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The XCELLARISPRO TWIST microneedling device and accessories is intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I. II, III and IV in adults aged 22 years or older and for treatment of wrinkles in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.

The XCELLARISPRO TWIST is a microneedling device and intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainlesssteel needles. The XCELLARISPRO TWIST has 4 component parts and 2 consumables. Component parts: (1) handpiece, (2) control unit, (3) power supply and (4) foot switch. Consumables: (1) sterile, single-use needling module (Ethylene oxide sterilized) and (2) disposable barrier sleeves that cover the handpiece during each patient use.

This document is a 510(k) premarket notification letter from the FDA regarding the XCELLARISPRO TWIST microneedling device. It clarifies that this device is not an AI/ML powered device, and therefore, the acceptance criteria and study information requested would not be present in this type of document. The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance testing and adherence to general and special controls, rather than human-in-the-loop or standalone AI performance studies.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance, cannot be extracted from the provided text.

The closest relevant sections in the document that discuss performance and criteria are under "Non-Clinical Performance Testing" on pages 8-10. These sections outline special controls and non-clinical tests conducted to demonstrate the device's safety and effectiveness without involving AI.

Summary of available information related to device performance in the provided text (not AI-related):

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI related):

The document does not present a formal table of acceptance criteria and reported performance in the way typically seen for AI/ML devices. Instead, it lists "special controls" that the device must meet through non-clinical performance data. These are more akin to design and function requirements than performance metrics in an AI context.

• Safety features (cross-contamination, fluid ingress): Due to a bellows. (Demonstrated).
• Maximum safe needle protrusion depth: Identified in pig skin with high-speed camera measurement. (Demonstrated). |
  | 3. Performance data demonstrate sterility of patient-contacting components (ISO 11737-2, ISO 11135). | Demonstrated for sterile, single-use needling module (Ethylene oxide sterilized). |
  | 4. Performance data supports shelf life (sterility, package integrity, functionality per ISO 11607-1). | Demonstrated. |
  | 5. Performance data demonstrate electrical safety and electromagnetic compatibility (EMC) per IEC 60601-1 and IEC 60601-1-2. | Demonstrated. |
  | 6. Software verification, validation, and hazard analysis. | Conducted. (The device has a control unit and adjustable settings, indicating software or firmware for operation, but this is not an AI/ML software). |
  | 7. Patient-contacting components biocompatible (cytotoxicity, irritation, sensitization, acute systemic toxicity, material pyrogenicity per ISO 10993-1). | Demonstrated. |
  | 8. Cleaning and disinfection validations for reusable components. | Performed for surfaces of the control unit and handpiece. |
  | 9. Labeling includes required information (operation, technical parameters, reprocessing, disposal, shelf life). | Included. |
  | 10. Patient labeling includes required information (operation, risks/benefits, post-operative care). | Included. |

Regarding the AI/ML specific questions:

2. Sample size used for the test set and the data provenance: Not applicable, as this is not an AI/ML device. Performance testing involved pig skin for physical measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a microneedling device's physical performance typically relies on instrumental measurements and engineering specifications, not expert human interpretation of data/images.
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): For the non-clinical performance tests mentioned, the ground truth would be based on validated objective measurements (e.g., high-speed camera measurements for needle protrusion and puncture rate, laboratory tests for sterility, biocompatibility, electrical safety).
8. The sample size for the training set: Not applicable (no AI training set).
9. How the ground truth for the training set was established: Not applicable (no AI training set).

Conclusion: The provided FDA 510(k) summary is for a traditional medical device (microneedling device) and focuses on demonstrating substantial equivalence through non-clinical performance and adherence to established regulatory controls, rather than on AI/ML algorithm performance. Therefore, the specific questions related to AI/ML acceptance criteria, study design, and ground truth establishment are not addressed in this document. The document explicitly states: "No clinical studies were performed to test the XCELLARISPRO TWIST microneedling device." This further confirms the absence of human "expert" involvement in establishing performance for this particular device submission beyond standard engineering and lab testing.

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The intended use of VHT 200 wound treatment system is to provide humidified oxygen to open, acute or chronic wounds as an adjunct therapy in wound management and treatment.

The VHT-200 wound treatment system is intended for the following kinds of wounds:

• · skin ulcerations due to diabetes, venous stasis, and post-surgical infections, and gangrenous lesions
• decubitus ulcers
• · amputations/infected stumps
• · skin grafts
• burns
• · frostbite

The VHT-200 Wound Treatment System is a prescription medical device. This system is designed for most topical skin injuries that can benefit from the properties of oxygen and moisture therapy treatments. All the benefits of oxygen and moisture modalities are self-contained into one system and applied without the need of switching applications. The VHT-200 is made for clinical office use. The VHT-200 wound treatment system is designed for the medical provider to add oxygen flow rate and frequency of the treatments based on experience and professional assessment of the individual patient's medical need.

This document is a 510(k) summary for the VHT-200 Wound Treatment System. It does not describe a study involving acceptance criteria and device performance in the way a clinical performance study for an AI-powered diagnostic device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various types of engineering and safety testing.

Therefore, many of the requested categories are not applicable to the information provided. The document outlines regulatory and engineering tests, not a clinical study involving human readers or AI algorithms.

Here's a breakdown based on the provided text, indicating where information is missing or not applicable:

No clinical performance study with acceptance criteria in the requested format was performed or described in this 510(k) summary. The provided text describes engineering, safety, and performance testing to demonstrate substantial equivalence to a predicate device, not a human-in-the-loop or standalone AI performance study against specific clinical acceptance criteria.

Here's how the information maps to your request:

1. A table of acceptance criteria and the reported device performance:
   This information is not provided in the context of a clinical performance study with specific metrics like sensitivity, specificity, or accuracy. The document states "The VHT-200 has been evaluated in various conditions and determined to be safe and effective" and lists types of engineering and safety tests, but does not provide a table of acceptance criteria and reported performance for clinical outcomes or diagnostic accuracy.

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. This document describes testing for a medical device (topical oxygen chamber), not an AI diagnostic algorithm evaluated on a test set of patient data. The "test set" here refers to conditions for engineering and safety tests.

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. This document describes testing for a medical device, not a clinical study requiring expert ground truth for diagnostic purposes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. This document describes testing for a medical device, not a clinical study requiring adjudication of expert interpretations.

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 document does not mention any MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The VHT-200 is a physical medical device (topical oxygen chamber) and does not involve an AI algorithm with standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable in the context of diagnostic "ground truth." The "ground truth" for the VHT-200 system would relate to its physical performance against engineering standards (e.g., oxygen concentration maintained, biocompatibility, electrical safety).

8. The sample size for the training set:
   Not applicable. This device does not use a training set in the context of AI or machine learning.

9. How the ground truth for the training set was established:
   Not applicable. This device does not use a training set.

Summary of "Performance Testing" from the document:

The 510(k) summary indicates that the VHT-200 Wound Treatment System underwent various tests to demonstrate its safety and effectiveness, and its substantial equivalence to the predicate device. These tests fall under engineering and regulatory compliance, not clinical diagnostic performance.

• Tests Performed:

  • Software validation
  • IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests)
  • IEC 80601-1-2 (Likely a typo and refers to IEC 60601-1-2 or another specific part of the IEC 60601 series)
  • IEC 80601-2-69 (Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrators) - This is highly relevant as the device includes an oxygen concentrator.
  • Biocompatibility evaluation
  • Performance testing (general statement, specific metrics not detailed)
  • Cleaning validation
  • Distribution testing

• Conclusion: Based on these tests, the VHT-200 was concluded to be as safe, as effective, and to perform at least as safely and effectively as the predicate device.

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The EPIFLO-28 is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) pressure ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.

EPIFLO-28 is an oxygen delivery device that incorporates a disposable oxygen concentrator. It consists of (1) the oxygen concentrator, and (2) the sterile cannula. The oxygen concentrator is a single patient, single use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen continuously for twenty eight days at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.

The provided text is a 510(k) Summary for the EPIFLO-28 device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantified performance metrics against a defined ground truth.

Therefore, many of the requested elements for describing specific acceptance criteria and a study proving their attainment are not explicitly present in the provided text. The document describes performance testing to validate specifications and clinical studies for biocompatibility and usability but does not detail a study designed to prove acceptance criteria in the manner usually seen for AI/ML device clearances (e.g., sensitivity, specificity, AUC against a gold standard).

However, I can extract the information that is available and indicate where the requested information is not provided.

Acceptance Criteria and Device Performance (as inferred or generally stated):

Detailed Study Information:

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

   • Biocompatibility (local tissue response): Wounds from an unspecified number of subjects were evaluated. Data provenance is not specified (e.g., country of origin, retrospective/prospective).
   • Usability (EPIFLO-28): 17 lay users and 18 healthcare professionals. Data provenance is not specified.
   • Usability (Predicate device): 61 patients over up to 12 weeks. Data provenance is not specified.
   • For performance testing related to oxygen delivery specifications, LED operation, and EMC compatibility, specific sample sizes and data provenance are not provided.

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

   • Not applicable / Not explicitly stated. For a medical device like the EPIFLO-28 (a topical oxygen delivery system), the "ground truth" for performance is typically objective measurements (e.g., oxygen concentration, flow rate, duration). For biocompatibility, it involves laboratory tests and clinical evaluation of tissue response by qualified personnel (e.g., pathologists, clinicians), but the number and specific qualifications are not detailed. For usability, the "ground truth" is user feedback and observations, not an expert-established clinical diagnosis.

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

   • Not applicable / Not explicitly stated. This type of adjudication method is usually relevant for diagnostic devices where subjective interpretation of images/data by multiple experts is involved to establish a consensus ground truth. For this device, performance is evaluated by objective measurements and biocompatibility by laboratory findings and clinical observations.

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:

   • No, an MRMC study was not done. This type of study is specific to diagnostic AI/ML systems where human readers interpret medical images/data. The EPIFLO-28 is a therapeutic device.

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

   • Not applicable. The EPIFLO-28 is a physical medical device, not an AI/ML algorithm. Its "performance" inherently involves its physical operation, not an algorithm's output.

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

   • Biocompatibility: Laboratory test results (cytotoxicity, sensitization, irritation, pyrogenicity, extractables/leachables analysis) and clinical evaluations of wound fluid, tissue punch biopsies for pro-inflammatory cytokines, proteases, and macrophages.
   • Usability: User feedback, observations, and responses to questions in case report forms.
   • Performance (Oxygen Delivery, etc.): Objective measurements against engineering specifications.

7. The sample size for the training set:

   • Training set concept is not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set" in the context of machine learning.

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

   • Not applicable. See point 7.

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The NATROX™ System is a low-dose tissue oxygenation system intended to provide topical oxygen to aid in the healing of chronic wounds such as:

• Skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions,
• Decubitis ulcers (bedsores), .
• Amputations/infected stumps, .
• Skin grafts,
• Burns, and
• Frostbite

The NATROX™ Topical Oxygen Delivery System is a small battery-powered electronic device approximately the size of a cell phone, containing an oxygen generator that produces 99% oxygen from room air at a rate of approximately 13 mL/hour. A small diameter tube transmits the oxygen to the wound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System (ODS), Island Oxygen Delivery Pad (IODP) wound dressing or into the patient's own wound dressing, The NATROX™ System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue.

The provided text describes the NATROX™ Topical Oxygen Delivery System and its safety and effectiveness. However, it does not contain specific acceptance criteria in a quantifiable format (e.g., "wound size reduction of X% with p-value

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The EPIFLO System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) pressure ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.

EPIFLO is an oxygen delivery system that incorporates a disposable oxygen concentrator. It consists of (1) the oxygen concentrator, and (2) the sterile cannula. The oxygen concentrator is a single patient, single use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen continuously for seven or fifteen days (depending on the model) at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.

The provided text describes the EPIFLO System, a transdermal continuous oxygen therapy device. However, it does not include a detailed study or specific acceptance criteria for device performance in the way typically expected for a medical device with measurable outcomes like accuracy or sensitivity/specificity.

Instead, the performance testing section (Section 7) states: "Testing was conducted to validate that the EPIFLO performed according to its specifications. These tests included performance testing for oxygen delivery per the specification for labeled durations, EMC compatibility and sterilization validation."

This indicates that the acceptance criteria were related to the device's functional specifications (e.g., oxygen delivery rate, duration, safety features) rather than clinical efficacy or diagnostic accuracy, as this is an oxygen delivery system, not a diagnostic or screening tool.

Given the information, I can only describe the reported device performance as it relates to its functional specifications, as specific metrics for clinical efficacy are not provided in this document.

Here's the breakdown of what can be extracted and what is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that testing was conducted to validate performance "according to its specifications." Specific numerical acceptance thresholds (e.g., "oxygen delivery must be 3.0 +/- 0.1 ml/hour") are not explicitly stated, but the reported performance values are presented as meeting these underlying, implied specifications.

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

This information is not provided in the document. The text mentions "Performance Testing" but does not detail the methodology, sample sizes, or nature of the test set (e.g., in-vitro, in-vivo, clinical subjects).

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

This information is not provided. As this is a device for oxygen delivery, not a diagnostic system requiring expert interpretation of images or data, the concept of "ground truth" established by clinical experts in the traditional sense (e.g., radiologists for imaging) is not directly applicable to the functional performance testing described. Ground truth for functional tests would typically be established by calibrated measurement instruments.

4. Adjudication Method for the Test Set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this document. Such studies are typically for diagnostic or screening devices where human readers interpret data, often with and without AI assistance, to measure changes in diagnostic performance. The EPIFLO System is an oxygen delivery device, not a diagnostic tool requiring human interpretation.

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

The described performance testing focuses on the device's functional operation (oxygen delivery rate, purity, duration, EMC, sterilization). This is inherently a "standalone" evaluation of the device's physical and operational characteristics without human intervention influencing its core function. However, it's not "algorithm-only" performance as the device's primary function is mechanical/chemical oxygen generation and delivery, not data processing.

7. Type of Ground Truth Used

For the functional performance testing described (oxygen delivery, EMC, sterilization), the ground truth would likely be established by:

• Instrumental Measurement: Calibrated sensors and measurement tools for oxygen flow rate, purity, and duration.
• Standardized Test Methods: Protocols for EMC (Electromagnetic Compatibility) and sterilization validation, which typically have defined pass/fail criteria.
  The document does not explicitly state the type of ground truth used, but these are the standard approaches for such device validations.

8. Sample Size for the Training Set

This information is not provided. As the EPIFLO System is a physical medical device (oxygen concentrator and cannula) and not an AI/ML algorithm requiring a training set, this question is not applicable in the context of this device.

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

This information is not provided and is not applicable, as the device is not an AI/ML algorithm that requires a training set and corresponding ground truth.

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The TransCu O2 low dose tissue oxygenation system is intended for use with wound dressings to treat the following: Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions Pressure ulcers Infected residual limbs Skin grafts Burns Frostbite

TransCu O2 is a low dose tissue oxygenation system for the treatment of wounds such as venous leg ulcers, diabetic foot ulcers and pressure ulcers. TransCu O2 is intended for use with wound dressings. TransCu O2 consists of a handheld electrochemical oxygen concentrator, an oxygen delivery extension set and a wound site oxygen delivery cannula. The TransCu O2 device incorporates enhanced fuel cell chemistry, utilizing a Proton Exchange Membrane to electrochemically generate the low dose pure oxygen. The battery operated device is lightweight, portable and can be worn discretely, functioning in remote communication with the wound site through long microbore tubing. TransCu O2 extracts oxygen from room air; concentrates the oxygen through the PEM; and then creates an oxygen rich environment by increasing the available oxygen at the wound site under the dressing.

The provided text describes a medical device, TransCu O2, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document is a regulatory filing for a medical device (TransCu O2) and primarily focuses on its substantial equivalence to a predicate device (OxyBox System - K023456). It outlines the device's description, intended use, indications, and classification.

The "Performance Testing" section simply states: "Bench testing validates that the TransCu O2 performs according to its specifications." This is a general statement and does not provide any specific acceptance criteria, study details, performance metrics, or data.

Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication, or comparative effectiveness studies, as these details are not present in the provided text.

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The AOTI Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of open acute or chronic wounds, such as;

• skin ulcerations due to diabetes, venous stasis, post surgical infections o and gangrenous lesions
• decubitus ulcers O
• amputations/infected stumps 0
• skin grafts O
• burns O
• frostbite o

The Hyper-Box Topical Wound Oxygen System is a non-invasive device intended to allow the application of topical oxygen at slightly above atmospheric (hyperbaric) pressure to wounds and ulcers of the extremities.

The provided text is a 510(k) summary for the Hyper-Box Topical Wound Oxygen System, which is a medical device. This type of submission focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices, rather than presenting a clinical study to prove effectiveness based on specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

Instead, the document focuses on regulatory compliance and comparison to predicate devices.

Here's the relevant information that can be extracted from the provided text:

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

• Not Applicable. The document does not describe specific performance acceptance criteria for clinical effectiveness or report device performance against such criteria. The "combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use" refers to general regulatory compliance and engineering specifications, not clinical performance metrics.

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

• Not Applicable. No clinical test set or data provenance is mentioned in the document.

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. No ground truth establishment by experts is described as there is no clinical test set.

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

• Not Applicable. No adjudication method is described as there is no clinical test set.

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

• Not Applicable. This is not an AI-assisted device, and no MRMC study is mentioned.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. No clinical ground truth is described in the context of device performance evaluation.

8. The sample size for the training set

• Not Applicable. This is not an algorithm, so there is no training set.

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

• Not Applicable. This is not an algorithm, so there is no training set or ground truth for one.

Summary of what is known from the document:

• Device Name: Hyper-Box Topical Wound Oxygen System
• Intended Use: Treatment of open acute or chronic wounds, such as skin ulcerations due to diabetes, venous stasis, post surgical infections, gangrenous lesions, decubitus ulcers, amputations/infected stumps, skin grafts, burns, and frostbite.
• Classification: Class III per 21 CFR 878.5650 (Topical oxygen chamber for extremities)
• Predicate Devices (used for demonstrating substantial equivalence, not for performance comparison in a clinical study context):
  • Advanced Hyperbaric Technologies Inc. Topical Hyperbaric Oxygen Extremity Chamber (Pre-Amendment)
  • Vascular One, Inc VX-400 Topical Hyperbaric Oxygen Chamber (K022028)
  • GWR Medical O2 Boot device (K971507)
  • Metro Medical Manufacturing HEC 1000 Topical Oxygen Chamber for Extremities (K020466)
• Regulatory Basis for Clearance: Substantial equivalence to predicate devices, based on similar intended use and similar technological features, materials, and design, and compliance with various voluntary, international standards (EN60601-1:1990, EN 60601-1-2:1993, CAN/CSA C22.2 No. 601-1M90:1994, UL 2601-1:1994 and 93/42/EEC Medical Device Directive). Software design and development followed FDA's "Guidance for the Content of Premarket Submissions for Software contained in medical devices."

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The Misty™ Wound Treatment System provides humidified hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, the device can also provide heat, gentle massage, moisture, and infrared and ultraviolet light therapy. The device is intended for the treatment of the following kinds of wounds: - skin ulcerations due to diabetes, venous stasis, and post surgical infections - gangrenous lesions, - decubitus ulcers . - amputations/infected stumps . - . skin grafts - . burns - frostbite ♥ Caution: Federal law restricts this device to use by or on the order of a physician or podiatrist.

The Wound Treatment System is composed of a rectangular, rigid plastic shell that is of sufficient size to accommodate the patient's foot. There are four fittings on the chamber: one for oxygen tubing that fills the chamber, one for a pressure sensor, one to allow the mist to enter the chamber and one for water transfer. The front panel control consists of a plastic panel with switches, indicators and timer controls; these connect to the Wound Treatment System via a cable. The system plugs into an AC wall outlet.

This 510(k) summary for the WHS-1000 Wound Treatment System (Misty™) does not contain information about acceptance criteria or a study proving the device meets said criteria. The document explicitly states "Performance Data: N/A" and "Clinical Data: N/A".

The 510(k) clearance for this device was based on a demonstration of substantial equivalence to an existing legally marketed device (the VX-400 Topical Hyperbaric Oxygen Chamber). This means that the FDA determined the new device has the same intended use and technological characteristics as the predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

Therefore, the requested information cannot be extracted from the provided text. The document does not describe a study involving human or AI performance, ground truth establishment, or multi-reader studies.

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The OxyBox System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitis ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.

OxyBox is a topical bandage system that incorporates a disposable oxygen concentrator. It consists of three separate component parts: (1) the oxygen concentrator, (2) the sterile cannula and (3) the bandage or wound dressing. Items (2) and (3) are medical grade commercial products that Oxyfast Corporation obtains from device manufacturers or distributors. The oxygen concentrator is a single patient, one time use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen (balance moisture) for seven days at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.

The provided text is a 510(k) summary for a medical device called OxyBox. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The section titled "7. PERFORMANCE TESTING" only states: "Testing was conducted to validate that the OxyBox performed according to its specifications. In addition, animal testing was conducted that demonstrated that topical oxygen delivered by the OxyBox provides increased epithelization compared to a control."

This is a high-level statement without any details about specific acceptance criteria, study design, sample sizes, or results.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided document.

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For Treatment of open acute or chronic wounds, e.g.,

• Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions
• Decubitus ulcers
• Amputations/infected stumps
• Skin grafts
• Burns
• Frostbite

The VX-400 Topical Hyperbaric Oxygen Chamber is a small, portable system that provides oxygen, at prescribed pressure for a prescribed duration, to a patient's limb. It is used at home or a clinical setting to help speed wound healing. The system consists of five (5) major components:

• 1. The Blue/Clear Plastic Chamber
• 2. The Control Unit
• 3. The Hand Held Controller
• 4. The Silicone Sleeve
• 5. Power Cube (Power Supply)

The VX-400 is a rectangular, yet rounded (10 x 24 x 16) rigid plastic shell constructed of two plastic half-panels, to which epoxy is applied and then heat-sealed together along the edges to form one chamber.

The chamber is a rigid plastic sleeve into which the patient places their limbs. There are two (2) hose barbs on the chamber, one for oxygen tubing that fills the chamber, and one for tubing to a pressure sensor. The controller consists of a plastic box with two (2) pieces of attached clear flexible tubing; these connect to the two (2) barbs on the chamber. The controller has a hose connected from the 50-psi oxygen source, a connector for a "power cube" that plugs into an AC wall outlet, and a cable that connects to the hand controller. The controller also incorporates a flowmeter. The hand-held controller can be programmed by the clinician to the prescribed time and pressure therapy, and then set to allow the patient to only turn the unit on and then off; it has a small 2 line LCD alphanumeric display and several push buttons.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the VX-400 Topical Hyperbaric Oxygen Chamber:

Important Note: The provided document is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, not a clinical study report or a document explicitly detailing acceptance criteria for a new clinical indication. Therefore, information typically found in clinical trials (like specific quantitative clinical acceptance criteria, sample sizes for test sets, expert ground truth establishment, MRMC studies, etc.) is largely absent. The document focuses on demonstrating engineering performance and safety relative to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the test set. It refers to "VX-400 device samples(s) tested," implying a limited number of physical units were used for the engineering tests. This is typical for premarket device testing where the focus is on device function and safety, not clinical efficacy in a large patient population.
• Data Provenance: The data is from non-clinical (engineering/bench) testing. The testing was conducted by "A Contract Testing Laboratory" and "Vascular One, Inc." within the United States. It is retrospective in the sense that the results were submitted after the tests were completed.

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

• This information is not applicable and not provided in the document. The "ground truth" for these engineering tests would be the established scientific and engineering principles and the specifications outlined in the FDA's "Reviewer Guidance." The tests were performed to verify the device's adherence to these specifications, not to assess clinical diagnoses or outcomes requiring expert medical consensus.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are used in clinical trials to resolve discrepancies in expert interpretations of medical data. Since this document describes engineering performance tests, such methods are not relevant. The "adjudication" here would be the pass/fail result of each engineering test against its pre-defined criteria.

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: "Discussion of Clinical Tests Performed: Not applicable." This device is a Class III device, but its 510(k) submission relies on substantial equivalence to existing predicate devices, which often means extensive new clinical efficacy studies are not required if technological characteristics are similar and safety is demonstrated through non-clinical means.

• Effect Size: Not applicable, as no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This concept is not applicable to this device. The VX-400 is a physical medical device (a hyperbaric oxygen chamber), not an algorithm or AI system. Its performance is inherent in its physical function and control system. While it is "software driven," its "standalone" performance would be its ability to maintain pressure and deliver oxygen as programmed, which is covered under the operational performance tests.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests described in the document is the engineering specifications and safety standards outlined by the manufacturer and the FDA guidance document (FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND). The tests were designed to verify that the device performed according to these pre-defined, measurable engineering and safety parameters.

8. The Sample Size for the Training Set

• This information is not applicable and not provided. "Training set" refers to data used to train algorithms or AI models. This device is a physical hyperbaric chamber, not an AI model requiring a training set for performance.

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

• This information is not applicable and not provided, as there is no training set for this type of device.

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