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The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

The Medtronic Extended infusion set manufactured by Unomedical a/s is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication administered by an external pump.

The insertion needle and soft cannula of the Medtronic Extended infusion set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevent needle stick injuries as the device does not require loading with the needle by the user, the needle is then automatically retracted after use.

The Medtronic Extended infusion set is designed to be used with a Medtronic Insulin infusion pump for up to 7 days.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training set, number of experts for ground truth, adjudication method, MRMC comparative effectiveness, standalone performance, and how ground truth was established) are not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and a clinical evaluation.

Here's the information that can be extracted relevant to acceptance criteria and performance, as much as possible for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a table format within the provided document. Instead, the document states that "The Medtronic Extended infusion set meets all the requirements for overall design, sterilization, biocompatibility, and usability confirming that the design output meets the design inputs and specifications for the device." The "Reported Device Performance" is derived from the "Clinical Evaluation" section.

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

• Test set sample size: For the clinical evaluation, 291 subjects were enrolled for the clinical study.
• Data provenance: The clinical study was conducted in the US and was a prospective study (implied by "clinical study has been conducted").

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. For a non-AI/ML device, "ground truth" and expert involvement in establishing it as typically understood in AI/ML validation is not directly applicable. The clinical study results establish the device's safety and effectiveness.

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

• This information is not provided in the document. Adjudication methods are typically relevant for human review of AI/ML outputs, which is not the primary focus here.

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, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating AI assistance to human readers, which is not relevant for this device.

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

• No, a standalone algorithm performance study was not done. This device is a physical medical device (infusion set), not an algorithm or AI.

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

• For the clinical evaluation, the "ground truth" is implied by clinical outcomes data related to safety (e.g., adverse events) and effectiveness of the infusion set over the 7-day wear time.

8. The sample size for the training set

• This information is not applicable as this is not an AI/ML device requiring a training set. The clinical evaluation used 291 subjects for its primary testing.

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

• This information is not applicable as this is not an AI/ML device requiring a training set.

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The neria™ guard Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.

The neria™ guard Infusion Set manufactured by Unomedical is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication. The insertion needle and soft cannula of the neria™ guard Infusion Set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevents needle stick injuries as the device does not require loading with the needle is then automatically retracted after use.

This document describes the premarket notification (510(k)) for the neria™ guard Infusion Set. Since this is an infusion set and not an AI/ML powered device, several of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding AI/ML study design are not applicable.

Here's the information extracted from the provided text regarding the acceptance criteria and the studies conducted for the neria™ guard Infusion Set:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various non-clinical performance tests conducted to demonstrate the safety and effectiveness of the neria™ guard Infusion Set and its substantial equivalence to the predicate device. The general acceptance criterion is that the device "meets all the requirements for overall design, sterilization, biocompatibility and usability confirming that the design inputs and specifications for the device." Specific quantitative acceptance criteria or precise performance metrics are not detailed in this summary for each functional test, but rather that the device "met the requirements" of the relevant standards and internal tests.

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

The document indicates that "a number of non-clinical performance tests" were completed. However, specific sample sizes for each test are not provided in this summary. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but these were non-clinical, in-vitro/bench testing.

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

This question is not applicable as the device is an infusion set, not an AI/ML powered device requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests would be established by the physical and chemical properties of the materials and the functional performance against engineering specifications and international standards.

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

This question is not applicable as the device is an infusion set, not an AI/ML powered device. Adjudication methods are typically relevant for human review of AI/ML performance.

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 as the device is an infusion set, not an AI/ML powered device.

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

This question is not applicable as the device is an infusion set, not an AI/ML powered device. The "standalone" performance here refers to the device's functional performance as described in the non-clinical tests.

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

For this medical device (infusion set), the "ground truth" is established by:

• International Standards: e.g., ISO, ASTM standards for sterilization, biocompatibility, packaging, and functional performance.
• Engineering Specifications: Internal requirements that define the performance characteristics and design criteria of the device.
• Predetermined Benchmarks: Performance of the predicate device (Unomedical Inset™ Subcutaneous Infusion Set) serves as a benchmark for comparison.

It's not an expert consensus or pathology-based ground truth as would be used for diagnostic image analysis.

8. The sample size for the training set

This question is not applicable as the device is an infusion set, not an AI/ML powered device that requires a training set.

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

This question is not applicable as the device is an infusion set, not an AI/ML powered device that requires a training set and associated ground truth.

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The MiniMed™ Mio™ Advance infusion set is indicated for subcutaneous infusion of medication administered by an external pump.

The MiniMed™ Mio™ Advance infusion set manufactured by Unomedical is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a pre-loaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication.

The insertion needle and soft cannula of the MiniMed™ Mio™ Advance infusion set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevents needle stick injuries as the device does not require loading with the needle by the user, the needle is then automatically retracted after use.

The MiniMed™ Mio™ Advance infusion set will include a 27-gauge introducer needle, and will be available in two different soft cannula lengths of 6 and 9mm and three different tubing lengths of 46, 60 and 110cm. The tube set is available in P-Cap assembly or luer lock.

The MiniMed™ Mio™ Advance infusion set has been updated from the predicate K032854 Unomedical Inset ''M Subcutaneous Infusion Set by the same manufacturer. The only modifications were made to the inserter component and include a single molded component rather than two pieces, and the addition of a needle safety shield. The connector and tubing of the tubing set remains unchanged.

The provided text describes a 510(k) premarket notification for the MiniMed™ Mio™ Advance infusion set. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or provided in this document as it pertains to a clinical trial.

Instead, the document details non-clinical performance data and a comparison to a predicate device to establish substantial equivalence.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of acceptance criteria for a clinical study. Instead, it refers to a set of non-clinical performance tests and adherence to various national and international standards. The "Performance" in this context refers to meeting these engineering and safety standards, rather than clinical efficacy metrics.

• Serter functionality tests. |
  | Packaging Tests | - Dynamic and Visual Peel Test.
• Print on Packaging and labelling. |
  | Transportation Tests | - In accordance with ASTM D4169-16. |
  | Dimensional Tests | - Distance soft cannula to set.
• Distance of introducer needle bevel to soft cannula.
• Length of tubes. |
  | Biocompatibility Tests | - Cytotoxicity Testing in accordance with ISO 10993-5.
• Sensitization Testing in accordance with ISO 10993-10.
• Irritation Sensitivity Testing in accordance with ISO 10993-10.
• Acute Systemic Toxicity testing in accordance with ISO 10993-11.
• Pyrogen/Endotoxin Testing in accordance with ISO 11737-1.
• Biocompatibility testing for the insertion device. (The infusion set which remains on the patient is the same as the predicate device, thus existing biocompatibility data is relied upon). |
  | Sterilization & Shelf Life | - Shelf life Testing in accordance with ISO 11607.
• Sterilization Testing in accordance with ISO 11135:2014.
• ISO 10993-7:2008 (Ethylene Oxide Sterilization Residual).
• ISO 11607-1:2009 (Packaging for terminally sterilized medical devices).
• ISO 11607-2:2006 (Validation requirements for forming, sealing and assembly processes).
• ISO 11737-1:2006 (Determination of a population of microorganisms on products).
• ISO 11737-2:2009 (Tests of sterility performed in the definition, validation and maintenance of a sterilization process).
• EN 556-1:2001 & EN556-1/AC:2006 (Requirements for medical devices to be designated "sterile").
• EN ISO 11138-1: 2006 (Biological indicators - General requirements).
• EN ISO 11138-2: 2006 (Biological indicators for ethylene oxide sterilization processes). |
  | Usability Testing | - In accordance with IEC 62366-1:2015. |
  | Other Standards | - ASTM F1980:2011 (Accelerated Aging of Sterile Barrier Systems).
• ISO 10993-1:2009 (Biological evaluation of medical devices -- Part 1).
• ISO 10993-18:2009 (Chemical characterization of materials).
• ISO 14971:2012 (Application of risk management to medical devices).
• ISO 15223-1:2016 (Symbols for medical device labels). |

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. The submission relies on non-clinical performance data and comparison to a predicate device, not a human clinical test set.

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 was no clinical ground truth established for this 510(k) submission.

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

Not applicable. No clinical test set was used 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. The device is an infusion set, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. The device is a physical medical device, not an algorithm.

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

Not applicable in the clinical sense. The "ground truth" for this submission is established through adherence to recognized national and international engineering and safety standards, and documented performance in non-clinical laboratory tests.

8. The sample size for the training set:

Not applicable. There is no AI component or training set described.

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

Not applicable. There is no AI component or training set described.

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The Unomedical Comfort™ Subcutaneous Infusion Set and Unomedical Comfort Short™ Subcutaneous Infusion Set are indicated for subcutaneous infusion of insulin administered by an external pump.

The Unomedical Neria Soft Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.

The Medtronic Silhouette® Subcutaneous (Luer Lock) Infusion Set is indicated for subcutaneous infusion of insulin from and infusion pump.

The Medtronic Silhouette Paradigm® Subcutaneous Infusion Set is indicated for use with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.

The Roche Accu-Chek Tender™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered with microdosage insulin pumps.

The Asante Comfort™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered by the Snap™ Insulin Pump System.

The Abbott Comfort™ Subcutaneous Infusion Set is indicated for infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir of a compatible Abbott pump.

The Comfort Subcutaneous Infusion Sets are sterile, non-pyrogenic, single use subcutaneous infusion sets. The current sets are designed to be used with commercially available infusion devices or are indicated for a specific pump where the set has a proprietary pump reservoir connection (e.g. Medtronic, Asante). Each has two basic components provided for each device. The first is a stand-alone subcutaneous indwelling Soft Cannula. This component of the set is provided as an integral assembly with a PFOA-Free PTFE soft cannula, adhesive backed fixation tape, an injection port and the female portion of a proprietary plastic "click-lock" connector. The assembly comes with a stainless-steel insertion needle. The insertion needle is mounted to a male portion of the proprietary plastic "click-lock" connector. The insertion needle comes to the user inserted through the injection port and the inner lumen of the soft cannula with the needle end protruding past the tip of the soft cannula. The male connector is locked to the female connector on the indwelling soft cannula. A needle protector is assembled over the soft cannula and the insertion needle. A separate male portion of the proprietary connector without the insertion needle is provided in the package. This component is used to attach to the female connector after the indwelling soft cannula has been inserted and the steel insertion needle has been withdrawn and protects the indwelling cannula when the infusion set is not attached. Each Soft cannula set comes individually packaged in its own blister pack sealed with paper lid stock.

The second component is the infusion tubing set. The infusion tubing set for all sets are comprised of a co-extruded tube with a stainless-steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient end. The proximal end of the current Comfort set terminates in either a standard luer lock connector or a proprietary connector compatible with the specified pump. The sets come individually packaged in blister packs sealed with paper lid stock.

This document describes the 510(k) premarket notification for several subcutaneous infusion sets. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly concerning a change in the sterilization facility and the adoption of a PFOA-free PTFE soft cannula.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states "The following verification testing was performed" but does not provide specific sample sizes for each test. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

Not applicable in this context. The study is a series of engineering/performance verification tests for a medical device (infusion sets), not a clinical study requiring expert assessment of medical images or patient outcomes to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements (e.g., flow rate, leak detection, pull force, bend cycles) with clear pass/fail criteria, not subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or AI-assisted clinical decision support systems, which is not the nature of this device.

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

Not applicable. This device is a physical medical device (infusion set), not an algorithm or AI system. Its performance is inherent to the device itself.

7. The Type of Ground Truth Used:

The ground truth or reference standard for these tests are the established engineering specifications and physical properties of the materials and assembled device. For example:

• Flow/Leak/Pull Tests: Engineering specifications for flow rates, pressure resistance, and tensile strength.
• Bend Test: Durability and integrity requirements under mechanical stress.
• Biocompatibility: Established ISO standards (ISO 10993) for material safety and equivalence.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context would refer to internal manufacturing process optimization and quality control, not data for an algorithm.

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

Not applicable, as there is no training set for an algorithm. The "ground truth" for manufacturing and quality (if considered analogous) would be established through industry standards, regulatory requirements, and internal design specifications, often validated by extensive testing and risk analysis during the device development lifecycle.

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These sets are intended to be used with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.

All of the Subcutaneous Insulin Infusion Sets are sterile, non-pyrogenic, single use subcutaneous infusion sets. Each set design has two main components provided for each device. The first is a subcutaneous indwelling Cannula component and the second is a tubing set component. For all sets, the connection of the indwelling cannula to the tubing set is made using a proprietary plastic "click-lock" connector system that enables the disconnection. The Cannula component has an adhesive backed fixation tape that is attached directly to the patient's skin over the injection site. The cannula is sometimes provided separately from, and sometimes provided pre-attached to the tubinq, but in all cases is able to be detached from the tubing to temporarily discontinue the infusion or to replace the cannula independent of the tubing. Some of the cannulas are stainless steel needles and others are soft catheters that are inserted with stainless steel insertion needles that are then removed and discarded. All except the Mio® are manually inserted into the subcutaneous tissue. The Mio® is provided integrated in an automated inserter. The second main component of the set is the tubing set. The infusion set tubing for all sets, except for the QuickSet, are comprised of a co-extruded tube with a stainless steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient that punctures and penetrates a septum in the cannula connector, creating an aseptic fluid path to the user and that enables the connection and disconnection. The QuickSet tubing connects and disconnects with a snap on connection to the cannula component. The sets are offered in different lengths of tubing. As these sets are specifically designed only to be used with the commercially available MiniMed Paradigm Insulin Infusion pumps which use a MiniMed Paradigm medication reservoir with a proprietary pump reservoir connection, all of these sets terminate at the proximal end with the P-Cap connector. The P-Cap connector has a stainless steel needle that punctures and penetrates the insulin cartridge, creating an aseptic fluid path to the user. The P-Cap also attaches to the pump housing creating a water tight interface between the pump housing and the P-Cap, precluding water ingress into the pump through the cartridge reservoir chamber. Once sealed onto the pump, the hydrophobic membrane in the P-Cap enables pressure equalization between the inside of the pump (external to the drug reservoir) and the external environment under all ambient pressure conditions. This venting mechanism is designed to allow equalization of a pressure differential created by an altitude change between sea level and 10,000 feet air within 10 minutes, will withstand 8 feet of water for 30 minutes, and have a dry out time of 10 minutes or less. All of the subject sets are identical to the predicate sets in design, materials, manufacture, user interface, labeling, indications for use and intended use except for the material of the P-Cap Membrane.

The provided text describes a 510(k) summary for insulin infusion sets, specifically focusing on an upgrade to the P-Cap Connector's membrane material. While it details performance testing related to water ingress, dry-out time, and airflow, it does not provide the level of detail typically found in a clinical study report for an AI/device performance evaluation that addresses the specific questions asked about acceptance criteria, human reader performance, ground truth establishment, or sample sizes for training sets.

The information given is primarily about the device's functional performance (e.g., maintaining gas permeability, preventing water ingress) and its substantial equivalence to predicate devices, rather than a clinical performance study involving human readers or a complex AI algorithm that requires extensive ground truth and reader studies.

Therefore, many of the requested fields cannot be directly answered from the provided document. I will fill in what can be inferred or directly stated, and clearly mark what information is not available in the text.

Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

This document describes the validation of a minor design change (P-Cap membrane material upgrade) to existing MiniMed insulin infusion sets (MiniMed Quick-Set®, MiniMed Sure-T®, MiniMed Silhouette®, MiniMed Mio®). The study performed was a pre-clinical benchtop performance verification to ensure the upgraded P-Cap membrane maintains its function, especially when wet, and that the devices remain substantially equivalent to their predicate devices. This is not a study involving human reader performance or an AI algorithm, but rather a functional test of a medical device component.

1. Table of Acceptance Criteria and Reported Device Performance:

• Provide an effective barrier to moisture transmission into the pump cartridge when subjected to pressure equal to submersion in 8 feet of water for 30 minutes.
• Wet components dry out within 10 minutes. | "All samples passed the tests."
• Cartridge chamber checked for presence of any moisture (implying no ingress).
• Wet Components dried out within 10 minutes. |
  | Dry and Wet Flow Test:
• Enable a minimum of 5 SCCM (Standard Cubic Centimeters per Minute) airflow through the membrane at a constant pressure.
• Tested both when dry and when wet (to simulate insulin leakage). (5 SCCM determined as minimum for pressure equalization to ambient in the cartridge chamber). | "All samples passed the tests."
• Flow of at least 5 SCCM achieved both dry and wet. |

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

• Sample Size: Three (3) different lots of POREX membrane (P/N D6014672-009) were used to produce three (3) different PQ (Product Quality/Performance Qualification) lots of the PCAP assemblies (P/N D7004363-029). The exact number of individual P-Cap assemblies tested from these lots is not specified.
• Data Provenance: Not explicitly stated, but the company is Unomedical A/S based in Denmark. The testing appears to be conducted by the manufacturer as part of their design verification activities. This is a pre-clinical/benchtop performance study.

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

• Not Applicable. This study is a benchtop performance verification of a physical component (P-Cap membrane) and does not involve human interpretation or a "ground truth" derived from expert consensus in the clinical sense (e.g., radiologists reviewing images). The acceptance criteria are based on engineering specifications and functional requirements.

4. Adjudication Method for the Test Set:

• Not Applicable. No human adjudication was performed, as this was a physical performance test.

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 performance study, not an AI or diagnostic imaging study involving human readers.

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

• Not Applicable. This is a medical device performance study, not an AI or algorithm-only study.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Ground Truth Type: The "ground truth" here is the pre-defined engineering and functional specifications for the P-Cap membrane's performance, such as minimum airflow (5 SCCM), water ingress prevention, and dry-out time (10 minutes or less). These are objective measurements rather than expert consensus on a clinical diagnosis.

8. The Sample Size for the Training Set:

• Not Applicable. This document describes a design verification study for a physical medical device component, not an AI algorithm that requires a training set.

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

• Not Applicable. As no training set for an AI algorithm was involved, the establishment of ground truth for a training set is irrelevant to this document.

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The neria™ soft 90 infusion set is Indicated for subcutaneous infusion of medication administered by an external pump.

The neria™ soft 90 subcutaneous infusion set is a new product designed by Unomedical based on the Unomedical Inset™ Subcutaneous Infusion Set and Unomedical Quick-Set® Subcutaneous Infusion Set.

The neria™ soft 90 is a 90 degree soft cannula infusion set with a standard luer-lock connection. The neria™ soft 90 subcutaneous infusion set consists of an introducer needle/insertion handle that inserts the soft cannula into the skin and is removed immediately after insertion, a cannula housing that rests upon the skin with adhesive tape, securing the soft cannula in place under the skin, tubing with disconnect option and a reservoir connector (standard luer lock) and disconnect cover for the tubing and cannula housing.

The proposed configurations are:

• includes tubing and cannula . Infusion Set
• Tubing Only ●
• . Cannula only

Acceptance Criteria and Device Performance for neria™ soft 90 Infusion Set

This document details the acceptance criteria and study information for the neria™ soft 90 Infusion Set, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device as being substantially equivalent to its predicate devices based on non-clinical performance data. Therefore, the "acceptance criteria" are implied by the successful execution of these tests and compliance with relevant standards. The "reported device performance" is that the device passed all tests.

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

The document does not explicitly state the sample sizes used for each of the non-clinical tests. It only indicates that "a number of tests" were completed. Given that this is a 510(k) submission for substantial equivalence based on non-clinical data, it is highly likely that standard testing protocols and sample sizes specified by relevant national and international standards (e.g., ISO, ASTM) were followed.

The data provenance is from Unomedical A/S (the manufacturer) and is retrospective in the sense that these tests were performed on the device prototypes and finalized designs prior to submission. The country of origin of the data is Denmark (where Unomedical A/S is located), as well as any external testing facilities used for specific tests.

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

This information is not applicable as the evaluation relies on non-clinical performance data (functional, mechanical, material, and sterilization tests) rather than human interpretation of medical images or clinical outcomes requiring clinical ground truth establishment. These tests are assessed against predefined specifications and industry standards by qualified laboratory personnel and engineers.

4. Adjudication Method for the Test Set

This information is not applicable for the non-clinical performance data presented. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human readers/interpreters where there is an element of subjective judgment, and discrepancies need to be resolved. The non-clinical tests involve objective measurements and pass/fail criteria based on established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." Therefore, there is no effect size related to human reader improvement with or without AI assistance.

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

No, there was no standalone algorithm performance study conducted. The neria™ soft 90 Infusion Set is a physical medical device, not an AI/software-as-a-medical-device (SaMD) or an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on pre-established physical, chemical, and biological specifications and standards. For example:

• Engineering specifications: Tensile strength limits, flow rates, dimensional tolerances.
• Material standards: Biocompatibility according to ISO 10993 standards.
• Sterilization standards: Assurance of sterility.
• Packaging standards: Peel strength, integrity.

These standards and specifications serve as the "ground truth" against which the device's performance is measured.

8. The Sample Size for the Training Set

This information is not applicable. The neria™ soft 90 Infusion Set is a physical medical device. It does not employ machine learning or AI algorithms that require a "training set."

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

This information is not applicable as there is no training set for this device.

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These infusion sets are indicated for the subcutaneous infusion of medication from an external Infusion Pump.

The asante comfort™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the currently marketed Comfort™ Subcutaneous Infusion Sets are both sterile, non-pyrogenic, single use subcutaneous infusion sets. For the connection to the infusion set, the current Comfort™ sets have a standard female luer connector compatible with many commercially available infusion devices while the new asante comfort™ sets have the unique connector/adapter only compatible with the Asante Insulin Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This connector/adapter is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded,us ing the same adhesive, to the pump end of a standard Comfort™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Comfort™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.

The asante conset™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the current Inset™ Subcutaneous infusion Sets are both sterile, nonpyrogenic, single use subcutaneous infusion sets with an integrated springpowered catheter insertion device. For the connection to the infusion set, the current Inset™ infusion sets have a standard luer connector compatible with commercially available infusion devices while the new Asante Conset™ sets have a unique connector/adapter compatible with the Asante Pearl™ Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This part is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded, using the same adhesive, to the pump end of a standard Inset™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Inset™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Asante Conset™ and Asante Comfort™ Subcutaneous Infusion Sets:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The following verification testing was performed on the modified sets" and then lists the criteria, followed by a conclusion that the new products are "substantially equivalent." It does not explicitly provide the numerical results for the modified sets, but the substantial equivalence claim implies that the acceptance criteria were met.

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

The document does not explicitly state the sample size used for the verification testing (Flow, Leak, and Pull tests). The data provenance is also not specified (country of origin, retrospective or prospective).

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

This information is not applicable and not provided. The study involves performance testing of a medical device (infusion sets) against engineering specifications, not a clinical diagnostic assessment that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The study involves objective engineering measurements, not subjective evaluations 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

This information is not applicable and not provided. This is a 510(k) submission for an infusion set, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness was performed.

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

This information is not applicable and not provided. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (Flow, Leak, Pull) is established by the specified acceptance criteria (e.g., minimum flow rate, no leaks, minimum pull force). These are objective engineering specifications derived from the predicate devices' performance and industry standards.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This information is not applicable and not provided, as there is no training set for this device.

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The i-port Advance™ injection port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. The i-port Advance™ may be used on a wide range of patients, including adults and children. Model numbers for the device include 020110, 020210, 020102 and 020202.

The i-port Advance™ injection port was designed and developed through a technological collaboration between Unomedical A/S and Patton Medical Devices and modifies the Patton Medical Device i-port@ injection port (K052389) to include the automated insertion component ("Inserter") of the Unomedical Inset™ Infusion Sct (K032854).

The Injection Port component is a prescription only, sterile, single use, non-pyrogenic, external, disposable injection port with an indwelling catheter through which physician-prescribed medications can be injected subcutaneously from a standard syringe and needle, pen or alternative manual injection device. The indwelling catheter is installed using the integrated Inserter, a manually-operated springloaded catheter insertion tool that introduces the indwelling catheter into the subcutaneous tissue by automatically inserting the prefixed introducer needle to a predetermined depth below the skin surface.

Once applied, the insertion needle is removed, and only the soft cannula remains under the skin, acting as a gateway to the subcutaneous tissue. The user injects medicines directly through the resealable septum at the top of the device. The needle of the syringe or insulin pen remains above the surface of the skin, while the medication is delivered through the soft cannula and into the subcutaneous tissue. The device, which may be worn for up to 72 hours and receive up to 75 injections, is designed to reduce the hardships of multiple daily subcutaneous injections.

The Unomedical A/S i-port Advance™ injection port is indicated for patients requiring multiple daily subcutaneous injections of physician-prescribed medications, including insulin. The device can remain in place for up to 72 hours, accommodating multiple injections without additional needle sticks. This device is suitable for both adults and children.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria with specific numerical thresholds for each test, but rather confirms that the device "meets all applicable design and performance requirements." The performance tests conducted are standard for this type of medical device and are designed to ensure safety and effectiveness.

2. Sample Size for the Test Set and Data Provenance

The document provided does not specify the sample sizes used for each performance test. The data provenance is "internal Unomedical protocols" and adherence to international standards (ISO, AAMI/ANSI). It is implied these are prospective tests conducted during the device development and validation phases, likely conducted in various Unomedical facilities. The country of origin of the data is implied to be relevant to Unomedical A/S (Denmark) and potentially Patton Medical Devices (USA), given the collaboration.

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

The provided text does not indicate the use of experts to establish ground truth for a test set. The studies conducted are performance and safety tests against engineering specifications and international standards, rather than clinical studies requiring expert interpretation of results (e.g., image analysis by radiologists). The "ground truth" for these engineering tests is derived directly from the test methodologies and metrics defined by the standards and internal protocols.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as the tests are for device performance against predefined specifications, not for interpretation by multiple human readers.

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

No MRMC comparative effectiveness study was done or mentioned. This device is a physical medical device (an injection port), not an AI algorithm or diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone algorithm study was done or mentioned. As stated, this is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for the performance tests conducted (Flow, Leak, Tension, Pull, Weld Strength, Disconnection Strength, Spring Loading Force, Insertion Depth, Biocompatibility, Sterility, Pyrogenicity, Packaging Integrity) is based on engineering specifications, international consensus standards (e.g., ISO, AAMI/ANSI), and internal Unomedical protocols. This means the device's performance was measured against established benchmarks for safety and functionality. For instance:

• Biocompatibility: Conformance to AAMI/ANSI/ISO 10993-1:2009.
• Sterility: Conformance to AAMI/ANSI/ISO 11135-1:2007 to a SAL of 10⁻⁶.
• Ethylene Oxide Residuals: Compliance with AAMI/ANSI/ISO 10993-7:2008.

8. Sample Size for the Training Set

No training set is mentioned or applicable as this is a physical medical device, not an AI/machine learning algorithm.

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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These sets are indicated for the subcutaneous infusion of medication, including insulin from compatible infusion pumps.

Not Found

The provided text is a 510(k) summary for an infusion set and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed performance study with acceptance criteria and results in the way one would expect for an AI/ML device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not mentioned in this document because it describes a medical device (infusion set) for which performance is typically verified through engineering testing against specifications, rather than clinical studies involving ground truth establishment by experts as seen in diagnostic AI/ML applications.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states: "Verification testing confirmed the product meets their specifications." It does not provide numerical acceptance criteria or specific performance metrics.

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

• Sample Size: Not specified. The document refers to "Verification testing" without detailing the sample size for these tests.
• Data Provenance: Not applicable. The "tests" would be engineering/bench tests of the physical device, not data from a human population.
• Retrospective/Prospective: Not applicable.

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

• Number of Experts: Not applicable. Ground truth as understood in AI/ML (e.g., expert consensus on images) is not relevant for the performance verification of an infusion set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Not applicable.

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

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance. This document describes an infusion set, which is a physical device.
• Effect size of human reader improvement: Not applicable.

6. If a Standalone (Algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

• The term "ground truth" as typically used for AI/ML devices is not applicable here. Performance was likely confirmed against engineering specifications using physical measurements and tests (e.g., flow rate, material compatibility, durability).

8. The Sample Size for the Training Set:

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

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

• Not applicable.

Summary Rationale:

The provided document is a 510(k) summary for an infusion set, which is a physical medical device. The 510(k) process primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. For such devices, performance data typically comes from engineering and bench testing to ensure the product meets its pre-defined specifications, rather than from clinical studies involving human data and expert ground truth establishment that is characteristic of AI/ML diagnostic or prognostic devices. Therefore, most of the questions derived from an AI/ML context are not relevant to this specific submission. The key performance statement is general: "Verification testing confirmed the product meets their specifications."

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These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Not Found

The provided text is a 510(k) summary for the Unomedical A/S Intuition Infusion Sets. It discusses the device's substantial equivalence to existing products and verifies that it meets specifications. However, the document does not contain the detailed information necessary to answer many of the specific questions asked about acceptance criteria and a study design, especially concerning AI/ML aspects.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The document only states "Verification testing confirmed the product meets their specifications" but gives no details about the size or nature of the test set, nor its provenance.

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 provided in the document. This type of device (infusion set) does not typically involve expert review for ground truth in the way medical imaging AI does. The "ground truth" for an infusion set would likely be functional performance metrics, material properties, and manufacturing tolerances, all assessed through engineering and quality control tests, not expert consensus on medical images or diagnoses.

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

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here for an infusion set.

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, an MRMC comparative effectiveness study was not done. This document describes an infusion set, which is a physical medical device, not an AI/ML algorithm used to assist human readers (e.g., in medical image interpretation). Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this submission.

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

Not applicable. This device is a physical infusion set, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

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

The document implies that the ground truth for performance was product specifications. For an infusion set, this would typically involve various engineering, material science, and functional tests (e.g., fluid flow rates, strength of materials, sterility, biocompatibility, force required for insertion, leakage rates). It would not be expert consensus, pathology, or outcomes data in the way these terms are used for diagnostic or AI devices.

8. The sample size for the training set

This information is not provided and is not applicable. This is a physical device, and the concept of a "training set" is relevant for AI/ML algorithms, not for the verification of a medical infusion set.

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

This information is not provided and is not applicable for the same reasons as point 8.

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