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SiOxC Cream is a skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment. Not to be used on Breached or Compromised skin or open sores.

SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist environment. SiOxC Cream is provided prescription only in various sizes for single patient use.

The provided text describes a 510(k) premarket notification for a medical device called "SiOxC Cream". However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML medical device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device for a topical cream, primarily through:

• Comparison of technological characteristics: This involves comparing the composition, principle of operation, preservative, available offerings, reapplication frequency, sterility, and biocompatibility of the SiOxC Cream with a predicate device (EPICERAM® Skin Barrier Emulsion).
• Non-clinical performance testing: This includes characterization of pH, viscosity, macroscopic and microscopic appearance, and preservative effectiveness testing (USP ) to support shelf-life.
• Biocompatibility testing: Conducted according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23.
• Human Repeat Insult Patch Test (HRIPT): This study assessed the potential for dermal irritation and sensitization.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it pertains to an AI/ML medical device, because the provided text is for a topical cream and lacks any mention of AI/ML or corresponding performance metrics.

The text states that SiOxC Cream is a "skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment." and that it is "unclassified". This is a non-AI/ML product review.

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The SiOxD® Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, first degree and partial thickness burns, skin tears) and draining wounds.

The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD Wound Matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. SiOxD Wound Matrix promotes a moist environment for the body's natural healing process.

The SiOxD Wound Matrix is not designed to be held in place with compression bandages or tapes. Only light pressure without mechanical compression or secondary bandaging is required for proper device function. The matrix applied to the wound bed naturally sloughs off during wound healing and does not require manual removal.

The provided document is a 510(k) summary for a medical device called the SiOxD® Wound Matrix. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study with defined endpoints.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and the reported device performance: This document focuses on demonstrating equivalence to a predicate device, not on presenting performance metrics against predefined acceptance criteria for the new device.
• Sample sized used for the test set and the data provenance: There is no mention of a clinical test set or data provenance in the context of device performance evaluation. The "material testing" mentioned is likely laboratory-based.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a clinical test set for ground truth establishment is not described.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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. The device is a wound matrix, not an AI or imaging device involving human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does provide regarding device performance and testing:

The document explains that the subject device (SiOxD Wound Matrix) is a line extension of an already cleared predicate device (SiOxMed LLC SiOxD Wound Matrix K222189 / K232847). The core of the submission is to demonstrate that the new device does not have significant technological differences from the predicate and performs similarly.

The key change described for the subject device is:

• Allowed use of alternate water raw materials in the manufacture of the device fiber matrix.

To address this change, material testing was performed:

• Material testing of key physical and chemical properties: This testing demonstrated that devices manufactured with any of the qualified water raw materials met "predetermined release criteria."
• Worst-case assessment of endotoxin levels: This assessment showed that devices manufactured with all water raw materials meet the "20 EU/Device acceptance criteria."

In summary, while specific performance acceptance criteria for clinical efficacy are not detailed, the report highlights that the manufacturing change (alternate water raw materials) was validated through laboratory material testing to ensure the device met internal "predetermined release criteria" for physical and chemical properties, and an "acceptance criteria" of 20 EU/Device for endotoxin levels. This is a common approach for demonstrating substantial equivalence for minor manufacturing changes in a 510(k) submission, where extensive new clinical studies are often not required if technological characteristics and intended use remain the same as a predicate.

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The SiOxD Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and fullthickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first degree and partial thickness burns, skin tears) and draining wounds.

The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD Wound Matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. SiOxD Wound Matrix promotes a moist environment for the body's natural healing process.

The SiOxD Wound Matrix is not designed to be held in place with compression bandages or tapes. Only light pressure without mechanical compression or secondary bandaging is required for proper device function. The matrix applied to the wound bed naturally sloughs off during wound healing and does not require manual removal.

The provided document K232847, a 510(k) summary for the SiOxD Wound Matrix, does not contain information on an AI/ML-based medical device. Therefore, it does not include details on acceptance criteria, study methodologies for AI performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document describes a medical device, the SiOxD Wound Matrix, which is a non-pyrogenic, sterile, single-use wound dressing made from hydrated amorphous silica in fibrous form. The submission is for a line extension of an already cleared device (K222189). The new submission adds new intermediate size offerings and single barrier packaging configurations.

Since this is a submission for a physical medical device (wound dressing) and not a software/AI device, the information requested in your prompt regarding AI/ML performance, acceptance criteria, and specific study details (like sample size for test/training sets, expert ground truth) is not applicable to this document. The "study that proves the device meets the acceptance criteria" in this context refers to standard medical device testing (e.g., sterilization, packaging integrity, biocompatibility), not AI model validation.

If you have a document pertaining to an AI/ML medical device, please provide it, and I will be happy to extract the relevant information.

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The SiOxD Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and fullthickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first degree and partial thickness burns, skin tears) and draining wounds.

The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD Wound Matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. SiOxD Wound Matrix promotes a moist environment for the body's natural healing process.

The SiOxD Wound Matrix is not designed to be held in place with compression bandages or tapes. Only light pressure without mechanical compression or secondary bandaging is required for proper device function. The matrix applied to the wound bed naturally sloughs off during wound healing and does not require manual removal.

The provided document is a 510(k) summary for the SiOxD Wound Matrix, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for performance as an AI/ML powered device. Therefore, much of the requested information regarding AI/ML specific studies (MRMC study, standalone performance, ground truth establishment for training/test sets, expert qualifications, adjudication methods, and sample sizes for training/test sets for AI/ML) is not available in this document.

However, I can extract the acceptance criteria and performance related to the device function and biocompatibility as described in the summary:

Acceptance Criteria and Reported Device Performance

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