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Safe Block Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental sticks from the patient end of the needle. The shield also serves to conceal the needle before and after injection.

SAFETY PEN NEEDLE. Safe Block Pen Needle is designated for use with pen injector for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. Safe Block Pen Needle are offered in one gauge size (31G) and in a various lengths (5mm and 8mm). The Safe Block Pen Needle is sterile (ETO sterilization), non toxic and non-pyrogenic. It's a disposable single use device. Additionally the Safe Block Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. Prior to injection the user will attach the Safe Block Pen Needle to the pen. The shield of Safe Block Pen Needle will hide the needle from the user prior to use. As the user proceeds with inserting the needle into the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. The Safe Block Pen Needle should be removed from the pen and discarded.

The provided document is a 510(k) premarket notification for the "Safe Block Pen Needle." It details the device's description, indications for use, comparison to predicate devices, and non-clinical testing performed. However, it does not contain a dedicated section outlining specific acceptance criteria or a detailed study report that proves the device meets those criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, materials, and a declaration that bench testing was performed.

Here's an analysis based on the information provided, specifically addressing your points:

1. A table of acceptance criteria and the reported device performance
   The document does not explicitly provide a table of acceptance criteria linked to specific performance results for the Safe Block Pen Needle in the format requested. Performance is generally stated as meeting relevant ISO standards or internal protocols.

   However, there is a "Table of specifications (including relevant tests)" on page 7 which lists characteristics for the applicant device and predicate devices. This table indicates the tests performed to ensure compliance with standards.

   Feature / Characteristics	Acceptance Criteria (Implied by standard and predicate comparison)	Reported Device Performance (Applicant Device)
   Intended Use	Consistent with predicate devices and safety features	Intended for use with pen injector devices for injection of drugs, including insulin. Safety shield automatically locks in place, reduces accidental sticks, and conceals the needle.
   Length / Tolerance	As per ISO 11608-2	5 mm, 8 mm (tolerance as per ISO 11608-2)
   Gauge	As per ISO 9626	G31 (as per ISO 9626)
   Tip configuration	As per ISO 11608-2, section 4.5	Per ISO 11608-2, section 4.5, visually sharp at 2.5X magnification, designed to minimize coring and fragmentation.
   Hub/needle bond strength	As per ISO 11608-2	Per ISO 11608-2
   Biocompatibility	As per ISO 10993-1	As per ISO 10993-1 (successfully passed tests for Cytotoxicity, Hemocompatibility, Sensitization/Skin Reactivity, Acute Systemic Toxicity)
   Compatibility test (type A needles)	As per ISO 11608-2 (torque test)	ISO 11608-2 (torque test)
   Lubrication	As per ISO 11608-2	As per ISO 11608-2
   Safety mechanism Activation	As per ISO 23908 and internal protocol	As per ISO 23908, internal protocol and test results.
   Safety overriding/unlocking force after activation	As per ISO 23908 and internal protocol	As per ISO 23908, internal protocol and test results.
   Sterilization	As per ISO 11135-1:2007 (for ETO) and ISO 11138-1:2006 (HSKP method)	Sterilization process validated using current standard ISO 11135-1:2007 using HSKP method (ISO 11138-1:2006).
   Shelf life	5 years	5 years from production date.

2. Sample sizes used for the test set and the data provenance
   The document states "Testing demonstrated the safety feature performance through laboratory testing and simulated user studies." However, it does not specify sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "internal protocol and test results" for the safety mechanism.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   This information is not provided in the document. The tests mentioned are non-clinical, laboratory, and "simulated user studies," which typically wouldn't involve expert ground truth in the manner of diagnostic image interpretation.

4. Adjudication method
   This information is not provided as it's not relevant for the type of bench and simulated user testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done
   No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests were conducted in support of this 510(k) submission."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   This is not applicable as the device is a physical medical device (pen needle with safety feature), not an algorithm or AI system.

7. The type of ground truth used
   For the non-clinical tests, the "ground truth" would be established by physical measurements against engineering specifications and relevant ISO standards. For the "simulated user studies," the ground truth would be based on predefined criteria for successful activation and locking of the safety mechanism. Pathology or outcomes data are not applicable here as there were no clinical studies.

8. The sample size for the training set
   This is not applicable as the document describes a physical medical device, not an AI or algorithm that requires a training set.

9. How the ground truth for the training set was established
   This is not applicable as there is no training set for this type of device.

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Artsana disposable sterile insulin syringes are intended for subcutaneous injection of insulin.

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The provided document is an FDA 510(k) clearance letter for the "Artsana Piston Syringes" and "Artsana Insulin Syringes." This type of document confirms that a device is substantially equivalent to a predicate device already on the market and does not contain detailed information about specific acceptance criteria or a study proving that the device meets such criteria.

The 510(k) clearance process is primarily focused on demonstrating substantial equivalence, not on extensive performance testing against predetermined acceptance criteria of a novel device. Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert involvement, and specific performance metrics is not available within this document.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the FDA's decision is based on comparing the Artsana syringes to existing, legally marketed piston syringes, rather than a de novo evaluation against a defined set of performance acceptance criteria and a specific study proving those criteria were met as one would find for a novel device.

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Artsana disposable sterile hypodermic needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Artsana disposable sterile pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

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Here's a breakdown of the requested information based on the provided FDA 510(k) summary for Artsana Hypodermic Needles and InsuPen® Insulin Pen Needles:

Important Note: The provided document is an FDA letter of substantial equivalence, not a detailed technical report or study summary. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, and detailed study designs) is not available within these pages. The FDA 510(k) process for these types of devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with detailed performance metrics as might be seen for novel or high-risk devices.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" for these types of devices are generally established by recognized standards (e.g., ISO for sterility, needle dimensions, penetration force) and the performance of the predicate device. The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets similar performance and safety profiles. Specific numerical criteria and corresponding data are not detailed in this summary.

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

• Sample Size for Test Set: Not specified in the provided document. The 510(k) process for hypodermic needles often relies on bench testing and comparison to predicate devices, rather than large-scale clinical test sets.
• Data Provenance: Not specified, but generally, for substantial equivalence, the data would come from internal testing conducted by the manufacturer (Artsana S.P.A.) or from established performance data of the predicate device. It is generally retrospective in the sense that it relies on existing knowledge and testing methodologies. Country of origin for testing is not stated, but the manufacturer is Artsana S.P.A. (an Italian company).

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

• Not applicable/Not specified in the context of this 510(k) submission. "Ground truth" in this context usually refers to objective measurements against established standards for physical and material properties (e.g., needle sharpness, sterility validation). Human expert consensus is typically not the primary method for establishing "ground truth" for basic medical devices like needles, unless it involves usability or patient feedback studies, which are not outlined here.

4. Adjudication method for the test set

• Not applicable/Not specified. The assessment is primarily against technical specifications and predicate device equivalence, not through expert adjudication in the classic sense.

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. This is not an AI-enabled device. This question is not relevant to a hypodermic needle or insulin pen needle.

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

• No. This is not an AI-enabled device and does not involve an algorithm in the sense of a diagnostic or therapeutic AI.

7. The type of ground truth used

• The ground truth would be based on objective technical standards (e.g., ISO standards for medical devices, specifically needles), bench testing results (e.g., injection force, integrity, flow rates, sterility tests), and data demonstrating equivalence to the performance characteristics of predicate devices. It would likely incorporate pathology indirectly through biocompatibility testing (e.g., materials not causing adverse tissue reactions). Outcomes data would typically not be a primary ground truth for basic device clearance unless significant clinical safety or efficacy questions were raised.

8. The sample size for the training set

• Not applicable/Not specified. For medical devices like needles, there isn't a "training set" in the machine learning sense. Performance is typically established through manufacturing process controls, quality assurance testing, and adherence to design specifications and standards.

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

• Not applicable. As there's no "training set" in the machine learning context, this question is not relevant. The performance and safety of these devices are assured through design validation, verification testing (against established standards), and manufacturing quality systems rather than through data training.

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