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A highly absorptive pillow dressing for the management of exudating wounds, infected and non-infected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.

Osmo/PCA Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb up to 20 times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the Osmo/PCA Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels. Osmo/PCA Pillow Wound Dressing contains highly absorptive polymer granules able to absorb up to 20 times their weigh in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Osmo/PCA Pillow Wound Dressing:

It's important to note that the provided text is a 510(k) summary for a medical device submitted to the FDA. 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials with detailed statistical performance metrics as might be found for novel, higher-risk devices. Therefore, much of the requested information regarding detailed study design, sample sizes, expert involvement, and comparative effectiveness studies is not present in this type of document.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details

Given the nature of a 510(k) submission for a wound dressing, the "study" primarily consists of biocompatibility testing and claims of comparable technological characteristics to predicate devices rather than a formal clinical trial with an algorithm. This device is not an AI/algorithm-based device, so questions related to AI performance metrics are not applicable.

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: Not specified for the biocompatibility testing. For claims of performance (e.g., absorbency), no specific test set sample size is provided, nor is the data provenance. The claims rely on the inherent properties of the materials.
• Data provenance: Not specified.

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 biocompatibility, testing is typically performed by certified labs according to standards. For performance claims, these are intrinsic material properties or comparative statements to predicate devices, not requiring expert consensus on a test set in the way an AI diagnostic device would.

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, as this is not an AI/algorithm-based device.

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

• Not applicable, as this is not an AI/algorithm-based device.

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

• For biocompatibility: Ground truth is established by adherence to and passing of tests defined by the "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1."
• For absorbency and containment: Ground truth would be based on laboratory testing of the material's physical properties.
• For intended use/indications: Ground truth is implicitly established by the demonstrated safety and performance (biocompatibility, absorbency) along with equivalence to predicate devices that already have these indications.

8. The sample size for the training set:

• Not applicable, as this is not an AI/algorithm-based device.

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

• Not applicable, as this is not an AI/algorithm-based device.

Summary of Device Performance Study for 510(k):

The "study" for the Osmo/PCA Pillow Wound Dressing to meet its acceptance criteria, as presented in this 510(k) summary, primarily relies on:

• Biocompatibility Testing: Performed according to "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1," supporting its safe use for temporary contact with breached skin.
• Engineering and Material Science Principles: The device's ability to absorb exudate (20 times its weight) and contain its granules within an LDPE mesh is a direct result of its material composition and design. These are inherent physical properties and are likely confirmed through in-house lab testing, not a clinical trial.
• Substantial Equivalence to Predicate Devices: The core of a 510(k) is to demonstrate that the new device has the same intended use and similar technological characteristics as legally marketed predicate devices (OsmoCyte™ Pillow Wound Dressing, Lamin® Hydrating Gel). This comparison effectively "proves" that the device meets acceptance criteria by showing it's "as safe and effective" as something already on the market, rather than through a standalone, comprehensive clinical study for de novo devices. The indications for use are explicitly stated to be "not different from the predicate devices identified above."

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A self adhesive highly absorptive island dressing for the management of exudating wounds, infected and non-infected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, cuts, abrasions and general first aid.

OsmoCyte® Island Wound Dressing utilizes a powdered polymer absorbent pad contained in a non-woven mesh pillow attached to a sheet of foam polyurethane and coated with a medical grade acrylic emulsion adhesive.

The provided text is a 510(k) summary for the OsmoCyte® Island Wound Dressing. This type of regulatory submission in the U.S. demonstrates substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the same way a new device would.

Therefore, the document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in terms of performance metrics like sensitivity, specificity, or reader improvement with AI.

Instead, the "Assessment of Performance Data" section states:

• Biocompatibility testing has been performed as recommended in the "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1." These tests support the safe use of OsmoCyte® Island Wound Dressing as a wound dressing temporary in contact with breached or compromised skin.

This indicates that the primary "acceptance criteria" for this type of device (a wound dressing) in this regulatory context are related to biocompatibility and substantial equivalence to existing devices, rather than a quantitative performance metric.

Given the nature of the document, the following sections from your request cannot be fully answered as they pertain to clinical or algorithm performance studies not described within this 510(k) submission:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The "performance" aspect discussed is biocompatibility and comparability to predicates in terms of absorption.
• 2. Sample sized used for the test set and the data provenance: Not applicable, no test set for performance described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method: 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 is not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an AI device.
• 7. The type of ground truth used: Not applicable for performance metrics. For biocompatibility, the "ground truth" would be the ISO standard's pass/fail criteria.
• 8. The sample size for the training set: Not applicable (no algorithm).
• 9. How the ground truth for the training set was established: Not applicable (no algorithm or training set).

Summary of available information:

• Device: OsmoCyte® Island Wound Dressing
• Type of "Study" to meet acceptance criteria: Biocompatibility testing as per ISO 10993-1.
• Implicit Acceptance Criteria: The device must demonstrate biocompatibility according to ISO 10993-1 standards and be substantially equivalent to predicate wound dressings in function (e.g., absorption) and intended use.
• Reported Device Performance (for biocompatibility): "These tests support the safe use of OsmoCyte® Island Wound Dressing as a wound dressing temporary in contact with breached or compromised skin."

Limitations on Labeling (from FDA's response letter):

The FDA's clearance letter also specifies important limitations on labeling, which act as "acceptance criteria" for claims and intended use:

• May not be labeled for use on third-degree burns.
• May not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
• May not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
• May not be labeled as a treatment or a cure for any type of wound.

The core of this submission relies on demonstrating substantial equivalence to predicate devices already on the market, rather than conducting de novo performance studies with quantitative acceptance criteria typically seen for novel devices or AI/software.

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Exudating wounds, infected or non-infected including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, cuts, abrasions and general first aid.

OsmoCyte® RA Wound Dressing utilizes a powdered polymer absorbent pad contained in a non-woven mesh pillow attached to a sheet of foam polyurethane and coated with a medical grade acrylic emulsion adhesive.

The provided text describes a 510(k) submission for the OsmoCyte® RA Wound Dressing, claiming substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through quantitative metrics.

The "Assessment of Performance Data" section only states: "Biocompatibility testing has been performed as recommended in the 'International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1.' These tests support the safe use of OsmoCyte® RA Wound Dressing as a wound dressing temporary in contact with breached or compromised skin." This indicates general safety testing, not performance against specific acceptance criteria.

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

Here's a breakdown of why each specific point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence to predicate devices, not on meeting predefined performance metrics.
2. Sample sized used for the test set and the data provenance: Not provided. No test set for performance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific performance test set or ground truth establishment is described.
4. Adjudication method: 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 a wound dressing, not an AI-assisted diagnostic tool.
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: Not applicable as no specific performance evaluation with ground truth is mentioned.
8. The sample size for the training set: Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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lamin®-2 Hydrating Gel is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and external contamination.

lamin®-2 Hydrating Gel acts to provide a moist wound environment and protect the wound. lamin®-2 Hydrating Gel was designed to provide a soothing, moist environment for each application to various types of wounds. lamin®-2 Hydrating Gel Wound Dressing is a low bioburden, preserved preparation of water, glycerin, carbopol (carbomer), prezatide copper acetate and parabens to form a hydrogel dressing.

The provided document is a 510(k) summary for the Iamin-2 Hydrating Gel, a medical device intended to serve as a hydrogel dressing for various wound types. The device is being submitted for substantial equivalence to existing predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and specific performance metrics in the way one might expect for a diagnostic or AI-powered device are not explicitly stated in this 510(k) summary. For a Class II (or unclassified) device like a wound dressing seeking substantial equivalence, the "acceptance criteria" are primarily met by demonstrating that the device has the same technological characteristics and intended use as legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.

Therefore, the table would look something like this, focusing on the comparison to predicate devices:

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

The 510(k) summary does not mention a specific "test set" or clinical study with patient samples in the traditional sense for evaluating the performance of the Iamin®-2 Hydrating Gel itself. This typically means that for devices like simple wound dressings established through precedent, the demonstration of substantial equivalence relies heavily on:

• Comparison of device characteristics: Chemical composition, physical properties, intended use, and technological characteristics are compared against legally marketed predicate devices.
• Existing knowledge and scientific principles: The understanding that hydrogels create a moist wound environment is well-established.

Therefore, there is no information provided on sample size, data provenance (e.g., country of origin), or whether data was retrospective or prospective.

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

This information is not applicable or provided in the context of this 510(k) submission. "Ground truth" as it's typically understood for diagnostic or AI systems (e.g., pathology reports for image analysis) is not relevant for demonstrating substantial equivalence for a wound dressing based on its physical and chemical properties matching predicates.

The "experts" involved are primarily the FDA reviewers who assess the submission based on regulatory guidelines and existing scientific understanding of wound care products.

4. Adjudication Method

This information is not applicable or provided. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical trials or performance studies where expert reviewers evaluate patient cases against a reference standard. Since no such study is described for the Iamin®-2 Hydrating Gel, there's no adjudication method mentioned.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or relevant for this type of device submission. MRMC studies are used to compare the diagnostic accuracy or effectiveness of different diagnostic methods or technologies, often involving human readers with and without AI assistance. The Iamin®-2 Hydrating Gel is a physical wound dressing, not a diagnostic tool or an AI-assisted system.

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

This is not applicable. The device is a physical hydrogel dressing, not an algorithm or an AI system. Therefore, no standalone algorithm performance study was conducted or reported.

7. Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) as it pertains to diagnostic accuracy is not applicable to this 510(k) submission.

For this device, the "truth" is established by:

• Scientific principles: The known benefits of a moist wound environment for healing.
• Regulatory precedent: The characteristics of legally marketed predicate devices that have already been deemed safe and effective for similar indications.
• Material science: The properties of the ingredients to form a hydrogel.

8. Sample Size for the Training Set

This is not applicable. The device is not an AI algorithm, so there is no "training set."

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

This is not applicable as there is no training set mentioned for an AI algorithm.

In summary, the provided 510(k) summary for the Iamin®-2 Hydrating Gel focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than on detailed clinical study data or performance metrics for a novel technology. This is a common approach for unclassified or Class II medical devices that fit well within existing product categories with established safety and effectiveness profiles. The "study" here is primarily the comparison of the device's characteristics and intended use to those of the predicate devices.

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OsmoCyte™ Wound Manager Sheet Dressing is indicated for the management of partial and full thickness wounds, both chronic and acute, with low to moderate exudate, including the following: Pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 18 and 200 degree burns, donor sites, postoperative incisions, minor chemical and thermal burns, superficial lacerations, cuts and abrasions, severe sunburn, dermal lesions (e.g. poison ivy), trauma injuries or incisions.

A sterile, hydropolymer dressing which protects the wound and provides a moist wound environment for low to moderate exudating wounds.

The provided 510(k) K965143 for the OsmoCyte™ Wound Manager Sheet Dressing does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way modern device submissions typically do for AI/ML devices or diagnostic tools.

This document is from 1997 and relates to a wound dressing, which falls under a different regulatory pathway and testing paradigm than, for example, a diagnostic AI system. For a wound dressing, the "performance" is more related to its physical characteristics, biocompatibility, and ability to fulfill its intended function (e.g., maintaining a moist wound environment, absorption).

Here's a breakdown based on the information provided and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The document establishes equivalence to predicate devices based on "function and intended use" and "technological characteristics." The performance is described in terms of its intended actions (moist environment, protection, absorption) and successful biocompatibility testing. There are no specific quantifiable clinical performance metrics (e.g., sensitivity, specificity, accuracy, wound healing rates) stated as acceptance criteria with corresponding performance values, which would be typical for a diagnostic or AI-enabled device.

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

• Sample Size for Test Set: Not applicable / Not mentioned. (The biocompatibility testing described would typically involve animal or in vitro models as per ISO 10993, but specific subject numbers are not provided in this summary.)
• Data Provenance: Not applicable for clinical performance data. Biocompatibility testing follows international standards (ISO 10993-1).

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

• Not applicable. This device is a wound dressing, not a diagnostic tool requiring expert ground truth for a test set.

4. Adjudication method 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 is not an AI-enabled device or a diagnostic tool involving human readers.

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

• For biocompatibility: Adherence to ISO 10993-1 standards and endpoints (e.g., cytotoxicity, sensitization, irritation).
• For functional claims: The ground truth would be the known physical properties and performance characteristics of similar predicate wound dressings.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/ML device.

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

• Not applicable.

Summary of what is present:

• The device is a sterile, hydropolymer dressing.
• Its function is to protect wounds, provide a moist healing environment, and absorb exudate.
• It is indicated for various partial and full-thickness wounds with low to moderate exudate.
• Biocompatibility testing was performed according to ISO 10993-1, supporting its safe use.
• The claim for substantial equivalence is based on similar function, intended use, and technological characteristics to several predicate wound and burn dressings already on the market.

Conclusion:

The K965143 document focuses on establishing substantial equivalence to existing predicate devices for a wound dressing. It demonstrates that the device functions similarly and is biocompatible. It does not present acceptance criteria or performance studies in the quantifiable, clinical outcome-based manner that would be expected for a diagnostic or AI-powered medical device. The "proof" consists of demonstrating equivalence to legally marketed devices and successful biocompatibility testing.

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lamin Impregnated Gauze Dressing is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and contamination.

lamin® Impregnated Gauze Dressing acts to provide a moist wound environment and protect the wound. lamin® Impregnated Gauze Dressing was designed to provide a soothing, moist environment for each application to various types of wounds as an impregnated gauze dressing. lamin® Impregnated Gauze Dressing is sterile impregnated cotton-blend non-woven gauze.

The provided text describes a medical device called "lamin® Impregnated Gauze Dressing" and its substantial equivalence to predicate devices. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, or any of the specific details requested in your prompt regarding AI/machine learning device performance.

This document describes a traditional medical device (a wound dressing) and its regulatory submission, which relies on demonstrating substantial equivalence to already-marketed predicate devices, primarily through biocompatibility testing. It is not an AI/ML powered device, and therefore the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, MRMC studies, etc.) are not applicable here.

Therefore, I cannot populate the table or answer the specific questions as the input text does not contain the relevant information for an AI/ML device.

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A hydrogel for the dressing and management of both graft recipient and donor sites, postoperative incisions, pressure ulcers, diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment, absorb wound exudate, and protect against abrasion, friction, desiccation, and contamination.

lamin® Wet Dressing (Copper-Saline) is sterile saturated cotton-blend non-woven gauze.

The provided text describes a 510(k) summary for the Lamin® Wet Dressing (Copper-Saline) and does not contain information about a study with acceptance criteria, device performance, sample sizes, expert involvement, or adjudication methods in the context of an AI/algorithm-based device. The document is for a medical dressing, not a software or AI device. Therefore, I cannot generate the requested information based on the input provided.

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An absorptive pillow dressing for the management of exudating wounds, infected and noninfected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.

OsmoCyte™ Ultra/PE Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb many times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the OsmoCyte™ Ultra/PE Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels. OsmoCyte™ Ultra/PE Pillow Wound Dressing contains a highly absorptive polymer able to absorb many times its weight in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.

The provided text is a 510(k) summary for the OsmoCyte™ Ultra/PE Pillow Wound Dressing, a medical device for wound care. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain information on performance criteria or a study demonstrating that the device meets specific acceptance criteria.

The "Assessment of Performance Data" section only mentions biocompatibility testing
per ISO 10993-1, which supports the safe use of the device. It does not provide any quantitative or qualitative performance criteria regarding the device's efficacy (e.g., absorption capacity, healing rates, or infection reduction) or a study to demonstrate these.

Therefore, I cannot populate the requested table or answer most of the other questions because the necessary information is not present in the provided text.

Here's what can be inferred or stated as missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not specified. The document does not mention a "test set" in the context of performance efficacy, only biocompatibility testing.

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

• Not applicable/Not specified. Ground truth establishment for a test set is not mentioned as such a study is not detailed.

4. Adjudication method for the test set:

• Not applicable/Not specified. Adjudication is not mentioned as such a study is not detailed.

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 device is a wound dressing, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this medical device type.

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

• No. This device is a wound dressing, not an algorithm.

7. The type of ground truth used:

• Not applicable/Not specified, as no formal performance study beyond biocompatibility is described. For biocompatibility, the "ground truth" would be the biological response observed in adherence to ISO 10993-1.

8. The sample size for the training set:

• Not applicable/Not specified. This device is a wound dressing, not an AI model requiring a training set.

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

• Not applicable/Not specified. This device is a wound dressing, not an AI model.

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