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Sterile, single-use dressings for management of pressure ulcers, 1st and 2nd degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites.

The AbsoClear product family is a series of single-use, sterile transparent synthetic wound dressings made of absorbent acrylic polymers. The dressings maintain a moist wound environment, which has been shown to be conducive to wound healing, but that also can also absorb wound exudate. Full transparency allows monitoring wound healing stages without removal of the dressing. The sterile dressings are supplied singly in sealed trilaminate pouches and are sterilized by gamma irradiation.

The provided text describes the AbsoClear® wound dressing. The acceptance criteria and the study that proves the device meets the acceptance criteria are outlined as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of clinical data for the AbsoClear device. Instead, the performance evaluations are based on:

• Bench Testing: Performed on "each lot" of AbsoClear product. The exact sample size per lot is not specified.
• Sterilization Validation: No specific sample size for a "test set" is mentioned, rather the process was validated per ISO 11137.
• Shelf-life Testing: No specific sample size for a "test set" is mentioned. Testing was done on product and packaging after specific storage conditions.
• Biocompatibility Testing: No specific sample size of devices is mentioned, but tests were performed on "the finished packaged, sterilized product."

The data provenance is not described as being from a specific country or retrospective/prospective in a clinical sense, as the studies are primarily lab-based (bench, sterilization, shelf-life, biocompatibility).

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

Not applicable. The studies described are not clinical studies that would involve experts establishing ground truth for a test set. The acceptance criteria are based on pre-defined technical specifications and international standards (e.g., ISO 11137, ISO 10993).

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set described that would require an adjudication method.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Additional clinical testing was not required."

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

Not applicable. The device is a physical wound dressing, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by:

• Technical Specifications: Pre-defined performance parameters for the wound dressing (e.g., absorption capacity, seal strength, MVTR).
• International Standards: Compliance with standards such as ISO 11137 for sterilization and ISO 10993 for biocompatibility. These standards define the methods and acceptance limits for various tests.
• Comparison to Predicate Device: The claim of substantial equivalence is based on the new device having "similar technological characteristics and materials as a previously cleared device." This implies the predicate device's established safety and effectiveness serve as the benchmark.

8. The Sample Size for the Training Set

Not applicable. The device is a physical wound dressing and does not involve a training set as would be found in machine learning algorithms.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.

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QuikClot Interventional-A Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anti-coagulation treatment.

The QuikClot Interventional-A Hemostatic Bandage that is the subject of this submission is described in detail in K090620 in that it is made of a soft, white, kaolin-impregnated gauze. QuikClot® Interventional-A Hemostatic Bandage may be provided in a kit form that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® bandage (K973036) or equivalent. The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by l 1/2"wide by 1/2" thick multi-layer pad.

Here's an analysis of the acceptance criteria and supporting studies for the QuikClot Interventional-A Hemostatic Bandage, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative format typical for regulatory submissions (e.g., "sensitivity must be > X%", "specificity must be > Y%"). Instead, it presents performance metrics from pre-clinical animal studies and clinical studies. The implicit acceptance criterion is that the device demonstrates efficacy in controlling bleeding in anticoagulated patients, comparable to or superior to control methods, with an acceptable safety profile.

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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.

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The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep™ Antegrade Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow® NextStep™ Antegrade catheter is intended for use in adult patients.

The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is a 15 Fr, 2 lumen, one piece Carbothane catheter with a preloaded stylet and step tip designed for antegrade placement. The catheter is available in multiple lengths. The procedure kit includes the necessary accessories to correctly insert the catheter.

The provided 510(k) summary for the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238) does not describe a study that uses AI/algorithm performance. Instead, it focuses on demonstrating the substantial equivalence of a medical device (a catheter) to a predicate device through traditional engineering and biological performance testing.

Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context.

Here's a breakdown of the information that is available based on your request, adapted for a medical device rather than an AI/algorithm:

Acceptance Criteria and Device Performance for Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238)

This submission describes a medical device, a chronic hemodialysis catheter, and its performance is assessed through laboratory testing to demonstrate substantial equivalence to a predicate device, not through an AI/algorithm performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion from Submission: "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. Based on the indications for use, design, safety and performance testing, the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheters met the requirements that are considered adequate for its intended use and is substantially equivalent to the predicate devices."

The following points are not applicable (N/A) as the submission describes a physical medical device and not an AI/algorithm:

2. Sample size used for the test set and the data provenance: N/A (This was a physical device performance study, not a data-driven test set.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth is not relevant for physical device testing this context; performance is measured against physical standards/benchmarks.)
4. Adjudication method for the test set: N/A (Not applicable for physical device 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: N/A (This is not an AI-assisted device.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is not an algorithm.)
7. The type of ground truth used: N/A (For physical devices, performance is measured against engineering specifications, industry standards, and predicate device performance, not "ground truth" derived from expert consensus or pathology in the sense of an AI model.)
8. The sample size for the training set: N/A (This is not an AI/algorithm that requires a training set.)
9. How the ground truth for the training set was established: N/A (Not applicable.)

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CELOX Vascular is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French

CELOX Vascular is a kit that consists of a hemostatic pad and an optional adhesive bandage. The adhesive bandage is a 3M Tegaderm 4" x 4-3/4" bandage (reference K973036), or equivalent self adhesive security bandage. The hemostatic pad is a CELOX Hemostatic Granules on Sheet cleared in K080079 on July 9, 2008.

The provided document describes the CELOX Vascular device and its substantial equivalence determination. Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative manner (e.g., minimum sensitivity, specificity, or specific hemostasis rates to be achieved in a clinical trial). Instead, it describes demonstrating hemostasis and performance as effectively as a predicate device.

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

• Sample Size for Test Set: 11 vascular access procedures.
• Data Provenance: Pre-clinical porcine model testing. (The country of origin for the testing is not specified, but the company is based in the UK.)
• Retrospective/Prospective: The nature of "pre-clinical porcine model testing" typically implies a prospective design for the animal study itself.

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

This information is not provided in the document. The document refers to the results of a "pre-clinical porcine model testing" and the observation of "demonstrated hemostasis" and "successfully controlling all bleeding." The methods for assessing hemostasis and whether experts were involved in defining "ground truth" for the success of these procedures are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study described is a pre-clinical animal (porcine) model assessing the device's ability to achieve hemostasis, not a study involving human readers or AI assistance.

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

This question is not applicable as the CELOX Vascular is a physical medical device (hemostatic pad and adhesive bandage), not an AI algorithm or software. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The ground truth for the device's performance (i.e., hemostasis) was established through direct observation and measurement of bleeding control in a pre-clinical porcine model. This can be considered outcomes data in an animal model context – the direct outcome being the cessation of bleeding.

8. The Sample Size for the Training Set

This question is not applicable. The CELOX Vascular is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

This question is not applicable as there is no training set for a physical device.

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QuikClot® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.

QuikClot® Interventional™ hemostatic bandage is a kit that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® 4" x 4-3/4" bandage (reference K973036). The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by 1 ½" wide by ½" thick multi-layer pad. The pad is held secured in place by stitching with polyester thread. QuikClot® Interventional™ hemostatic bandage is packaged in a plastic tray within a peelable foil pouch and irradiated to a SAL of 104.

The QuikClot® Interventional™ hemostatic bandage is intended for topical application as an adjunct to manual compression for the local management and control of surface bleeding from vascular access sites, percutaneous catheters, or tubes utilizing introducer sheaths up to 12 Fr.

Here's an analysis of the acceptance criteria and the study that supports the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 25 vascular access procedures.
• Data Provenance: Pre-clinical porcine model testing (animal study). The country of origin is not specified but it is an animal-based study, not human. Given the context of a 510(k) submission, it is retrospective to the submission date.

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

• The document does not specify the number or qualifications of experts used to establish the ground truth for the pre-clinical porcine model testing. Given it's an animal model, the ground truth would typically be established by veterinarians, researchers, or technicians competent in animal surgery and hemostasis assessment.

4. Adjudication method for the test set:

• The document does not explicitly state an adjudication method. In a pre-clinical animal study, adjudication is often implicitly handled by the experimental design, observation protocols, and direct measurement of bleeding cessation by the researchers.

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 multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hemostatic bandage, not an AI-powered diagnostic or assistive tool, so such a study would not be applicable.

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

• No, a standalone (algorithm only) performance study was not done. This device is a physical hemostatic product, not an algorithm.

7. The type of ground truth used:

• The ground truth used was the observed cessation of bleeding (hemostasis) in the pre-clinical porcine model following vascular access procedures. This is a direct outcome measurement.

8. The sample size for the training set:

• This information is not applicable and therefore not provided. The QuikClot® Interventional™ hemostatic bandage is a physical medical device, not an AI or machine learning model that requires a "training set." The studies conducted were for performance validation.

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

• This information is not applicable for the same reason as point 8.

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3M™ Tegaderm™ CHG Dressings (Chlorhexidine Gluconate I.V. Securement Dressing), can be used to cover and protect catheter sites and to secure devices to skin. Common applications include IV catheters, other intravascular catheter and percutaneous devices.

3M™ Tegaderm™ CHG Dressing, Chlorhexidine Gluconate I.V. Securement Dressing, is used to cover and protect catheter sites and to secure devices to skin. Available in a variety of shapes and sizes to meet the needs of the caregiver.

Tegaderm™ CHG Dressing consists of a transparent adhesive dressing and an integrated pad containing Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity. The dressing is a barrier to liquid (waterproof), bacteria and viruses* and yeast, and protects the IV site from outside contamination. The pad absorbs up to eight times its weight in fluid. In vitro testing (log reduction, barrier, and zone of inhibition) demonstrates that the Tegaderm™ CHG dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria and yeast in the dressing. Tegaderm™ CHG Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

• In vitro testing has proven that Tegaderm CHG provides a viral barrier from viruses 27 nm in diameter, (e.g. HCV) or larger (e.g. HBV and HIV) while the dressing remains intact without leakage.

This document is a 510(k) Premarket Notification for a medical device (3M™ Tegaderm™ CHG Dressing) and primarily focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the way you've described for an AI/device performance evaluation.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided text. The document describes the device's function and properties, and mentions "in vitro testing" as proof of certain antimicrobial effects, but it does not detail those tests with acceptance criteria or performance metrics in a structured format as typically found in clinical performance studies.

Here's an analysis based on the available information:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific study. The document focuses on demonstrating substantial equivalence to predicate devices and inherent properties.
• Reported Device Performance:
  • "In vitro testing (log reduction, barrier, and zone of inhibition) demonstrates that the Tegaderm™ CHG dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria and yeast in the dressing."
  • "In vitro testing has proven that Tegaderm CHG provides a viral barrier from viruses 27 nm in diameter, (e.g. HCV) or larger (e.g. HBV and HIV) while the dressing remains intact without leakage."

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

• Sample Size: Not specified. The descriptions refer to "in vitro testing" which typically involves laboratory experiments with microbial cultures, not patient-derived "test sets" in the context of clinical studies.
• Data Provenance: The testing is described as "in vitro testing," meaning laboratory-based. No country of origin for the data is mentioned, nor is it classified as retrospective or prospective study design.

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 as this document describes in vitro (laboratory) tests, not human- expert-interpreted data.

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

• Not applicable. The "test set" refers to microbial cultures in a lab, not data requiring expert 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

• Not applicable. This is a medical dressing, not an AI diagnostic device. No human reader or AI component is involved.

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

• Not applicable. This is a medical dressing, not an algorithm.

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

• Ground Truth: For the "in vitro testing," the ground truth would be established by standard microbiological methods (e.g., direct measurement of log reduction, observation of zone of inhibition, successful barrier against organisms). This is empirical, objective lab data rather than expert consensus or pathology.

8. The sample size for the training set

• Not applicable. As a medical dressing, there is no "training set" in the context of machine learning or AI.

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

• Not applicable.

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The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments such as irrigating solutions, antimicrobial and enzymatic debriding solutions, suspensions, and other solutions. It is intended to provide a moist healing environment and allow debridement to facilitate the normal wound healing process.

The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments. It is provided as a sterile, single-use, disposable device.

The provided text describes a 510(k) summary for a medical device (DermaStream™ occlusive wound dressing) but does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document focuses on:

• Device Identification: Name, classification, manufacturer, contact.
• Predicate Devices: Identifying similar legally marketed devices (KCI Wound Cell Transparent Wound Dressing, 3M Tegaderm Transparent Dressing, KCI V.A.C. Instillamat).
• Device Description: An occlusive wound dressing permitting topical wound treatment introduction, sterile, single-use, disposable.
• Intended Use: To provide a moist healing environment and allow debridement to facilitate normal wound healing.
• Technological Characteristics Comparison: Stating it is substantially equivalent to predicate devices, being a combination of their features, with the primary difference being solution/drainage provision via gravity vs. vacuum.
• FDA Correspondence: Confirming the substantial equivalence determination.

Therefore, I cannot provide the requested table or elaborations on the study details because the necessary information is not present in the provided text. The document is essentially a regulatory submission summary, not a performance study report.

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