Search Results

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)

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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

The DualCap Solo™ is designed to fit securely on luer access valves. 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.

This document is a 510(k) Summary of Safety and Effectiveness for the Catheter Connections DualCap Solo™. It doesn't describe an AI/ML device, but rather a medical device with an administrative change related to its packaging. Therefore, the requested information about AI model performance, training data, ground truth establishment, and expert involvement is not applicable.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (the Sponsor's Cleared Device - K113842) by proving that a change in packaging configuration does not alter the device's safety or effectiveness.

Here's an analysis of the provided information within that context:

1. Table of Acceptance Criteria and Reported Device Performance

The device is claiming substantial equivalence based on the packaging change not affecting the core characteristics or performance. The "acceptance criteria" here are essentially "identical" or "substantially equivalent" when compared to the previously cleared device.

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

The document does not specify a distinct "test set" in the context of an algorithm. Instead, it refers to various specifications and internal test methods.

• For hermetic foil/polymer lid material, polymer sealing surface, and sealing process, "specifications" are compared. It does not mention a sample size for this comparison, suggesting a review of documentation rather than a physical test on a sample.
• For indications for use, "label specifications" were compared, also implying documentation review.
• For design, materials, sterilization method, and method of operation, "requirements (design input) and verification (design output)" were compared. Again, no specific test set sample size is mentioned.
• For seal peel force/strength, an "Internal Test Method ATM 1208 based on ASTM F88" was used. The document mentions "performance data" but does not provide details on the sample size used for these tests.
• The data provenance is internal to Catheter Connections, Inc., as indicated by references to internal document designations (e.g., "MSP 21-PX008", "ASC 1168", "ATM 1208"). The data is implicitly prospective in the sense that the testing was performed on the new modified device for this submission.

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

Not applicable. This device is not an AI/ML device requiring expert ground truth for a test set. Ground truth, in this context, would be established by the engineering and quality control standards applied during the manufacturing and testing of the device, referencing industry standards (e.g., ISO-10993, ASTM F88).

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as would be used for clinical or image-based studies. The assessment is based on comparing specifications and performance data to established standards and the predicate device.

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

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The "ground truth" here is embodied by:

• Identicality to predicate device specifications: For material, sealing process, indications for use, and sterilization method.
• Substantial equivalence to predicate device characteristics: For design, materials (more broadly), and method of operation.
• Compliance with recognized standards: Such as ISO-10993 (biocompatibility) and ASTM F88 (peel strength).
• Risk Analysis: Performed according to internal methods to ensure no new safety or effectiveness questions are raised.

8. The Sample Size for the Training Set

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

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

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

Ask a specific question about this device

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

The DualCap Solo™ is designed to fit securely on luer access valves. 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.

This document is a 510(k) Premarket Notification Summary for the Catheter Connections' DualCap Solo™. It does not contain a detailed study report with specific acceptance criteria and performance data in the format requested. Instead, it makes a general claim of substantial equivalence to a predicate device (DualCap™ K093229) based on performance testing.

Therefore, I cannot fulfill most of your request directly from the provided text. I can, however, extract the claimed Indications For Use and the general statement about performance data.

Here's what can be extracted and what cannot:

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

• Cannot be provided specifically. The document states, "The Catheter Connections' DualCap Solo™ will meet all established acceptance criteria for performance testing," but does not list these criteria or the numerical results from the performance testing.

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

• Cannot be provided. The document states "Verification testing was performed according to protocols," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Cannot be provided. This type of information is usually relevant for studies involving subjective assessments, such as imaging or diagnostic AI. The DualCap Solo is a physical device for disinfecting and acting as a barrier, so "ground truth" would be established through microbiology and engineering testing, not expert interpretation of outputs.

4. Adjudication method for the test set:

• Not applicable/Cannot be provided. For the same reason as point 3, adjudication methods like 2+1 or 3+1 are not relevant for this type of device testing.

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

• Not applicable/Cannot be provided. This is an AI-specific study type, and the DualCap Solo is not an AI diagnostic or assistive device.

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

• Not applicable/Cannot be provided. The device is not an algorithm.

7. The type of ground truth used:

• Inferred based on device type: For a disinfectant and barrier cap, the "ground truth" would likely involve microbiological assays (to confirm disinfection efficacy) and physical barrier integrity tests (to confirm it prevents contamination). The document mentions "Biocompatibility requirements according to ISO-10993" and "Sterilization requirements of ISO 11137" which are examples of standards guiding such ground truth establishment.

8. The sample size for the training set:

• Not applicable/Cannot be provided. This device is not an AI model requiring a training set.

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

• Not applicable/Cannot be provided. This device is not an AI model requiring a training set.

Summary of available information:

Indications For Use (as per K113842):
"When left in place for five (5) minutes, DualCap Solo™ disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed."

General Statement on Performance:
"Performance data gathered demonstrated that the Catheter Connections' DualCap Solo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™)."
"The Catheter Connections' DualCap Solo™ will meet all established acceptance criteria for performance testing."

Type of Ground Truth (Inferred):
Microbiological efficacy (disinfection), physical barrier effectiveness, biocompatibility, and sterility testing, based on standards like ISO 11137 and ISO 10993.

The document is a regulatory submission for substantial equivalence, which typically focuses on demonstrating that a new device is as safe and effective as an already cleared predicate device, rather than providing a detailed scientific study report with all raw data and acceptance criteria specifics.

Ask a specific question about this device

When left in place for five (5) minutes, DualCap Duo™ disinfects needleless Luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

The DualCap Duo™ is designed to fit securely on Luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, non-pyrogenic, preservative free and DEHP free.

The provided text describes a medical device called "Catheter Connections' DualCap Duo™" and its substantial equivalence to a predicate device, but it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics. Instead, it generally states that performance data demonstrate equivalence and that the device "will meet all established acceptance criteria for performance testing."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other specific study details since they are not present in the provided text.

However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance:
* Not Available. The document states, "The Catheter Connections' DualCap Duo™ will meet all established acceptance criteria for performance testing," but does not list specific criteria or the quantitative performance results against them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not Available. No details about sample size or data provenance (country of origin, retrospective/prospective) are mentioned for any testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
* Not Applicable / Not Available. This device is a disinfectant cap, not an AI/imaging device requiring expert ground truth for a test set in the same manner. No information about experts establishing ground truth is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not Applicable / Not Available.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not Applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not Applicable. This is not an algorithm. The device's performance is standalone in the sense that its disinfection capabilities are intrinsic to the product. The document states, "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols," and "Performance data gathered demonstrated that the Catheter Connections' DualCap Duo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™)."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not Applicable / Not Available. For a device that disinfects, performance would likely be measured through microbiological testing against certain pathogen reductions or barrier efficacy, but the specific "ground truth" methodology is not detailed.

8. The sample size for the training set:
* Not Applicable / Not Available. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:
* Not Applicable / Not Available. This is not an AI/machine learning device.

Information that is available about the device and its testing:

• Device Name: Catheter Connections' DualCap Duo™
• Intended Use/Indications For Use: When left in place for five (5) minutes, it disinfects needleless Luer access valves. Thereafter, the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
• Key Technological Characteristic/Mechanism: Contains 70% isopropyl alcohol to disinfect. Provides a physical barrier.
• Standards Used for Evaluation (referenced, not detailed):
  • ISO 11137: 2006, Sterilization of health care products - Radiation.
  • ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.
  • Other unspecified "additional standards and protocols."
• Conclusion of Performance Data: "Performance data gathered demonstrated that the Catheter Connections' DualCap Duo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™)." This indicates that the new device's performance was found to be comparable to that of an already cleared device (K093229 - DualCap™) based on the testing performed according to the referenced standards. The device is deemed "safe and effective for its intended use."

To summarize, the document asserts that testing was performed and demonstrated substantial equivalence to a predicate device, and that the device meets acceptance criteria. However, it does not provide the specific acceptance criteria, quantitative performance results, or detailed study methodology that would be required to complete the requested table and answer many of the questions.

Ask a specific question about this device

When left in place for five (5) minutes the female component of DualCap™ disinfects needleless Luer access valves and the male component of DualCap™ disinfects the IV administration line male Luer connections; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

The DualCap™ is designed to fit securely on Luer access valves and IV administration line male Luer connections. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, non-pyrogenic, preservative free and DEHP free.

Additionally DualCap™, the device will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterile to the kitting manufacturer (DualCap™ will be packaged in metalized unit container and will be impervious to ETO). The Catheter Connections' DualCap™ will be incorporated into the procedure kit.

The provided text does not describe an acceptance criteria study for a medical device that makes use of AI/ML. The document is a 510(k) premarket notification for a device called "Catheter Connections DualCap," which is an alcohol-impregnated cap designed to disinfect Luer access valves and IV administration line male Luer connections.

Therefore, I cannot provide information for the following points as they are not applicable to the provided document:

1. A table of acceptance criteria and the reported device performance.
2. Sample sized used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices through design characteristics, intended use, and existing scientific methods for assessing safety and effectiveness (e.g., sterilization, biocompatibility, and performance testing), not through clinical studies involving human readers or AI/ML algorithms.

The document indicates that "The Catheter Connections' DualCap™ will meet all established acceptance criteria for performance testing" and that "Performance data gathered demonstrated that the Catheter Connections' DualCap™ is substantially equivalent to the noted predicate devices." However, it does not explicitly list these acceptance criteria or the detailed results of the performance testing. It mentions that "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols." The standards referenced are ISO 11137:2006 for sterilization and ISO-10993 for biocompatibility.

In summary, the provided text describes a traditional medical device (not an AI/ML device) and confirms that performance testing was conducted to demonstrate substantial equivalence, but it does not provide the specific details of acceptance criteria or study outcomes.

Ask a specific question about this device