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510(k) Data Aggregation
(30 days)
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(27 days)
LacertaMatrix is indicated for use in the management of the following wounds:
- partial and full-thickness wounds
- pressure ulcers
- venous 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, lacerations, partial thickness burns, and skin tears)
- draining wounds
LacertaMatrix is a single use, non-pyrogenic wound dressing intended for use in local management of full thickness and partial thickness wounds.
LacertaMatrix includes alligator derived hyaluronic acid (HA) and is provided sterile in various size offerings up to 100cm² in a dual pouch configuration for aseptic transfer. Following placement, LacertaMatrix is gradually broken down and resorbed over time (typically over a period of within 2 weeks), as new tissue forms in its place.
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(138 days)
CollOvine™ Wound Powder is indicated for the management of wounds including:
- full-thickness & partial-thickness wounds
- pressure ulcers
- venous ulcers
- diabetic ulcers
- partial thickness burns
- donor sites and other surface wounds
- abrasions
- traumatic wounds healing by secondary intention
- acute wounds
CollOvine™ Wound Powder is a sterile advanced wound care device composed of medical grade ovine collagen. CollOvine Wound Dressing is soft, absorbent, and readily conforms to the wound bed.
CollOvine™ Wound Powder is intended to maintain the moist wound environment.
CollOvine™ Wound Powder is a primary wound dressing that can be sprinkled over the wound bed without the need to precut.
CollOvine™ Wound Powder should be used with suitable non-occlusive absorbent secondary dressing and secured with standard non-irritating fixations such as medical grade tape or semi-occlusive dressing as appropriate.
CollOvine™ Wound Powder is a primary dressing, to maintain the moist wound bed environment.
CollOvine™ Wound Powder is soft, pliable and free flowing.
The ovine collagen for CollOvine™ Wound Powder is obtained from animal tissue, with sourcing, collection, storage and viral inactivation carried out in compliance with ISO22442.
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(268 days)
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(83 days)
Theracor is intended to cover, protect, and provide a moist wound environment.
Theracor is indicated for use in the management of the following wounds:
- Partial and full-thickness wounds
- Pressure ulcers
- Venous 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, lacerations, partial-thickness burns, and skin tears)
- Draining wounds
Theracor is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. The device is intended to cover, protect, and provide a moist wound environment. As a resorbable device, Theracor is aseptically processed and lyophilized to remove moisture while preserving the structural components of the umbilical cord matrix. The device is packaged in sheet form and should be rehydrated prior to applying to the wound bed.
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(119 days)
LacertaMatrix is indicated for use in the management of the following wounds:
- partial and full-thickness wounds
- pressure ulcers
- venous 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, lacerations, partial thickness burns, and skin tears)
- draining wounds
LacertaMatrix is a single use, non-pyrogenic wound dressing intended for use in local management of full thickness and partial thickness wounds. LacertaMatrix includes alligator derived hyaluronic acid (HA). LacertaMatrix is provided sterile in various size offerings up to 100cm² in a dual pouch configuration for aseptic transfer. Following placement, LacertaMatrix is gradually broken down and resorbed over time (typically over a period of within 2 weeks), as new tissue forms in its place.
This device is limited to only one-time application to the wound. This device can only be used once within 24 hours and should be completely remove by rinsing with PBS to remove any residual device. Second application is restricted. Please use other FDA cleared dressing.
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(273 days)
MatriDerm pluS+ is indicated for the management of wounds including full thickness and partial thickness wounds, chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), partial thickness burns, trauma wounds (abrasions, lacerations and skin tears) and draining wounds.
MatriDerm pluS+ Bi-Layer is a non-pyrogenic, single use, prescription use three-dimensional dermal matrix consisting of two layers. The first layer is composed of collagen fibers, a key component of the native extracellular matrix, and hydrolyzed elastin. The second layer consists of a medical grade silicone grid to control moisture loss from the wound providing a flexible adherent covering for the wound surface and adding increased mechanical strength to the device. The device conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The device serves as a scaffold for cellular invasion and capillary growth and promotes a moist environment for the body's natural healing process. The device is supplied sterile and is provided in different sizes providing flexibility of choice based on the treatment protocol, wound location, size, and depth.
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(455 days)
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(105 days)
Indications for Use (Describe)
Prescription Use
Collagen Wound Dressing is indicated for the management of exuding wounds including:
- Full thickness and partial thickness wounds
- Pressure and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- Partial thickness burns
- Donor sites and other bleeding surface wounds
- Abrasions
- Traumatic wound healing by secondary intention
- Dehisced surgical incisions
Over-The-Counter Use
Intended for the management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.
Collagen Wound Dressing is a wound care device composed of pure freeze-dried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing that can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable. Please reapply the dressing as needed based on the patient's wound healing situation.
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(184 days)
Helios Dermal Scaffold is intended for the management of wounds that include:
- Partial- and full- thickness wounds
- Pressure, diabetic, and venous ulcers
- Partial thickness burns
- Surgical wounds – donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds – abrasions, lacerations and skin tears
- Tunneled/undermined wounds
- Draining wounds
Helios Dermal Scaffold is an acellular dermal tissue matrix derived from fetal bovine dermis. The single-use device is supplied sterile and is provided in sheet form in a variety of sizes and configurations, including meshed, solid, and fenestrated designs ranging from 1.5 - 500 cm² to be trimmed by the surgeon to meet the individual patient's needs.
The provided FDA 510(k) clearance letter for the Helios Dermal Scaffold does not contain any information regarding acceptance criteria or the study details typically associated with AI/ML device performance validation.
This document is for a medical device (a dermal scaffold), which is a biological product, not a software or AI/ML-driven diagnostic device. The performance data section refers to physical and biological characteristics of the scaffold, such as:
- Device Characterization Testing: Dimensional verification, color and appearance, suture retention strength, acellularity (histology), collagen denaturation.
- Design Validations: Viral inactivation, sterilization.
- Biocompatibility
- Shelf-life
- Packaging testing
These tests are standard for biological and implantable materials, ensuring their physical integrity, safety, and compatibility with the human body. They do not involve AI/ML algorithms, image analysis, or diagnostic accuracy.
Therefore, it is not possible to extract the requested information (acceptance criteria, sample size, ground truth, expert opinions, MRMC studies, etc.) from this document, as those concepts are not applicable to the type of device described.
To answer your prompt with the requested information, the input document would need to be a 510(k) clearance letter for an AI/ML medical device, typically referencing a clinical study or performance study that evaluates diagnostic accuracy, sensitivity, specificity, or reader agreement.
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