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The TSK Syringe is a low dead volume syringe intended for use in patients that need injection and withdrawal of substances for examination, treatment, diagnosis or prevention.

The TSK Syringe is a syringe intended for use with a needle to inject or withdraw substances, for general use. The TSK Syringe leaves a low volume of fluid when the plunger is fully depressed.

There are two model numbers for the TSK Syringe. The technological differences are as follows:

The provided text is a 510(k) Clearance Letter and 510(k) Summary for the TSK Syringe. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance in the context of an AI/human reader study.

This document describes a physical medical device (syringe), not a software or AI-powered medical device that would involve AI performance metrics, human reader studies, ground truth establishment, or training/test set sample sizes in the way you've outlined.

Therefore, I cannot provide the requested information from this document. The details about acceptance criteria and study design for AI-based performance evaluation are not present.

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The TSK SELECT™ Needle is indicated for subcutaneous injections of pharmaceutical products, or for withdrawal of fluids.

The TSK SELECT™ Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen needle intended for use with a luer-tip syringe. The TSK SELECT™ Needle consisting of a stainless-steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene, or polycarbonate, depending on the hub type, designed to be connected with a male luer fitting of a syringe. The TSK SELECT™ Needle is intended for manual use by health care professionals for administration of fluids. The TSK SELECT™ Needle is provided sterile, is single use only, non-toxic, non-pyrogenic, and sterilized by gamma irradiation.

There is no indication that the TSK SELECT™ Needle incorporates artificial intelligence (AI) or machine learning (ML). The provided 510(k) clearance letter and summary describe a physical medical device (hypodermic needle) and its non-clinical performance and biocompatibility testing.

Therefore, the specific information requested about AI/ML device acceptance criteria and study details (such as sample size for test/training sets, data provenance, expert ground truthing, adjudication methods, MRMC studies, standalone performance, and effect size with AI assistance) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Indications for Use Comparison: Showing the new device has the same intended use as the predicate.
• Technological Comparison: Highlighting similarities and differences in materials, design, and features, and providing justification (e.g., "does not raise new or different questions of safety and effectiveness") for any differences.
• Non-Clinical Testing: Demonstrating compliance with recognized standards for physical performance, sterilization, and biocompatibility.

Since the request is specifically about AI/ML device criteria and studies, and this device is not an AI/ML device, I cannot provide the requested information based on the input. The document does not contain any data relevant to AI/ML performance metrics.

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To inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.

TSK STERIJEKT is a sterile Hypodermic Single Lumen Needle, packaged individually for single patient use. It consists of a stainless steel beveled cannula bonded to a plastic hub. Sizes include 14G-31G and various lengths. The needle is intended to fit any luer lock or luer slip syringe tip.

This document describes a 510(k) summary for the TSK STERIJEKT Premium Disposable Hypodermic Needle. The information provided is for a traditional medical device (hypodermic needle) and not an AI/ML powered device. Therefore, many of the requested categories in your prompt relating to AI/ML studies (e.g., sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, standalone performance) are not applicable to this submission.

Here's an attempt to answer the applicable parts of your request based on the provided text, while labeling the non-applicable sections.

Acceptance Criteria and Device Performance for TSK STERIJEKT Premium Disposable Hypodermic Needle

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided 510(k) summary. The summary only lists the tests performed and their outcomes ("Meets Specification" or "Pass").
• Data Provenance: Not specified in the provided 510(k) summary. The manufacturer is "Tochigi Seiko KK, Japan." It is implied the tests were conducted by or on behalf of the manufacturer, but specific details about the origin (e.g., country) of the data from these tests are not provided. The study type (retrospective/prospective) is not applicable or specified for these types of device performance tests.

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 applicable for this type of medical device. Ground truth, in the context of AI/ML, refers to a definitively correct answer established by experts. For a hypodermic needle, "ground truth" is determined by established physical, chemical, and biological testing standards and specifications, not expert consensus on interpretations. The "experts" would be the scientists and engineers conducting and analyzing these standard tests.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve disagreements among human readers when establishing ground truth. For the physical and biological tests of a hypodermic needle, the outcome is typically an objective pass/fail against a predefined specification, not a subjective interpretation requiring 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

• Not applicable. This device is a hypodermic needle, not an AI/ML diagnostic or assistive tool. An MRMC study comparing human readers with and without AI assistance is irrelevant to its evaluation.

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

• Not applicable. This device is a hypodermic needle, not an algorithm. Standalone performance refers to an AI algorithm's performance without human intervention.

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

• Standardized Test Specifications/Reference Methods: For physical tests (Protector Removal, Needle Bond Strength), the "ground truth" is defined by adherence to engineering specifications and performance limits. For biological tests (Sensitization, Intracutaneous, Hemolysis, Systemic Toxicity, LAL Pyrogen Test, Cytotoxicity), the "ground truth" is determined by meeting the requirements of established biocompatibility and sterility standards (e.g., ISO 10993 series and pharmacopeial standards), which dictate acceptable biological responses.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. This is not an AI/ML device, so there is no "training set" and thus no ground truth established for one.

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