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The SteriCap™ Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs.

The SteriCap™ Mini Needle is a device intended to provide a means of fluid delivery into the human body via body surface puncture. The device is a single lumen needle available in sizes ranging from 23G - 33G. The distal end of the needle has a spring-loaded needle cap, which protects the needle prior to use.

This document describes the premarket notification (510(k)) for the SteriCap Mini Needle, which is a medical device. The information provided heavily focuses on the safety and performance of this physical medical device and its equivalence to a predicate device, rather than a "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered medical device, which would typically involve clinical performance metrics like sensitivity, specificity, AUC, etc.

Therefore, many of the requested items related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document as it concerns a hypodermic needle.

However, I can extract information related to the performance data provided to support the substantial equivalence of the SteriCap Mini Needle, which serves as the "acceptance criteria" and "device performance" in this context.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The product line extension met all specified criteria and did not raise new safety or performance questions." This indicates a pass/fail criteria for each test, implying the device performs as expected according to established standards for hypodermic needles. The document lists the types of testing performed rather than specific numerical acceptance criteria or measurements.

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

• Sample Size: Not specified in the provided document. The performance data section vaguely states "The following performance data were provided in support of the substantial equivalence." without giving specific sample numbers for each test.
• Data Provenance: Not specified in terms of country of origin. This would typically be laboratory test data, not patient-derived data, for a hypodermic needle. The document implies these are "in-house" or contract lab tests designed to meet ISO standards.
• Retrospective or Prospective: Not applicable. These are physical component tests, not clinical studies on patient data.

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

• Not Applicable. The "ground truth" for a physical device like a needle is established by engineering specifications, validated test methods (often international standards like ISO), and material properties, not by human experts adjudicating images or cases.

4. Adjudication method for the test set

• Not Applicable. See point 3. Testing involves objective measurements against predefined engineering specifications.

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 is a physical medical device (hypodermic needle), not an AI/ML algorithm.

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

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

7. The type of ground truth used

• Engineering Specifications and International Standards: The 'ground truth' or benchmark for the SteriCap Mini Needle's performance is based on established ISO standards (e.g., ISO 594-1 & 2, ISO 7864, ISO 9626, ISO 6009) and the physical and mechanical properties expected of hypodermic needles.

8. The sample size for the training set

• Not Applicable. This refers to an AI/ML algorithm's training data. This document is about a physical device.

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

• Not Applicable. See point 8.

In summary, this document is a 510(k) submission for a conventional medical device (hypodermic needle) and describes its performance based on engineering and material testing against established international standards, not a clinical study of an AI/ML device.

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The Mini Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs into the body.

The Mini Needle is a device intended to provide a means of fluid delivery into the human body via body surface puncture. The device is a single lumen needle available in 30G, 32G and 33G sizes. The distal end of the needle cap, which protects the needle prior to use.

This document is a 510(k) Premarket Notification for the "Mini Needle" device and focuses on establishing substantial equivalence to a predicate device rather than a comprehensive study proving novel acceptance criteria for a new type of device. Therefore, some of the requested information (like effect size of MRMC studies, number of experts for ground truth, or training set details) is not applicable or not provided in the document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Mini Needle are primarily based on demonstrating substantial equivalence to a predicate device (TSK Hypodermic Needle) and meeting relevant ISO standards for medical needles. The device performance is reported as meeting these specified criteria.

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

The document states: "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size used for each of the listed tests (Dimensional, Bond/Material Strength, Biocompatibility, Sterilization, Packaging).

Data Provenance: The data appears to be from prospective testing conducted by the manufacturer, OcuJect, LLC, on their Mini Needle devices. There is no mention of country of origin for the data beyond the manufacturer's location in Newport Beach, CA, USA.

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

This information is not applicable in the context of this 510(k) submission. For mechanical devices like needles, "ground truth" is typically established through adherence to engineering specifications and ISO standards, not expert consensus on medical images or diagnoses. The testing involves physical and chemical evaluations by qualified personnel in laboratories, not medical experts establishing a "ground truth" for a diagnostic outcome.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert opinions might differ on a diagnostic outcome (e.g., classifying an image). For mechanical and physical testing of a needle, the results are objective measurements against defined criteria.

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. The Mini Needle is a physical medical device (a hypodermic needle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This is not applicable. The Mini Needle is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements against established engineering specifications and international standards (ISO standards) for hypodermic needles. These standards detail acceptable dimensional tolerances, material properties, strength, sterility, and biocompatibility.

8. The Sample Size for the Training Set

This is not applicable. As a physical medical device, the Mini Needle does not involve a "training set" in the context of machine learning or AI development.

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

This is not applicable for the same reasons as above.

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