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The indication for use is admixing of drug into an IV container and administration/transfer of drug from the container to an external IV line, while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the admixing, administration and disposal process.

The Injector is a sterile device for single-use within the PhaSeal® closed transfer device system for preparation and administration of parenteral drugs.

Here's a breakdown of the acceptance criteria and study information for the Infusion Adapter C100, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

Based on the provided text, the device in question, the Infusion Adapter C100, is being submitted for 510(k) clearance, which typically involves demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with human subjects in the same way a novel drug or high-risk device might. The information provided heavily focuses on performance and material testing for safety and functionality.

Here's a breakdown of the requested information based on the document:

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

• Sample Size: The document does not specify the exact sample size for each test. It states "Performance testing refer to verify integrity of the device and compatibility with the relevant other PhaSeal components." and lists various tests. For the material testing, it refers to "product after 24h and 72h of chemical exposure." Typical 510(k) submissions for devices like this involve a sufficient number of units to demonstrate statistical reliability for the specific tests (e.g., n=3 or n=10 per test) but these numbers are not explicitly stated.
• Data Provenance: Not explicitly stated, but the submitter Carmel Pharma AB is located in Mölndal, Sweden. It is highly likely the testing was conducted either internally at their facilities or by contract testing laboratories, which could be in Sweden or other countries. The document does not specify if the data is retrospective or prospective, but as these are laboratory performance and material tests, they would be conducted prospectively for the submission.

2. 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 question is not applicable in the context of this device and submission type. The "ground truth" for these types of tests (e.g., pulling force, liquid flow, biocompatibility) is established by predefined engineering specifications, industry standards, and regulatory requirements, not by expert consensus on interpreting data like imaging. The "experts" involved would be engineers, material scientists, and toxicologists conducting and interpreting the tests against established criteria. Their qualifications are implicitly assumed to be appropriate for performing these specific tests within standard laboratory practices.

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

• This concept of "adjudication" (e.g., 2+1, 3+1) is typically associated with clinical studies where multiple human readers or evaluators independently assess patient data and their disagreements are resolved. For the performance and material testing described here, adjudication is not applicable. The results are objective measurements against predefined pass/fail criteria.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices, particularly those involving human interpretation of images or other subjective data, often in the context of AI assistance. The Infusion Adapter C100 is a drug delivery accessory, and its evaluation focuses on physical performance, material compatibility, and biocompatibility, not on human interpretation or AI assistance.

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

• No, a standalone (algorithm-only) performance study was not done. This device is a physical medical device, not a software algorithm.

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

• The "ground truth" for the performance tests outlined here consists of predefined engineering specifications, industry standards, and regulatory requirements. For example, a successful "pulling force" test means the device withstood a certain force without separating or failing, as specified in its design requirements. For biocompatibility, the ground truth is adherence to internationally recognized standards for biological evaluation of medical devices (e.g., ISO 10993 series), where specific test results (e.g., absence of cytotoxicity) are considered "passing."

7. The sample size for the training set

• This question is not applicable. This device is a physical product and does not involve AI or machine learning models that require a "training set" of data.

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

• This question is not applicable, as there is no training set for this device.

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The indication for use of the PhaSeal system and included components are reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.

The Injector and Connector is a sterile device for single-use within the PhaSeal® closed system drug transfer device for preparation and administration of parenteral drugs.

The provided document describes the 510(k) summary for the Carmel Pharma ab's Injector N34, N35, N35C and Connector C35, C45, which are components of the PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs. The device relies on demonstrating substantial equivalence to previously cleared predicate devices rather than meeting specific quantitative acceptance criteria through a clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This submission is a 510(k) for substantial equivalence, not a performance study with quantitative acceptance criteria against specific metrics. The "acceptance criteria" here are qualitative, focusing on whether the new devices are "substantially equivalent" to predicate devices. The performance is demonstrated by comparing technological characteristics and intended use.

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

The document does not describe a specific "test set" in the context of a performance study with a sample size of clinical cases or data points. This is a submission for substantial equivalence based on bench testing and comparison of technical specifications to predicate devices. Therefore:

• Sample size for the test set: Not applicable, as there's no clinical "test set" described. The testing mentioned is "performance testing" which likely refers to engineering/bench tests rather than clinical data.
• Data provenance: Not applicable. There is no clinical data (e.g., country of origin, retrospective/prospective) used to prove performance in the context of this 510(k) summary.

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

Not applicable. This is a technical comparison for substantial equivalence, not a study involving expert-established ground truth for a test set of medical conditions.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication.

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

No. The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study, nor does it quantify an effect size of human readers improving with or without AI assistance. The device is a physical medical device (injectors and connectors), not an AI-powered diagnostic tool.

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

No. The document does not describe any standalone algorithm performance study. The device is a physical medical device.

7. Type of Ground Truth Used

Not applicable. Since there is no clinical "test set" and outcome evaluation in the traditional sense, there is no ground truth (e.g., pathology, outcomes data) as would be used in a diagnostic study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which the new devices are compared.

8. Sample Size for the Training Set

Not applicable. This is a submission for a physical medical device, not an algorithm that requires a training set.

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

Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply.

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The indication for use is reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.

The single lumen docking station of the Protector is fitted to the drug vial for the parenteral drug. The Injector is connected to the Protector and liquid transfer takes place through tightly fitting elastomeric double membranes to minimize leakage during reconstitution, administration and disposal processes. The Protector equilibrates the pressure difference which occurs when fluid or air is added to, or removed from the drug vial.

The provided text describes a 510(k) summary for a medical device called "PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs" and its components (Protector P14, P21, P28, and P50). However, the document does not contain acceptance criteria, a specific study proving the device meets those criteria, or the detailed information requested in your prompt (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details).

Instead, the document details a substantial equivalence comparison to predicate devices for regulatory clearance. The core of the submission is to demonstrate that the new devices (Modified P14, P21, P28, P50) are functionally equivalent to previously cleared devices (Predicate P14, P21, P50 from K001368).

The relevant sections are "5. Technological characteristics, comparison to predicate device" and "6. Discussion of performance testing."

Here's a breakdown of what can be extracted and what information is missing based on your prompt:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or a direct measurement of "device performance" in terms of specific metrics like leakage rates or contamination levels. Instead, it relies on demonstrating equivalence to predicate devices, which are presumed to meet established safety and effectiveness standards.

The closest we can get to "performance" is the comparison table which shows direct equivalence in intended use, material, spike type (with one exception for P28), drug vial size, expansion chamber, and sterilization method.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document states "The Protectors have been tested and found in compliance with applicable requirements and standards specifications," but does not detail what tests, how many samples, or where the data originated from.

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

• This type of information is entirely absent. The submission is based on demonstrating substantial equivalence through material and design comparisons and general performance testing (details not provided), not an expert-driven ground truth assessment.

4. Adjudication method for the test set

• Not applicable/Not specified. There's no mention of a formal adjudication process for test results in this 510(k) summary.

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 an AI/software device. No MRMC comparative effectiveness study was conducted or is relevant to this submission.

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.

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

• Not applicable in the context of expert-derived ground truth. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices. The new devices are deemed "substantially equivalent" if they meet the same functional and material characteristics and do not raise new safety or effectiveness concerns.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a "training set."

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

• Not applicable. (See answer for #8).

Study that proves the device meets the acceptance criteria:

The document refers to a general "Discussion of performance testing" stating: "The Protectors have been tested and found in compliance with applicable requirements and standards specifications."

This is a high-level statement indicating that the device has undergone testing, but the 510(k) summary does not provide details of a specific study or its results to quantitatively demonstrate compliance with acceptance criteria. The core approval mechanism here is demonstration of substantial equivalence to predicate devices, not a novel performance study against specific acceptance metrics. The FDA's letter confirms this, stating, "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

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The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible to administer drugs into the patient using the sealed double membrane technique.

PhaSeal is a closed system for handling of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the drug to the patient, and waste handling.

All drug transferring utilizes a double membrane technique. Each component device is sealed off with an elastomeric membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.

The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible administer drugs into the IV line of the patient using the PhaSeal Injector. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug aerosols and spills that occur during the administration and disposal processes.

This document is a 510(k) summary for the PhaSeal Y-site Line, an intravascular administration set. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K980381) rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report as one might find for a novel device undergoing extensive clinical trials.

Therefore, the requested information elements related to specific acceptance criteria, detailed study design, expert ground truth, and AI-specific metrics (like MRMC studies) are not fully present in the provided text because this type of submission is for a device deemed substantially equivalent to an already approved one.

However, I can extract the available information and point out where the requested details are absent.

Description of Device and Comparison to Predicate

The PhaSeal Y-site Line is a component of the PhaSeal closed system for handling parenteral drugs, particularly cytotoxic drugs. It serves as a port for IV administration when a Luer Lock fitting is not available in the patient's IV line. It uses a built-in connector that works with the PhaSeal Injector, utilizing a double membrane technique designed to prevent leakage of hazardous drug aerosols and spills.

The device is considered substantially equivalent to previously cleared PhaSeal devices included in 510(k) Number K980381. This claim of substantial equivalence replaces the need for extensive de novo performance studies in this specific 510(k) submission. Therefore, detailed acceptance criteria and a specific performance study in the manner requested are not explicitly outlined for this particular submission entry (K060866) beyond the general safety and efficacy implied by substantial equivalence to its predicate.

Requested Information Based on Provided Document:

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

Note: The document states, "The device is substantially equivalent to previously cleared PhaSeal devices included in 510(k) Number K980381." This means the foundational acceptance criteria and performance data would have been established and met by the predicate device. This specific 510(k) (K060866) relies on demonstrating that the Y-site Line performs equivalently.

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

• Not explicitly stated in this 510(k) summary. Since this is a substantial equivalence submission, a new, independent performance study with a specific "test set" and sample size as described for a de novo device is not presented. The "data" refers to the established performance of the predicate device (K980381).
• Data Provenance: The predicate device (PhaSeal system) was developed by Carmel Pharma AB (Molndal, Goteborg, Sweden). The provided text does not specify the country of origin of testing data for the predicate, nor whether it was retrospective or prospective.

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

• Not applicable/not explicitly stated in this 510(k) summary. This type of information is typically for diagnostic devices, particularly those involving image interpretation where expert consensus is needed to establish "ground truth." This device is an administration set. The "ground truth" for its safety and effectiveness would be established through engineering validation, material testing, and potentially clinical use data of the predicate, as opposed to expert interpretation of data.

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

• Not applicable/not explicitly stated in this 510(k) summary. This concept is generally applied to diagnostic studies where multiple readers interpret data and discrepancies are adjudicated.

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 an intravascular administration set, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant 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 medical device, not an algorithm, so "standalone" performance in this context is irrelevant.

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

• For this type of device (intravascular administration set), the "ground truth" for its performance, safety, and effectiveness would be established through a combination of:
  • Engineering specifications and tests: Demonstrating the physical integrity of the component, the sealing mechanism (double membrane), burst pressure, leak tests, and flow rates.
  • Biocompatibility testing: Compliance with ISO 10993 standards.
  • Sterilization validation: Ensuring the device is sterile.
  • Clinical performance data (for the predicate): Evidence from the predicate device (K980381) demonstrating its effectiveness in preventing drug exposure during preparation, administration, and waste handling in actual use, likely supported by observational studies or post-market surveillance.
• None of these specific details are provided in this 510(k) summary. The summary relies on the overarching claim of substantial equivalence to K980381.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a "training set."

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

• Not applicable. As above, no training set is involved.

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The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line (e.g. IV regulators). The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal double membrane technique.

PhaSeal is a closed system for handling of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the patient, and waste handling. All drug transferring utilizes a patented double membrane technique. Each component device is sealed off with an elastomeric membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) premarket notification summary for a medical device (PhaSeal Infusion Adapter). It describes the device, its intended use, and states its substantial equivalence to previously accepted PhaSeal devices. The letter from the FDA confirms the substantial equivalence determination and permits the device to proceed to market, subject to general controls and regulations.

The text does not include:

• A table of acceptance criteria or reported device performance.
• Details about a sample size, test set, data provenance, or ground truth establishment.
• Information regarding expert involvement, adjudication methods, or MRMC studies.
• Any standalone algorithm performance data.
• Details about a training set or its ground truth.

Therefore, I cannot fulfill your request for this specific information using the provided document.

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PhaSeal® closed system for the preparation and administration of parenteral drugs

PhaSeal Infusion Adapter - Intravascular Administration Set: The Infusion Adapter serves as the connecting part between the IV bag and an external IV line. (Example IV regulators.) The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed double membrane technique.

PhaSeal Protection Cap - Special accessories: The Protection Cap is intended to be used as a mechanical cover for the membrane in the bayonet fitting of PhaSeal devices The Protection Cap mates with the other PhaSeal components equipped with the bayonet fitting. One end of the Protection Cap has a male bayonet fitting and in the other a female bayonet fitting.

PhaSeal Secondary Set - Intravascular Administration Set: The Secondary Set is a non-vented infusion set used when drug is handled as an admixture and is administered via Intravenous infusion. The Secondary Set has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal technique.

PhaSeal Extension Set - Intravascular Administration Set: The Extension Set serves as the port for bolus injection with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Extension Set has a built in Connector which makes it possible inject drugs into the IV line of the patient using the sealed double membrane technique.

PhaSeal is a closed system for preparation and administration of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the administration of the drug to the patient, and waste handling. All drug transferring utilizes a patented double membrane technique. Each component devices is sealed off with an elastomeric membrane cover. The membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.

The provided text is a 510(k) summary for the PhaSeal® closed system for the preparation and administration of parenteral drugs. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth cannot be extracted directly from this type of regulatory submission.

Here's an analysis based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria or quantitative performance metrics typically associated with a clinical study. The submission focuses on demonstrating substantial equivalence in function and components to already marketed predicate devices.

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

The document does not describe a clinical "test set" in the context of a performance study. No sample sizes for testing or data provenance (country, retrospective/prospective) are mentioned, as the basis of the submission is a comparison to predicate devices, not a de novo performance evaluation.

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

This information is not applicable or available. Ground truth establishment for a test set implies a performance study (e.g., diagnostic accuracy), which is not detailed in this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable or available, as no performance study with a test set requiring adjudication is described.

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

This information is not applicable or available. The submission does not detail any comparative effectiveness study, especially one involving human readers with and without AI assistance. The PhaSeal system is a physical medical device, not an AI-powered diagnostic tool.

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

This information is not applicable or available. The PhaSeal system is a physical device, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable or available. The submission doesn't describe establishing ground truth for a performance study. Instead, it relies on the known safety and efficacy of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable or available. There is no mention of a "training set" as this is not an algorithm-based device.

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

This information is not applicable or available, as there is no training set described.

Summary of what the document DOES provide, relevant to its purpose:

The document explains the function of the PhaSeal system components (Infusion Adapter, Protection Cap, Secondary Set, Extension Set) and argues for their substantial equivalence to existing predicate devices based on:

• Similar components: "all use similar components"
• Similar function: "provide a pathway to administer fluids from a container to a patient's vascular system" or "a protection and mechanical cover for a connections to IV systems."

This 510(k) submission is a regulatory filing aimed at demonstrating that the new device is as safe and effective as a legally marketed predecessor, not a detailed report of a clinical performance study with specific acceptance criteria.

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