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The extriCARE® 1000 NPWT System is intended to generate negative pressure to remove wound exudates, infectious material, and tissue debris from the wound bed.

The extriCARE® 1000 NPWT System is intended for use in wounds with low to moderate levels of exudate. Appropriate wound types include:

• Chronic wounds
• Acute wounds
• · Traumatic wounds
• · Subacute and dehisced wounds
• · Partial-thickness burns
• · Ulcer wounds (such as diabetic or pressure)
• · Flaps and grafts
• · Closed surgical incisions

The extriCARE 1000 NPWT System is intended for use in healthcare facilities.

The extriCARE 1000 Negative Pressure Wound Therapy (NPWT) system consists of a portable, battery-powered pump unit intended to generate vacuum pressure to remove low to moderate level of wound exudates, infectious material, and tissue debris from the wound bed. Three preset vacuum pressures can be selected by the user - 80, 100, and 125mmHg. The extriCARE 1000 is packaged and provided with the following components:

• 1. extriCARE 1000 Negative Pressure Wound Therapy Pump
• 2. extriCARE 1000 50cc Collection Canister

The extriCARE 1000 Negative Pressure Wound Therapy (NPWT) Pump accessory that is included in this 510(k) applications and will be commercialized separately is the extriCARE 1000 50cc Collection Canister (additional cannister replacements).

The provided document describes the extriCARE® 1000 Negative Pressure Wound Therapy System and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria, performance metrics, and a dedicated test set as typically found in AI/ML performance evaluations.

Therefore, many of the requested fields cannot be directly extracted from the provided text because the document does not detail a clinical or performance study in the way a medical device utilizing AI/ML would. The document focuses on regulatory clearance for a physical medical device (a negative pressure wound therapy system) based on its technological characteristics, intended use, and non-clinical testing demonstrating safety and performance.

However, I can extract information related to the non-clinical testing performed and the general claims of performance the device makes.

Here's the closest possible interpretation of your request based on the provided text:

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

The document categorizes "non-clinical testing" as proof of meeting internal standards and regulations and having performance characteristics substantially equivalent to predicate devices. Specific quantitative acceptance criteria are not explicitly stated as numerical targets, but the "Results" कॉलम indicates success.

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

This information is not provided in the document. The non-clinical tests described are likely laboratory-based and do not involve "test sets" in the context of patient data for AI/ML evaluation.

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

This information is not applicable/provided. The evaluation is for a physical medical device, not an AI/ML algorithm requiring expert ground truth in the traditional sense.

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

This information is not applicable/provided. Adjudication methods are typically relevant for human review of AI/ML outputs, which is not the subject of this document.

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

This information is not applicable/provided. This document concerns a standalone medical device (Negative Pressure Wound Therapy System), not an AI-assisted diagnostic tool that would involve human readers.

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

The document mentions "Software Verification and Validation" for the device's proprietary algorithm, stating it was completed and had no unresolved anomalies. The software was determined to be of a "moderate" level of concern. While this confirms standalone software performance was evaluated, it's not in the context of an AI/ML diagnostic algorithm making predictions requiring human review. It pertains to the control software of the NPWT pump.

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

For the functional performance testing and electrical safety/EMC testing, the "ground truth" would be established by engineering standards, regulatory requirements (e.g., IEC standards), and internal specifications for the device's operation. For the software verification and validation, the ground truth would be the software requirements specifications and expected behavior to ensure the device operates safely and effectively. This is not "ground truth" in the clinical sense of pathology or expert consensus on a medical finding.

8. The sample size for the training set

This information is not applicable/provided. This device is not described as involving an AI/ML model that is trained on a dataset. The software mentioned is control software, not a learning algorithm.

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

This information is not applicable/provided. As above, there is no mention of a training set or AI/ML model development.

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The extriCARE® 3000 Negative Pressure Wound Therapy System is intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed. It is indicated for the following wound types:

• chronic
• · acute
• · traumatic
• subacute and dehisced wounds
• · partial-thickness burns
• · ulcers (such as diabetic or pressure)
• · flaps and grafts.

The extriCARE® 3000 Negative Pressure Wound Therapy System is intended for use in healthcare facilities.

The extriCARE 3000 Negative Pressure Wound Therapy (NPWT) pump is a portable, rechargeable, battery-powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed. The extriCARE 3000 Negative Pressure Wound Therapy (NPWT) is packaged and provided with the following components:

• 1. extriCARE 3000 Negative Pressure Wound Therapy Pump
• 2. extriCARE 3000 100cc Collection Canister

The extriCARE® 3000 Negative Pressure Wound Therapy (NPWT) pump accessories that are included in this 510(k) application and will be commercialized separately are the following:

• 1. extriCARE® 3000 100cc Collection Canister (additional canister replacements)
• 2. extriCARE® 3000 400cc Collection Canister

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a quantitative format for specific clinical outcomes. Instead, it describes various non-clinical tests conducted and states that the device "met all test requirements" or "acceptance criteria established."

Here's a summary of the non-clinical tests and their reported outcomes:

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

The document primarily describes non-clinical bench testing. It does not refer to a "test set" in the context of patient data or clinical trials. Therefore, no sample size for a patient test set or data provenance (country of origin, retrospective/prospective) is provided. The "test sets" referred to are related to the individual non-clinical tests (e.g., electrical safety, EMC).

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

Given that the document focuses on non-clinical testing and does not detail a clinical "test set" with patient data requiring ground truth establishment, this information is not applicable and therefore not provided.

4. Adjudication Method for the Test Set

As no clinical "test set" or ground truth establishment by experts is described, adjudication methods are not applicable and not provided.

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

No, an MRMC comparative effectiveness study is not mentioned or described in the provided document. The submission is for a Negative Pressure Wound Therapy (NPWT) system, which is a medical device, not typically an AI-powered diagnostic tool that would undergo MRMC studies for human reader improvement.

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

No, a standalone algorithm performance study is not applicable as the device is a physical medical device (NPWT pump) and not an algorithm or AI system for diagnostic interpretation.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is established by adherence to recognized engineering standards (e.g., IEC standards for electrical safety and EMC) and pre-defined performance specifications set by the manufacturer for the device's functionality. This is not "expert consensus, pathology, or outcomes data" in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical NPWT system, not an AI model that would require a "training set" of data.

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

This information is not applicable and not provided for the same reasons as point 8.

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The extriCARE® Negative Pressure Wound Therapy gel strip is intended to be used in conjunction with extriCARE® 2400 and extriCARE® 3600 Negative Pressure Wound Therapy (NPWT) Systems, providing additional sealing if necessary.

The extriCARE®2400 and extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudates, infectious materials, and tissue debris from the wound bed. The extriCARE® 2400 and extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

extriCARE® Negative Pressure Wound Therapy Gel Strip

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "extriCARE® Negative Pressure Wound Therapy Gel Strip." This document focuses on the regulatory clearance and indications for use, but it does not contain information about:

• Acceptance criteria and reported device performance in a table.
• Details of a study proving the device meets acceptance criteria.
• Sample sizes, data provenance, number of experts, adjudication methods for test sets.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Types of ground truth used.
• Training set sample size or how ground truth for training was established.

Therefore, I cannot fulfill your request for this specific information based on the provided input. The document is strictly a regulatory approval notice.

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The extriCARE® 3600 Negative Pressure Wound Therapy 1000cc canister is intended to be used in conjunction with extriCARE® 3600 Negative Pressure Wound Therapy (NPWT) Systems, adding to the original canister selections.

The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudates, infectious materials, and tissue debris from the wound bed. The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Not Found

This document is a 510(k) clearance letter from the FDA for the extriCARE® 3600 Negative Pressure Wound Therapy 1000cc canister. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily covers:

• The FDA's determination of substantial equivalence.
• Regulatory requirements and guidelines for the manufacturer.
• The indications for use of the device.

Therefore, I cannot provide the requested information about acceptance criteria and study details from this document.

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The extriCARE® NPWT foam kit is intended to be used in conjunction with the extriCARE® 2400 NPWT pump. The extriCARE® 2400 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extriCARE Negative Pressure Wound Therapy System is indicated for the following wound types: chronic. acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

The extriCARE® Negative Pressure Wound Therapy (NPWT) System consists of extriCARE® NPWT Pump, canister, connection tubing, and dressing kit. In operation, the dressing is attached to an extriCARE® Negative Pressure Wound Therapy pump via the tubing. The pump is used to provide the negative pressure to the system. Pressure and mode selections are digitally programmable.

The extriCARE NPWT foam dressing kit is a new accessory to the NPWT system. The foam dressing kit is designed to be an alternative solution to the bandage dressing kit in the original system. The foam dressing kit consists one of each of the following: polyurethane foam, transparent film drape, paper ruler, Suction Bell with connecting (drainage) tube and clamp. The single-use foam dressing kit is packed in Paper/poly peel pouch bag, which is sterilized using ETO. The foam is used to pack the wound.

The extriCARE® NPWT foam dressing kit can be sold alone or as a part of the extriCARE 2400 system. The associated accessories include:

• . Large foam dressing kit
• . Medium foam dressing kit
• . Small foam dressing kit

The provided text describes a 510(k) premarket notification for the extriCARE 2400 NPWT System with extriCARE 2400 NPWT pump and extriCARE NPWT Foam Dressing Kit. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of a diagnostic or AI device.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, MRMC studies, standalone performance) are not applicable to the information contained in this document, as it pertains to a medical device approval that is based on demonstrating equivalence rather than a clinical performance study with defined thresholds.

Here's an attempt to extract the relevant information based on your request, with an understanding that the context is a 510(k) submission for a non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a typical performance study for diagnostic AI. Instead, the "acceptance criteria" are implied by the need for the device's performance to be comparable to or meet the functional requirements of the predicate devices. The performance tests conducted aimed to verify that the device design met its function and performance requirements.

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

The document does not specify a "test set" in the context of diagnostic data, nor does it provide sample sizes for the performance tests mentioned. The testing was conducted on "aged samples" of the device itself (pump and foam dressing kit).
Data provenance (country of origin, retrospective/prospective) is not applicable or provided for this type of device and submission.

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

Not applicable. "Ground truth" in the context of diagnostic accuracy or AI performance is not relevant for this medical device submission, which focuses on functional performance and substantial equivalence.

4. Adjudication Method

Not applicable, as no ground truth for a diagnostic performance test was established.

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

Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical device (pump and dressing kit), not an algorithm or AI system for standalone performance evaluation in the diagnostic sense.

7. Type of Ground Truth Used

Not applicable. As mentioned, the concept of "ground truth" for diagnostic or predictive purposes is not relevant for this device's submission. The "truth" for this submission revolves around the device's functional integrity, safety, and performance characteristics as measured by engineering tests.

8. Sample Size for the Training Set

Not applicable. This document describes a physical medical device and its accessories, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for an AI model.

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The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafis.

The system consists of a vacuum pump, canister, tubing, NPWT bandage or NPWT Foam Kits. In operation, the device is attached via the tubing to a Negative Pressure Wound bandage or foam kits. Maximum pressure and continuous mode or intermittent mode selection are digitally programmable. The extriCARE 3600 pump can be sold alone or as a part of the extriCARE 3600 system with extriCARE bandages or foam kits. The extriCARE bandages are an all-in-one wound dressing; with no wound packing required which is cleared in the predicate K110078. The foam kit consists of Polyurethane foam, transparent film drape, paper ruler, Suction Bell with connecting (drainage) tube and clamp, which is included in this submission for review.

The provided 510(k) summary describes a Negative Pressure Wound Therapy (NPWT) system, which is a medical device and not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML device performance (e.g., sample size for training, expert ground truth, MRMC study, AI improvement effect size) are not applicable to this document.

However, I can extract the information provided regarding the device's acceptance criteria and the studies conducted to demonstrate its performance as a medical device.

Acceptance Criteria and Device Performance for extriCARE® 3600 Negative Pressure Wound Therapy System

Since this is a medical device (Negative Pressure Wound Therapy System) and not an AI/ML algorithm, the acceptance criteria are not typically expressed in terms of metrics like sensitivity, specificity, or AUC, but rather in terms of compliance with functional, safety, and performance standards. The "reported device performance" in this context refers to the successful completion of these tests.

Study Details:

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

   • Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in the context of clinical trials or data-driven algorithm validation. Instead, it mentions "representative samples of the device" for functional, mechanical, EMC, and electrical safety testing. For biocompatibility, "bandage samples and foam kits samples" were tested. No specific number of devices or clinical cases is provided.
   • Data Provenance: The document does not provide information on the country of origin of data or whether tests were retrospective or prospective, as these are not relevant for the type of bench and biocompatibility testing described.

2. 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):

   • This question is not applicable as the document describes a physical medical device undergoing bench and biocompatibility testing, not an AI/ML algorithm requiring expert-labeled ground truth for a test set.

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

   • This question is not applicable for the same reasons as above. Adjudication methods are relevant for resolving discrepancies in expert-labeled ground truth in AI/ML performance studies.

4. 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:

   • This question is not applicable. An MRMC comparative effectiveness study is used for evaluating the impact of AI on human reader performance, which is not relevant for a physical NPWT system.

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

   • This question is not applicable as the document concerns a physical medical device, not a standalone AI algorithm.

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

   • For functional and safety testing, the "ground truth" is adherence to established engineering specifications, international standards (e.g., IEC 60601 series), and biocompatibility standards (ISO-10993). There isn't a "ground truth" in the sense of clinical diagnoses or outcomes data for this type of device submission.

7. The sample size for the training set:

   • This question is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

   • This question is not applicable for the same reason mentioned above.

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extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.

extriCARE® Negative Pressure Wound Therapy 100cc canister extriCARE® Negative Pressure Wound Therapy 250cc canister extriCARE® Negative Pressure Wound Therapy 400cc canister

I apologize, but the provided text from the FDA 510(k) summary (K132252) for the ExtriCARE® Negative Pressure Wound Therapy system does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or details of a device performance study.

The document is a letter of substantial equivalence from the FDA, confirming that the ExtriCARE® device is substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory classification, general controls, and labeling requirements.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance: This information is not present.
• Sample size and data provenance for the test set: Not mentioned.
• Number and qualifications of experts for ground truth: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• MRMC comparative effectiveness study details: Not mentioned.
• Standalone algorithm performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not mentioned.
• Sample size for the training set: Not applicable, as this is a physical medical device.
• How ground truth for the training set was established: Not applicable.

The document states the device's Indications for Use, which is: "extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing." This describes the intended function but does not provide performance metrics or studies to support specific claims.

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extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.

extriCARE® Negative Pressure Wound Therapy Foot Dressing

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the ExtriCARE® Negative Pressure Wound Therapy Foot Dressing, confirming its substantial equivalence to a predicate device. It discusses regulatory compliance and general information but does not detail device performance or studies in the way you have requested.

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The extriCARE 2400 Negative Pressure Wound Therapy Pump System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.

The system consists of a vacuum pump, canister, and tubing. In operation, the device is attached via the tubing to a Negative Pressure Wound bandage. Maximum pressure and mode selection are digitally programmable. The extriCARE pump can be sold alone or as a part of the extriCARE 2400 system with extriCARE bandages. The extriCARE bandages are an all-in-one wound dressing, with no wound packing required.

The provided text describes the extriCARE 2400 Negative Pressure Wound Therapy System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria related to AI or a diagnostic performance claim.

Instead, the document focuses on:

• Device Description and Intended Use: Explaining what the extriCARE 2400 system is and what it's designed to do (generate negative pressure to remove wound exudates, infectious material, and tissue debris).
• Substantial Equivalence: Arguing that the device is technologically similar to existing predicate devices (NPD 1000, MobIVAC W.C., Renasys Gauze Dressing Kit).
• Performance Testing: Listing functional and mechanical tests (e.g., vacuum pressure calibration, flow rate, alarm verification, battery verification, exudate removal, bandage tests like peel strength, shear adhesion, leakage), and compliance with EMC and electrical safety standards (IEC 60601-1-2, UL 60601-1). These are engineering performance tests, not diagnostic accuracy studies.
• Biocompatibility Testing: Reporting results for tests on the bandage (Guinea Pig Maximization Sensitization, Cytotoxicity, Intracutaneous Irritation) to ensure it's safe for body contact.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study proving a device meets them, especially regarding diagnostic accuracy, AI performance, or MRMC studies, as this information is not present in the provided text.

Specifically, the following points from your request cannot be answered from the provided document:

1. A table of acceptance criteria and the reported device performance: While performance tests are listed, the acceptance criteria for these tests (e.g., "vacuum pressure must be within X% of target") are not explicitly stated, nor are the detailed quantitative results ("reported device performance") beyond "successfully passed" or "did not elicit sensitization/non-cytotoxic/non-irritant" for biocompatibility tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable as this is not a diagnostic device or AI study.
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.
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 consensus, pathology, outcomes data, etc): Not applicable.
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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