Search Results

MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination.

MediClear™ PreOp can be left on the preoperative incision site for up to 7 days.

MediClear™ PreOp is intended to be used on intact skin and for external use only.

MediClear™ PreOp consists of a clear polyurethane film coated with an antimicrobial silicone adhesive containing 3% w/w chlorhexidine and 0.5% w/w silver salts and is intended to cover and protect skin from the risk of contamination prior to an invasive procedure (i.e. incision or insertion). The chlorhexidine and silver contained in the adhesive provides continuous antimicrobial activity while the polyurethane barrier film acts as a protective patient covering to isolate a procedural site from microbial and other contamination.

MediClear™ PreOp provides an effective physical barrier against external contamination including fluids, bacteria, and yeast. In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear. * In vitro effectiveness does not predict clinical performance.

MediClear™ PreOp is a breathable, transparent, self-adhesive silicone film that conforms to the contours of the body.

The document describes the acceptance criteria for the MediClear™ PreOp device and the studies performed to demonstrate that it meets these criteria.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: The document explicitly states: "In vitro effectiveness does not predict clinical performance." This is an important disclaimer for the antimicrobial activity results.

2. Sample Size Used for the Test Set and the Data Provenance:
The document does not provide specific sample sizes for any of the non-clinical tests mentioned. All tests listed are in vitro or bench tests conducted in a laboratory setting. There is no indication of human or animal data provenance (e.g., country of origin, retrospective/prospective) for these non-clinical tests.

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 as the studies described are non-clinical bench and in vitro tests. Ground truth in this context would typically refer to the reference standards or control groups used in the laboratory experiments, as well as the expertise of the scientists performing and interpreting the tests according to the cited ISO and ASTM standards. The document does not specify the number or qualifications of these scientific personnel.

4. Adjudication Method for the Test Set:
This information is not applicable as the studies described are non-clinical bench and in vitro tests. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies or studies involving human readers/interpreters where disagreements need to be resolved.

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:
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The device is a physical surgical drape, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone algorithm-only performance study was not performed. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the antimicrobial activity, the "ground truth" or reference for evaluating reduction would be the initial microbial counts before exposure to the device, as measured by standard microbiological assays. For biocompatibility tests, the ground truth refers to established biological responses to control materials or the absence of adverse effects as defined by the ISO 10993 series. For barrier performance, it's the ability to prevent penetration under defined conditions specified by ASTM/AAMI standards. These are laboratory-based ground truths derived from scientific standards and experimental controls.

8. The sample size for the training set:
This information is not applicable. The device is a physical medical device and does not involve AI or machine learning algorithms that require a training set.

9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.

Ask a specific question about this device

To be used as a urological catheter inserted through the urinary tract by individuals that are > 30 kg and over 12 years of age. SilverCoat™ Silicone Foley Catheters should not be used on patients with known hypersensitivity or allergy to silver or silver-containing organics or inorganics.

SilverCoat™ Silicone Foley Catheters are 100% silicone Foley catheters that have a lubricious coating impregnated with silver ions. The silver is retained in the hydrophilic coating through ionic bonding and is covalently bonded to the silicone surface. The coating will not peel, flake or crack. The coating hydrates rapidly becoming slippery (lubricious) and maintains its lubricity for at least seven days. The SilverCoat™ catheter complies with the FDA recognized consensus standard, ASTM F623-99 Standard Performance Specification for Foley Catheter. The catheters are comprised of a twolumen shaft with proximal funnel, inflation valve, and distal retaining balloon. Balloon fill volumes are in millimeters and the shaft size is in French (Fr.) which is indicated on the funnel of each individual catheters are supplied in individually packaged, sealed single use pouches and they are sterilized by ethylene oxide. The SilverCoat™ Foley Catheter is a prescription-only device and it is intended to be used in healthcare facility/hospital, home, and ambulatory settings.

This document is a 510(k) summary for the Covalon SilverCoat™ Silicone Foley Catheter, comparing it to the predicate device, Medline SilverTouch™ Silicone Foley Catheter. This is a premarket notification for a medical device and therefore does not contain information about studies of AI performance or clinical studies. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not applicable or not present in a 510(k) summary:

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

The document does not provide a formal table of acceptance criteria with specific numerical thresholds and corresponding device performance values for each test. Instead, it lists the types of performance tests conducted to demonstrate substantial equivalence to the predicate device and compliance with recognized standards.

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

The document does not specify the sample sizes used for the "test set" for each type of performance testing. This is common for 510(k) submissions, which typically focus on demonstrating compliance with recognized standards and substantial equivalence rather than detailed statistical analysis of clinical studies.

The data provenance is not explicitly stated as "country of origin." However, the sponsor, Covalon Technologies, Inc., is based in Mississauga, Ontario, Canada, and the testing would have been conducted by or for them, likely in Canada or a facility compliant with international standards for medical device testing. The testing described is generally prospective in nature, as it involves newly manufactured devices undergoing specific tests.

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 section is not applicable. The provided document describes non-clinical performance testing for a urological catheter. "Ground truth" and "experts" in the context of diagnostic performance (e.g., radiologists interpreting images) are concepts relevant to AI/diagnostic device studies, which are not described here. The "ground truth" for these tests would be the established scientific methods, physical properties, and safety standards against which the device is evaluated.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints where agreement among reviewers is required to establish a gold standard. The tests described are laboratory-based performance tests (e.g., physical properties, biocompatibility, microbial resistance) that do not involve human adjudication in this manner.

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 section is not applicable. The document is a 510(k) summary for a physical medical device (Foley catheter) and does not involve AI, human readers, or image interpretation. Therefore, no MRMC comparative effectiveness study or AI assistance evaluation was conducted.

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

This section is not applicable. The device is a physical medical device and does not involve an algorithm.

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

As mentioned in point 3, the concept of "ground truth" as it applies to diagnostic performance is not relevant here. For the performance tests listed (e.g., physical properties, biocompatibility, microbial resistance, silver elution), the "ground truth" is based on:

• Recognized consensus standards: ASTM F623-99 and EN 1616, Annex A/D.
• Established scientific methodologies: For tests like Kirby-Bauer, AMES assay, cytotoxicity, etc.
• Predetermined specifications: Derived from the predicate device and design requirements.

8. The sample size for the training set

This section is not applicable. There is no "training set" as this device does not involve machine learning or AI.

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

This section is not applicable for the same reasons as point 8.

Ask a specific question about this device

SurgiClear™ is intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires.

SurgiClear™ may also be used to cover and secure primary dressing.

SurgiClear™ inhibits microbial growth within the dressing and prevents external contamination.

SurgiClear™ is composed of a clear polyurethane film coated with a silicone adhesive containing chlorhexidine and silver salts.

This document (K121819) is a 510(k) Premarket Notification for a medical device called SurgiClear™ Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver, submitted by Covalon Technologies Inc. in 2012.

The 510(k) summary focuses on demonstrating that the new device is "substantially equivalent" to already legally marketed predicate devices, rather than providing detailed acceptance criteria and study results in the format requested, which is more typical for AI/ML device submissions.

Here's an attempt to extract and interpret the information provided in the context of your request, with significant caveats that the level of detail is much lower than what would be expected for AI/ML performance studies:

Acceptance Criteria and Reported Device Performance

The provided document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) because it's a submission for a physical medical product (a wound dressing), not an AI/ML diagnostic or predictive algorithm.

Instead, the "acceptance criteria" are implied by the battery of tests performed to demonstrate safety and effectiveness for a physical device, and the "reported device performance" is that the device met these criteria, leading to a determination of substantial equivalence.

Implied "Acceptance Criteria" and "Reported Device Performance" (based on tests conducted):

Study Details (Based on available information)

Given this is a physical medical device and not an AI/ML algorithm, many of the requested points are not applicable or the information is not provided in the document.

2. Sample size used for the test set and the data provenance:
* Test Set (In vitro log reduction): Not specified. This typically involves standardized bacterial cultures.
* Test Set (Biocompatibility): Not specified. These studies typically use cell cultures (cytotoxicity), animal models (systemic toxicity, sub-chronic toxicity), and guinea pigs/rabbits (sensitization, irritation).
* Test Set (Porcine wound healing study): Not specified, but involved porcine models. Data provenance is implied as in-vivo animal study.
* Test Set (Human repeat insult patch test): Not specified, but involved human subjects. Data provenance is implied as prospective clinical study (human subjects).
* Country of Origin: Studies likely conducted in Canada or via contract research organizations for a Canadian company.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* Not applicable in the AI/ML sense. Ground truth for these studies would be established by laboratory technicians, pathologists, and clinicians/toxicologists, following established scientific and regulatory protocols rather than "expert consensus" on imaging or data interpretation.

4. Adjudication method for the test set:
* Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation discrepancies in AI/ML studies. For these types of device tests, results are typically objective measurements or observations interpreted by trained personnel according to pre-defined criteria.

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 wound dressing and does not involve human readers or AI assistance.

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:
* In vitro log reduction: Measured bacterial count reductions.
* Biocompatibility: Histopathological findings, cytotoxicity assays, irritation scores, systemic toxicity measurements, sensitization reactions.
* Porcine wound healing study: Clinical observations of wound healing, possibly histopathology.
* Human repeat insult patch test: Clinical assessment of skin reaction (e.g., erythema, edema) by dermatologists or trained clinicians.

8. The sample size for the training set:
* Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:
* Not applicable.

Conclusion:

The provided document is a 510(k) summary for a physical medical device (wound dressing) and therefore does not contain the type of detailed information about acceptance criteria, sample sizes, expert ground truth, or study designs that would be relevant for an AI/ML medical device submission. The performance testing section mentions several standard biological and clinical studies (in vitro log reduction, biocompatibility, porcine wound healing, human repeat insult patch test) which confirmed the device's safety and effectiveness, leading to a determination of substantial equivalence to predicate devices.

Ask a specific question about this device

IV Clear® is intended to cover and protect insertion sites, and secure devices to skin. Common applications include IV catheters, central venous lines, PICCs, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices. IV Clear® inhibits microbial growth within the dressing and prevents external contamination.

IV Clear® is composed of a clear polyurethane film coated with a silicone adhesive containing chlorhexidine and silver salts.

This document describes the premarket notification (510(k)) for the IV Clear® Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the format typically used for AI/ML device evaluations. This submission primarily focuses on establishing substantial equivalence to predicate devices based on safety and efficacy, rather than AI performance.

Therefore, many of the requested sections about AI performance studies, sample sizes for training/test sets, ground truth establishment, expert qualifications, and MRMC studies are not applicable to this 510(k) summary. I will answer the applicable questions based on the provided text.

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in a tabular format as would be expected for an AI/ML device. Instead, it lists types of performance tests conducted to demonstrate substantial equivalence for the dressing.

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

The document does not provide sample sizes for any test sets in the context of an AI/ML device study. It refers to a "Porcine wound healing study," a "Human repeat insult patch test," and a "Human regrowth prevention study," but no details on sample size, data provenance, or study design (retrospective/prospective) are given for these tests. These are biological/clinical tests for a medical dressing, not data sets for AI evaluation.

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 applicable and not present in the document. The studies referenced are for a physical medical device (dressing), not an AI/ML diagnostic or assistive device that would require expert-established ground truth for its performance evaluation.

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

This information is not applicable and not present in the document. Adjudication methods are typically used when establishing ground truth for evaluating AI/ML models, which is not the context of this 510(k) summary.

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

This information is not applicable and not present in the document. This is a 510(k) for a medical dressing, not an AI/ML device, and therefore no MRMC study or AI assistance evaluation would be conducted or described.

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

This information is not applicable and not present in the document. This is not an AI/ML device.

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

For the studies mentioned (e.g., porcine wound healing, human repeat insult patch test, human regrowth prevention), the "ground truth" would likely be based on standard biological, clinical, or laboratory measurements and observations relevant to wound healing, skin irritation, and microbial growth inhibition. Precise details are not provided in this 510(k) summary. It would not typically involve "expert consensus" in the way it's used for image/data labeling in AI/ML.

8. The sample size for the training set

This information is not applicable and not present in the document. There is no AI/ML model for which a training set would be required.

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

This information is not applicable and not present in the document. There is no AI/ML model for which ground truth for a training set would be established.

Ask a specific question about this device

ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness wounds including: Pressure ulcers, Diabetic ulcers, Ulcers caused by mixed vascular etiologies, Venous ulcers, First and Second degree burns, Donor and graft sites, Abrasions, Dehisced surgical wounds, Traumatic wounds healing by secondary intention.

ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is an advanced wound care dressing composed of collagen, sodium alginate and silver chloride provided in a sterile sheet or rope form. ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are pliable, absorbent dressings that absorb moisture such as wound fluid forming a gel, thus maintaining a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. The dressings act as an effective barrier to bacterial and fungal penetration. The silver content is intended to prevent colonization of the dressing. The dressings can be cut to fit specific wounds and are able to be layered for the management of deep wounds.

The provided document is a 510(k) summary for the ColActive Ag™ Collagen with Silver, Antimicrobial Dressing, which focuses on demonstrating substantial equivalence to previously marketed wound dressings. This type of regulatory submission does not typically include detailed clinical studies or performance data with acceptance criteria in the way envisioned by the prompt for an AI-based device. Instead, it relies on demonstrating similar characteristics and safety to existing devices.

Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, training set size, etc.) are not applicable to this 510(k) submission for a wound dressing.

However, I can extract the information that is relevant to the document provided, focusing on what was included to demonstrate safety and equivalence.

Here's a breakdown based on the provided text, acknowledging the limitations for an AI-centric evaluation:

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

The document does not specify quantitative "acceptance criteria" for device performance in the same way an AI device might have metrics like sensitivity or specificity thresholds. Instead, it focuses on demonstrating biocompatibility and substantial equivalence to predicate devices. The "performance" is primarily shown through the successful completion of standard biocompatibility tests.

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

• Sample Size for Test Set: Not specified in the 510(k) summary. Biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) typically involve in vitro and in vivo animal studies (using specific numbers of cells/animals per test), but these details are not provided here.
• Data Provenance: Not specified, but generally, ISO 10993 tests are conducted in certified laboratories. The country of origin of the data is not mentioned.
• Retrospective or Prospective: Not applicable in the context of biocompatibility testing for this wound dressing.

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

• Number of Experts: Not applicable. Biocompatibility testing relies on standardized protocols and laboratory analysis, not expert consensus on medical imaging or diagnoses.
• Qualifications of Experts: Not applicable in this context.

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

• Adjudication Method: Not applicable. Biocompatibility testing has objective endpoints measured in a lab, not subjective interpretations requiring adjudication.

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

• MRMC Study: No, this type of study is not relevant for a wound dressing. This is a medical device, not an AI diagnostic or assistive tool for human readers.

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

• Standalone Performance: Not applicable. This is a physical wound dressing, not an algorithm.

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

• Type of Ground Truth: For biocompatibility, the "ground truth" is established by the results of standardized biological tests performed according to ISO 10993-1. These tests assess endpoints like cytotoxicity, irritation, and sensitization. For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical wound dressing, not a machine learning model.

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

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device

ColActive™ Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including:

• Pressure ulcers
• Diabetic ulcers
• Ulcers caused by mixed vascular etiologies
• Venous ulcers
• Second degree burns
• Donor and graft sites
• Abrasions
• Dehisced surgical wounds
• Traumatic wounds healing by secondary intention

ColActive™ Collagen Wound Dressing is an advanced wound care dressing composed of collagen and sodium alginate provided in a sterile sheet or rope form. Collagen Wound Dressings are pliable, absorbent dressings that absorb moisture such as wound fluid forming a gel, thus maintaining a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. The dressings can be cut to fit specific wounds and are able to be layered for the management of deep wounds.

The provided text is a 510(k) Notification for the ColActive™ Collagen Wound Dressing. This document is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission generally does not include clinical studies with acceptance criteria and detailed performance data in the same way a PMA (Premarket Approval) submission would.

In this context, the "study that proves the device meets the acceptance criteria" refers to the demonstration of "substantial equivalence" to a predicate device, as required for 510(k) clearance. The acceptance criteria are implicit in the FDA's requirements for substantial equivalence, which primarily revolve around demonstrating similar materials, intended use, and functioning compared to an already approved device, along with biocompatibility.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not contain information about a "test set" in the context of clinical performance data or a specific dataset used for evaluation related to efficacy or diagnostic accuracy. The "tests" mentioned are biocompatibility tests (ISO 10993).

• Sample Size for Biocompatibility: Not specified in the document. Biocompatibility testing typically involves in vitro and/or in vivo studies on materials, not human-patient "test sets" for performance evaluation in the same way clinical trials do.
• Data Provenance: Not applicable for clinical trial data. For biocompatibility, the tests were conducted according to ISO 10993-1, an international standard.

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

This information is not applicable to this 510(k) submission. There is no mention of a "test set" requiring expert ground truth for performance evaluation (e.g., image interpretation, disease diagnosis). The submission focuses on substantial equivalence based on material composition, intended use, function, and biocompatibility.

4. Adjudication Method for the Test Set

This information is not applicable as there is no specific "test set" or clinical performance study described that would require an adjudication method.

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 physical wound dressing, not an AI or diagnostic imaging device that would involve human readers or MRMC studies.

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 wound dressing and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Predicate Device Characteristics: The established safety and effectiveness of the identified predicate devices (FIBRACOL PLUS Collagen Wound Dressing with Alginate and SkinTemp Kollagen Wound Management Material) served as the primary "ground truth" for substantial equivalence.
• Biocompatibility Standards: ISO 10993-1 outlines the scientific principles and methods for evaluating the biological safety of medical devices, which acts as a "ground truth" for material safety.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of machine learning or clinical trials described for this wound dressing.

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

This is not applicable as there is no training set mentioned.

Ask a specific question about this device