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Collacare Dental is indicated for the management of oral wounds and sores, including:

• denture sores
• oral ulcers (non-infected or viral)
• periodontal surgical wounds
• suture sites
• burns
• surgical wounds and traumatic wounds

Collacare Dental is a collagen matrix, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Collacare Dental is supplied sterile and non-pyrogenic, in various sizes, and for single use only. Sizes available include the following:
Dental Sponges: 3.6cm x 1.8cm, 2.5cm x 2.5cm and 2.5cm x 5cm
Dental Cone: Height-17mm Ø Top - 10mm Ø Bottom - 14mm

This document is a 510(k) Pre-market Notification for Collacare Dental, a collagen dental matrix. It's a regulatory submission to the FDA, not a study report with acceptance criteria and performance metrics in the typical sense for an AI/CADe device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present and not applicable to this type of document.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through a comparison of features and a summary of performance testing related to biocompatibility and viral reduction. It doesn't report on specific clinical performance metrics (e.g., sensitivity, specificity, accuracy) of the device in treating oral wounds or sores, as it's a medical device composed of material rather than a diagnostic algorithm.

Here's a breakdown based on the provided document, addressing what is present and what is not applicable:

1. Table of acceptance criteria and the reported device performance

This document does not define specific quantitative "acceptance criteria" for clinical performance (e.g., statistical thresholds for wound healing rates, reduction in pain, etc.) nor does it report on such device performance. Instead, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices.

The reported "performance" is more about the device's characteristics and safety aspects, rather than clinical efficacy metrics:

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 is a 510(k) for a medical device (collagen matrix), not an AI/CADe device. There is no "test set" in the context of diagnostic performance evaluation. The "testing" mentioned is laboratory-based (biocompatibility, viral inactivation) on the device material itself, not human subjects data.

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. See point 2.

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

• Not Applicable. See point 2.

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/CADe device, so MRMC studies are not relevant.

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

• Not Applicable. This is not an AI/CADe device.

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

• Not Applicable. For the biocompatibility and viral reduction tests, the "ground truth" would be established by validated laboratory assays and recognized safety standards for those specific tests, rather than clinical consensus or pathology.

8. The sample size for the training set

• Not Applicable. This is a medical device, not an AI model, so there is no training set.

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

• Not Applicable. See point 8.

Summary of the Study (as described in the document):

The "study" in this context is a series of laboratory-based tests to demonstrate the safety and material properties of the Collacare Dental device, primarily by showing it is substantially equivalent to existing, legally marketed predicate devices.

• Biocompatibility Testing: Included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity. The conclusion was that there were no new biocompatibility issues compared to the predicate device (Collacare Dental K110388).
• Collagen Type and Purity Evaluation: Conducted to ensure no denaturing occurred during the manufacturing process.
• Viral Reduction Assessments: Performed to demonstrate viral deactivation within an acceptable safety range.

The purpose of these tests was to support the claim of substantial equivalence to predicate devices, thereby meeting the regulatory requirements for premarket notification as defined in CFR21, Part 807. The FDA acknowledged this in the letter dated May 1, 2014, stating that the device is "substantially equivalent."

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Procoll may be used for the management of full and partial thickness wounds including:

• Diabetic ulcers .
• . Venous ulcers
• Pressure ulcers .
• Ulcers caused by mixed vascular etiologies
• Abrasions .
• . Traumatic wounds
• 1st and 2nd degree burns .
• Dehisced surgical wounds .
• Exuding wounds .

Procoll is a collagen matrix, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Procoll is supplied sterile and non-pyrogenic, in various sizes, and for single use only.

This document describes the 510(k) premarket notification for a device named "Procoll," a collagen matrix wound dressing. The submission asserts that Procoll is substantially equivalent to a predicate device, Collagen Sponge (K092805).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain any explicit acceptance criteria for device performance in terms of clinical outcomes or specific quantitative metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on material composition, manufacturing processes, and biocompatibility.

The "reported device performance" is essentially the evidence presented to support substantial equivalence:

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

This submission is a 510(k) for substantial equivalence, not a clinical trial report. Therefore, there is no "test set" in the sense of a patient cohort evaluated for clinical outcomes. The "testing" referred to is for material characterization, biocompatibility, and viral inactivation.

• Sample Size: Not applicable in the context of a clinical test set. Material samples were tested for composition and safety.
• Data Provenance: The biocompatibility testing and biochemical characterization were conducted internally or by contracted labs. The viral inactivation validation was also conducted. The country of origin of the data is not explicitly stated beyond the submitter's location in Ireland. This is retrospective in the sense that it's laboratory testing and characterization, not prospective human clinical data.

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

This information is not applicable as there was no clinical "test set" or "ground truth" derived from expert consensus on clinical outcomes. The "ground truth" for the material properties and safety aspects would be established by standard analytical and biological testing methodologies and interpretations by qualified laboratory personnel and regulatory affairs experts. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

This is not applicable as there was no clinical "test set" requiring adjudication of outcomes.

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

This is not applicable. This device is a wound dressing, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This device is a physical wound dressing, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here refers to the verifiable properties of the device and its safety characteristics, not clinical outcomes.

• Material Composition: Established through biochemical characterization (e.g., spectroscopy, chromatography) confirming Type I collagen and its non-denatured state.
• Biocompatibility: Established through in-vitro and in-vivo testing according to ISO 10993-1:2009 standards, interpreted by toxicologists and biocompatibility experts.
• Viral Inactivation: Established through validated viral inactivation studies demonstrating the reduction or elimination of pathogenic organisms.
• Sterility and Non-pyrogenicity: Established through standard microbiological and pyrogenicity testing methods.

Essentially, the ground truth is based on recognized scientific and regulatory testing standards for medical device materials and safety.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of machine learning or AI for this device. The development of Procoll involved material science, manufacturing process development, and safety testing, not statistical model training.

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

This is not applicable as there was no training set.

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Collagen Powder may be used for the management of wounds such as:

• Diabetic ulcers
• Venous ulcers
• Pressure ulcers
• Ulcers caused by mixed vascular etiologies
• Full-thickness & partial thickness wounds
• Abrasions
• Traumatic wounds
• 1st and 2nd degree burns
• Dehisced surgical wounds
• Exuding wounds

Collagen Powder is a collagen matrix in powder form intended for application as a wound management device. The product is supplied sterile for single use only.

The provided text is a 510(k) summary for Collagen Powder. It asserts substantial equivalence to predicate devices based on materials, intended use, and biocompatibility. However, it does not include acceptance criteria or the details of a study proving the device meets specific performance criteria in the way typically expected for a medical device efficacy study (e.g., clinical trial data, performance metrics).

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance

Reasoning: The document primarily focuses on demonstrating "substantial equivalence" based on materials, intended use, and biocompatibility testing against a predicate device. It does not define specific performance metrics (e.g., wound healing rates, infection reduction) for the Collagen Powder or report results against such criteria. The "testing" mentioned is for biocompatibility, viral inactivation, and particle size, which are typically safety and characterization tests rather than performance efficacy tests against clinical acceptance criteria.

Study Information

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

   • Not specified. The document mentions "Biocompatibility and Testing" and "Biochemical characterization," and "Viral inactivation validation assessment," and "Particle size analysis." These are laboratory tests, not clinical studies with human participants. No sample sizes or data provenance for a clinical test set are provided.

2. 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 clinical test set with ground truth established by experts is described.

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

   • Not applicable. No clinical test set requiring adjudication is described.

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, not performed. This device is a topical wound dressing, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.

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

   • No, not applicable. This is a physical wound dressing, not an algorithm.

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

   • Not applicable for clinical performance. For the characterization tests (biocompatibility, viral inactivation, particle size), the "ground truth" would be established by validated laboratory assays and standards (e.g., ISO 10993).

7. The sample size for the training set:

   • Not applicable. No training set for an algorithm is discussed.

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

   • Not applicable. No training set for an algorithm is discussed.

Summary of Device Rationale from the Document:

The 510(k) submission for Collagen Powder relies on demonstrating substantial equivalence to existing, legally marketed predicate devices (Collagen Sponge K092805 and Collatek Powder K012990). This is achieved by:

• Stating that Collagen Powder has the same intended use (management of various types of wounds) as the predicates.
• Confirming that its materials of construction match Collagen Sponge (K092805).
• Providing biocompatibility evaluation (ISO 10993-1:2009) to show it meets requirements and introduces no new biocompatibility issues.
• Conducting biochemical characterization to confirm the collagen is predominantly Type I and not denatured.
• Performing viral inactivation validation to assure safety.
• Conducting particle size analysis for product characterization.

Crucially, this type of 510(k) submission for an Unclassified device like a topical wound dressing does not typically require extensive clinical efficacy studies with predefined "acceptance criteria" and "performance metrics" in the same way a novel diagnostic or therapeutic device might. Substantial equivalence is often established through comparison to predicates and demonstrating equivalent safety and performance characteristics via bench testing and material characterization, rather than comparative clinical outcomes data for specific performance metrics like wound healing rates.

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Collacare Dental is indicated for the management of oral wounds and sores, including:

• denture sores
• oral ulcers (non-infected or viral)
• periodontal surgical wounds
• suture sites
• burns
• surgical wounds and traumatic wounds

Collacare Dental is a conformable collagen matrix manufactured from purified type I collagen derived from bovine Achilles tendon. Collacare Dental is supplied sterile and non-pyrogenic, in various sizes, and for single use only.

The provided text discusses the Collacare Dental device, its intended use, and its substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) Summary for a medical device submitted to the FDA. The purpose of a 510(k) submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria through a dedicated study.

Here's a breakdown of what is and isn't present in relation to your request:

Information NOT present in the document:

• Acceptance Criteria for Device Performance: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, healing rates, etc.) with corresponding acceptance thresholds.
• Study Proving Acceptance Criteria: There is no description of a study designed to test the Collacare Dental device against performance acceptance criteria.
• Reported Device Performance: Since there are no acceptance criteria or a study, there's no reported performance data against such metrics.
• Sample Size for Test Set: No test set is mentioned, thus no sample size.
• Data Provenance: No data from specific tests are presented.
• Number of Experts/Qualifications for Ground Truth: Not applicable as there's no performance study described.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned or referenced.
• Standalone Performance Study: No standalone performance study details are provided.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• Ground Truth Establishment for Training Set: Not applicable.

What the document does describe instead of a performance study against acceptance criteria:

The document focuses on demonstrating Substantial Equivalence based on:

1. Materials of Construction: It explicitly states, "Collacare Dental is substantially equivalent in materials of construction to Collagen Sponge (K092805), Collagen Wound dressing - Oral (K040403), Salicept Oral Patch (K012126)..." and later, "...the materials of construction and finished product material match that of Collagen Sponge (K092805)."
2. Intended Use: The intended uses for Collacare Dental are listed and are presumed to be similar to the predicate devices.
3. Biocompatibility: It states, "There are no new biocompatibility issues arising with the use of Collacare Dental as the materials of construction and finished product material match that of Collagen Sponge (K092805). A complete biocompatibility evaluation was undertaken in line with the requirements of ISO 10993-1." This implies a biocompatibility assessment was done, but it's not a performance study of the device's efficacy against specific clinical outcomes.

Conclusion:

Based on the provided text, the device Collacare Dental gained market clearance through substantial equivalence to existing predicate devices, primarily by demonstrating similar materials of construction, intended use, and a satisfactory biocompatibility assessment. The document does not describe specific performance acceptance criteria or a study designed to prove the device meets such criteria through quantitative performance metrics.

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Collexa may be used for the management of wounds such as:

• Diabetic ulcers
• · Venous ulcers
• . Pressure ulcers
• Ulcers caused by mixed vascular etiologies .
• Full-thickness & partial thickness wounds .
• Abrasions .
• Traumatic wounds .
• 1st and 2nd degree burns .
• Dehisced surgical wounds .
• Exuding wounds .

Collexa is a collagen matrix sponge with a polyurethane foam backing intended for topical use on wounds as described in the intended use section of this 510(k) summary. The polyurethane foam is absorbent and acts as a reservoir for wound exudates. The product is supplied sterile for single use only.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study conducted to prove the device meets acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

The document is a 510(k) summary for a medical device called Collexa, a topical wound dressing. It primarily focuses on demonstrating substantial equivalence to predicate devices and includes information about the device's intended use, description, and biocompatibility. While it mentions that "Biocompatibility testing has confirmed that Collexa meets all the biocompatibility testing requirements in accordance with ISO 10993-1:2009," it does not provide details of this testing or present specific acceptance criteria or performance results in the format you requested.

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Collagen Sponge may be used for the management of wounds such as:

• Pressure ulcers .
• . Venous stasis ulcers
• . Diabetic ulcers
• First and second degree burns .
• Partial and full thickness wounds .
• Superficial injuries .

Collagen Sponge is a collagen matrix sponge intended for topical use. The product is supplied sterile for single use only.

This request asks for acceptance criteria and study data for a medical device from the provided text. However, the provided text is a 510(k) summary for a Collagen Sponge, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance acceptance criteria and a detailed study for a new device's performance.

Therefore, the requested information, specifically acceptance criteria and a study proving those criteria are met, is not available in the provided document.

The document states:

• "Collagen Sponge is substantially equivalent in materials of construction and intended use to CollaGUARD (K061746) and to Collieva (K081782) manufactured by Syntacoll GmbH." (Page 5-1, Section 6)
• "There are no new biocompatibility issues arising with the use of Collagen Sponge as the materials of construction and finished product material match that of CollaGUARD (K061746)." (Page 5-2, Section 9)
• "Collagen Sponge is substantially equivalent to the predicate devices delineated in this submission and meets the requirements for premarket notification as defined in CFR21, Part 807." (Page 5-2, Section 10)

This type of submission (510(k)) generally relies on demonstrating equivalence to an already legally marketed device (predicate device) rather than conducting extensive new clinical studies with defined acceptance criteria for novel performance claims.

As a result, I cannot provide the tables and detailed study information as requested.

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Collieva™ may be used for the management of wounds such as:

• · Pressure ulcers
• Venous stasis ulcers
• · Diabetic ulcers
• · First and second degree burns
• · Partial and full thickness wounds
• · Superficial injuries

Collieva™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.

The provided text is a 510(k) summary for the device Collieva™, a topical wound dressing. It declares substantial equivalence to a predicate device (CollaGuard™) and includes information on intended use and biocompatibility. However, it does not contain any information about a study with acceptance criteria or reported device performance data.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document focuses on regulatory submission for substantial equivalence rather than performance testing against specific criteria.

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CollaGUARD may be used for the management of wounds such as:

• Pressure ulcers .
• . Venous stasis ulcers
• . Diabetic ulcers
• First and second degree burns .
• Partial and full thickness wounds .
• Superficial injuries .

CollaGUARD™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.

The provided text is a 510(k) Summary for a medical device called CollaGUARD. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a performance study with acceptance criteria in the way a typical clinical trial or algorithm validation study would.

Therefore, the requested information elements related to specific acceptance criteria, device performance metrics, sample sizes for test/training sets, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.

Here's an explanation based on the provided text, highlighting what is and isn't available:

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

• Not Applicable in this context. This document is a 510(k) summary demonstrating substantial equivalence, not a report of a performance study with specific acceptance criteria and outcome metrics. The "performance" being demonstrated here is primarily that the device is "substantially equivalent" to a predicate, not that it meets specific numeric clinical efficacy targets.
• The document implies that the device performs equivalently to its predicate by stating: "CollaGUARD™ is substantially equivalent in materials of construction and intended use to Collagen Topical Wound Dressing (K040558) manufactured by Collagen Matrix Inc." and "The collagen products have an extensive and established history of safety and effectiveness."

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 / Not Provided. No specific "test set" in the context of a performance study (e.g., patient data for algorithm validation) is mentioned. The submission relies on existing knowledge and biocompatibility testing.

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 / Not Provided. Ground truth establishment by experts for a test set is not part of this type of submission.

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

• Not Applicable / Not Provided. No adjudication method is described for a 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 / Not Provided. This device is a topical wound dressing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.

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

• Not Applicable / Not Provided. This is a physical medical device (wound dressing), not an algorithm.

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

• Not Applicable / Not Provided for a "study ground truth." The "ground truth" for this 510(k) submission is the regulatory precedent set by the predicate device (K040558) and the established safety and effectiveness of collagen products, supported by biocompatibility testing against ISO standards.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable / Not Provided.

Summary of what the document does state regarding acceptance and evidence:

• Device Name: CollaGUARD™
• Intended Use: Management of wounds such as Pressure ulcers, Venous stasis ulcers, Diabetic ulcers, First and second-degree burns, Partial and full-thickness wounds, Superficial injuries.
• Acceptance Criteria (Implied by 510(k) Process): The core acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. This involves showing similar intended use, technological characteristics, and safety and effectiveness.
• Study Proving Acceptance (Evidence Provided):
  • Biocompatibility Testing: CollaGUARD's biocompatibility testing was completed against the requirements of ISO 10993 -1:2003. The device "passed the requirements of all tests and has been shown to be a biocompatible topical wound dressing." This is a specific study mentioned.
  • Comparison to Predicate Device: CollaGUARD™ is stated to be "substantially equivalent in materials of construction and intended use to Collagen Topical Wound Dressing (K040558) manufactured by Collagen Matrix Inc."
  • Historical Data: "The collagen products have an extensive and established history of safety and effectiveness." This refers to a long-standing understanding of collagen's role in wound healing, not a specific new study for CollaGUARD.
• Conclusion: Based on the substantial equivalence to the predicate device and satisfactory biocompatibility testing, the FDA determined that the device could be marketed.

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