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The V.A.C. ® GranuFoam® Silver Protection dressing is intended for use with the V.A.C. ® family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute, and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts and partial thickness burns.

The V.A.C. Granufoam Silver Protection dressing is an addition to the V.A.C. 9 product line of dressings designed specifically for use with the V.A.C. 0 Family of negative pressure devices. The V.A.C. GranuFoam Silver Protection dressing is comprised of black, reticulated, polyurethane foam covered with a silver coating.

The provided text describes the V.A.C. GranuFoam Silver Protection Dressing and its substantial equivalence to predicate devices, focusing on its use as an antimicrobial barrier and for negative pressure wound therapy. However, the details required to fill out a comprehensive table of acceptance criteria and a detailed study description for a typical AI/device performance evaluation are not fully present in the document.

Here's an attempt to extract and infer information based on the provided text, and point out where information is missing for a complete response:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the comparative in vitro or bench testing. The document refers to "testing" and "conducted on the dressings," but doesn't provide numbers of samples or experimental runs.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing described appears to be laboratory-based ("in vitro testing", "bench testing") rather than involving human subjects. Therefore, a "retrospective or prospective" classification isn't directly applicable in the typical clinical study sense.

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

• Not applicable. The studies mentioned (in vitro, bench testing) are not clinical studies involving expert interpretation or "ground truth" establishment in a diagnostic context. They assess material properties and antimicrobial activity.

4. Adjudication method for the test set

• Not applicable. As per point 3, this is not a study where expert adjudication would be relevant.

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 a medical device (dressing) submission, not an AI/diagnostic software submission. Therefore, MRMC studies and AI assistance are not relevant.

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

• No. This is not an algorithm or AI device.

7. The type of ground truth used

• For Antimicrobial Barrier Effectiveness: The "ground truth" would be established by microbiological laboratory standards and comparison to the known antibacterial performance of the predicate devices. The specific metrics (e.g., zone of inhibition, bacterial log reduction) are not detailed.
• For Compatibility with V.A.C. Negative Pressure Systems: The "ground truth" would be established by engineering specifications and performance characteristics (e.g., fluid handling capacity, tensile strength, pore size) of the predicate devices.
• For Biocompatibility: The "ground truth" is established by the international standard ISO-10993, which outlines methods for evaluating biological responses to medical devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. As per point 8, this is not an AI/machine learning device.

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The V.A.C. GranuFoam Silver Dressing is indicated as an effective barrier to bacterial penetration for patients who would benefit from the V.A.C. family of negative pressure devices to help promote wound healing. The barrier functions of the dressing may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts, and partial burns.

The V.A.C.® GranuFoam™ Silver dressing is a modification to the V.A.C. product line of black, reticulated, polyurethane foam dressings, designed specifically for use with the V.A.C. family of feedback-controlled devices, including the miniV.A.C. 9, V.A.C.® Freedom™ and V.A.C.® ATS™ systems, all currently marketed by KCI under 510(k) K032310. The modification is the addition of a silver containing coating to the GranuFoam™ dressing to allow for a silver option to the dressing line.

The provided text is a 510(k) summary for the V.A.C.® GranuFoam™ Silver Dressing. It does not describe an AI/ML device or a study proving its performance against specific acceptance criteria in the way typically expected for such devices (e.g., sensitivity, specificity, AUC). Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a medical dressing, primarily through bench testing for biocompatibility and in-vitro antimicrobial effectiveness.

Therefore, many of the requested categories are not applicable to this document. I will fill in the relevant information and indicate where information is not present or not applicable in the context of this type of medical device submission.

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

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 in the document for any testing.
• Data Provenance: Not specified, but tests were conducted by "licensed commercial reference laboratories" under GLP studies (Good Laboratory Practice), suggesting adherence to established scientific and regulatory standards. The 510(k) summary originated from Kinetic Concepts, Inc. in San Antonio, TX, USA, suggesting the data is likely from or overseen by US entities.

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. The ground truth for biocompatibility and antimicrobial effectiveness would be established through laboratory testing and standardized assays, not expert consensus in the clinical sense.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical and often image-based studies involving human interpretation. The reported studies are bench and in-vitro 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

Not applicable. This device is a medical dressing, not an AI/ML diagnostic tool, so an MRMC study is irrelevant.

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

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

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

• Biocompatibility: Established through standardized GLP (Good Laboratory Practice) studies in accordance with ISO-10993 for surface devices in contact with breached or compromised surfaces. This involves specific assays to determine toxicity, irritation, and sensitization. The "ground truth" is adherence to these established safety norms determined by the test results.
• Antimicrobial Effectiveness: Established through "separate in-vitro laboratory evaluations" using "licensed commercial reference laboratories." The "ground truth" here is the measured antimicrobial activity against specific microorganisms under controlled laboratory conditions.

8. The sample size for the training set

Not applicable. This device is a medical dressing, not an AI/ML model that requires a training set.

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

Not applicable. This device is a medical dressing, not an AI/ML model that requires a training set.

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The V.A.C.® family of devices with woundsite feedback control are negative pressure devices used to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site.

All models of the VAC family of devices, including the V.A.C.® ATS™, mini V.A.C.®, and the V.A.C.® Freedom™, consist of a vacuum control unit with an integrated collection canister and power supply.

The provided 510(k) summary for the V.A.C.® Therapy family of devices does not include information about specific acceptance criteria or an analytical study with performance metrics in the way a typical AI/ML device submission would.

This particular 510(k) is for a medical device (powered suction pump) that was reviewed for substantial equivalence to existing predicate devices based on its design, intended use, and functional testing. The "study" referenced is primarily design verification and validation testing, not a clinical trial or performance study with quantified metrics and statistical analysis against ground truth.

Therefore, many of the requested categories cannot be directly extracted from the provided text. However, I will answer the questions based on the information that is present and explain where information is not available.

Response based on the provided text:

Acceptance Criteria and Device Performance Study (V.A.C® Therapy family of devices)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document describes a "510(k) Summary" for a conventional medical device (Powered Suction Pump). The acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through design verification and validation testing (including functional and electrical safety), rather than through a comparative performance study with specific quantifiable metrics like sensitivity/specificity for diagnosis or a precise treatment outcome measure.

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

• Sample Size for Test Set: Not applicable or not specified in relation to patient data. The "testing" mentioned refers to internal device verification and validation (functional and electrical tests), not a clinical trial on a patient cohort.
• Data Provenance (country of origin, retrospective/prospective): Not applicable, as this was not a study involving patient data.

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)

• Number of Experts & Qualifications: Not applicable. Ground truth, in the context of clinical outcomes or diagnostic accuracy, was not established for a test set in this 510(k) submission. The "ground truth" for this device's performance would be its ability to consistently apply controlled negative pressure and function safely, which is assessed through engineering and functional tests.

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

• Adjudication Method: Not applicable. There was no clinical test set requiring adjudication of findings.

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

• MRMC Comparative Effectiveness Study: No, an MRMC study was not done. This device is not an AI/ML diagnostic or therapeutic assistance tool for human readers/clinicians, but rather a direct treatment device.
• Effect Size of Human Readers with/without AI: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical medical device (powered suction pump), not an algorithm or software. It functions with human setup and monitoring, applying negative pressure directly to a wound.

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

• Type of Ground Truth: For the device's functional performance, the ground truth would be adherence to engineering specifications and safety standards for powered suction pumps (e.g., maintaining specified negative pressure levels, electrical safety standards). For "intended use," the predicate devices' established safety and effectiveness serve as the comparative ground truth. No patient-level ground truth (like pathology or clinical outcomes) was utilized for a performance study described here.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for an AI/ML algorithm.

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The V.A.C. Abdominal Dressing is a specialty dressing indicated for temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary. The Intended Use of this dressing is for use in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome.

The V.A.C. Abdominal Dressing will be provided in a kit to provide an easy, tailored method of applying the dressing in the open abdomen. The V.A.C. Abdominal Dressing is supplied sterile, for single use only, double-pouched and packaged as one kit.

Each V.A.C. Abdominal Dressing kit contains:

• One (1) internal contact laver .
• Two (2) 16 mm outer layer polyurethane open-cell foam pieces .
• Four (4) V.A.C. Drapes .
• One T.R.A.C.TM pad assembly .

The provided text is a 510(k) summary for the V.A.C.® Abdominal Dressing, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific performance metrics and acceptance criteria as would be found for a new diagnostic or AI-driven medical device. Therefore, the information requested in the prompt, such as acceptance criteria, reported performance, sample sizes, expert qualifications, and ground truth establishment, is not available in this document.

The document states:

"Substantial equivalence for the V.A.C. Abdominal Dressing is based on the indications, intended use and technological features."

And also, regarding biocompatibility:

"Material Biocompatibility issues have been addressed based upon biomaterial history. The material used in the KCI V.A.C. Abdominal Dressing are the same materials used for many years in the existing commercially available devices."

This indicates that the device's acceptance was based on its similarity to previously cleared devices in terms of materials, indications, and function, not on a new study demonstrating quantitative performance metrics against specific acceptance criteria.

Thus, I cannot populate the table or answer the specific questions about study details, as these types of studies were not conducted or reported for this 510(k) submission.

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The V.A.C. System is a powered suction pump system that is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound* healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.

• The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, pressure ulcers, flaps and grafts.

This notification for The V.A.C. device is for labeling change only, to include an additional indication. There have been no significant modifications or design changes to the currently cleared and marketed V.A.C. device, 510(k) No.K992448.

The provided text describes the V.A.C. System, a powered suction pump intended to promote wound healing. However, the document provided is a 510(k) summary and subsequent FDA approval letter for a labeling change only, not a new device submission that would typically include a detailed clinical study for novel acceptance criteria.

The key statement is: "This notification for The V.A.C. device is for labeling change only, to include an additional indication. There have been no significant modifications or design changes to the currently cleared and marketed V.A.C. device, 510(k) No.K992448."

Therefore, the document does not contain specific acceptance criteria from a new study proving performance against those criteria in the way one would expect for a novel device or a major design change. Instead, it refers to existing market experience and previously established safety and effectiveness.

Here's a breakdown of what can be inferred or is explicitly stated, addressing the prompt's questions as much as possible, while also noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This table cannot be created from the provided text, as formal acceptance criteria for a new clinical study are not presented. The document focuses on expanding the "Indications for Use" based on existing data and market experience of an already cleared device.

The implied acceptance criteria for the labeling change appear to be:

• Safety and Effectiveness for Partial-Thickness Burns: Demonstrated through existing clinical experience and literature for an already cleared device.

The reported "performance" (or evidence supporting the labeling change) is:

• "KCI has worked through non-KCI clinicians to gather data to establish the safety and effectiveness of the V.A.C. System."
• "V.A.C. units have been used internationally treating well over 20,000 acute and chronic wound patients."
• "Major burn centers have been using V.A.C. therapy to assist with healing burns for several years."
• "We believe the findings of the clinical studies, cases reported in the literature, as well as informal reports by clinicians warrants the additional claim that V.A.C. treatment assists in healing partial-thickness burns."

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

• Sample Size: "well over 20,000 acute and chronic wound patients" used internationally prior to this submission. This is the collective experience, not a single 'test set' for this specific labeling change. The document does not specify a separate 'test set' for the partial-thickness burn indication beyond the general market experience.
• Data Provenance: The data comes from "non-KCI clinicians" and "Major burn centers" using V.A.C. internationally. This suggests a collection of real-world use data, likely a mix of prospective and retrospective observations, reported cases, and literature. Specific countries are not mentioned beyond "internationally."

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

This information is not provided. The text mentions "non-KCI clinicians" and "Major burn centers" but does not detail a specific panel of experts used to establish ground truth for a controlled test set in the context of this submission. The "ground truth" seems to be derived from the accumulated clinical experience of various practitioners.

4. Adjudication Method for the Test Set

This information is not provided. Given that the evidence is based on accumulated market experience and literature reviews rather than a single, controlled clinical trial, a specific adjudication method as typically understood for a new study's test set would not apply.

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

• No, an MRMC comparative effectiveness study was not done (or at least not reported in this document). The submission is for a labeling change based on existing device use and general clinical experience, not a study comparing human readers with and without AI assistance. The device in question is a medical pump, not an AI diagnostic tool.

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

• Not applicable. The V.A.C. System is a medical device (powered suction pump), not an algorithm or AI system. Its performance is intrinsically linked to its application by a healthcare professional ("human-in-the-loop").

7. The Type of Ground Truth Used

• The ground truth relies on clinical outcomes and observations from real-world usage ("safety and effectiveness," "healing burns," "assists in healing"). This is based on aggregated clinical experience, reports, and published literature, rather than a single, pre-defined ground truth like pathology or a tightly controlled expert consensus for a specific test set.

8. The Sample Size for the Training Set

• Not applicable in the AI/Software sense. The V.A.C. System is a hardware device. If "training set" refers to the prior data informing its original clearance and subsequent use, it would be the "well over 20,000 acute and chronic wound patients" mentioned. However, this is not a 'training set' in the context of machine learning.

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

• Not applicable in the AI/Software sense. For a medical device like the V.A.C., the "ground truth" for its efficacy and safety (which guides its development and indications) is established through established medical practices, clinical trials (for its initial clearance, K992448), and ongoing clinical experience and research.

In summary, this document is an FDA 510(k) summary for a labeling change of an already cleared medical device. It does not describe a new clinical study with defined acceptance criteria, test sets, or ground truth establishment in the way one would for a novel device or an AI/software product. Instead, it leverages the extensive real-world experience and existing literature on the device to justify the expanded indication.

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The V.A.C. Instillamat device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.

The V.A.C. Instillamat device is a modified V.A.C. device manufactured by Kinetic Concepts Inc. The V.A.C. Instillamat device combines technologies and features of the V.A.C. Plus device previously cleared by the FDA in 1999 [510(k) No. K992448] and the Ambulatory V.A.C. device previously cleared by the FDA in 1997 [510(k) No. K971548] with the additional modifications to provide a controlled delivery system for applying secondary wound treatments to a wound.

This document is a 510(k) summary for the V.A.C. Instillamat device, which is a medical device for wound care. It discusses the device's classification, applicant information, description, indications for use, and substantial equivalence.

Based on the provided text, there is no acceptance criteria or study information that proves the device meets specific performance criteria in the way you've outlined for an AI/device performance study.

Here's why and what information is available:

• This is a 510(k) submission for substantial equivalence. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not typically involve detailed performance studies with acceptance criteria in the manner of a novel AI algorithm.
• The "study" referenced is compliance with safety standards. The document states: "The V.A.C. Instillamat device has essentially the same technologies and features as the previously cleared predicate devices and has been independently tested and successfully approved to the following medical safety standards: UL2601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4." This demonstrates electrical safety, electromagnetic compatibility, and general safety requirements for medical electrical systems, not clinical performance for wound healing or specific diagnostic accuracy.

Therefore, many of your requested points cannot be answered from this document.

Here's a breakdown of what can be extracted or inferred, and what cannot:

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

   • Acceptance Criteria: The implicit acceptance criterion is adherence to the listed safety standards (UL2601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4) and being "substantially equivalent" to predicate devices (V.A.C. Plus, Ambulatory V.A.C.) in terms of technology, features, and indications for use.
   • Reported Device Performance: The document states the device was "independently tested and successfully approved to" these standards. No specific performance metrics like accuracy, sensitivity, or specificity (common for AI algorithms) are provided because this is not that type of 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 as no clinical performance study on a "test set" is described for this 510(k). The "testing" refers to compliance with engineering and electrical safety standards.

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. Ground truth establishment for a test set is not mentioned.

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 a powered suction pump for wound care, not an AI diagnostic or assistance tool for 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, but a physical medical device.

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

   • Not applicable in the context of clinical performance. For the safety standards, the "ground truth" is typically defined by the requirements of those standards (e.g., specific voltage limits, leakage current limits, EMC emission/immunity limits), and the device's electrical and mechanical performance is measured against these.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device.

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

   • Not applicable.

In summary: The V.A.C. Instillamat device gained clearance (K021501) through a 510(k) pathway by demonstrating substantial equivalence to predicate devices (V.A.C. Plus, Ambulatory V.A.C.) and by successfully complying with relevant medical electrical safety and electromagnetic compatibility standards (UL2601-1, IEC 60601 series). This process does not involve clinical performance studies with acceptance criteria, sample sizes, or ground truth methodologies as would be seen for a diagnostic or AI-powered device.

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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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The V.A.C. PLUS is a powered suction pump that is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound* healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.

*The V.A.C. PLUS is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.

This notification for The V.A.C. Plus device is for labeling changes only, as have evolved over time. There have been no significant modifications or design changes to the presently cleared and marketed V.A.C. Plus device, 510(k) No. K945062.

The labeling changes have not been fully itemized, but include changes in the listing of specific wound types addressed.

The provided document K992448 describes a 510(k) premarket notification for the V.A.C. PLUS device. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is present:

• Device Type: The V.A.C. PLUS is described as a "Powered Suction Pump" intended for wound healing and removal of infectious material/fluids from wounds.
• Nature of Submission: This 510(k) notification is specifically for "labeling changes only" for an already cleared device (K945062). The document explicitly states: "There have been no significant modifications or design changes to the presently cleared and marketed V.A.C. Plus device, 510(k) No. K945062."
• Clinical Studies: The document mentions "Clinical studies are provided to support these claims" (referring to the listed wound types like acute, chronic, traumatic, subacute, dehisced, diabetic, and pressure ulcers). However, it does not provide details about these clinical studies. It only makes a general statement that such studies exist to support the indications for use.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not specify any performance-based acceptance criteria or report performance data.
2. Sample sized used for the test set and the data provenance: No details about a test set or its sample size are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on ground truth establishment for a test set is present.
4. Adjudication method: Not applicable as no test set details are given.
5. MRMC comparative effectiveness study: This type of study is not mentioned.
6. Standalone performance study: No details about a standalone algorithm performance study are given. The device is a physical pump, not an AI algorithm.
7. Type of ground truth used: Not specified, as no study details are provided.
8. Sample size for the training set: Not specified, as no study details are provided.
9. How the ground truth for the training set was established: Not specified, as no study details are provided.

The document's purpose is to seek clearance for updated labeling based on previously established equivalence and existing clinical evidence, not to present a new clinical study to establish acceptance criteria for a modified device.

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The Home Care Bead Bed is designed to provide Air Fluidized Therapy that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers, while providing minimized dehydration.

The Head Cushion System is an air inflatable cushion system designed to raise a patient's upper body. This cushion system is a replacement to the foam cushion wedges presently available on the FluidAir Bead Bed.

The Home Care Bead Bed is indicated for patients who would benefit from advanced pressure relief and a dry patient environment. Particular classes of such patients include (among others), victims of the following:

• Pressure Ulcers especially draining wounds .
• . Skin Flaps and Grafts
• · Burns
• · Acute Exfoliative Dermatitis
• · Oncology:
  • · Aids in pain relief
  • · Reduces risk of Pathological Fractures

The Home Care Bead Bed is designed to provide Air Fluidized Therapy by supporting the patient on a surface of fluidized Microspheres (or "beads"). A large volume of air is forced upward through the microsphere mass causing the beads to behave as a fluid, helping reduce interface pressures while providing a dry patient environment with minimized dehydration. The Home Bead Bed is designed for home health care use allowing easy two-man transportation, installation and serviceability. The Home Bead Bed is a modification of the predicate fluidized bead bed, FluidAir® (by KCI), currently on the market and complies with the weight regulations for mobile and wood floor homes.

The Home Care Bead Bed is comprised of the Head Pedestal (containing the Head Cushion System Control unit), the Foot Pedestal (containing the Power-Controller unit), the Tank unit with the Soft Diffuser, a wooden Floor Board, the Beads, Filter Sheet and the Head Cushion System incorporated into the Cover Sheet.

The Foot Pedestal encloses the Air Supply unit that provides air to the soft diffuser and the Head Cushion System. The Air Supply unit contains similar components used in the FluidAir power unit such as blowers, heat exchanger, thermostat controls, cooling fans and filters. The Power-Control Unit located at the Foot Pedestal (refer to membrane diagram) has an "On/OFF" button and a "Fluidization" knob that allows the care giver to increase or decrease the fluidization. By turning the knob toward "MAX", the blower speed increases and sends more air through the Soft Diffuser thus increasing the fluidization rate. By turning the knob toward "MIN", the blower speed decreases and less air is blown through the diffuser thus decreasing the fluidization rate. The "Temp" knob on the Power-Control Unit allows the care giver to adjust the temperature of the air flowing to the beads. This heating and cooling regulation system is similar to the one used on the FluidAir.

The Head Cushion System consists of a head cushion (consisting of two air bladders) and a knee gatch bladder made of vinyl Gore-Tex® fabric and sewn onto a Gore-Tex® fabric cover sheet, similar to the FluidAir bed cover sheet, and placed atop the Home Care Bead bed. The two head cushion bladders and the knee gatch bladder are controlled by small bore servo valves located in the Head Pedestal. These valves are connected to individual port pins for appropriate control. The top head cushion bladder is operated in a pressure feedback mode, while the bottom head cushion operates only in an ON or OFF mode (no pressure feedback control). The knee gatch valve is plumbed in such a way as to draw air from the bottom head cushion bladder whenever the "High" setting is selected. Otherwise, the knee gatch bladder remains deflated. Forty (40) degrees of elevation can be achieved when both head cushions are inflated. The knee gatch bladder provides greater patient positioning when the bottom head cushion is elevated.

The Hand Control has an ON and OFF control for fluidization, and SOFT and FIRM and HIGH and LOW controls for the Head Cushion System. When the Head Cushion System's power is turned ON, the system defaults to the LOW setting of mid-range firmness for the Top Head cushion. The Bottom Head cushion and Knee Gatch cushion remain deflated. The FIRM and SOFT control buttons adjusts the firmness level of the Top cushion. The HIGH control button fully inflates the Bottom Head cushion and the Knee Gatch bladder. The head will elevate to a maximum of 40 degrees, depending on the firmness of the Top Head Cushion. The LOW control button returns the Low setting, which will return the head elevation to approximately 10 degrees. When the Head Cushion System is turned OFF, all cushions in the Head Cushion System are deflated.

This document is a 510(k) summary for the "Home Care Bead Bed" and describes its intended use, indications, and contraindications. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document states that the Home Care Bead Bed is a modification of a previously marketed device, the FluidAir® (K881917), and is considered "substantially equivalent." The FDA clearance (K972176) is based on this substantial equivalence, not on a new study demonstrating performance against specific acceptance criteria for the modified device.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, rather than detailed performance study results.

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The Simpulse mattress is for supporting bedridden patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. It employs a series of transverse inflatable cushions that can be sequentially inflated and deflated to provide pulsation pressures beneath the patient.

The Simpulse is indicated for patients who would benefit from: A pressure relieving surface with the additional benefit of pulsation to assist in the prevention and treatment of the complications of immobility such as skin breakdown and decubitus ulcers.

The Simpulse™ is a powered, Pulsating Therapy Mattress that can be used as an Overlay or Mattress Replacement System and is designed for use in all care settings (home, acute and extended). The Simpulse provides pulsating air suspension therapy that combines the benefits of pressure relief with the advantages of pulsation therapy.

The Simpulse" is comprised of two major components: the Air Supply Unit, and the Mattress Assembly.

The Mattress Assembly is comprised of: the pulsating air surface, the air base, the underliner and the cover sheet. The pulsating air surface is the component that pulses. It consists of ten separate interlocking air cushions that are plumbed to provide pulsation (five cushions are plumbed to Channel A and five are plumbed to Channel B). By only inflating the 5 inch pulsating air surface, the Simpulse " can be used as a mattress overlay.

When the Simpulse is used as a Mattress Replacement System, the 3 inch air base is inflated and serves as a static pressure air base that keeps the patient suspended when the bed is articulated. It also serves as an air support and remains inflated in case of a power outage. The underliner serves as an envelope to provide structure to the mattress. It has tie points that snap together and hold the pulsating air surface in place in relation to the air base. It also has straps that secure the entire Mattress Assembly to the bed frame.

The cover sheet is a fitted sheet made of nylon with a urethane backing that fits over the Mattress Assembly and provides a protective barrier between the patient and the air bladders.

The Air Supply Unit is mountable on the footboard of a standard hospital bed or can be placed upright on the floor and is microprocessor controlled to achieve the two modes of operation (Pulsation and/or Static). All user input to the microprocessor control is accomplished through the membrane panel switch are located on the Air Supply Unit.

The Air Supply Unit utilizes two separate pump and valve assemblies to channel compressed air to the Mattress Assembly, creating two sections referred to as Channel A and Channel B. This provides a single target pressure for the entire mattress as well as the means for the mattress to pulsate. The hose set has a connection on one end that mates to an air connection on the side of the Air Supply Unit. This connection also serves as a CPR emergency air deflation system by simply disconnecting the hose from the Air Supply Unit. The other end connects to the air cushions (Channel A, Channel B and the Air Base).

The target pressure is set by pressing the "Soft/Firm" buttons located on the membrane control panel. These buttons have five LED's evenly spaced between them and the user can adjust the firmness of the mattress within the range of these five LED's. If the user pushes and holds one of the buttons, the LED location will not increment until the user releases the button and pushes it again. Once the user selects the pressure setting, the pressure feedback system will automatically maintain the pressure setting within a target pressure range of plus or minus 1" H2O. If the actual pressure moves out of the target pressure range, the microprocessor controller will activate the corresponding pump to increase the pressure or open the corresponding valve to decrease the pressure until the pressure is within the target pressure range.

In the Static mode, all of the cushions in the air surface are inflated to an equal pressure and operate in a continuous pressure feedback mode as previously described. In the Pulsating On mode, the cushion closest to the footboard will decrease in pressure together with every other cushion along the mattresses length (Channel A), while the other set of cushions (Channel B) increase in pressure. Once the cushions of Channel A reach the lowest point and begin to increase in pressure, the cushions of Channel B start to decrease in pressure. When the Channel B cushions reach the minimum pressure and then begin to increase in pressure, the cushions of Channel A will once again begin to decrease in pressure. This completes a full cycle. By pressing the "Pulsation Cycle Time" button, the pulsation cycle time can be adjusted over a range of between 5, 10 or 20 minutes. An LED light will indicate which time period has been selected.

The "Auto Firm" control will fill Channels A & B and the Air Base to a maximum inflation level. During the time that Auto Firm is activated, The Pulsation On/Off buttors, Pulsation Cycle Time Button and the Soft/Firm buttons as well as their respective LED indicators will be disabled. The mattress will stay at the maximum inflation level until the Auto Firm Off button is pushed or twenty minutes elapse from the time the Auto Firm On button was first pushed. The Simpulse will then default to the same settings of operation as before the AutoFirm was activated.

This document is a 510(k) Summary for the Simpulse™ mattress, dating from 1997. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) summary is a regulatory document submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically focuses on device description, indications for use, contraindications, and comparisons to predicate devices, rather than detailed performance studies with acceptance criteria in the manner requested.

Therefore, I cannot provide the requested information based on the provided text. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

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