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Collatek is indicated for dry, light and moderately exudating partial and full thickness wounds such as:

• First and second degree burns
• Severe sunburns
• Superficial injuries, cuts, abrasions and surgical wounds

Collatek Hydrogel may be used under clinical guidance in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:

• Pressure (stage I-IV) and venous stasis ulcers
• Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• Donor sites and grafts

Collatek Hydrogel is a sterile wound-dressing from polyacrylic acid and collagen. The dressing encourages healing by maintaining a moist environment at the wound site in the case of dry of lightly exudating wounds. The collagen used in the dressing is from animals born, raised and slaughtered in the USA.

The provided text is a 510(k) summary for the Collatek Hydrogel wound dressing. It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, materials, safety, sterility, and packaging. This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered medical device.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or AI-specific studies (MRMC, standalone performance) because the document describes a traditional medical device (wound dressing) and not an AI/ML device.

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Collatek Foam may be used in the management of:

• Partial and full thickness wounds
• Pressure (stage I-IV) and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Venous stasis and diabetic ulcers
• 1st and 2nd degree burns
• Cuts, abrasions and surgical wounds

Collatekto Fourn is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to manage full and partial thickness wounds with moderate to heavy exudate. Collatek® Foam is composed of two scparate layers: a collagen matrix layer and a medical grade foam layer. Collatek Foam's collagen matrix layer is made from insoluble fibrous type I bovinc collagen derived from cowhide. Collatek@ Foam's foam layer is a medical grade polyurothane fourn. Collatek® Foam will be initially available in a 4"x 4" size pad, additional sizes may be introduced at a later time.

This 510(k) summary for the Collatek® Foam wound dressing does not describe a study involving performance acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it focuses on demonstrating substantial equivalence to predicate devices. Therefore, the device does not have explicit acceptance criteria or a study "proving" it meets those criteria in the traditional sense of a performance study.

Here's a breakdown based on the information provided, highlighting what is not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This submission does not describe a "test set" in the context of a clinical performance study with patient samples. The evidence relies on direct comparison to predicate devices and biocompatibility testing. The biocompatibility tests were likely performed on material samples, not patient data.

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

• Not Applicable. No test set with ground truth established by experts is described for performance evaluation.

4. Adjudication method for the test set

• Not Applicable. No test set with ground truth adjudication is described.

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 a wound dressing, not an AI-assisted diagnostic or imaging device, so MRMC studies and AI assistance are not relevant.

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

• Not Applicable. This is a physical medical device (wound dressing), not an algorithm or AI system.

7. The type of ground truth used

• Not Applicable. For the performance as a wound dressing, the "ground truth" for substantial equivalence is based on the established safety and effectiveness profile of the predicate devices, material properties, and proven biocompatibility and sterility. There isn't an "expert consensus," "pathology," or "outcomes data" specifically collected for this device's performance in a clinical study to establish a ground truth.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device requiring a training set.

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

• Not Applicable. This is not an AI or machine learning device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or evidence provided is a demonstration of substantial equivalence to legally marketed predicate devices (VigiFOAM® and SkinTemp®) for the same intended use. This is common for 510(k) clearances, especially for devices where the technology is well-understood and similar alternatives exist.

The key elements used to "prove" substantial equivalence are:

• Comparison to Predicate Devices: A side-by-side comparison (Table 1-2.1.2 is mentioned but not provided in the excerpt) showing similarity in:
  • Indications for Use
  • Instructions for Use
  • Technological Characteristics (design, fluid handling)
  • Materials (constituents)
• Biocompatibility Testing: Performed by North American Science Associates, Inc. (NAMSA) in accordance with Good Laboratory Practices (GLP), demonstrating the device meets or exceeds FDA Blue Book Memorandum G95-1 and ISO 10993 requirements. This addresses safety.
• Sterility Validation: Confirmation that the sterilization process (electron beam) achieves a Sterility Assurance Level (SAL) of 10^-6 (implied) in accordance with ANSI/AAMI/ISO 11137-1994. This addresses sterility.

Essentially, the company is arguing that because their device is fundamentally the same as already cleared devices, and it passes standard safety and sterility tests, it is equally safe and effective.

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Collatek Sheet may be used in the management of:

• Partial and full thickness wounds
• Pressure (stage 1-1V) and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Venous stasis and diabetic ulcers
• 1st and 2nd degree burns
• Cuts, abrasions and surgical wounds

Collatek® Shect is a stcrile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Collatek® Sheet is packaged as a sclfadhering island dressing which is able to conform to most wound sites. Collatek® Sheet consist of a hydrocolloid sheet with a clear adherent medical tape backing on one side and a peel-off silica-coated paper on the other. It is to be used manage full and partial thickness wounds with light exudate.

The provided 510(k) summary for the "Collatek® Sheet" wound dressing primarily focuses on establishing substantial equivalence to predicate devices through comparisons of design, function, materials, and intended use. It does not describe a study that involves acceptance criteria and device performance in the way typically expected for a detailed clinical or performance study report.

Instead, the submission states:

"Bench testing was performed to verify that the performance characteristics of Collatek® Sheet are comparable to the currently marketed predicate device. Collatek® Sheet is designed to absorb light amounts of exudates while forming a protective gelatinous barrier. The collagen helps to protects the wound bed and newly formed granulation tissue by formation of an occlusive gelatinous barrier that is conducive to wound healing."

And regarding safety:

"Biocompatibility texting has confirmed that Collatek(s) Sheet meets requirement as stated in the FDA Blue Book Memorandum G95-J and in ISO10993. Biocompatibility tests were performed by North American Science Associates, Inc. (NAmSA) in accordance with GLP. Biocompatibility data has shown that Collatek® Sheet is safe for use as a medical device for wound care management and is substantially equivalent to the commercially available predicate devices (Cutinova® hydro and DuoDerm® CGF)."

Given the information provided, I cannot populate the table or answer most of your specific questions related to acceptance criteria and a study proving its performance against those criteria, as the document details a substantial equivalence claim based on comparison to existing devices and bench testing/biocompatibility rather than a direct performance study with defined acceptance criteria and clinical outcomes.

Here's what can be inferred or explicitly stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Information Not Provided: The document mentions "bench testing" and "Biocompatibility tests" but does not specify sample sizes for these tests or the data provenance.

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)

• Information Not Applicable/Provided: This type of information is typically relevant for studies involving human judgment (e.g., image interpretation, clinical assessment). The described "bench testing" and "biocompatibility testing" are laboratory evaluations, not dependent on expert ground truth in the clinical sense.

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

• Information Not Applicable/Provided: Adjudication methods are typically used in clinical trials or studies where human assessment is involved. This is not described for the bench or biocompatibility testing mentioned.

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, an MRMC comparative effectiveness study was not done. This type of study is not mentioned or implied in the document.

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

• Information Not Applicable/Provided: The device is a wound dressing, not an algorithm or AI. Standalone performance as an algorithm is not relevant.

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

• For bench testing: The "ground truth" would be established by validated test methods and physical/chemical properties, measured against established standards or predicate device performance.
• For biocompatibility testing: The "ground truth" is adherence to specific ISO standards (ISO10993) and FDA guidelines (FDA Blue Book Memorandum G95-J), assessed through specific laboratory assays (e.g., cytotoxicity, sensitization, irritation).
• No clinical ground truth (expert consensus, pathology, outcomes data) derived from patient studies is described in this 510(k) summary.

8. The sample size for the training set

• Information Not Applicable/Provided: The device is a physical wound dressing, not a machine learning algorithm that requires a training set.

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

• Information Not Applicable/Provided: As above, this is not relevant for this type of device.

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Collatek Powder may be used in the management of:

• Partial and full thickness wounds
• Pressure (stage I-IV) and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Venous stasis and diabetic ulcers
• 1st and 2nd degree burns
• Cuts, abrasions and surgical wounds

Collatek® Powder is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to fill in full and partial thickness wounds with moderate to heavy exudate. Collatek® Powder is able to conform to any wound site. Collatek® Powder is a hydrophilic, hydrocolloid wound-powder with a collagen base. Collatek® Powder's collagen is an insoluble fibrous type 1 bovine collagen derived from cowhide. Collatek® Powder will be available in a 1 gram size packet, additional sizes may be introduced at a later time.

The provided document does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria using metrics like sensitivity, specificity, or accuracy. This submission is for a Traditional 510(k) for a wound dressing, which typically relies on demonstrating substantial equivalence to a predicate device based on design, function, materials, and intended use, rather than a performance study against quantitative acceptance criteria for diagnostic or AI-based devices.

Instead, the document focuses on demonstrating that the Collatek® Powder is substantially equivalent to existing predicate devices (hyCURE® Powder, Comfeel® Powder, and Medifil® II Particles) by comparing:

1. Indications for Use: Collatek® Powder's indications are comparable to the predicate devices.
2. Instructions for Use: The manner of use is similar to other wound care products and predicate devices.
3. Technological Characteristics: Collatek® Powder is analogous in design to the predicate devices, being a hydrocolloid wound dressing designed for moderate to high exudating wounds.
4. Materials: The material (fibrous Type I bovine collagen) is the same as some predicate devices.
5. Safety: Biocompatibility testing confirmed compliance with FDA Blue Book Memorandum G95-1 and ISO 10993. (Results are reported to be in Appendix K, which is not provided).
6. Sterility and Packaging: Sterilization methods and packaging are described, with validation in accordance with ANSI/AAMI/ISO 11137-1994.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and performance study details as they are typically associated with AI/diagnostic device submissions. The information requested (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets) is not relevant or present in this type of 510(k) submission for a wound dressing.

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