisted interpretation devices. This submission concerns sterile auto-disable syringes, which are physical medical devices, not diagnostic software.

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

This is not applicable. This is not an algorithmic device.

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

The "ground truth" for the performance of the syringe device is defined by the requirements and test methods specified in the cited international ISO and ASTM standards. For example, for "Seal Strength," the ISO/ASTM standard dictates the method and acceptable range, which serves as the objective ground truth. For "Biocompatibility," the ground truth is whether the device materials elicit a toxic response beyond defined limits, as determined by standardized biological tests.

8. The sample size for the training set

This is not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

This is not applicable for the reason stated above.

Ask a specific question about this device