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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.

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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