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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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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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The KCI Wound Cell Transparent Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Dressing may also be used as a secondary fixation device for other topical wound treatments such as antimicrobial and enzymatic debriding solutions and suspensions, alginates, gels and foams.

The KCI Wound Cell Transparent Dressing is indicated for:

• Non-exudating to minimally exuding wounds
• Pressure sores
• Lacerations/abrasions
• Partial and full thickness wounds
• Surgical incisions
• Second degree burns
• Donor sites
• IV sites

Occlusive Wound Dressing (21 CFR 878.4020)
The KCI occlusive wound dressings differ in that the Wound Cell includes an injection port. This injection port facilitates the application of topical wound care products after the wound dressing has been placed over the wound to serve as a secondary fixation device in addition to its other intended uses.

This 510(k) summary (K02078) is for a labeling revision of the KCI Wound Cell Transparent Wound Dressing, not for a new device requiring performance studies to demonstrate substantial equivalence based on acceptance criteria. The original device, KCI Wound Cell Transparent Wound Dressing, was already determined to be exempt from 510(k) requirements. The current submission only addresses modifications to the labeling regarding the application of topical wound treatment products through the injection port.

Therefore, the provided document does not contain information regarding traditional acceptance criteria and device performance studies of the kind requested.

Here's why and what can be extracted:

• Device Type: This is a wound dressing, which are typically evaluated for biocompatibility, sterility, integrity, and sometimes moisture vapor transmission rates (MVTR) or adherence.
• Nature of Submission: This is a labeling revision for an already-exempt device. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This means the manufacturer is essentially confirming that the label changes do not alter the substantial equivalence or safety/effectiveness of the device.
• Lack of Performance Data: There is no mention of clinical trials, technical performance tests, or comparative studies against specified acceptance criteria in this document. The argument for substantial equivalence rests on the fact that the changes are minor (labeling for drug application) and do not alter the previously established (or exempt) characteristics of the device.

Given this, I cannot fill out the requested table or answer most of the questions because the information is not present in the provided text.

However, I can provide what is available:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not specified or discussed in the context of this labeling update. The previous exemption implies the device met initial safety and efficacy requirements, likely based on general controls for wound dressings.
• Reported Device Performance: Not reported in this document. The submission focuses on the lack of change in performance due to labeling revision.

2. Sample size used for the test set and the data provenance: Not applicable. No test set usage discussed. Data provenance is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No experts for ground truth establishment are mentioned.

4. Adjudication method for the test set: Not applicable. No test set adjudication mentioned.

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 passive 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. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is established for device performance in this document.

8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.

In summary, this 510(k) pertains to regulatory modifications for labeling an already available and exempt device rather than demonstrating the device's technical performance against specific criteria through a study.

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KERUX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing

The proposed Kerlix MD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with Polyhexamethylene Biguanide Hydrochloride. The dressing is packaged in Tyvek/Poly pouches as well as Tyvek/Styrene trays and is available in both sponge and roll form.

The provided text is a 510(k) summary for a medical device (Kendall Kerlix MD Antimicrobial Gauze Dressing) and the FDA's clearance letter. It describes the device, its intended use, and its substantial equivalence to predicate devices based on nonclinical testing. However, it does not contain any information regarding clinical studies, acceptance criteria for device performance, or human-in-the-loop performance evaluation.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance through substantial equivalence, which primarily relies on comparison to existing legally marketed devices, rather than a clinical performance study with specific acceptance criteria.

To elaborate on why the requested information cannot be found in the provided text:

• Acceptance Criteria and Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, wound healing rates) or acceptance criteria are mentioned. The document states "Biocompatibility testing... has demonstrated that it meets the requirements of quidelines presented in the 10993 ISO Standard, Part 1," but these are safety/biocompatibility guidelines, not performance criteria for a diagnostic or therapeutic effect.
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts related to clinical performance studies, which are not detailed in this 510(k) submission. The document relies on "nonclinical testing" (biocompatibility) and comparison to predicate devices' intended use and composition.

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To be used as a temporary dressing in the external auditory canal following tympanoplasty or stapedectomy procedures.

The OTOSILK™ Graft Dressing is a sterile, disposable graft dressing constructed of non-adherent material, designed for use with split thickness skin grafts used in procedures such as tympanoplasty, canalplasty, mastoid tympanoplasty, correction of congenital aural atresia, and removal of canal exostoses.

Split thickness skin grafts may be taken from several sites, using either a razor blade or dermatome. The OTOSILK dressing will be used as a carrier for this skin graft to the ear canal. The graft is placed dermis side up on the dressing and the uncovered material is trimmed away. The skin graft and dressing are then applied to the canal. The dressing is removed from the canal one to two weeks post-operatively. The blue color of the OTOSILK Graft Dressing increases visualization of the dressing, ensuring total removal from the ear canal without disturbing the graft.

This document, a 510(k) summary for the OTOSILK™ Otological Graft Dressing, does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The provided text focuses on:

• Product Description: What the device is and how it's used.
• Indication For Use: The medical conditions it's intended for.
• Predicate Device: A comparison to an existing, legally marketed device.
• Limited Testing Information: A brief statement that "Sterile finished device samples passed biocompatibility testing and were determined to be non-reactive and non-cytotoxic."

There is no discussion of:

1. Acceptance criteria: No specific performance metrics (e.g., success rates, complication rates, visualization scores) are defined.
2. Reported device performance: No data on the device's actual performance in a clinical or simulated setting is presented, other than the biocompatibility statement.
3. Study details:
   • Sample size for test set or training set.
   • Data provenance (country of origin, retrospective/prospective).
   • Number and qualifications of experts.
   • Adjudication method.
   • Multi-reader multi-case (MRMC) comparative effectiveness study.
   • Standalone algorithm performance.
   • Type of ground truth used or how it was established.

This document appears to be a regulatory submission summary, which typically provides high-level information and often refers to detailed reports that are not included here. To answer your questions, one would need access to the full test reports and clinical study data that would have been submitted alongside this summary.

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