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The PowerLoc® MAX Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports.

The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.

The SafeStep® Huber Needle Set is a device intended for insertion of a subcutaneously implanted port and for the infusion of fluids into the port. The Safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.

PowerLoc® MAX Power-Injectable Infusion Set
The PowerLoc® MAX Power-Injectable Infusion Set is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling.
The PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles and 2 ml/s for 22 gauge needles. The PowerLoc® MAX Power-Injectable Infusion Set is offered with and without a Y-site.

SafeStep® Huber Needle Set
The SafeStep® Huber Needle Set is a standard right angle Huber needle and infusion set with a needlestick prevention feature, designed for use with a vascular access infusion system. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is manufactured with conventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-site.

Stabilization accessory
The stabilization accessory is intended for use as an accessory to the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set, and is supplied pre-loaded with the subject devices. It is placed centrally over the implanted port so that the base surrounds the implanted port under the skin. The infusion set needle handle is pressed down until the needle has entered the port septum, then the stabilization accessory is lifted off of the needle. The stabilization accessory is then discarded per hospital protocol.

This document is a 510(k) Premarket Notification from the FDA regarding the PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set. It establishes substantial equivalence to existing predicate devices, indicating that no new clinical study was required to prove safety and effectiveness for a new medical device. Instead, the submission focuses on demonstrating that the new packaging configurations and additional kit components of the subject devices do not alter their fundamental safety and performance characteristics compared to the previously cleared predicate devices.

Therefore, the typical acceptance criteria and study design for proving the performance of a novel AI-powered medical device are not applicable in this context. This submission is for a conventional medical device (infusion sets and needles) and relies on bench testing, material comparisons, and risk management rather than clinical performance studies with AI.

However, I can extract information related to the acceptance criteria for this specific submission, which pertains to the device's substantial equivalence and safety/performance after changes, rather than a de novo AI device.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance (as applicable to this submission):

For this 510(k) submission, the "acceptance criteria" are not related to a specific performance metric of an AI model (like accuracy, sensitivity, specificity). Instead, they revolve around demonstrating that the new configurations and kit components of the PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set maintain the same safety and performance profiles as their cleared predicate devices.

The document implicitly states that for the original devices (the predicates), their performance was deemed acceptable for their stated indications. For this new submission, the acceptance criteria are met by demonstrating "substantial equivalence" based on:

• Product Code
• Review Branch
• Intended Use
• Indications for Use
• General Device Description
• Y-Site presence
• Duration of Use
• Device Materials
• Sterility Method (Ethylene Oxide)
• Sterility Assurance Level (SAL 10-6)
• Number of Uses (Single-use)
• Anatomical Site Use
• Principle of Operation
• Safety Infusion Set Device Components
• Sizes (Needle Gauge, Needle Length)
• Needle OD
• Tubing Dimensions (ID, OD, Length)
  Note: The addition of new kit components is acknowledged but they are themselves legally marketed, cleared devices. |
  | Safety and Performance After Changes: The new packaging configurations and additional kit components do not negatively impact the biological safety or functional efficacy of the devices. | Met: "Testing was performed to show that the kit components maintain their biological safety and functional efficacy after ethylene oxide (EO) sterilization. The kit components met all predetermined acceptance criteria. Risk management, including a failure modes and effects analysis (FMEA), of the subject devices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Risk Management for Medical Devices. The risks were analyzed, mitigated and reduced to an acceptable level, and re-evaluation showed that the remaining risks are outweighed by the benefits of the device, and that the device is acceptable for its intended use." (Page 14) |

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

• This 510(k) submission does not involve a "test set" in the context of an AI model's performance on clinical data.
• The evaluation is based on "safety and performance tests" (Page 15) conducted on the physical devices and their components. The document does not specify the sample sizes for these bench tests, but it states that the "kit components met all predetermined acceptance criteria" and that a "risk management" process was followed.
• Data provenance is not applicable in the sense of patient data from specific countries or retrospective/prospective studies. The "data" here refers to engineering and biocompatibility test results.

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

• This is not applicable as there is no "ground truth" in the context of clinical images or patient data being interpreted by AI.
• The ground for proving substantial equivalence relates to regulatory standards, engineering specifications, and established biocompatibility principles. The FDA review team acts as the expert body for evaluating this submission.

4. Adjudication Method for the Test Set:

• Not applicable for the reasons stated above.

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

• Not applicable. This submission is for physical medical devices (infusion sets/needles), not an AI algorithm assisting human readers. Therefore, there is no AI assistance component to measure improvement.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is not an AI algorithm.

7. Type of Ground Truth Used:

• The "ground truth" in this submission is the accepted safety and performance of the predicate devices and the physical/chemical characteristics of the materials and design, verified through bench testing and adherence to recognized standards (e.g., sterilization, biocompatibility, risk management according to ISO 14971:2012).

8. Sample Size for the Training Set:

• Not applicable. There is no AI model or training set involved.

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

• Not applicable for the reasons stated above.

In summary, this FDA 510(k) document demonstrates substantial equivalence for conventional medical devices after a minor change (new packaging/kit components), rather than proving the performance of a novel AI-powered medical device through clinical studies. The "acceptance criteria" here refer to meeting regulatory requirements for substantial equivalence and ensuring that the modified devices maintain their established safety and functional efficacy through engineering and biocompatibility testing.

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The BCT Antimicrobial Dressing & BCT Silver Bandage Dressings are intended for the management of wounds and to provide an antimicrobial barrier. These dressings are applied topically and are in direct contact with the wound. Both are intended to be used for indications such as:

• Partial and full thickness wounds;
• Pressure ulcers;
• Diabetic ulcers;
• Surgical wounds;
• Acute wounds ( 1st and 2nd degree burns )

BCT Antimicrobial Dressing consists of polyethylene terphthalate (PET) non-woven, silver-coated activated carbon fiber cloth and polyethylene (PE) film. BCT Silver Bandage contains the same ingredients, but includes an adhesive layer. The dressings and bandages contain 100 µg/cm² of silver and are available in several sizes to accommodate different wound sizes.

BCT Antimicrobial Dressing and BCT Silver Bandage absorbs wound fluid and exudates containing infectious organisms into the dressing fabric, where the silver exerts its antimicrobial action. The silver ions act locally within the dressing, eliminating the absorbed bacteria and pathogens.

The activated carbon fiber cloth in BCT Dressings absorbs bacterial toxins and offensive odors.

The dressings are individually packaged in a pouch. All dressings are sterile and are for single use only.

Here's a breakdown of the acceptance criteria and study information for the BCT Antimicrobial Dressing & BCT Silver Bandage, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" for performance evaluation in the typical sense of clinical trials. The antimicrobial testing referenced AATCC Test Method 100-2004, which is a standardized lab test. The biocompatibility tests were "appropriate in vivo and in vitro tests" according to ISO 10993. These are lab-based tests, not human subject trials.
• Data Provenance: The studies were non-clinical (lab-based). The sponsor is Bio-medical Carbon Technology Co., Ltd. from Taiwan. The AATCC and ISO standards are international standards.

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

• This information is not applicable as the studies were non-clinical (biocompatibility and antimicrobial effectiveness) and did not involve expert-established ground truth in the context of diagnostic or interpretive performance. The "ground truth" for these tests are the established parameters and endpoints of the specified ISO and AATCC standards.

4. Adjudication Method for the Test Set

• Not applicable. There was no human interpretation or adjudication involved in the non-clinical biocompatibility or antimicrobial effectiveness tests.

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, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not an AI-powered diagnostic or interpretive tool. Therefore, the concept of "human readers improve with AI" is not relevant to this submission.

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

• Not applicable. This device is a physical wound dressing and does not involve any algorithm or AI component.

7. The Type of Ground Truth Used

• For Biocompatibility: The "ground truth" is adherence to the requirements and established safety profiles outlined in ISO 10993 standards.
• For Antimicrobial Activity: The "ground truth" is the quantitative reduction in microbial population as measured by AATCC Test Method 100-2004, with a specific criterion of "> 4 log reduction".

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI, so there is no training set in this context.

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

• Not applicable. As there is no training set, there is no ground truth established for it.

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Biatain Silicone Ag Foam Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions.

Biatain Silicone Ag Foam Dressings are wound dressings for exuding wounds with delayed healing due to bacteria or where there is a risk of infection. Biatain Ag Foam Dressings consist of a Top film (Printed high moisture-permeable barrier polyurethane (PU) film); a Center part (Soft, absorbing polyurethane (PU) antimicrobial foam (same Biatain Ag foam from Coloplast cleared via K100218) pads adhered to the top film with hot melt acrylic adhesive to avoid delamination when wet); a Border part (Perforated laminate of acrylic adhesive/melt blown polyurethane film/silicone adhesive, where the acrylic adhesive adheres to the top film, and the silicone adhesive is for skin adherence); and a Release liner: 3-part release liner that covers both center and border part. The foam contains silver, which is released upon contact with wound exudate. The dressings are available in different sizes. The dressing is square-shaped with rounded corners. Foam thickness is 3 mm. Biatain Silicone Ag foam dressing is protected with semi-permeable film backings that are waterproof and provide bacterial barriers. The dressings are individually-packed in a pouch: All dressings are sterile and are for single use only.

This 510(k) summary describes a medical device, the Biatain Silicone Ag Foam Dressing, which is a topical wound dressing. The submission aims to demonstrate substantial equivalence to a predicate device rather than providing a study on novel performance claims. As such, the information you've requested regarding acceptance criteria and a study proving those criteria (which are typically associated with AI/ML device performance or new functional claims) is not directly applicable to this type of submission.

Specifically:

• No new performance claims: The document states that "Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device." There are no explicit acceptance criteria for diagnostic accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/ML systems or novel diagnostic/therapeutic functions.
• Focus on substantial equivalence: The core of this 510(k) is to demonstrate that the new device (Biatain Silicone Ag Foam Dressings) is "substantially equivalent in performance, indications, design and materials" to a legally marketed predicate device (Coloplast's Biatain Ag Adhesive Dressings, cleared under K100218). This means the focus is on showing the new device is as safe and effective as the existing one, not on proving new levels of performance against specific clinical benchmarks.

Therefore, many of the requested categories are not relevant to this specific premarket notification:

1. Table of acceptance criteria and reported device performance: Not applicable. The document does not define specific performance acceptance criteria or report performance metrics in the way an AI/ML device or a device with new functional claims would. The "performance" being assessed here is largely about equivalence in material properties and physical characteristics demonstrated through bench testing.
2. Sample size for test set and data provenance: No "test set" in the context of clinical performance evaluation (e.g., patient data for diagnostic accuracy) is mentioned. Bench testing data is used.
3. Number of experts used to establish ground truth & qualifications: Not applicable. There is no ground truth establishment in the diagnostic sense.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This is a wound dressing, not an AI-assisted diagnostic tool.
6. Standalone performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How ground truth for training set was established: Not applicable.

Summary of relevant information from the provided text:

• Device: Biatain Silicone Ag Foam Dressings
• Claim: Substantial Equivalence to predicate device (Biatain Ag Adhesive Dressings, K100218).
• Support for claim: Bench testing (comparing material properties, design, and performance characteristics to the predicate) and biocompatibility testing.
• Indications for Use: Management of moderately to highly exuding leg ulcers and pressure sores. Also for 2nd degree burns, donor sites, post-operative wounds, and skin abrasions.

To answer your request based on the provided text, the response must reflect that these specific questions are not addressed in this type of 510(k) submission which focuses on substantial equivalence rather than novel performance claims against specific clinical outcomes or diagnostic accuracy.

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To be used as an occlusive wound dressing. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds, and to be used in emergency situations and to be left in place only while the patient is transported to the hospital.

SAM Chest Seal with Valve: The SAM Chest Seal with valve is an adhesive dressing composed of a hydrogel based adhesive with a clear backing and check valve. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound. The one way valve prevents air pressure from increasing in the pleural space.
SAM Chest Seal: The SAM Chest Seal is an adhesive dressing composed of a hydrogel based adhesive with a clear backing. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound.

The provided text is a 510(k) summary for the SAM Chest Seal product family, which includes the SAM Chest Seal with Valve and the SAM Chest Seal. It describes the device, its intended use, and its comparison to predicate devices. It states that the device is substantially equivalent to the predicate devices.

However, the document does not contain information regarding a clinical study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert evaluations.

Here's a breakdown of why the requested information cannot be provided from this document:

1. Clinical Data: Section H explicitly states, "Clinical data are not included in this submission." This means no study was performed to demonstrate performance against specific acceptance criteria.
2. Performance Testing (Non-clinical): Section G states, "Performance testing demonstrated that the Chest Seal devices perform as well as, or better than, the predicate device." This refers to non-clinical data, likely bench testing or engineering evaluations, and does not provide specific metrics or acceptance criteria in the document.
3. Regulatory Nature: This is a 510(k) submission, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical trials with detailed performance metrics.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study that proves the device meets them because the provided text indicates that no clinical data was included in this submission to establish such criteria or performance.

The document concludes that the devices are "substantially equivalent" to predicate devices based on non-clinical data, design, function, materials, and intended use. This is the primary "proof" used for 510(k) clearance in this case, not a clinical study with detailed performance metrics.

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Biatain Ag Foam Adhesive & Non-Adhesive Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions. Biatain Ag Foam Non-Adhesive Dressings are additionally indicated for diabetic foot ulcers. Biatain Ag Foam Cavity Dressings are indicated for deep wounds with moderate to high amounts of exudate. Biatain Ag Foam Cavity Dressings are indicated for stage II, III and IV pressure ulcers, leg ulcers, diabetic foot ulcers and first or second degree burns with significant loss of tissue.

Biatain Ag Foam Dressings are wound dressings for exuding wounds with delayed healing due to bacteria, or where there is a risk of infection. Biatain Ag Foam Dressings consist of soft, absorbing polyurethane (PU) foam pads with a moisture-permeable PU topfilm on one side and a smooth, wound-contact surface on the other side. The foam is directly on the topfilm, except for Biatain Ag Cavity which has no topfilm. The foams contain silver, which is released upon contact with wound exudate. The dressings are available in different sizes and shapes, including squares and rectangles, with rounded corners. Biatain Ag Non-Adhesive Foam Dressings also have bevelled edges. Foam thicknesses are 3 mm or 4.4 mm. The dressings are individually-packed in a pouch. All dressings are sterile and are for single use only.

The provided text describes a 510(k) summary for Biatain Ag Foam Dressings and indicates that substantial equivalency is supported by bench testing and biocompatibility testing. It does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of device performance metrics such as sensitivity, specificity, or reader studies.

The document is a regulatory submission for a medical device (wound dressing) and its focus is on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. Such submissions typically do not include detailed performance studies with acceptance criteria in the way an AI/software device would.

Therefore, most of the requested information cannot be extracted from the given text.

Here's what can be extracted based on the document:

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

   • Not applicable / Information not provided. The document states "Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device." It does not present specific acceptance criteria or performance metrics (like sensitivity, specificity, agreement rates) in a tabular format typically seen for algorithm performance. The "performance" here refers to the overall product functionality and safety, not AI-driven diagnostic accuracy.

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

   • Not applicable / Information not provided. This document does not describe a clinical performance study with a test set. The "bench testing" mentioned generally involves laboratory tests, not patient data in the sense of a clinical trial for AI performance.

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 / Information not provided. This information pertains to studies where ground truth needs to be established through expert review, typically for AI or diagnostic devices. This document describes a physical wound dressing, not a diagnostic tool requiring expert ground truth for performance evaluation.

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

   • Not applicable / Information not provided. As there's no clinical performance test set or expert ground truth process described, adjudication methods are not relevant here.

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 / Information not provided. This document describes a physical medical device (wound dressing), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to this submission.

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

   • Not applicable / Information not provided. The device is a physical wound dressing, not an algorithm.

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

   • Not applicable / Information not provided. For "bench testing" and "biocompatibility testing," ground truth refers to established laboratory standards and test methodologies, not clinical ground truth like pathology or expert consensus for AI performance.

8. The sample size for the training set

   • Not applicable / Information not provided. This document is not about an AI device, so there is no concept of a "training set."

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

   • Not applicable / Information not provided. As above, there is no AI training set.

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The Aplion Topical Care System is an occlusive wound dressing which is intended to provide a moist wound healing environment to facilitate the normal wound healing process. It also permits the introduction of topical wound treatment solutions and suspensions.

An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gasses such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing (21 CFR 878.4020).

The Aplion Topical Care System ("Aplion System") consists of an occlusive wound dressing, a tubeset connection, and a small fluid-delivery component.

The provided text is related to a 510(k) premarket notification for an occlusive wound dressing, the "Aplion Topical Care System." It describes the device, its indications for use, and a statement about its safety and biocompatibility.

Crucially, the document does not describe a study involving device performance metrics, acceptance criteria, or any AI/algorithm-related elements. This submission is for a Class I, 510(k) exempt device, where the FDA review focused on substantial equivalence to predicate devices rather than clinical performance trials with specific acceptance criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or expert details for ground truth.
3. Adjudication methods.
4. MRMC comparative effectiveness studies or effect sizes.
5. Standalone algorithm performance.
6. Details about training sets or how their ground truth was established.

The document explicitly states: "As a Class I, 510(k) exempt device, FDA review of the Aplion System is not necessary; nonetheless the materials used in the Aplion System were chosen for their biocompatibility, function, and suitability for the intended use of the device. Biocompatibility testing of the entire system was completed according to ISO 10993-1 and 510(k) Memorandum G95-1."

This indicates that the "study" demonstrating the device meets criteria was focused on biocompatibility testing against established ISO standards, not a comparative performance study with an AI component or clinical endpoints that would typically have the acceptance criteria and detailed study information requested. The acceptance criteria would be compliance with ISO 10993-1 for biocompatibility.

Absence of information for the requested fields:

• 1. A table of acceptance criteria and the reported device performance: Not present. The standard for acceptance was substantial equivalence to predicate devices (K020781 and K060046) and compliance with ISO 10993-1 for biocompatibility. No specific performance metrics (e.g., healing rate, infection reduction) or their acceptance criteria are reported.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present. Biocompatibility testing generally uses laboratory samples or animal models, not a "test set" in the context of clinical performance.
• 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 for this type of submission. Ground truth for biocompatibility is based on standardized assay results.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 an occlusive wound dressing, not an AI-powered diagnostic or assistive tool for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For biocompatibility, the "ground truth" would be the results of standardized biological tests as per ISO 10993-1.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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• For use in the management of psoriasis and the protection of psoriatic plaques
• As a protective dressing
• For management of superficial, dry to lightly exudating dermal wounds.

Envela™ is substantially similar in terms of component materials, shape, dimensions, and mode of action to existing occlusive wound dressings.

The document provided is a 510(k) summary statement and a clearance letter for a medical device called Envela™ (Hydrohesive™ Occlusive Dressing). This type of document is for regulatory clearance to market a device, not for a clinical study proving performance against acceptance criteria in the way you've outlined for an AI/algorithm-driven device.

Here's why your request cannot be fully answered with the provided text, and what information can be extracted:

• This is a Class I device, subject to General Controls. Class I devices generally do not require extensive clinical studies or performance data like higher-risk devices, especially those involving AI/algorithms. Their clearance is often based on substantial equivalence to existing predicate devices, focusing on materials, dimensions, and known mechanisms of action.
• The document explicitly states "Performance Standards: Not applicable to Class I occlusive dressings; subject to General Controls." This means there are no specific quantitative performance metrics (like sensitivity, specificity, accuracy) defined or evaluated in a study for this type of device within this regulatory pathway.
• The "study" referenced for this type of clearance is primarily a comparison to predicate devices, not a clinical trial to establish efficacy or an AI performance study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, experts, adjudication methods, or MRMC studies, as these types of evaluations are not typically required or documented for a Class I occlusive dressing seeking 510(k) clearance via substantial equivalence.

However, I can extract information related to the device and its regulatory clearance as presented:

1. Table of Acceptance Criteria and the Reported Device Performance

• Acceptance Criteria (Implicit - Substantial Equivalence): The primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to legally marketed predicate devices. This means the device must be as safe and effective as a legally marketed device that is not subject to premarket approval.
• Reported Device Performance (Implicit - Substantial Equivalence): The reported "performance" is that the device is "substantially similar in terms of component materials, shape, dimensions, and mode of action to existing occlusive wound dressings." This statement serves as the basis for regulatory acceptance, rather than a specific numerical performance metric from a study.

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

• Not applicable / Not provided. The document does not describe a "test set" or a study with a sample size in the context of performance evaluation for an AI/algorithm. The clearance is based on comparison to predicate devices.

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 provided. Ground truth establishment by experts is not described for this type of device clearance.

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

• Not applicable / Not provided. Adjudication methods are not described.

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

• No. This is not an AI-driven device, and no MRMC study was conducted or is relevant for this
  510(k) clearance.

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

• No. This is not an AI-driven device, and no standalone algorithm performance was assessed.

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

• Not applicable / Not provided. No "ground truth" was established in the context of performance study for this device. The basis for clearance is comparison to predicate devices and their known clinical use.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" as this is not an AI/algorithm device.

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

• Not applicable / Not provided. No training set or ground truth for it was established.

In summary, the provided document is a regulatory filing for a Class I medical device based on substantial equivalence to predicate devices, not a performance study for an AI or algorithm that would involve the criteria you listed.

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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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MedTrade Product's Antiseptic Barrier Silver Foam Dressings should be used under health care professional direction for the following indications: Pressure ulcers Lower extremity ulcers, including: 1. Venous 2. Arterial Mixed etlology 3. Diabetic ulcers Donor sites

MedTrade Product's Antiseptic Barrier Silver Foam Dressing is an exudate handling system intended for low to moderate exuding wounds. The antibacterial activity acting in the dressing is supported by laboratory testing demonstrating significant antibacterial activity against Pseudomonas aeruginose, Staphylococcus aureus & Escherichia coli. The island dressing maintains a moist wound environment, which is conducive to optimal wound healing. During use the absorbent island gently expands as it takes up exudate. During use the lesion size may initially increase. This is normal and to be expected prior to wound granulation. Dressings are supplied sterile in single use pouches. Product is gamma irradiated in accordance with the Sterilisation of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilisation. 30 Edition (ANS/AAMI/SO11137 - 1995) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification for Method 1 for dosimetric release with a sterility assurance level of 10 7. Packaging will consist of a single dressing in either a paper / paper / poly pouch, the pouches will then be placed in to a sales carton, with an Instructions For Use Leaflet.

The provided document is a 510(k) premarket notification for a medical device, specifically an Antiseptic Barrier Silver Foam Dressing. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a new effectiveness study with specific acceptance criteria and performance metrics for the new device.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test or training sets, expert consensus details, or MRMC comparative effectiveness studies.

Instead, the submission demonstrates equivalence through a comparison of characteristics with a predicate device.

Here's an analysis of the information available in the document in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable in the traditional sense for a 510(k) submission.
• The document provides a "COMPARATIVE FEATURES" table, which lists characteristics of the proposed device and its predicate (MedTrade Product's Self Adhesive Foam Island Dressing, K993627). This table serves to show that the new device's specifications are similar to those of a device already on the market.
• The document mentions "laboratory testing demonstrating significant antibacterial activity against Pseudomonas aeruginosa, Staphylococcus aureus & Escherichia coli" for the antibacterial activity of the silver in the dressing. This is the closest thing to reported device performance but no specific acceptance criteria (e.g., "X% reduction in bacterial count") or detailed study results are provided within this summary.

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

• Not provided. 510(k) submissions demonstrating substantial equivalence typically do not involve new clinical trials with test sets in the same way a PMA submission would. The "test set" here would implicitly be the data supporting the predicate device or the bench testing data (e.g., antibacterial activity), but no sample sizes are given.
• Data Provenance: The antibacterial activity testing is stated as "laboratory testing." No country of origin is specified for this testing. The information on the predicate device's performance is inherent to its prior clearance and presumably from a variety of sources.

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

• Not applicable/Not provided. This type of information relates to clinical studies and expert review for establishing ground truth, which is not described as being part of this 510(k) submission.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. No clinical test set requiring adjudication is described.

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

• No an MRMC study was done. This is a comparison of human reader performance with and without AI assistance, which is irrelevant for a foam dressing device.

6. Standalone (Algorithm Only) Performance Study:

• No standalone study was done. This concept applies to AI algorithms, not a physical medical device like a wound dressing. The antibacterial activity is a "standalone" performance characteristic of the dressing itself, but it's not an algorithm.

7. Type of Ground Truth Used:

• Not explicitly stated in the context of clinical outcomes for the new device.
  • For the antibacterial claims, the "ground truth" would be established by standard microbiological methods showing inhibition or reduction of bacterial growth.
  • For biocompatibility, the "ground truth" would be the successful completion of ISO/Tripartite guidelines for dermal sensitization, cytotoxicity, acute systemic toxicity, and hemocompatibility/hemolysis.
  • For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device (MedTrade Product's Self Adhesive Foam Island Dressing K993627 and Maersk Medical's Arglaes-AB Antiseptic Barrier Dressing K99080).

8. Sample Size for the Training Set:

• Not applicable/Not provided. Training sets are used for machine learning models, which is not relevant to this device.

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

• Not applicable/Not provided.

In summary, this 510(k) submission relies on demonstrating substantial equivalence to existing devices through a comparison of design, composition, and function, as well as providing general statements about laboratory testing for specific claims (like antibacterial activity and biocompatibility), rather than presenting a new, full-scale clinical trial with detailed acceptance criteria and performance data as might be found in a PMA submission or for AI/diagnostic devices.

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Advanced Medical Solutions Ltd's Silver Foam Wound Dressings are indicated for moderately to heavily exuding, partial to full thickness wounds, including: pressure ulcers; leg ulcers; diabetic foot ulcers; graft wounds and donor sites; skin tears; first and second-degree burns; surgical wounds; lacerations and abrasions.

(Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings are sterile, extremely absorbent, conformable, and semi-permeable to moisture vapour, and assist in maintaining a moist environment for optimal wound healing. (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings contain nominally 1% ionic silver (silver sodium hydrogen zirconium phosphate); the action of which protects the dressing from bacterial colonisation, and provides an effective barrier to bacterial penetration. The antimicrobial properties of the dressing are effective for up to 7 days, as demonstrated in vitro, against bacterial and fungal strains known to be detrimental to wound healing, such as; Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Streptococcus pyogenes, Staphylococcus epidermidis, MRSA (Methicillin resistant Staphylococcus aureus) MRSE (Methicillin resistant Staphylococcus epidermidis), and VRE (Vancomycin resistant Enterococcus faecium). The antibacterial effect in the (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings supports the reduction of odour caused by microorganisms absorbed in wound exudate. (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings may be used with a compression bandage.

This is a 510(k) premarket notification for a medical device (wound dressing), not a study describing AI software. Therefore, the requested information about acceptance criteria, study design, and AI performance metrics is not applicable and cannot be extracted from the provided text.

Specifically:

• No AI component: The device described is a physical wound dressing containing silver, not an AI software or system.
• No clinical study to prove acceptance criteria for AI: The document is a regulatory submission demonstrating substantial equivalence to a predicate device, primarily through comparison of physical characteristics, intended use, and existing in-vitro antimicrobial testing, not a clinical trial evaluating advanced performance metrics for AI.
• No "acceptance criteria" in the context of AI performance: The "acceptance criteria" here refer to regulatory requirements for demonstrating safety and effectiveness of a physical medical device, not performance benchmarks for an AI algorithm.

Therefore, I cannot provide the requested table and information as it pertains to AI performance.

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