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SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container.

The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.

SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (EO gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.

The SureFine Pen Needle device, K250658, is a Class II hypodermic single lumen needle intended for use with a pen injector for the subcutaneous injection of insulin. The information provided is from an FDA 510(k) Clearance Letter.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SureFine Pen Needle are based on compliance with international standards ISO 9626, ISO 11608-2, and ISO 10993-1, 10993-4, 10993-5, 10993-7, 10993-10, and 10993-11 for biocompatibility and sterilization validation according to ISO 11135.

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

The document does not explicitly state the specific sample sizes for each test mentioned (ISO 9626, ISO 11608-2, Biocompatibility). However, it indicates that "Bench tests for the device's performance were conducted" and "Biocompatibility of the SureFine Pen Needle was evaluated". The testing was conducted by Shina Med Corporation, a company based in the Republic of Korea. The nature of these tests (bench testing, lab-based biocompatibility) suggests they are prospective tests performed on manufactured samples of the device. The data provenance is primarily from internal testing and validation by the manufacturer, following international standards.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the "test set" in the context of device performance. The testing performed is against established international standards (ISO 9626, ISO 11608-2, ISO 10993 series), which themselves represent a form of "ground truth" for device safety and performance criteria. The evaluation results are reported as "Pass" or "Met," implying adherence to these predefined standards rather than an expert panel establishing a de novo ground truth for each specific test.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method (such as 2+1, 3+1, none). The evaluation is based on objective measurements and established criteria set forth by the ISO standards. For instance, a flow rate test would have a pass/fail threshold, not require expert adjudication in the traditional sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes bench tests and biocompatibility evaluations for a medical device (pen needle), not a diagnostic or AI-assisted system that would typically undergo an MRMC comparative effectiveness study involving human readers. Therefore, there is no mention of an effect size of human readers improving with or without AI assistance.

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

No. This device is a physical medical instrument (a pen needle), not a software algorithm or AI system. Therefore, the concept of "standalone performance" in the context of algorithms is not applicable here.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's performance is adherence to established international standards and regulatory requirements:

• ISO 9626: Specifies requirements for stainless steel needle tubing for the manufacture of hypodermic needles.
• ISO 11608-2: Specifies requirements and test methods for single-use needles used with pen-injectors.
• ISO 10993 series: Biological evaluation of medical devices, covering various aspects of biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity).
• ISO 11135: Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices.
• ISO 10993-7: EtO residual limits.
• LAL testing: To ensure absence of bacterial endotoxins.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI algorithm, so there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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Shina Syringe, Shina Safety Syringe is a plastic sterile syringe and hypodermic single lumen needle intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is (not) included. lt is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

This document describes the acceptance criteria and study proving the device meets those criteria for the Shina Syringe and Shina Safety Syringe.

The listed information primarily focuses on bench testing for mechanical, physical, and biocompatibility properties, rather than effectiveness studies involving human subjects or AI-assisted diagnoses. Therefore, several requested sections, particularly those related to clinical studies, human readers, ground truth establishment for training sets, and effect sizes of AI assistance, are not applicable based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with various ISO standards and USP . The document does not explicitly present specific numerical results for each test item but states that the tests demonstrated that the device performs in a substantially equivalent manner to the predicate device and meets the requirements.

Syringe

Needle

Syringe with needle (Model : WNLS0125)

Syringe with needle (Particulate test for various models including WNLG0123, WNLS0123, WNSG0125, WNLS0125, WNLG0323, WNLS0323, WNSG0325, WNLS0325, WNLG0523, WNLS0523, WNSG0525, WNLS0525, WNLG1023, WNLS1023, WNSG1025, WNLS1025)

Safety test

Biocompatibility (for 25G Model, 23G Model, and Syringe Model SSN2301)

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

The document does not explicitly state the sample size for each bench test conducted. The provenance of the data is that these are bench tests conducted by the manufacturer, Shina Med Corporation, in the Republic of Korea. The studies are by nature retrospective in the context of device development, where the device is manufactured and then tested to established standards.

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

This section is not applicable. The ground truth for these types of mechanical, physical, and biocompatibility tests is established by published international standards (ISO, USP, ASTM), not by expert consensus in diagnostic interpretation.

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

This section is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple experts. The reported studies are bench tests against defined international standards.

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 section is not applicable. No MRMC comparative effectiveness study was performed or discussed, as the device is a syringe and needle, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a physical medical device (syringe and needle) and does not involve an algorithm or AI.

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

The ground truth used for these tests are established international and national standards for medical devices, specifically:

• ISO 7886-1: Sterile hypodermic syringes for single use
• ISO 7864: Sterile hypodermic needles for single use
• ISO 9626: Stainless steel needle tubing
• USP : Particulate Matter in Injections
• ISO 23908: Sharps injury protection
• ISO 10993 series for Biological evaluation of medical devices (Parts 4, 5, 7, 10, 11, 23)
• ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials

8. The sample size for the training set

This section is not applicable. As this is a physical medical device submission focusing on bench testing, there is no AI model or "training set" in the context of machine learning.

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

This section is not applicable for the same reasons as section 8.

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Sure-fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel(U-100), a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with expoxy.

The provided document describes a 510(k) premarket notification for "Sure-Fine Insulin Syringes." The submission is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information (such as effect size of human readers with/without AI assistance, standalone algorithm performance, number of experts for ground truth, and training set details) is not applicable to this type of medical device submission.

Here's the information that can be extracted from the document:

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

The acceptance criteria are implicitly tied to various testing standards to demonstrate biocompatibility and performance. The reported performance is that the device complies with these standards, supporting its substantial equivalence.

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

The document does not explicitly state the sample sizes for each specific test. These are typically determined by the requirements of the individual ISO and ASTM standards cited for each test. Data provenance is not specified, but these are laboratory tests performed on the device components or final product itself, not clinical data from countries of origin. The study described is a series of laboratory and biocompatibility tests, not a clinical study involving patients or data sets.

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

Not applicable. This is not a study requiring expert readers to establish ground truth. The "ground truth" for these tests comes from established scientific and engineering principles within each standard.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations. The results are typically quantitative measurements or qualitative assessments (e.g., presence/absence of cytotoxicity) as defined by the standard.

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 not an AI-assisted diagnostic tool, but a medical syringe.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used:

The ground truth is based on recognized industry standards and scientific testing procedures (ISO 10993 series, ASTM F756-17, ASTM F1980, ISO 8537, ISO 7864, USP ) for biocompatibility and performance of syringes.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

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

Not applicable. This is not a machine learning or AI-driven device.

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Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color. The modified Sure-Fine Insulin syringe is substantially equivalent to the predicate device (Sure-Fine Insulin Syringes, K152879). The biggest difference between the modified device and predicate device is the addition of needle gauge (27G) and the addition of needle length (1/4"). The devices operate in the principles of a piston syringe fluid path is sterile (EO gas sterilization), Non-toxic, Non-pyrogenic and single use disposable.

This document is a 510(k) Pre-market Notification for "Sure-Fine Insulin Syringes." It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K152879) rather than presenting a standalone study with acceptance criteria and device performance metrics in the typical sense of AI/software device evaluation.

The changes in the current device (K191531) compared to the predicate device (K152879) are primarily the addition of a new needle gauge (27G) and a new needle length (1/4").

Therefore, the "acceptance criteria" and "study" described in the document are about demonstrating that these new configurations and the overall modified device continue to meet established standards for insulin syringes.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a typical "acceptance criteria" table with specific quantitative thresholds. Instead, it refers to compliance with recognized international standards for medical devices, which inherently contain the acceptance criteria for various tests. The "reported device performance" is essentially the finding that the device complies with these standards.

Note: The document states "appropriate testing was completed to demonstrate that the syringes comply with the following FDA recognized standards". It does not provide the raw data or specific test results for each of these standards in this summary. The "reported performance" is the claim of compliance.

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

• Sample Size: The document does not specify the sample sizes used for the testing conducted against the ISO standards. This information would typically be found in the full test reports, not in the 510(k) summary.
• Data Provenance: The document doesn't explicitly state the country of origin for the testing data itself, but the manufacturer is SHINA MED CORPORATION in South Korea (Rep. of Korea). The testing would presumably be conducted by or for the manufacturer, either in Korea or by a certified testing lab. The study is prospective in the sense that the testing was performed to support this specific submission for the modified device.

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

• This question is not applicable to this type of device submission. Insulin syringes are physical medical devices, and their performance is evaluated through engineering and biological testing against established international standards (like ISO standards), not by human expert interpretation or ground truth labeling in the way an AI/software device would be.

4. Adjudication Method for the Test Set

• This question is not applicable. There is no "test set" that requires adjudication by human experts. Device performance is determined by objective measurements against specified physical and chemical properties and functional requirements outlined in the ISO standards.

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 question is not applicable. This submission is for an insulin syringe, which is a physical medical device, not an AI/software device that involves human readers or AI assistance.

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

• This question is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is defined by the requirements and test methods specified in the referenced international standards (ISO 7864, ISO 9626, ISO 8537, ISO 10993-1). Compliance with these standards serves as the "ground truth" that the device is safe and effective for its intended use. For example, a needle's sharpness or a syringe's dose accuracy would be measured against specific, quantifiable criteria in these standards.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

• This question is not applicable. As there is no training set for a physical device.

In summary: The acceptance criteria and "study" for this device are based on demonstrating compliance with recognized international standards for medical devices, particularly those related to sterile hypodermic needles and insulin syringes. The document asserts that "appropriate testing was completed" to show this compliance, thereby proving the device meets the acceptance criteria for substantial equivalence to its predicate for its intended use, including the newly added specifications.

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Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Sure-Fine Insulin Syringes are designed for the subcutaneous injection of a dose of U-100 insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color.
Category: U-100
Insulin syringe: 1/2cc and 1cc, 3/10cc, 1/2cc and 1cc
Needle Gauge: 28Gauge, 29Gauge, 30Gauge, 31Gauge
Needle Length: 1/2", 5/16"
Cap color: Needle cap: Orange, Plunger Cap: Orange or white
This device operates in the principles of a piston syringe fluid path is sterile (EO gas sterilization), single use disposable.

This document is a 510(k) Summary for the Sure-Fine Insulin Syringes, which is a regulatory submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not describe an acceptance criteria or a study designed to establish clinical performance of a novel device in the same way one might describe for a diagnostic AI algorithm.

Instead, the document details non-clinical testing to demonstrate that the Sure-Fine Insulin Syringes meet established performance and safety standards, proving substantial equivalence to a predicate device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with specific numerical thresholds for accuracy, sensitivity, or specificity as one would expect for an AI/diagnostic device. Instead, it lists the voluntary standards and clauses from those standards that the device was designed and tested to meet. The "reported device performance" is the conclusion that the device successfully met these requirements, thus demonstrating substantial equivalence.

| Standard/Test | Acceptance Criteria (implied by standard) | Reported Device Performance |
| :----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------- |
| Performance Testing (per ISO 8537:2007) | Compliance with physical and functional requirements for sterile single-use hypodermic syringes for insulin. (e.g., freedom from extraneous matter, extraction, lubrication, range of sizes, graduated scale, barrel, piston/plunger, nozzle, needles, assembled syringe performance). | Successfully met the applicable requirements. |
| Biocompatibility Testing (per ISO 10993 Series) | Compliance with biological safety requirements for devices in contact with patients (e.g., in vitro cytotoxicity, irritation, sensitization, acute systemic toxicity, interaction with blood, pyrogenicity). | Successfully passed testing as outlined. |
| Sterilization & Shelf-life Testing (per ISO 11135, ISO 10993-7) | Sterility Assurance Level (SAL) of 10-6; maximum levels of ethylene oxide and ethylene chlorohydrins within limits; a 5-year shelf-life. | Validated sterilization with SAL = 10-6; EO/ECH levels did not exceed limits; 5-year shelf-life supported. |

Important Note: This is a traditional medical device (insulin syringe), not an AI/software device. Therefore, the questions related to AI-specific metrics, ground truth, expert consensus, and MRMC studies are not applicable. The device's performance is assessed through engineering and biological safety tests against established standards for its mechanical function and material safety.

The following questions are not applicable to this specific submission as it pertains to a physical medical device (insulin syringe) and not an AI or diagnostic software. Therefore, there are no details on test sets, ground truth establishment by experts, or MRMC studies.

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

• Not Applicable. This is a physical medical device. Testing involved physical samples of the syringe, not a "data test set." The document does not specify the number of samples tested for each engineering or biological test.

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. There is no "ground truth" to be established by experts in the context of an insulin syringe's physical and functional properties.

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. This is a physical medical device, not an AI or diagnostic software. No human readers or AI assistance are involved in its primary function or evaluation for substantial equivalence.

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

• Not Applicable. This is a physical medical device; no algorithm is present.

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

• Not Applicable.

8. The sample size for the training set

• Not Applicable. This is a physical medical device; there is no "training set" in the context of an AI or machine learning model.

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

• Not Applicable.

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SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

The SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and the needle tube with blister paper sealed on the opening hole of primary container.

The needle hub can be connected with the pen. The hub has internal threads, which allows it to be screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.

The SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization) and non-pyrogenic. The pen needles are disposable, single use devices.

The provided document is a 510(k) premarket notification for the SureFine Pen Needle, a medical device. It does not describe a study proving the device meets acceptance criteria but rather demonstrates substantial equivalence to a predicate device.

Here's an analysis of the provided information in the context of your request:

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

The document provides a comparative table between the SureFine Pen Needle (Subject Device) and its predicate device (ShinaPen® K113186). The acceptance criteria are implied by the performance specifications of the predicate device, and the "reported device performance" is essentially the subject device's matching of these characteristics.

Beyond this comparative table, the document states that the SureFine Pen Needle was "designed and successfully tested to meet the applicable requirements outlined in ISO 7864:1993, ISO 9626:1991 and ISO 11608-2:2012." The specific clauses listed for each ISO standard represent the acceptance criteria for those performance aspects.

For example, for ISO 7864:1993, acceptance criteria would be:

• Clause 4: Cleanliness requirements met.
• Clause 5: Limits for acidity or alkalinity met.
• Clause 6: Limits for extractable metals met.
• Clause 7: Size designation accurate.
• Clause 11.3: Freedom from defects.
• Clause 11.4: Lubricant requirements met.
• Clause 12: Needle point specifications met.
• Clause 13.1: Bond between hub and needle tube specifications met.
• Clause 13.2 a): Patency of lumen demonstrated.

Similar detailed acceptance criteria are implied for the other ISO standards and biocompatibility tests mentioned.

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

The document broadly mentions "Performance Testing", "Biocompatibility Testing", and "Sterilization and Shelf-life Testing" without specifying the exact sample sizes for each test. These were non-clinical tests.

• Test Type: Non-clinical (bench testing, biocompatibility, sterilization validation).
• Data Provenance: The manufacturer is SHINA MED CORPORATION, located in the Republic of Korea. The testing was conducted to international standards (ISO).
• Retrospective/Prospective: These are prospective tests on the SureFine Pen Needle device design.

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)

This information is not applicable/provided in the context of this 510(k) submission. This type of submission relies on non-clinical performance and substantial equivalence to a predicate device, not expert-derived ground truth as would be relevant for diagnostic AI/imaging devices. The "ground truth" here is the adherence to established engineering standards (ISO) and the characteristics of the predicate device.

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

This information is not applicable/provided. Adjudication methods are typically used in clinical studies, particularly for diagnostic devices where multiple readers interpret images or data, and discrepancies need resolution. This document describes bench testing and demonstrates substantial equivalence, not clinical evaluation with human readers.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the SureFine Pen Needle is. The document explicitly states: "No prospective clinical trials were conducted in support of this Traditional 510(k)."

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

A standalone performance evaluation was done in the sense that the device itself (the pen needle) was tested against technical specifications and international standards (ISO). However, this is not an "algorithm-only" standalone performance study as described for AI devices. The device's performance was evaluated inherently by its physical and material properties and its function when used with compatible pen injectors.

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

The "ground truth" for this device's evaluation is primarily engineering specifications, material science standards, and established international performance standards (ISO standards). For biocompatibility, the ground truth is defined by the results of specific biological evaluations (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity tests). For functional compatibility, the ground truth is simply successful operation with specified insulin injectors.

8. The sample size for the training set

This information is not applicable/provided. The SureFine Pen Needle is a mechanical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of machine learning.

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

This information is not applicable/provided. As explained above, there is no training set.

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