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ACTIV Cap is intended for use on a needleless vascular access port as an active cleaning and disinfecting device prior to IV access and to act as a passive, protective barrier for up to 7 days if not removed. ACTIV Cap disinfects needleless vascular access ports in one (1) minute after application and achieves at least a >5-log reduction as tested in vitro against 6 organisms - Staphylococcus aureus, Staphylococcus epidermis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans.

The Subject Device is a sterile, single-use device that is used to clean and disinfect needleless vascular access ports and then act as a cover for the access port between uses. Covering between uses maintains the port's cleanliness. The Subject Device is made of a plastic inner threaded housing snapped into an outer cap and incorporates a foam substrate that protrudes into the central bore of the inner housing and is moistened with the active disinfectant, 70% Isopropyl Alcohol (IPA). The IPA-filled cap is sealed with a poly/foil film to prevent excessive loss of the active ingredient and maintain the sterile barrier.

The Subject Device reduces the risk of unintentional removal by requiring a slight compression force (i.e., pinching) on the cap's side to remove, which force causes the outer housing to engage the inner housing so as to allow the inner and outer housings to be rotated in unison in order to attach and remove the Subject Device from a threaded needleless vascular access port. Without compression, once secured to a needleless vascular access port the Subject Device's outer housing can be rotated in relation to the inner housing and needleless vascular access port to further clean the surface of the access port.

Once the Subject Device is installed on a needless vascular access port, the device passively disinfects the contacting surfaces with the 70% IPA moistened foam.

Ten (10) sealed devices are assembled onto a card hanger that can be hung in an IV pole. Twenty (20) assembled cards are packaged into an inner carton. The instructions for use are printed on the outside on the inner carton. Twenty-four (24) inner cartons are packaged into a corrugated shipper. The packaging shipper is sterilized by gamma irradiation to a Sterility Assurance Level (SAL) of 10-6.

The provided text is a 510(k) summary for the Cleansite Medical ACTIV™ Cap. This document is a premarket notification to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. As such, it primarily focuses on non-clinical testing and comparison to achieve regulatory clearance rather than a comprehensive clinical study to prove device effectiveness in a real-world setting with human subjects.

The document does not describe a study that proves the device meets acceptance criteria in the context of clinical effectiveness or a multi-reader multi-case (MRMC) study. Instead, it details non-clinical (laboratory) performance testing to show substantial equivalence to a predicate device and demonstrate safety and basic function.

Therefore, the following information cannot be extracted from the provided text:

• Sample size used for the test set and data provenance (retrospective or prospective): The document refers to laboratory tests, not a clinical test set with human data.
• Number of experts used to establish ground truth and qualifications: Ground truth for a clinical study would typically involve medical professionals interpreting patient data, which is not applicable here.
• Adjudication method: Not applicable for non-clinical lab tests.
• Multi-reader multi-case (MRMC) comparative effectiveness study and effect size: This type of study involves human readers, which is not described.
• Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, in a clinical sense, is not established or used. The "ground truth" for the non-clinical tests is the established laboratory standard and organism counts.
• Sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

However, I can provide the acceptance criteria and reported device performance from the "Summary of Testing Performed" table, along with information available about the context of these tests.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The device's performance is evaluated against various non-clinical standards and internal criteria to demonstrate safety and basic functional equivalence to a predicate device. The "Summary of Testing Performed" table outlines these criteria and the results.

1. Table of Acceptance Criteria and the Reported Device Performance:

• Not considered to have a cytotoxic effect.
• Did not elicit sensitization reactions.
• No irritation was observed.
• Non-pyrogenic
• No acute systemic toxicity was observed.
• Non-hemolytic
• Organic/inorganic constituents detected do not pose significant systemic risks to the patient. |
  | T=0 | Sterilization Validation (Gamma, VDmax25) | ISO-11137-2 (FDA No. 14-409) - Sterility Assurance Level (SAL) of 10^-6. | Acceptable
• SAL 10^-6
• Bioburden: 21-35 CFUs
• Product Sterility: No positives |
  | T=0 | Transportation Challenger | ASTM D4169 (FDA No. 14-499), ASTM D4322 (FDA No. 5-99). Acceptance: No damage to the device or its sterile barrier. | Acceptable
• No Damage to the device or its sterile barrier. |
  | T=0 | Endotoxin | ANSI/AAMI ST72 (FDA No. 14-541). Acceptance: Low endotoxin levels. | Acceptable
• . Acceptance: Met all criteria with regard to subvisible particulates greater than 10 microns. | Acceptable
• Met all acceptance criteria with regard to subvisible particulates greater than 10 microns. |
  | T=0 | Torque to Needleless Access Port | N/A - Reference Only; Comparable to predicate device. | Reference Only
• Comparable to predicate device |
  | T=0 | IPA Ingress | N/A - Acceptance: Average IPA dosages below 14 mmol/L ("mM") "critical concentration" calculated for neonatal patients in the Sauron article. | Acceptable
• The results show that the average IPA dosages were below the 14 mmol/L ("mM") "critical concentration" calculated for neonatal patients in the Sauron article. |
  | T=0, T=6 Months | Packaging Integrity | ASTM F1886/F1886M (FDA No. 14-501), ASTM F2096 (FDA No. 14-482), ASTM F88/F88M (FDA No. 14-482). Acceptance: No visual defects, no air leak at test pressure, seal strength >1.0 lbs. | Acceptable
• No visual defects observed.
• No air leak at test pressure
• Seal strength >1.0 lbs. |
  | T=0, T=6 Months | Functionality/Needleless Connector Displacement | N/A - Acceptance: No leaks when submerged in water for devices installed on needleless valve types. | Acceptable
• None of the devices installed on each needleless valve type were observed with a leak when submerge in water. |
  | T=0, T=6 Months | Resistance to Separation from Axial Load | ISO 80369-7 (FDA No. 5-133). Acceptance: None of the devices separated below the minimum specification of 7.86 lb. | Acceptable
• None of the devices separated below the minimum specification of 7.86 lb. |
  | T=0, T=6 Months | Microbial Inactivation | N/A - Acceptance: At least a >5-log reduction at 1-minute and 7-day contact exposure, against S. aureus, S. epidermidis, E. coli, P. aeruginosa, C. albicans, and C. glabrata, at a 99.9% confidence level. (This is based on the Indications for Use statement). | Acceptable
• At 1-minute and 7-day contact exposure minimum of 5 log reduction achieved at a 99.9% confidence level. |

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

The document describes non-clinical, laboratory-based performance testing rather than a clinical "test set" from patient data. The "sample sizes" for these tests would refer to the number of device units or test replicates used in each specific lab procedure. These specific numbers are not provided in the summary but would be detailed in the full test reports referenced by the standards (e.g., ISO, ASTM, USP).

• Data Provenance: The data comes from in vitro (laboratory) testing performed on the device itself, not from human subjects or clinical settings, therefore it is not retrospective or prospective in the clinical sense. The tests are performed on the device components and assembled units under controlled lab conditions. The "country of origin of the data" is not specified but would typically be associated with the testing labs.

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

This information is not applicable. The "ground truth" for non-clinical performance tests is established by documented industry standards (ISO, ASTM, USP) and the measurable outcomes of the tests (e.g., bacterial log reduction, force measurements, chemical concentration). These tests are performed by qualified lab technicians and scientists, not "experts" in the sense of clinical reviewers establishing diagnostic ground truth.

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

Not applicable. Adjudication methods are relevant for clinical studies that involve expert review of ambiguous or complex patient data. Here, the results are quantitative measurements against defined 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:

Not applicable. This device is a physical medical device (an antiseptic cap for IV ports), not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI algorithms.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for the performance claims (e.g., microbial inactivation) in this context is the measured log reduction of specified microorganisms in in vitro laboratory tests, compared against the predefined acceptance criterion of ">5-log reduction". For other tests, the "ground truth" is adherence to established engineering, material, and sterilization standards (e.g., ISO, ASTM, USP as listed).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses.

BD PureHub™ Disinfecting Cap will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed.

BD PureHub™ Disinfecting Cap is a sterile, single use disinfectant cap designed for needle-free Luer connectors. It has high-density polyethylene housing and polyester urethane sponge saturated with 70% Isopropyl Alcohol (IPA) solution. PureHub™ disinfects needle-free Luer connectors one minute after application and acts as a physical barrier for up to seven days, if not removed. It is available in two packaging configurations - Bulk Single Unit and IV Pole Strip.

The BD PureHub™ Disinfecting Cap is intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses. It will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" alongside specific numerical targets and then directly compare them to reported device performance in a single table for each test. Instead, it states that "The subject device met all the predetermined acceptance criteria for the above listed performance tests and demonstrated substantial equivalence to the predicate device."

However, we can infer some criteria and reported performance from the comparison table and the list of non-clinical tests:

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

The document does not provide specific sample sizes for each non-clinical test. It lists the types of tests performed.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. The tests were performed "in accordance with 21 CFR §820.30" and various ISO standards, implying controlled laboratory conditions rather than human clinical trials.

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

This information is not applicable as the study involved non-clinical performance and biocompatibility testing, not expert-adjudicated clinical ground truth. The "ground truth" for these tests would be established by the methodologies defined in the respective ISO standards (e.g., ISO 10993 for biocompatibility) and internal specifications.

4. Adjudication Method for the Test Set:

Not applicable. The tests are laboratory-based and follow standardized protocols, not human adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical disinfecting cap, not an AI-powered diagnostic or assistive tool for human readers.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance):

Yes, a standalone study was performed, as the device is a physical product and its performance (e.g., antimicrobial efficacy, physical barrier, biocompatibility) was evaluated directly through laboratory testing without human intervention being part of the device's function.

7. Type of Ground Truth Used:

The ground truth for the non-clinical tests was established by:

• Established Test Methods and Standards: e.g., ISO 10993-1 for biocompatibility, ISO 11137-2:2013 (VDmax25) for sterilization, USP 788 for particulate matter.
• Defined Performance Criteria: For tests like antimicrobial efficacy, the "ground truth" is a measurable reduction in microorganism count (> 4-log reduction).
• Internal Specifications: Tests were performed "to an internal specification or a Standard."

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. (See #8)

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The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to I.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus, Staphylococus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used in the home or healthcare facility.

The 3M™ Curos Jet™ Disinfecting Cap is a single use, sterile cap that contains 70% Isopropy Alcohol and is intended to disinfect and protect needleless connectors. The Curos Jet™ Disinfecting Cap is translucent green in color. The device consists of a molded high-density polyethylene (HDPE) cap designed to fit onto female threads of a needleless connector, containing a HDPE plunger within. This plunger, when the cap is screwed onto a connector, travels towards a reservoir of 70% Isopropyl Alcohol, releasing it onto the needleless connector for disinfection. The Curos Jet™ Disinfecting Cap is offered in one size only, however it is packaged in "single" (1-cap) and "strip" (5-cap) configurations on a foil seal.

The provided document is a 510(k) summary for the 3M™ Curos Jet™ Disinfecting Cap. It describes the device, its intended use, comparison to predicate/reference devices, and non-clinical performance testing. However, it does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, which is implied by several of your questions (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)").

This document is for a medical device, specifically a disinfecting cap, not an AI/ML software as a medical device (SaMD). Therefore, many of your questions related to AI/ML device testing (such as ground truth establishment for training/test sets, expert consensus, MRMC studies, and human-in-the-loop performance) are not applicable to the information provided in this regulatory submission.

The acceptance criteria and performance data relate to the disinfection efficacy of the physical cap.

Here's a breakdown of the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for disinfection efficacy is defined as "≥ 4 Log count reduction" against specific microorganisms.

Note: The document also mentions other acceptance criteria for "foil seal peel strength, cap retention force to needleless connectors, as well as cap compatibility with needleless connectors via pressure/vacuum leak testing," but the specific numerical acceptance values for these are not provided in this summary. The summary states that "All testing was completed in accordance with approved company protocols and was completed to demonstrate that the Subject Device seals and acts as a cover for needleless connectors."

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

• Sample Size: The document does not specify the exact sample size (number of caps or tests) used for the microbiology efficacy testing. It refers to "test results" and "mean Log reduction" which suggests multiple trials were conducted.
• Data Provenance: The efficacy testing was conducted in vitro. The document does not specify the country of origin for the data collection, but given it's part of a US FDA submission by a US company (3M Company, St. Paul, Minnesota), it's highly likely the tests were conducted in the US or in labs compliant with US regulatory standards for medical devices. The testing is described as "non-clinical performance test data," implying it's laboratory-based, not patient-based data. It is retrospective in the sense that the testing was completed and results summarized for the submission.

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

• This question is not applicable. The "ground truth" for this device's performance is objective laboratory measurement of microbial reduction, not subjective expert interpretation of, for instance, medical images.

4. Adjudication Method for the Test Set

• This question is not applicable. There is no human interpretation or adjudication involved in the microbial log reduction testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable. This is a physical medical device, not an AI/ML diagnostic or assistive technology for human readers.

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

• This question is not applicable. This is a physical medical device, not an algorithm. The "performance" is the inherent disinfectant action of the cap.

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

• The ground truth for the primary efficacy claim (disinfection) is objective laboratory measurement of microbial reduction (colony-forming unit counts before and after disinfection), which is a direct measure of the device's intended biological effect on microorganisms.
• For other performance aspects (foil seal peel strength, cap retention force, compatibility, sterility, biocompatibility), the ground truth is established through physical, chemical, and biological testing according to established international standards (e.g., ISO, FDA guidance).

8. The Sample Size for the Training Set

• This question is not applicable. This device does not involve an AI/ML algorithm that requires a "training set."

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

• This question is not applicable. This device does not involve an AI/ML algorithm that requires a "training set."

In summary, the provided document details the non-clinical performance testing of a physical medical device (disinfecting cap) based on a defined microbiological acceptance criterion. It does not involve AI/ML technology or human reader studies.

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When left in place for 3 minutes, the CapKlenZ disinfects needleless luer access valves; thereafter the CapKlenZ provide a physical barrier to contamination up to 168 hours under normal conditions if not removed.

CapKlenZ consists of a solid reservoir made of polyethylene, which contains an absorbent material and 70% isopropyl alcohol (70% IPA).

The opening of the reservoir is mechanically attached to a threaded membrane made of non-DEHP, non-latex elastomer, which lays in the internal geometry of the reservoir, this membrane is intended to be threaded to a needleless port connector and adapt to its shape. The reservoir and its contents are sealed with an extrusion laminated composite of polyester, polyethylene, aluminum foil, and a peelable sealant, which has to be removed before use.

Once the needleless port connector is threaded, the shape and elasticity of the threaded membrane, isolates the proximal end of the needleless port connector within the interior of the reservoir along with the absorbent material and 70% IPA. When the needleless port connector is threaded into the membrane, the circular movement of the connector scrubs its tip against the absorbent material and exposes it to 70% IPA in order to disinfect it.

This document describes the acceptance criteria and supporting studies for the CapKlenZ device, a disinfectant cap for needleless luer access valves.

1. Tabular Summary of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

• Antimicrobial Efficacy Testing: Not explicitly stated, but testing was performed on "baseline (T=0)" and "aged devices (T=2 years)". This suggests a study design involving new and aged samples of the device. The data provenance is internal testing by Star Mountain Medical, Inc. The nature of the test (in-vitro) indicates a controlled laboratory setting, not patient data.
• Microbial Barrier Testing: Not explicitly stated, but testing was performed on "baseline (T=0)" and "aged devices (T=2 years)". Similar to antimicrobial efficacy, this suggests a study design involving new and aged samples. The data provenance is internal testing by Star Mountain Medical, Inc.
• Alcohol in the fluid path Testing: Not explicitly stated. The study referenced "Sauron et. al., 2015, 'Using isopropyl alcohol impregnated disinfection caps in the neonatal intensive care unit can cause alcohol toxicity'" for methodology. This testing was performed internally by Star Mountain Medical, Inc.

3. Number of Experts and Qualifications for Ground Truth - Test Set:

• The document describes non-clinical performance and laboratory testing, not studies involving human interpretation or expert evaluation of test results. Therefore, no information on human experts used to establish a ground truth for a test set is provided or applicable in the context of this device's non-clinical evaluation.

4. Adjudication Method for the Test Set:

• Not applicable, as this involves non-clinical laboratory testing with objective measurements against predefined acceptance criteria, rather than subjective interpretation by human readers.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a physical disinfectant cap, and its effectiveness is evaluated through microbiological, chemical, and physical bench tests, not through human reader interpretation of images or data that would typically involve an MRMC study.

6. Standalone (Algorithm Only) Performance:

• Not applicable. The CapKlenZ is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone performance" (algorithm only without human-in-the-loop) does not apply.

7. Type of Ground Truth Used:

• For the antimicrobial efficacy tests, the ground truth was quantitative bacterial and fungal count reductions measured in a laboratory setting.
• For the microbial barrier tests, the ground truth was absence of microbial ingress measured in a laboratory setting.
• For the alcohol in fluid path testing, the ground truth was quantification of alcohol leakage by gas chromatography and visual/functional inspection outcomes (Pass/Fail criteria).
• For performance testing, the ground truth was objective measurements against established engineering standards (ISO, ASTM, ISTA) and internal test methods, resulting in Pass/Fail outcomes.
• For biocompatibility and sterilization testing, the ground truth was compliance with established ISO and USP standards.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML models. The reported testing is for device validation and verification.

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

• Not applicable, as there is no "training set" for this physical medical device.

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SwabTip™ is intended for use on ISO male luer connectors as a cover to protect the luer from potential contamination. The SwabTip™ acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabTip™ will disinfect the male luer (30) seconds after application and maintains a disinfected luer surface for up to four days (96 hours) if not removed.

SwabTip™ Male Disinfectant Cap is an accessory to the terminal male luer of an intravenous administration set that is used to disinfect and maintain a physical barrier when the administration set is not in use. The SwabTip™ is a cap that when attached to an ISO compatible male luer slip, lock, or spin luer, delivers a small volume of 70% isopropyl alcohol to the external surfaces of the male luer including the internal threads. SwabTip™ is a single use sterile fluid path cap, provided in multi-unit delivery strip.

The provided document describes the acceptance criteria and study that proves the SwabTip™ Male Disinfectant Cap meets these criteria, supporting its substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• This table specifically refers to the "Efficacy Study" (time-kill study) for antimicrobial activity.
• Other performance data mentioned includes: Microbial Barrier Performance Test, Male Luer Compatibility Testing, Visual Inspection, Foil Functional Test, Lid Peel Force, Integrity by Weight, Seal Leak Testing of Holder and Foil Lid, IPA Ingress/Alcohol Fluid Path Testing, Pyrogenicity Testing, and Particulates. The document states that the results of these tests "demonstrated that the subject device meets the performance requirements and ultimately supports a substantial equivalence determination," and that "Test results from the performance testing conducted demonstrate that SwabTip™ met all acceptance criteria requirements," but does not provide specific numerical outcomes or acceptance criteria for each of these additional tests in the provided text.

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

• Sample Size for Efficacy Study: For the antimicrobial efficacy time-kill study, the sample size was 10 samples for each of the six challenge strains, totaling 60 samples evaluated for antimicrobial activity.
• Data Provenance: The document states "A time kill study was conducted to determine how rapidly and effectively SwabTip™ kills a variety of microorganisms. SwabTip™ was tested for antimicrobial activity against six selected organisms using an industry standard protocol for time-kill assays." There is no specific information about the country of origin of the data or whether it was retrospective or prospective, but it implies a controlled laboratory study.

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

• This document describes performance testing of a medical device (disinfectant cap) against specific microbial challenges and physical/chemical properties, not a diagnostic or AI-driven image analysis tool. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of clinical interpretations (e.g., radiologists for imaging) is not applicable here. The ground truth (e.g., log reduction of bacteria) is established through standardized laboratory protocols and measurements.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where human interpretation of data (e.g., medical images) is involved. For the laboratory performance tests described (antimicrobial efficacy, physical integrity, etc.), such adjudication methods are not relevant. The results are based on objective measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The SwabTip™ is a device with a direct physical and chemical function, not a diagnostic or AI-assisted system.

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

• This question is also not applicable. The SwabTip™ is a physical device that performs disinfection, not a software algorithm. The "standalone performance" is the device's inherent ability to disinfect and maintain cleanliness, which was evaluated through the various performance tests listed.

7. The Type of Ground Truth Used

• The ground truth for the efficacy study was based on quantitative microbiological measurements (Log$_{10}$ reduction) of specific microbial strains after exposure to the device, conducted under industry standard protocols for time-kill assays.
• For other tests (e.g., Luer compatibility, physical integrity, biocompatibility), the ground truth was established by meeting specified engineering, material, and safety standards (e.g., ISO standards, USP requirements), against which the device's performance was measured.

8. The Sample Size for the Training Set

• This document describes the validation of a physical medical device, not the development of an AI model. Therefore, there is no "training set" in the context of machine learning. The studies described are performance validation tests.

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

• As there is no "training set" in the context of AI model development, this question is not applicable.

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When left in place for 30 seconds the Light Blue DualCap® disinfects needleless luer access valves and the Dark Blue DualCap® disinfects the IV administration line male luer connections; the caps provide a physical barrier to contamination up to 7 days, under normal conditions if not removed.

The DualCap® Disinfectant Cap is designed to fit securely on Luer access valves and IV administration line male Luer connections. The cap contains 70% isopropyl alcohol. The Subject device is not made with natural rubber latex, is non-pyrogenic, non-preservative and is not made with DEHP. The product consists of a Light Blue DualCap® for use on Luer access valves and a Dark Blue DualCap® for use on IV administration line male Luer connections. The Light Blue DualCaps® and Dark Blue DualCaps® are available in a number of packaging combinations such as two Light Blue DualCaps®, a Light Blue DualCap® and Dark Blue DualCap® combination, and as singles.

Additionally, DualCap® Disinfectant Caps will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk to the kitting manufacturer.

The provided text describes a 510(k) summary for the DualCap® Disinfectant Caps, which is a medical device intended to disinfect needleless luer access valves and IV administration line male luer connections. The document outlines acceptance criteria related to disinfection efficacy and physical barrier integrity, along with the performance data supporting these claims.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for the "test set" in the traditional sense of a clinical trial. The performance data is primarily based on in vitro studies and bench testing.

• In vitro antimicrobial efficacy studies: "worst case conditions" were used, but no specific number of samples (e.g., number of caps tested, number of replicates per organism) or test runs are detailed.
• Air-tight seal study: No specific number of caps or connections tested is provided.
• Biocompatibility testing: Standard battery of tests was performed in accordance with ISO 10993. The number of samples for each test (e.g., cytotoxicity, sensitization) is not specified.
• Physical tests (ISO 594): No specific number of caps or connections tested is provided.
• Prevention of disinfectant entry: Not specified.

Data Provenance: All studies described appear to be in vitro laboratory studies or bench testing. The document does not indicate any human clinical trials, patient data, or geographical origin of data (e.g., country).

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

Not applicable. The ground truth for this device's performance is established by the results of standardized laboratory tests and engineering benchmarks (e.g., ISO 594, microbial log reduction). It does not involve human interpretation of images or clinical data that would require experts to establish a "ground truth."

4. Adjudication Method for the Test Set

Not applicable. As the ground truth is established by objective laboratory measurements and standardized test results rather than expert consensus on subjective data, an adjudication method is not relevant.

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

No. No MRMC comparative effectiveness study was conducted. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the effect of AI on their performance is measured. The DualCap® Disinfectant Caps are a physical device with a disinfection and barrier function, not a diagnostic AI tool.

6. Standalone (Algorithm Only) Performance Study

Yes, in essence. The performance studies described (microbiological efficacy, physical tests, biocompatibility) represent the "standalone" performance of the device itself (the cap with its integrated alcohol) without human intervention influencing the core disinfection or barrier function during the test. While users apply the cap, the efficacy tests are assessing the inherent properties of the device system.

7. Type of Ground Truth Used

The ground truth used is primarily objective laboratory measurements and international standard compliance:

• Microbiological performance: Measured log reduction of specific microorganisms.
• Physical performance: Conformance to engineering standards (ISO 594) through metrics like leakage, separation force, and thread compatibility.
• Biocompatibility: Results of standardized in vitro and in vivo biological tests as per ISO 10993.
• Barrier function: Demonstrated air-tight seal.
• Prevention of fluid path contamination: Direct measurement of alcohol presence in the fluid path.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set" of data for development. The design and validation are based on engineering principles, material science, and microbiological efficacy, not machine learning.

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

Not applicable. (See point 8)

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The Curos Red is intended for use on dialysis catheter female Luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. In three (3) minutes after application, the Curos Red will disinfect the female Luer and act as a cover until removed. The Ivera Curos Red was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Red in the home or healthcare facility.

The Curos Red Port Protector contains 70% Isopropyl alcohol and is intended for use on dialysis catheter open female luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. The Curos Red has a highly visible red color that may allow improved compliance monitoring by easy visual verification to ensure that all open female luers are disinfected and covered. The Curos Red may be used in the home or healthcare facility.

Here's a breakdown of the acceptance criteria and study information for the Curos Red Port Protector, extracted from the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Beyond the bacterial count reduction, the device also met the following acceptance criteria (details on specific thresholds are not provided in the summary but are implied by meeting the requirements of the standards):

• ISO 594-2 testing: for ease of assembly, rotational force to remove (un-torque evaluation), and leakage using water under pressure and leakage using vacuum with air.
• Simulated Clinical Condition Evaluation testing: to demonstrate that the device seals and acts as a cover for the port.
• Sterilization: Validated Gamma sterilization process complying with ISO11137-1:2006, ISO11137-2:2006, and ISO11137-3:2006/(R) 2010.
• Biocompatibility: Materials of construction meet FDA recognized standard ISO10993.

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

• Sample Size: Not explicitly stated for the efficacy studies. However, efficacy testing typically involves multiple replicates per organism and condition.
• Data Provenance: The studies were conducted by Ivera Medical and are in vitro (laboratory-based) tests. The country of origin is not specified but is implicitly the location of Ivera Medical (Carlsbad, California, and San Diego, California, based on the contact information). The studies are prospective in the sense that they were conducted to specifically test the Curos Red device's performance against predefined criteria.

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 summary. Efficacy testing (like pathogen reduction) relies on standardized laboratory protocols, and the "ground truth" is typically defined by the experimental results themselves against the known inoculation concentrations, rather than expert consensus on interpretation.

4. Adjudication method for the test set

• This information is not applicable for the in vitro efficacy testing described. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations where human interpretation is involved.

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

• No, a MRMC comparative effectiveness study was not done. This device is a medical accessory for disinfection and port coverage, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

• Yes, the primary performance studies were standalone. The efficacy tests (bacterial count reduction) were performed directly on the device and its disinfectant properties, without human interpretation in the loop influencing the disinfection process or its outcome. The leakage and sealing tests were also evaluating the mechanical properties of the device independently.

7. The type of ground truth used

• For the efficacy studies (bacterial count reduction), the ground truth was established through microbiological testing against known concentrations of target microorganisms. The reduction in viable organisms after exposure to the device's disinfectant determined the effectiveness.
• For mechanical tests (ISO 594-2, Simulated Clinical Condition Evaluation), the ground truth would be based on engineering and performance specifications defined by the relevant standards and the manufacturer's internal protocols.

8. The sample size for the training set

• This information is not applicable as this device does not involve a "training set" in the context of machine learning or AI models. The device's performance is determined by its physical and chemical properties.

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

• This information is not applicable as there is no training set for this type of medical device.

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When left in place for five (5) minutes, the Dark Blue DualCap disinfects male luer connectors; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

The Dark Blue DualCap" is designed to Internet on all ISO standard mater and man and newides effective disintection of the male luer fromector after five minutes of applicat sterite. This device is not made with natural rubber latex, is non-pyrogenic, preservative free and is not made with DEHP, Additionally Datk Blue DualCap® will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterite to the kitting manufacturer for incorporation into the procedure Kits,

The provided document describes the Catheter Connections' Dark Blue DualCap® for Male Luers (K142399), a device intended to disinfect and protect male luer connectors. Here's an analysis of the acceptance criteria and supporting studies based on the provided text, using the requested format:

Acceptance Criteria and Device Performance

Study Details

The document refers to a 510(k) Premarket Notification Submission (K142399) for the Catheter Connections' Dark Blue DualCap® for Male Luers. The submission device is explicitly stated to be physically identical to the predicate device (DualCap™ for Male Luers, K123967) in terms of "intended use, design, materials, operation, function, and sterilization method." Therefore, the performance data provided supports the substantial equivalence by demonstrating the new device performs identically to the predicate.

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

   • Sample Size: The document does not specify exact sample sizes for each test in the performance data section. It mentions "Time Kill Studies" and "Additional in vitro antimicrobial efficacy studies" without giving the number of samples per test. For physical testing, it states "Applicable testing using ISO594-1 and ISO 594-2 was completed" and "passed all tests," again without specific sample counts.
   • Data Provenance: Not explicitly stated, but the testing appears to be laboratory-based ("in vitro antimicrobial efficacy studies") rather than from human clinical studies. The origin country of the data is not mentioned, but the submission is to the U.S. FDA. The studies are prospective in nature, designed to assess specific performance characteristics.

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

   • This type of information (experts establishing ground truth) is typically relevant for studies involving human interpretation (e.g., image analysis, diagnosis) or clinical endpoints where expert consensus is needed. For the performance data presented (biocompatibility, microbiological efficacy, physical compatibility, disinfectant containment), the "ground truth" is established by adherence to recognized standards (e.g., ISO, ASTM, FDA guidelines) and objective laboratory measurements, rather than expert consensus on a test set. Therefore, this information is not applicable in the context of the provided performance data.

3. Adjudication method for the test set:

   • Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical trials or studies where multiple readers or experts assess cases, and their disagreements need resolution. Since the described tests are objective laboratory measurements against defined standards, an adjudication method is not applicable.

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, an MRMC comparative effectiveness study was not done. This device is not an AI-powered diagnostic tool or one that involves human readers for interpretation.

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

   • This question is typically relevant for software or AI medical devices. The Dark Blue DualCap is a physical device (disinfectant cap). Therefore, the concept of "standalone algorithm performance" is not applicable. The performance tests assessed the device's inherent physical and functional properties.

6. The type of ground truth used:

   • Biocompatibility: Adherence to established FDA guidelines and international standards (ISO 10993) for biological evaluation.
   • Microbiological Efficacy: Objective measurement of log reduction against specified microorganisms, following industry standard protocols (ASTM E 2315-03, 2008). The ground truth is the quantitative antimicrobial activity observed in the laboratory.
   • Physical Compatibility: Compliance with international standards for luer connectors (ISO594-1 and ISO 594-2). Ground truth is successful meeting of the physical specifications.
   • Disinfectant Containment: Objective measurement or observation of the absence of disinfectant ingress into the fluid path.

7. The sample size for the training set:

   • This pertains to machine learning models (AI). As this is a physical medical device, there is no "training set" in the context of an algorithm.

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

   • As there is no training set for an algorithm, this question is not applicable to the device described.

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SwabCap® is intended for use on swab-able luer access valves as a cover to protect the luer access valves from potential contamination. The SwabCap® acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap® will disinfect the valve five (5) minutes after application and maintains a disinfected valve surface for up to seven (7) days if not removed.

SwabCap is a plastic threaded cap that houses a small sponge saturated with 70% isopropyl alcohol. The device is designed to securely fit on swab-able luer access valves to disinfect the valve surface and maintain antiseptic conditions between line accesses. SwabCap" is a sterile, single-use device, provided as a stand-alone product.

This FDA 510(k) summary for the SwabCap® device (K130975) focuses on demonstrating substantial equivalence to a predicate device (SwabCap® K083508) rather than providing a detailed study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial for a novel AI device. The submission is primarily aimed at extending the indications for use (from 96 hours to 7 days of disinfection) for a modified version of an already cleared device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, sample size for training set, ground truth for training set) are not applicable or explicitly mentioned in this type of regulatory submission as they would be for an AI/ML medical device.

However, I can extract the relevant information and infer some aspects based on the provided document.

Acceptance Criteria and Device Performance

The acceptance criteria here are implicitly related to maintaining the efficacy of disinfection for an extended period (up to 7 days) while demonstrating safety and substantial equivalence to the predicate device. The performance is assessed through non-clinical testing.

Study Details (Based on available information)

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: Not specified in the provided summary. As this is a non-clinical submission for a device component, these "test sets" would likely refer to laboratory samples (e.g., luer access valves, material samples) subjected to standardized testing protocols, not a human patient cohort.
   • Data Provenance: Not specified. Experiments would typically be conducted in a controlled lab setting, likely in the US where the manufacturer is located, or by certified contract research organizations. The testing described is prospective, in that it evaluates the device's performance under controlled conditions.

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)

   • Not applicable/mentioned. For non-clinical antimicrobial efficacy, toxicology, and sterilization testing, the "ground truth" is established by validated laboratory assays and adherence to relevant standards (e.g., ISO, ASTM, USP). The expertise would be in microbiology, material science, and toxicology, employed by the testing facility, rather than clinical experts for ground truth labeling.

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

   • Not applicable. This concept is relevant for human interpretation tasks, not for non-clinical laboratory testing of device efficacy. Assays have defined endpoints and criteria for success, typically interpreted by a single qualified lab technician or scientist according to a protocol.

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. This is not an AI/ML device, and thus an MRMC study is not relevant.

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

   • Not applicable. This is not an AI/ML algorithm; it is a physical medical device (disinfectant cap). Its performance is inherently "standalone" in the sense that it mechanically disinfects, without human interpretation in its function.

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

   • Validated Laboratory Assays: This includes standardized microbiological methods to quantify bacterial reduction/inhibition, chemical analysis to verify alcohol concentration, and material science tests for biocompatibility and structural integrity. The "ground truth" is the quantitative result of these assays compared against predetermined acceptance limits derived from regulatory standards and scientific principles.

7. The sample size for the training set

   • Not applicable. This is not an AI/ML device requiring a training set.

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

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

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When left in place for five (5) minutes, the dark blue DualCap™ for male luer connectors disinfects the IV administration line male luer connectors; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

The dark blue DualCap™ for male luers is designed to fit securely on IV administration male luer connections. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile. This device is not made with natural rubber latex, non-pyrogenic, preservative free and DEHP free.

The provided text is a 510(k) Premarket Notification Submission for the "Catheter Connections' Dark Blue DualCap™ for Male Luers". It describes the device, its intended use, and compares it to a previously cleared device (Sponsor's Cleared Device - K093229). The core of this submission is to demonstrate substantial equivalence to the predicate device, primarily focusing on a change in packaging configuration.

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

• This document does not describe a study in the traditional sense of a clinical trial or performance study with specific metrics like sensitivity, specificity, or reader performance. Instead, it's a regulatory submission demonstrating substantial equivalence to a predicate device, largely based on a change in packaging. The "studies" mentioned are comparisons of specifications, risk analysis, and standard engineering tests (peel strength, sterility, biocompatibility).

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly stated in terms of number of devices or units tested for each characteristic. The "comparison of specifications" implies reviewing documentation rather than physical testing on a large sample. "Standard Peel strength tests" were performed, but the sample size for these tests is not specified.
• Data Provenance: The document describes a comparison between a "Modified Device" and a "Sponsor's Cleared Device". The data would likely be from internal testing and specifications of the manufacturer for both devices. There is no mention of country of origin of data in a broad sense, nor if the data is retrospective or prospective, as it pertains to specific engineering tests and comparisons rather than patient data.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable. This submission is not based on expert consensus for ground truth on clinical outcomes or diagnostic accuracy. It relies on engineering specifications, regulatory standards (like ISO), and internal testing to demonstrate substantial equivalence for a device designed for disinfection and physical barrier functions.

4. Adjudication Method:

• Not Applicable. This is not a study requiring adjudication of expert opinions or clinical data.

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

• No. This is not a diagnostic device involving human readers or interpretation. Therefore, an MRMC study and effects of AI assistance are not relevant.

6. Standalone (Algorithm Only) Performance:

• Not Applicable. This is a physical medical device (disinfectant cap), not an AI algorithm. Its performance is evaluated through material science, microbiology (implied by disinfection claim, though not detailed in this section), and structural integrity, not algorithmic output.

7. Type of Ground Truth Used:

• The "ground truth" here is established through:
  • Regulatory Standards: Adherence to ISO standards (e.g., ISO 11137 for sterilization, ISO 10993 for biocompatibility).
  • Engineering Specifications: Comparisons of design, materials, manufacturing processes, and performance characteristics (e.g., peel strength) against the predicate device.
  • Risk Analysis: To determine if changes introduce new safety or effectiveness concerns.

8. Sample Size for the Training Set:

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

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

• Not Applicable. No training set is involved.

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