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Churchill Medical Dual Chamber Empty Container is intended for indiodions For Society, and administration of total parenteral nutrition ( TPN ) solutions.

The Churchill Medical Systems Dual Chamber Empty Container is a sterile non-invasive fluid container used for compounding, storage and administration of total parenteral nutrition (TPN) solutions. This device is a sterile, single use disposable I.V. container that is horizontally divided into two chambers. The top chamber is intended for the storage of amino acid/ dextrose mixtures. The bottom chamber is intended to store lipid emulsions. Additive medication may be introduced into the bottom compartment by access through a non-latex injection port. The chambers are designed to be filled with TPN solution by a pharmacy operation. The filled container is intended to be stored with the divider/seal intact until the time of administration to the patient. At the time of patient use the divider/seal (Fig 1) is removed by peeling the external seal that separates the container top chamber from bottom chamber. The combined fluids are and then dispensed to the patient through a secondary set not included with this device. The container is made from extruded stock non-DEHP vinyl. Each chamber is provided with a Pharmacy filling port, filling port clamp, nonlatex injection site, and one patient delivery port located at the device bottom. All materials used and manufacturing processes are identical to the original All materials asou and and is a two-piece component that consists submission rod and a tightly fitting "U" shaped over piece. The of a contor synnditor and separated when the divider is placed over the exterior bag surface. The divider/seal does not contact any fluid or medication but, works to occlude the two chambers from one another by forming a compression seal when the bag is squeezed between.

The provided document describes an Abbreviated 510(k) submission for a device modification, the "Vitalmix empty container Rev. 1". This type of submission focuses on demonstrating substantial equivalence to a predicate device for a modified existing device. Therefore, a comprehensive study proving the device meets acceptance criteria in the manner of a novel device or a clinical trial is not presented. Instead, the submission relies on direct comparison to predicate devices and engineering bench testing to ensure the modifications do not alter fundamental safety and effectiveness.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document focuses on device specifications and comparison to predicate devices, rather than a formal test set with a specific sample size. For an abbreviated 510(k) submission concerning a device modification, the testing would likely be bench testing on a representative number of units to confirm that the modification does not negatively impact existing specifications.
• Data Provenance: The data provenance is primarily from bench testing (implied for mechanical, ETO, and pyrogenicity criteria) and comparison to predicate devices. It is retrospective in the sense that it relies on the established safety and effectiveness of the predicate devices. The country of origin of the data is not specified but would presumably be related to where Churchill Medical Systems or its testing facilities are located (based on the Dover, NH address).

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

• Not applicable in this context. This submission is for a medical device modification, not a diagnostic or AI-driven system requiring expert ground truth setting for a test set. The "ground truth" for the device's performance is against established engineering specifications and the performance of legally marketed predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. As above, this is an engineering assessment, not a clinical study requiring adjudication of expert interpretations. The "adjudication" is against established industry standards and FDA regulations for medical device manufacturing and performance.

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

• No. An MRMC study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess the impact of a new technology on reader performance. This device is an empty fluid container, which does not involve human readers interpreting clinical cases.

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

• Not applicable. This device is a passive medical device (an empty container) and does not involve any algorithms or AI to be assessed for standalone performance.

7. The Type of Ground Truth Used

• The "ground truth" for this device's safety and effectiveness is largely based on:
  • Engineering Specifications: Defined parameters for leak resistance, mixing, material composition, sterilization residuals, and pyrogenicity.
  • Predicate Device Performance: The established safety and effectiveness profile of legally marketed predicate devices (K960581, K911567, K020485, K072464). The "substantial equivalence" argument frames the ground truth around these existing devices.

8. The Sample Size for the Training Set

• Not applicable. This device does not use an AI/ML 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 AI/ML algorithm, no ground truth needed to be established for it.

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The Churchill Medical Systems Extension Sets is an accessory device used to deliver medical fluids.

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The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a medical device called the "Churchill Medical Systems Extension Set." This type of document declares that a device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

However, this document does NOT contain any information about acceptance criteria for device performance, nor does it describe any study related to device performance.

The letter focuses on the regulatory process of 510(k) clearance, confirming that the device can be marketed based on its substantial equivalence to pre-existing devices. It mentions:

• Device Name: Churchill Medical Systems Extension Set
• Regulation Number: 880.5440
• Regulation Name: Intravascular Administration Set
• Regulatory Class: II
• Product Code: FPA
• Indications for Use: "The Churchill Medical Systems Extension Sets is an accessory device used to deliver medical fluids."

Since the content does not describe acceptance criteria or a study proving the device meets those criteria, I cannot fill out the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies.

The document is purely a regulatory clearance notice, not a performance study report.

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Churchill Medical Systems Vial Access Spike with Needleless Connector is used in I.V. therapy to pierce glass and plastic stopper top vials for the transfer of medical fluids. This device climinates the use of metal hypodermic needles to reduce the chance of inadvertent needle sticks.

The Churchill Medical Systems vial access device is a sterile, single use, one piece shrouded plastic cannula designed to penetrate septums covering plastic or glass medication vials. The device is intended to be marketed with and without needleless connector port permanently attached.

The provided text describes a 510(k) summary for a medical device called the "Universal Vial Access Spike with Needleless Connector" by Churchill Medical Systems, Inc. However, the document does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and performance studies.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device is manufactured and tested in accordance with certain physical, chemical, and biological specifications. It references standards but does not provide specific quantitative acceptance criteria or detailed results.

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

• Sample size: Not specified.
• Data provenance: Not specified, but generally, such studies for 510(k) submissions are conducted internally by the manufacturer or their contracted labs. Given the device type, it's likely physical and chemical lab testing, not patient data. Retrospective or Prospective: N/A (not applicable as it's not a clinical study with patient data).

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. The nature of the device (a vial access spike) suggests that "ground truth" would be established through laboratory testing against predefined specifications rather than expert consensus on medical images or clinical outcomes.

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

• This information is not provided. Given it's a device for fluid transfer and needle stick prevention, not diagnostic imaging, adjudication methods like 2+1 or 3+1 are not typically 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:

• No. This type of study (MRMC for AI assistance) is not applicable to this device. The device is a physical medical instrument, not an AI-powered diagnostic tool.

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

• No. This is not an AI algorithm. Its performance is evaluated based on its physical and material properties and its ability to prevent needle sticks, which is a standalone function of the device itself.

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

• The "ground truth" for this device would be the specific, quantifiable parameters defined by the referenced industry standards (ISO 10993, USPXX111, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements) and internal physical testing requirements. For example, burst pressure for the spike, material compatibility, sterility assurance level, and ability to prevent needle sticks in simulated use.

8. The sample size for the training set:

• N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

• N/A. This device does not involve a "training set" or "ground truth" for training in the machine learning sense. The "ground truth" for its physical performance characteristics is established by adherence to recognized standards and validated internal test methods.

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The Churchill Medical Systems Wing Safe Huber Type Needle Sets intended use is for the delivery of medical fluids into implantable chemotherapy ports.

Churchill Medical Systems Wing Safe Huber Needle Set

The provided text is a 510(k) premarket notification letter from the FDA to Churchill Medical Systems, Inc., regarding a medical device called "Wing Safe Huber Type Needle Sets." This document primarily grants clearance for the device to be marketed based on its substantial equivalence to a legally marketed predicate device.

It does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the actual 510(k) submission, which is a much more extensive document. The provided letter is merely the FDA's decision letter following their review of such a submission.

Therefore, I cannot fulfill your request for information on acceptance criteria and study details based on the provided text.

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Churchill Medical Systems Mini Transfer Device is used for transferring and or dispensing medications, diluents and additives from rubber stoppered multi dose vials.

The Churchill Medical Systems Mini Transfer Device is a standard vented access device. It contains a universal piercing spike with female luer lock and .22 micron hydrophobic filter. The purpose of the filter within the spike body is to provide air-venting.

The provided text describes a 510(k) premarket notification for a medical device called the "Vented Vial Access Device" (also referred to as "Mini Transfer Device"). The document outlines the device's description, intended use, and a performance summary. However, it does not detail specific acceptance criteria or a comprehensive study report with quantitative results in the way a modern clinical trial or AI/software validation study would.

Instead, the performance summary focuses on compliance with established standards and comparison to a predicate device for the purpose of demonstrating "substantial equivalence" to obtain market clearance.

Here's an attempt to structure the information based on your request, highlighting what is available and what is not:

Acceptance Criteria and Study for the Churchill Medical Systems Mini Transfer Device (K013950)

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a typical clinical trial format (e.g., specific sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by compliance with recognized standards and demonstration of substantial equivalence to a predicate device. The study described is a series of tests to ensure this compliance and equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not specify the sample sizes used for the various tests (physical, chemical, biological, or functional comparison). It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). The implication is that standard manufacturing and testing batches were used as per the mentioned ISO and USP standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and therefore not provided in the 510(k) summary. For a device like a vial access device, "ground truth" is typically established by objective measurement against engineering specifications and validated test methods, rather than expert consensus on diagnostic images or clinical outcomes. The "experts" involved would be quality engineers, microbiologists, and other technical professionals conducting the tests, ensuring compliance with standards.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements against established standards, not subjective interpretations 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 conducted for diagnostic imaging devices or AI-driven systems where human interpretation is a key component and the goal is to show improvement with AI assistance. The Mini Transfer Device is a mechanical access device.

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

This concept is not applicable to this medical device. The device is a physical product, not a software algorithm that operates without human interaction.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Compliance with international and national standards (e.g., ISO 10993-1, USP 24, ISO 11607-1, ISO 11135).
• Adherence to internal company specifications for physical and chemical properties.
• Performance comparison to a legally marketed predicate device (Baxter Healthcare Chemo-Aide Dispensing Pin), demonstrating "similar technical characteristics" and performance.

These are objective, measurable criteria related to the device's physical properties, biocompatibility, sterility, and functional operation (transferring/dispensing fluids) as designed.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or an "algorithm" in the sense that would require a training set.

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

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

Summary Takeaway:

The K013950 510(k) summary demonstrates compliance and substantial equivalence through a series of tests against established industry standards and comparison to a predicate device. It does not provide detailed quantitative performance metrics or studies akin to those for AI/software devices or complex diagnostic tools. The focus is on ensuring the device meets safety and effectiveness requirements through adherence to manufacturing and testing protocols relevant to its classification as an IV administration set accessory.

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Churchill Medical Systems Stopcock is a valve for use in I.V. therapy and pressure monitoring to direct and control the flow of medical fluids.

The Churchill Medical Systems 4 way stopcock consist of a housing with two one male luer with rotating lock ring. The diversion handle opens or closes each port.

The provided text describes a 510(k) summary for the Churchill Medical Systems 4 Way Stopcock. This document is a premarket notification for a medical device and does not detail a study proving specific acceptance criteria in the way a clinical trial or performance study for an AI/ML medical device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and biological specifications and internal performance testing, rather than an AI model's performance.

Therefore, many of the requested sections about AI/ML device performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device submission.

However, I can extract the relevant information from the provided text regarding the closest equivalents to "acceptance criteria" and "device performance" as presented in this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is the sum of various tests conducted by Churchill Medical Systems, Inc. in accordance with established international and national standards and internal protocols.

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

• Sample Size for Test Set: Not specified in the provided text. The submission mentions "testing summary results" and conformance to various standards, implying that samples were tested to demonstrate compliance, but specific quantities are not provided.
• Data Provenance: Not specified. The testing was conducted internally by Churchill Medical Systems, Inc.

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

• Not Applicable. This is a physical medical device (stopcock), not an AI/ML algorithm requiring expert ground truth for image or data interpretation. The "ground truth" here is the adherence to the specified physical, chemical, and biological performance parameters as defined by the standards (ISO, USP) and internal requirements.

4. Adjudication method for the test set:

• Not Applicable. As above, this is for a physical device, not an AI/ML algorithm interpretation. Performance is assessed against quantitative and qualitative standards.

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

• No. This is a physical medical device (stopcock), not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.

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

• Not Applicable. This is a physical medical device. It does not involve an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is compliance with established international standards (ISO), national pharmacopeia (USP), and internal validated specifications for physical properties, chemical compatibility, biological safety (e.g., cytotoxicity, sensitization, pyrogenicity), and sterility. The device is also compared to the performance characteristics of a predicate device to demonstrate substantial equivalence.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. As above, a training set is not applicable for this type of device.

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Accessory device used to allow pressurized fluid flow in one direction and stop, or check flow in the opposite direction.

The Churchill Medical Systems Pressure Activated Check Valve consists of acrylic-polycarbonate alloy valve body and a silicone valve with male and female luer lock connections. The device opens at cracking pressures of greater than 3.5 PSI +/- 1 PSI and prevents back flow.

The provided text describes a 510(k) summary for a medical device called a "Pressure Activated Check Valve," but it does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way typically expected for an AI/ML device.

This document is a premarket notification for a Class II medical device (a check valve accessory) and focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed performance studies and acceptance criteria for a novel technology or AI algorithm.

Therefore, many of the requested categories for AI/ML device evaluations are not applicable or cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Explanation: The document does not explicitly list "acceptance criteria" for performance. Instead, it describes the functional specifications of the device (cracking pressure, preventing backflow) as part of its description and states that it was tested "in accordance with" various physical, chemical, and biological specifications and standards.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not applicable/specified. The testing mentioned refers to physical, chemical, and biological specification testing of the device itself, not data used for an AI/ML model.

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 check valve, not an AI/ML algorithm requiring expert-established ground truth from a test set (e.g., medical images).

4. Adjudication method for the test set:

• This is not applicable as there is no mention of a test set requiring adjudication by experts.

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. The device is a mechanical check valve, not an AI-assisted diagnostic tool.

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

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

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

• This is not applicable. The "ground truth" for a mechanical device would be its physical properties and functional performance against engineering specifications and relevant standards.

8. The sample size for the training set:

• This is not applicable. There is no AI/ML model for which a training set would be used.

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

• This is not applicable. There is no AI/ML model or training set.

Summary of the Study (Based on the Provided Text):

The "study" or performance evaluation described in the K011888 summary is a demonstration of substantial equivalence to a predicate device (KVQ Check Valve Accessory, K98441). This involves:

• Performance Summary: Stating that the device is manufactured and tested in accordance with physical, chemical, and biological specifications conforming to ISO 10993, USPXX111, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements, as well as documented internal requirements for physical testing.
• Conclusion: The device shares similar technical characteristics with existing check valves and "performs similarly to the predicate device." The summary results "confirm this device to be safe and effective and substantially equivalent to the predicate device."

This type of submission for a physical, mechanical medical device focuses on meeting established standards and demonstrating similarity to already approved devices, rather than an AI/ML-specific validation process.

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