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The "Carilex" VT · 200-i NX suction therapy unit is indicated on use with patients with the following wounds:

• · Traumatic
• Dehisced wounds
• Partial thickness burns
• · Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers
• Acute wounds
• · Flaps and grafts

The device is not intended for home use. Wound irrigation/Instillation function is not intended for use in a homecare setting.

Carilex VT 200-i NX is a powered, portable suction device with battery backup that provides localized negative pressure wound therapy when used with the VT Dressing kits to remove body fluids, irrigation fluids, infectious material and tissue debris from the wound.

Carilex VT 200-i NX have shown that they may help promote the healing of several different kind of wounds via fluid removal. When in use, the vacuum air suction pump in the control unit suck the air from the wound through the connecting hose and dressing to create a negative pressure environment of the wound. The suction of the pump will help remove excess fluids from the wound. VT Dressing kits will be placed onto the wound by healthcare professional and a tube will be connected from the wound to the canister on the pump. After the dressing and tube are correctly applied and connected, turn on the VT · 200 i NX device and set to the pressure setting that is prescribed by healthcare provider. The canister will then collect the excess fluid. This device is not intended for home use.

Carilex VT-200-i NX is an updated version of Carilex VT-100/VT-200 (K173407) via engineering change, and its software and hardware modifications are made to add instill function. The instillation mode is a modified continuous mode, where wound irrigation solution is simultaneously infused during negative pressure suction to assist in wound cleaning and removal of infectious substances. There has been no change to the operating principle, mechanism of action or fundamental scientific technology of the predicate device. The Carilex VT-200-i NX is developed with technology and components that are almost identical to Carilex VT·100/ VT·200.

Carilex VT-200-i NX use the same collection canisters as predicate, VT-100, and VT-200 that are supplied non-sterile, single-use with a volume capacity of 300 ml or 1000ml. The canister is permanently sealed to minimize the potential of users coming into contact with exudates. Two tubes with two connector attached to its distal end is attached to the canister, and this connector which can be provided with or without lock feature attaches to the corresponding tubing included in the Carilex VT Dressing Kits.

The Carilex VT-200-i NX is a powered, portable suction device used for negative pressure wound therapy. The device has an instillation mode for wound irrigation.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria were demonstrated through a series of bench tests comparing the Carilex VT-200-i NX to its predicate device, Carilex VT-100/VT-200 (K173407). The aim was to show the overall system performance, including suction pressure, fluid removal rate, and alarm functions.

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

The document describes "head to head simulated use testing" and "the above tests" (referring to the listed methods 1-11 and the electrical/EMC tests) as being performed to demonstrate substantial equivalence. However, it does not explicitly state the specific sample sizes used for each of these performance tests (e.g., number of runs, devices tested, or duration). The data provenance is also not specified; it is implied to be internal bench testing performed by the manufacturer/sponsor for regulatory submission.

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

Since the tests described are bench tests involving simulated use, and not clinical studies with patient data requiring expert adjudication of ground truth, there is no mention of experts being used to establish ground truth for the test set. The "ground truth" for these tests would be the established performance specifications and expected outcomes under controlled testing conditions, as measured by standard laboratory equipment and procedures.

4. Adjudication Method for the Test Set

Not applicable, as the tests were bench tests comparing device performance to specifications and a predicate, rather than human-interpreted data requiring adjudication.

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

No multi-reader multi-case comparative effectiveness study was mentioned. The submission focuses on the stand-alone performance and technical equivalence to predicate devices, not on human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The studies described are for the "algorithm only" in the sense that they evaluate the performance of the device itself (Carilex VT-200-i NX) without human intervention in operating the core functions during the specified tests. The tests directly assess the device's technical capabilities (suction pressure, fluid removal, alarm functions, instillation mode) against predetermined benchmarks and its predicate device.

7. Type of Ground Truth Used

The ground truth for the performance tests was based on established engineering specifications, physical measurements (e.g., pressure, fluid volume, time delays for alarms), and direct comparison to the performance of a legally marketed predicate device (Carilex VT-100/VT-200). For the electrical and EMC tests, the ground truth was compliance with recognized international standards (AAMI/ANSI ES60601-1 and IEC 60601-1-2).

8. Sample Size for the Training Set

This information is not applicable. The Carilex VT-200-i NX is a medical device for negative pressure wound therapy, not an AI/machine learning device that requires a "training set" in the context of data-driven model development. The modifications were engineering changes to hardware and software to add an instill function to an existing device.

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

This is not applicable, as there is no mention of a training set for an AI/machine learning model. The device's functionality is based on electromechanical principles and control software for specific therapy modes.

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Carilex VT • 100/VT • 200 is indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VT · 100/VT · 200 suction therapy unit is indicated on use with patients with the following wounds: Traumatic, Dehisced wounds, Partial-thickness burns, Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers, Acute wounds, Flaps and grafts.

Carilex VT • 100 and VT • 200 are suction pumps with collection canisters for negative pressure wound therapy. The VT · 100 and VT · 200 are modified from their precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853). The pump is connected to the wound dressing via a tube connected to a disposable canister. The devices provide negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The devices can operate either by a mains power supply or internal battery. The VT • 200 is developed with technology and components that are almost identical to VT • 100, but for marketing differentiation it is designed with a new outer case which contains extra room to allow incorporation with different types of air compressors in the future.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Carilex VT-100 and VT-200 devices:

Acceptance Criteria and Study for Carilex VT-100 and VT-200 (K173407)

Based on the provided FDA 510(k) summary, the Carilex VT-100 and VT-200 are powered suction pumps for negative pressure wound therapy. The substantial equivalence was primarily determined through non-clinical testing and comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical tests (bench tests). It does not specify a "test set" in the context of patient data or clinical samples. The testing involved multiple devices (VT-100 and VT-200 models) in a laboratory setting. No information on the number of individual devices tested or their origin (provenance) is provided beyond the company being based in Taoyuan City, Taiwan.

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

Not applicable. This was a non-clinical, bench testing study. There was no "ground truth" derived from expert consensus on patient data. The "ground truth" for the bench tests would be the established performance specifications of the predicate device and relevant international standards.

4. Adjudication Method for the Test Set:

Not applicable. As this was non-clinical bench testing, an adjudication method for a test set (e.g., 2+1, 3+1) is not relevant. Pass/fail criteria were based on predetermined engineering specifications and conformity to standards.

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

No. A MRMC study was not conducted as this was a non-clinical evaluation to demonstrate substantial equivalence to a predicate device, focusing on engineering and performance criteria rather than human reader interpretation of medical images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The VT-100 and VT-200 are physical powered suction pumps, not AI algorithms. Their performance is tested directly, not as an algorithm's output.

7. Type of Ground Truth Used:

The "ground truth" for this substantial equivalence determination was based on:

• Predicate Device Specifications: The performance characteristics (suction pressure, fluid removal rate, etc.) and safety profile of the legally marketed predicate device (VOLTERA Powered Suction Pump, S1001-3 Series, K112853).
• International Standards: Conformity to recognized standards such as AAMI/ANSI ES60601-1 and IEC 60601-1-2 for safety and electromagnetic compatibility.
• Engineering Specifications: Pre-determined performance specifications for the VT-100 and VT-200 devices themselves.

8. Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" in the context of this device and study type, as it does not involve machine learning or AI.

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

Not applicable, as there was no training set.

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Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of fluids, excess exudates, infectious material, and tissue debris.

The Carilex VT Dressing Kits is indicated for use for patients with the following wounds:

• Traumatic
• Dehisced wounds
• Partial-thickness burns
• Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers
• Acute wounds
• Flaps and grafts

Carilex VT Dressing Kits is the wound dressing to be used with the Carilex VT suction pumps for negative pressure wound therapy. This single-use dressing is manufactured using a reticulated flexible polyether and polyurethane hydrophobic material, housed in a medical grade peel pouch, and sterilized by Ethylene Oxide. The Carilex VT Dressing Kits is available in three sizes; 1) small 2) medium and 3) large

The provided text describes the Carilex VT Dressing Kits (K172725) and its equivalence to a predicate device, the DeRoyal Foam Kits (K112458). The document focuses on regulatory approval and substantial equivalence based on non-clinical tests.

Acceptance Criteria and Device Performance:

The document doesn't explicitly list "acceptance criteria" in a typical quantitative sense (e.g., sensitivity, specificity for an AI device). Instead, it states that the dressing kits met "all pre-determined acceptance criteria and passed the tests" during performance/comparison testing against the predicate device. These criteria would likely be related to the physical and functional performance of the dressing kits in managing wounds through fluid removal, as described in their intended use.

The "reported device performance" is implicitly that it performs comparably to the predicate device, thereby demonstrating substantial equivalence. The "Technological Comparison to Predicate Devices" table (pages 4-5) highlights the similarities across various attributes:

1. Table of Acceptance Criteria and Reported Device Performance (Implied):

Missing Information:

The provided document is a 510(k) summary for a medical device (wound dressing kits), not an AI/software device. Therefore, many of the requested details, such as sample sizes, ground truth establishment methods, expert qualifications, and MRMC study specifics, are not applicable to this type of submission and are not present in the document.

Here's why and what can be gleaned:

2. Sample size used for the test set and the data provenance: Not applicable. This refers to performance testing of the physical medical device and its components, not data-driven AI. The "test set" would be the manufactured dressing kits themselves subjected to various physical and chemical tests (e.g., sterilization validation, material testing, fluid absorption/removal efficiency, biocompatibility). The document mentions "Performance/Comparison Testing of VT Dressing Kits with the predicate" and "The biocompatibility tests were performed with the final finished form of VT Dressing Kits." No details on the exact sample sizes of physical units tested or data provenance (country of origin, retrospective/prospective) are provided, as these are typically part of internal technical reports referenced in the 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI (e.g., image annotations by radiologists) is not relevant here. The "ground truth" for this device would be established engineering and scientific standards for material properties, sterility, and device function.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This relates to expert consensus for AI ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic or interpretive devices.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this physical device relies on established engineering and medical standards for material properties, sterility, and functional performance. Things like ISO 10993 (biocompatibility) are the "ground truth" against which the device is measured.

8. The sample size for the training set: Not applicable. There is no AI model or algorithm being "trained" for this physical device.

9. How the ground truth for the training set was established: Not applicable.

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Carilex VT·One/VT·One 60days is indicated for patients who benefit from removal of fluids and excess exudates, infectious material, and tissue debris, which may promote wound healing. The VT-One/VT-One 60days suction therapy unit is indicated on use with patients with the following wounds: Traumatic, Dehisced wounds, Partial thickness burns, Chronic wounds including pressure ulcers, diabetic foot ulcers, and venous leg ulcers, Acute wounds, Flaps and grafts.

Carilex VT One and VT One 60days are suction pumps with collection canisters for negative pressure wound therapy. Carilex VT.One 60days are modified from its precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853), and they are smaller, portable and lighter in weight. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery. The intended use, performance, and technology for Carilex VT·One and VT·One 60days are mostly identical. However, the VT·One 60days is programmed to stop working after 60 days of use and will not re-start after this time. This feature makes VT One 60days a single patient use NPWT pump that has a lifetime of 60 days; while VT-One is a durable medical device with a minimum lifetime of 3 years.

This document describes the FDA's 510(k) summary for the Carilex VT.One/VT.One 60days powered suction pump. The device is a negative pressure wound therapy (NPWT) system.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The pumps met all pre-determined acceptance criteria and passed the tests." However, it does not provide a specific table of acceptance criteria or detailed reported device performance values for the non-clinical tests beyond confirming they passed. It only lists the tests performed.

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

The document does not specify the sample size used for the test set in the non-clinical performance/comparison testing. It only states that "Performance/Comparison Testing of VT.One 60days with the predicate" was conducted. This implies a comparison between the proposed device and the predicate. The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but given it's non-clinical testing of a medical device, it would have been conducted in a lab environment.

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

This question is not applicable. The study described is non-clinical performance and safety testing of a medical device against established standards and a predicate device. It does not involve establishing ground truth from expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This question is not applicable as the study involved non-clinical performance testing against technical standards and a predicate, not human adjudication of medical data.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not performed."

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

This question is not applicable. The device is a powered suction pump, not an AI algorithm. Its performance is mechanical and electrical, not algorithmic. The term "standalone" in this context typically refers to the performance of an AI model without human intervention.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was compliance with established international standards (IEC60601-1, IEC60601-1-2) for medical electrical equipment safety and essential performance, and comparability to the predicate device's performance specifications. This is a technical, rather than medical, ground truth.

8. The Sample Size for the Training Set

This question is not applicable. The device is a mechanical/electrical pump, not an AI/ML algorithm that requires a "training set."

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

This question is not applicable for the same reason as above (not an AI/ML algorithm).

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