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The SmartPilot YpsoMate NS-A2.25 is indicated for use with the compatible disposable autoinjector to capture and record injection information that provides feedback to the user.

The SmartPilot YpsoMate NS-A2.25 is an optional, battery operated, reusable device designed to be used together with a compatible autoinjector (a single use, needle based, pre-filled injection device for delivery of a drug or biologic into subcutaneous tissue). Figure 1 shows the SmartPilot YpsoMate NS-A2.25 with the paired autoinjector. The SmartPilot YpsoMate NS-A2.25 records device data, injection data and injection process status. The SmartPilot YpsoMate NS-A2.25 also provides guidance feedback to the user during the injection.

Note that the SmartPilot YpsoMate NS-A2.25 does not interfere with autoinjector function.

The provided 510(k) clearance letter details the substantial equivalence of the SmartPilot YpsoMate NS-A2.25 device to its predicate. While it lists various performance tests and standards met, it does not contain specific acceptance criteria values or detailed study results for metrics like sensitivity, specificity, or improvement in human reader performance. This document primarily focuses on demonstrating that the new device does not raise new questions of safety and effectiveness compared to the predicate, due to similar technological characteristics and adherence to relevant safety standards.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC studies), and ground truth establishment (especially for AI-driven performance) cannot be extracted directly from this regulatory document. The information primarily pertains to hardware, software, and usability testing.

However, based on the provided text, here's what can be inferred or stated about the device's acceptance criteria and proven performance:

Device: SmartPilot YpsoMate NS-A2.25

Indication for Use: The SmartPilot YpsoMate NS-A2.25 is indicated for use with the compatible disposable autoinjector to capture and record injection information that provides feedback to the user. Specifically compatible with Novartis/Sandoz Secukinumab (Cosentyx).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with quantitative acceptance criteria and reported performance values for metrics typically associated with AI/software performance (e.g., sensitivity, specificity, accuracy of data capture in a clinical context). Instead, it focuses on meeting established engineering, safety, and quality standards.

Here's a summary of the types of performance criteria implied by the successful completion of the listed tests:

Note: The device's primary function is to "capture and record injection information that provides feedback to the user," and it "does not capture dosing information" or "electronically controlled dosing." Therefore, criteria related to dosing volume accuracy or AI interpretation of medical images/signals for diagnosis are not applicable to this device. The focus is on the accurate capture of event data (injection start/end, result) and providing timely feedback, as well as general device safety and functionality.

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

The document describes various types of tests (e.g., Biocompatibility, EMC, Software V&V, Mechanical, Lifetime, Human Factors), but does not specify the sample sizes used for each test dataset.

Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that Ypsomed AG is based in Switzerland and the testing references international and US standards, the testing likely involved a mix of internal validation, third-party lab testing, and possibly user studies in relevant regions. All tests described are part of preclinical (non-clinical) performance validation, making them inherently prospective for the purpose of demonstrating device function and safety prior to marketing.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts in the context of establishing ground truth for the device's functional performance, as it is not an AI-driven diagnostic or interpretative device that relies on human expert consensus for its output. Its performance is evaluated against engineering specifications and physical/software functional requirements. The "Human Factors" testing would involve users, but not necessarily "experts" adjudicating correctness in the sense of accuracy for a diagnostic task.

4. Adjudication Method for the Test Set

Not applicable. The device's performance is determined by meeting pre-defined engineering and regulatory standards and testing protocols, not by expert adjudication of its output, as it does not produce subjective or interpretative results like an AI diagnostic algorithm.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not performed/applicable. An MRMC study is relevant for AI systems that assist human readers in tasks like image interpretation to demonstrate improved diagnostic accuracy. This device is an "Injection Data Capture Device" providing feedback and recording information; it does not involve human readers interpreting data that the device enhances.

6. Standalone (Algorithm Only) Performance

While the device has software and algorithms to detect injection events and provide feedback, the document does not report "standalone" performance metrics in the way an AI diagnostic algorithm would (e.g., sensitivity, specificity). Its performance is demonstrated through the verification and validation of its hardware and software components (e.g., ability to detect spring position, successful data transfer, correct LED/audible feedback). The "Influence Testing" evaluates its performance in conjunction with the autoinjector, proving it does not negatively interfere.

7. Type of Ground Truth Used

The ground truth for the verification and validation of this device is engineering specifications, physical measurements, and adherence to established regulatory and industry standards. For example:

• Biocompatibility: Measured against established thresholds for cytotoxicity, sensitization, and irritation.
• EMC/Safety: Compliance with current versions of IEC standards.
• Software V&V: Compliance with software lifecycle processes and cybersecurity standards, and correct execution of defined functions (e.g., data recording, feedback activation).
• Mechanical/Lifetime: Physical measurements (e.g., activation force, dimension checks), cycle counts, and functional checks after simulated use/aging.
• Human Factors: User performance and subjective feedback against usability goals.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of its direct function (data capture and feedback).

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning system that requires a "training set" in the conventional sense (i.e., for learning to perform a complex, data-driven task like image recognition or diagnosis). Its functionality is based on programmed logic and sensor readings, not statistical learning from a large dataset.

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

Not applicable, as there is no "training set" for the type of device described. Input signals (e.g., from the inductive sensor about spring position) are processed based on predefined engineering parameters and logical rules to determine injection status, not learned from a dataset.

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The Clickfine and Penfine Classic Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

The subject devices are sterile, non-pyrogenic, single use pen needles designed to be used with commercially available pen-injectors. The back end of the needle punctures the rubber injection port of the drug reservoir in the pen. When the injection is needed, the needle is inserted into the chosen site and the pen-injector delivers the fluid through the needle. The materials of construction, (siliconized stainless-steel needle encased in a polypropylene hub with a polypropylene protective cap) as well as the sterile packaging (a polypropylene outer protective container and the peel tab) which provides the sterile barrier and the manufacturing (which includes radiation sterilization) are unchanged from the currently marketed devices. They subject devices will be marketed in the same sizes as the predicate devices - 32 and 31 gauges and 4, 4.5, 5, 6, 8, 10, and 12 mm lengths.

This FDA 510(k) summary focuses on the substantial equivalence of a medical device (pen needle) to a predicate device, rather than the performance of an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the tests. It states "All samples tested" for both breakage and stiffness, implying that a sufficient number was tested to meet the requirements of the specified ISO standards, but the exact number isn't provided. Data provenance is not applicable here as it's a physical device performance test, not a data-driven model.

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

Not applicable. Ground truth for physical device performance is established by standardized measurement methods defined by international standards (ISO). No human expert consensus for "ground truth" in this context is mentioned.

4. Adjudication method for the test set

Not applicable. The tests are pass/fail based on objective measurements against ISO standards. No adjudication method is described.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The ground truth for the device's performance (breakage and stiffness) is defined by the objective measurement criteria and methodologies outlined in the referenced ISO standards (ISO 9626:2016).

8. The sample size for the training set

Not applicable. This is not an AI/ML device; 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; there is no "training set" or corresponding ground truth establishment process.

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The Orbit Inserter is indicated to aid the user with the insertion of the cannula into the subcutaneous tissue for compatible infusion sets listed on the labeling.

The Orbit Inserter is intended to be used to assist patients and their caregivers by providing a mechanism to automate the insertion of compatible Ypsomed Infusion Sets primarily in a home setting.

The Orbit Inserter is a manually operated, spring-loaded insertion aid for automatic insertion of compatible Orbit infusion sets. It assists the user with insertion of the infusion set cannula into the subcutaneous tissue. The device is non-invasive, non-sterile and intended for multiple uses by the same patient. The Orbit Inserter is made of plastic and is powered by a stainless-steel spring.

This document is a 510(k) Summary for the Orbit Inserter, a medical device. The information provided focuses on demonstrating substantial equivalence to a predicate device and does not involve AI or algorithms, nor does it present data from diagnostic imaging studies or multi-reader multi-case studies typically associated with AI performance evaluations.

Therefore, many of the requested points in your prompt are not applicable to the content of this document. I will answer the applicable questions and explain why others do not apply based only on the provided text.

Here's a breakdown of the acceptance criteria and study information for the Orbit Inserter based on the provided text:

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

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

The document mentions "after 550 activations" for Life-cycle Testing, which implies a sample size of at least one device tested for 550 activations. It doesn't explicitly state the number of devices or the data provenance (country of origin, retrospective/prospective). However, the company, Ypsomed AG, is based in Switzerland.

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

This is not applicable. The device is a mechanical inserter, not an AI or diagnostic tool requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" here is the device's physical performance according to engineering and usability specifications.

4. Adjudication method for the test set

This is not applicable. As it's a mechanical device performance test, there's no need for adjudication by multiple experts in the sense of agreeing on a diagnosis or marking a lesion. The results are objective measurements and observations against pre-defined 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

This is not applicable. This document describes a mechanical medical device, not an AI system. Therefore, no MRMC study, human readers, or AI assistance is relevant to its performance evaluation.

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

This is not applicable. The device is a mechanical inserter; there is no algorithm or AI component to test in a standalone manner.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications and ISO standards for mechanical, visual, functional, and biological properties, as well as summative user validation for usability. It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a mechanical device. This concept applies to machine learning models.

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

This is not applicable for the same reason as point 8.

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Orbit®micro Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

All Orbit micro Infusion Sets are used for the subcutaneous delivery of fluids and medication from an external infusion pump. All Orbit micro Infusion sets are comprised of tubing that is connected on one end to the medication reservoir of the infusion pump using a luer lock connection and on the other end to the patient, attached to the skin by an adhesive base, anchoring a catheter that is inserted into the subcutaneous tissue. All Orbit micro Infusion sets have a patented design feature which allows the tubing to freely rotate 360° at the adhesive attachment and to disconnect the tubing set from the infusion base. The subject devices use a stainless steel indwelling cannula instead of the Teflon cannula in the predicate devices.

This document describes the 510(k) submission for the Orbit®micro Infusion Set. This is a medical device and not an AI/ML powered device, therefore the typical acceptance criteria and study data for AI/ML devices, such as those related to accuracy, sensitivity, specificity, MRMC studies, or ground truth establishment based on expert consensus/pathology, are not applicable here.

The provided text details the performance testing conducted to demonstrate the substantial equivalence of the Orbit®micro Infusion Set to a predicate device (K130468). The acceptance criteria are essentially the specifications that the device must meet, and the "results" column indicates whether these criteria were passed.

Here's the information as requested, adapted to the context of a medical device rather than an AI system:

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

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

The document does not specify the exact sample sizes used for each performance test. The tests are physical/mechanical property tests of the device components and entire system, not tests on biological or imaging data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical sense for an AI/ML context. The tests were conducted by Ypsomed AG, a Swiss company.

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

Not applicable. Ground truth for these types of device performance tests is established by adherence to international standards (e.g., ISO) and engineering specifications, often measured by calibrated equipment, rather than requiring expert human interpretation.

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

Not applicable. This is not an AI/ML study involving human readers or interpretation.

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 medical device, not an AI system. No MRMC study was conducted.

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 algorithm. The performance tests ("standalone") refer to the device's inherent mechanical and material properties.

7. The type of ground truth used

The "ground truth" for the device's performance is based on established engineering principles, international standards (like ISO 9626, ISO 10555-1, ISO 8536-8, ISO 10993-1), and the predefined specifications set by the manufacturer to ensure the device performs as intended and is safe. This isn't "expert consensus," "pathology," or "outcomes data" in the context of diagnostic accuracy, but rather compliance with physical and biological requirements through standardized testing.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI system that requires a training set.

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

Not applicable. No training set for an algorithm was used.

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The Clickfine AutoProtect Pen Needle for use with pen injector devices for the injection of fluids, including insulin and exenatide.

Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

The pen needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of fluids. Each needle is individually packaged in a sealed protective container with a peel tab.

The pen needle is used by peeling back the peel tab and snapping or screwing the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into the chosen site. While inserting the needle into the skin, the safety shield glides into the housing enabling the needle to penetrate the skin barrier and the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism is activated. The pen-injector delivers the medicinal product through the needle.

After the injection, in order to remove the needle from the skin, the user withdraws the pen injector from the skin. As the pen and needle is withdrawn from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (providing passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect Pen Needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used.

This document describes a 510(k) premarket notification for the "Clickfine AutoProtect Pen Needle" (K152514). The purpose of this submission is to expand the range of needle lengths to include a 5 mm needle. The document references various ISO standards and internal protocols for performance testing to demonstrate substantial equivalence to the predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the 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):

The document does not explicitly state the sample sizes for each specific test or the country of origin of the data. However, it indicates that the testing was conducted as part of "Design Control Activities" by Ypsomed AG, which is a Swiss company. The testing is prospective in nature, as it is conducted to verify the performance of the modified device before it is marketed. The data provenance can be inferred as originating from Ypsomed AG's internal testing facilities, likely in Switzerland, to demonstrate compliance with international standards.

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

This is a medical device, not an AI/imaging device requiring expert adjudication for ground truth of imaging data. The "ground truth" for these tests is established by objective measurements against predefined acceptance criteria from international standards (ISO). Therefore, no human experts were used to establish a "ground truth" in the way it would be for, for example, classifying medical images. The expertise lies in the engineers and technicians performing the tests and interpreting the results against the standard requirements.

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

Not applicable in the context of this device. The testing involves objective measurements and functional assessments against standards, not subjective interpretations 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 is a physical medical device (pen needle), not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device. The "performance" described is the device's mechanical and functional compliance with established safety and quality standards, not an algorithm's performance.

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

The ground truth is based on established international ISO standards (e.g., ISO 11608-2, ISO 9626, ISO 7864, ISO 23908) which define specific, measurable requirements for physical and functional characteristics of hypodermic needles and sharps injury protection devices. These standards represent scientific and engineering consensus on acceptable device performance and safety.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device, not an AI model.

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The pen needles are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

All of the subject device pen needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The subject device pen needles are used by peeling back the peel tab. The hub of the currently marketed Clickfine Pen Needle is snapping or screwing onto the threaded end of the pen injector. The modified Penfine Classic Pen Needle is attached to pen injectors with only a "screwing" motion. For all needles the back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the fluid is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then unscrewed for the pen injector, discarded and replaced with a new needle before the next injection.

This FDA 510(k) summary describes the "Clickfine Pen Needle" and "Penfine Classic Pen Needle" by Ypsomed AG. The document details the device's intended use and demonstrates its substantial equivalence to a predicate device.

Here's an analysis of the provided text based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several tests and associated clauses from international standards (ISO 11608-2, ISO 9626/A1, ISO 7864) which serve as the acceptance criteria. The reported device performance is that "The verifications have shown evidence that the subject device pen needles meet the acceptance criteria of these standards." and "Based on the results it can be concluded that the device performance is acceptable for the product." While the specific quantitative results for all tests are not provided in this summary, the criteria themselves are detailed.

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

The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). It generally states that "appropriate verification and/or validation activities" were performed.

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

This type of information is not relevant or applicable for the device described (hypodermic single lumen needles). The performance is assessed against engineering and material standards, not against expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable, as the tests are objective measurements against established engineering and material standards, not subjective interpretations requiring adjudication.

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

No. This type of study is not relevant for a medical device like a pen needle, which is evaluated based on its physical and functional properties against technical standards. MRMC studies are typically used for diagnostic devices that involve human interpretation of images or other data.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence. The studies performed were "standalone" in the sense that they evaluated the device itself against established engineering and material standards. There is no "algorithm" or "human-in-the-loop" aspect for a hypodermic needle's performance. The tests described are laboratory-based assessments of the physical and mechanical properties of the needles.

7. The Type of Ground Truth Used

The ground truth for this device is based on established international engineering and material standards (ISO 11608-2, ISO 9626/A1, ISO 7864). These standards define objective, measurable criteria for the performance, dimensions, and material properties of hypodermic needles.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML-based system that requires "training data." Its performance is evaluated through physical tests and measurements.

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

Not applicable, as there is no "training set" for this type of device.

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The Clickfine Pen Needle is intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

The Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needles are used by peeling back the peel tab and snapping or screwing the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the insulin is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.

This submission (K131125) is an administrative change to revise the Indications for Use for the Clickfine Pen Needle to align with predicate devices, allowing for Over-the-Counter (OTC) marketing for all compatible injection pens. As such, no new performance data was required or submitted to demonstrate safety and effectiveness. The FDA concluded substantial equivalence based on the administrative nature of the change and the existing clearance of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this was an administrative submission and no new performance and safety data were required or submitted, there are no specific acceptance criteria or reported device performance metrics in this document. The device did not undergo a new study to establish performance against new criteria.

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

Not applicable. No new performance studies were conducted.

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

Not applicable. No new performance studies were conducted.

4. Adjudication Method for the Test Set:

Not applicable. No new performance studies were conducted.

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

No. This was an administrative change, not a comparative effectiveness study.

6. If a Standalone Performance Study Was Done:

No. This submission did not involve a standalone performance study. The substantial equivalence was based on existing predicate devices.

7. The Type of Ground Truth Used:

Not applicable. No new performance studies were conducted. The "ground truth" for this submission was the existing clearances and intended uses of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. No new studies involving training sets were conducted.

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

Not applicable. No new studies involving training sets were conducted.

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The Clickfine AutoProtect Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin and exenatide.

Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

The Clickfine AutoProtect Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needle is used by peeling back the peel tab and snapping the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into the chosen site. While inserting the needle into the safety shield glides into the housing enabling the needle to penetrate the skin barrier and into the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism will be activated. The pen-injector delivers the medicinal product through the needle.

After the injection, in order to remove the needle from the skin, the user moves the pen injector away from the skin. As the pen and needle is moved away from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (provide passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect Pen Needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used.

The provided document for K131123 states that no performance and safety data were required because the submission was for an administrative change to revise the Indications for Use. Therefore, the document does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The submission is specifically to align the Indications for Use of the Clickfine AutoProtect Pen Needle with those of the predicate device, the BD AutoShield Pen Needle (K060007), to allow for Over-The-Counter (OTC) marketing for all compatible injection pens. The document explicitly states: "As this was an administrative change, no performance and safety data were required to be submitted in support of the change."

As a result, I cannot provide the requested information.

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Orbit Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

Orbit Infusion sets are comprised of tubing that is connected on one end to the medication reservoir of the infusion pump using a luer lock connection and on the other end to the patient, attached to the skin by an adhesive base, anchoring a catheter that is inserted into the subcutaneous tissue. These sets have a patented design feature which allows the tubing to freely rotate 360° at the adhesive attachment and to disconnect the tubing set from the infusion base.

The Orbit Infusion Set is intended for the subcutaneous delivery of fluids and medication from an external infusion pump. The device aims to demonstrate substantial equivalence to the predicate device, Talon Infusion Set (K033290), by meeting performance and safety criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The study concluded that "The verifications have shown evidence that the Orbit Infusion Sets meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product."

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

The document does not explicitly state the sample size used for each specific test. The data provenance is described as "relevant assessments specified in the following international and internal standards and protocols." This suggests that the tests were conducted in a controlled laboratory environment according to established engineering and medical device standards. There is no mention of country of origin of the data, or if it was retrospective or prospective human subject data, as these are technical performance tests on the device itself.

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 these performance tests is based on the specified engineering and medical device standards, which are objective measurements. Expert consensus or clinical interpretation of data is not required to establish ground truth for these types of device performance criteria.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or clinical outcomes where ambiguity might exist. For objective performance tests with clear pass/fail criteria based on standards, an adjudication method is not relevant.

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 submission is for a medical device (infusion set) and not an AI or imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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 algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used

The ground truth for the performance tests is based on objective measurements defined by international and internal engineering/medical device standards. For example, "Material strength per ISO 9626," "No leak when subjected to pumping pressures up to 20psi," and "No separation...when subjected to a minimum force of 10N (ISO 10555-1, Annex B)."

8. The sample size for the training set

Not applicable. This is a physical medical device being evaluated against engineering and safety standards, not a machine learning model that requires a training set.

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

Not applicable. As this is not a machine learning model, there is no training set and therefore no ground truth establishment for a training set.

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The Clickfine AutoProtect pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen. Additionally, after withdrawal of the pen needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.

The Ypsomed Clickfine AutoProtect Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needle is used by peeling back the peel tab and snapping the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into the chosen site. While inserting the needle into the safety shield glides into the housing enabling the needle to penetrate the skin barrier and into the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism will be activated. The pen-injector delivers the medicinal product through the needle. After the injection, in order to remove the needle from the skin, the user moves the pen injector away from the skin. As the pen and needle is moved away from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (provide passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect pen needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent iniection, another disposable needle must be used.

The provided text is a 510(k) summary for a medical device (Clickfine AutoProtect Pen Needle) and describes its safety and effectiveness based on compliance with various standards, rather than a study comparing its performance against specific acceptance criteria with quantifiable metrics. Therefore, it is not possible to fully answer your request in the format you provided, as the document does not contain the specific statistical results, sample sizes for test sets, expert qualifications, or adjudication methods typically found in a clinical study report for AI/CAD devices.

However, I can extract the information that is present and indicate where information is missing.

Here's an attempt to structure the available information, noting the missing elements:

Device: Clickfine AutoProtect Pen Needle

Description of Device: The Ypsomed Clickfine AutoProtect Pen Needle is a sterile, non-pyrogenic, single-use needle designed for use with pen-injectors to administer prescribed fluids. Its key feature is an automatic safety shield that covers the needle after withdrawal from the skin to minimize the risk of accidental needle-stick injury. Once locked, the needle cannot be reused, and a red indicator confirms activation of the safety lock.

Intended Use: The Ypsomed Clickfine AutoProtect Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injection pen. Additionally, after withdrawal of the pen needle from the body, the attached needle safety shield automatically covers the needle to minimize the risk of accidental needlestick.

1. Table of Acceptance Criteria and Reported Device Performance

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Material Composition | ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of medical devices (Specific metrics not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO 9626:1991Amd.1:2001...]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Sterility & Single Use | ISO 7864:1993 Sterile hypodermic needles for single use (Specific metrics not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO 7864:1993...]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Biocompatibility | ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system (Specific metrics not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO 10993-1:2009...]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Seal Integrity | Seal Integrity of Sterile Barrier (Specific criteria not provided in summary) | "Ypsomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices. The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [Seal Integrity of Sterile barrier]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Sharps Injury Protection (Safety Mechanism) | ISO/FDIS 23908 (N156) Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, catheters, introducers for catheters and needles used for blood sampling (Specific metrics not provided in summary, but implies successful activation and locking) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO/FDIS 23908 (N156)...]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Simulated Use (Sharps Injury Prevention) | Simulated Use Studies per FDA Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features, dated August 9, 2005 (Specific metrics like activation rate, accidental sticks not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [Simulated Use Studies per FDA Guidance...]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |

As this is a 510(k) for a physical medical device and not an AI/CAD system, several of your requested points are not applicable or the information is not provided because such studies are not typically performed for this type of device.

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

• Sample size: Not specified. The document states "Ypsomed has performed the relevant assessments specified in the following international and internal standards and protocols." The specific number of devices tested for each standard is not provided.
• Data provenance: Not explicitly stated, but implying tests were conducted in accordance with international standards (ISO) and FDA guidance, likely in a controlled laboratory setting or clinical simulation. It is a prospective assessment of newly produced devices.

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

• Not applicable in the context of device performance testing against engineering standards. "Ground truth" here refers to the specifications and requirements defined by the referenced ISO standards and FDA guidance. Experts would be involved in developing those standards and subsequently in conducting and interpreting the tests, but no specific number or qualifications are mentioned for this particular submission.

4. Adjudication method for the test set:

• Not applicable in the context of device performance testing against engineering standards. Testing against standards is typically objective measurement against predefined technical 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 device is a physical pen needle with an automatic safety mechanism, not an AI/CAD system that assists human readers in interpreting medical images or data.

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 algorithm. The "standalone" performance refers to the device's inherent functional characteristics, specifically its ability to perform injections and activate its safety mechanism as designed. This was assessed through compliance with the listed standards and simulated use studies.

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

• The "ground truth" for this device's performance is established by the requirements and test methods defined in the cited international standards (ISO) and FDA guidance documents. These standards set the benchmarks for sterility, material properties, mechanical function, biocompatibility, and sharps injury prevention features. Compliance is demonstrated through objective physical and biological testing.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, 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 an AI/ML model, this question is irrelevant.

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