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Geistlich Bio-Gide® is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects; and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Shape is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth; and
• guided bone regeneration in dehiscence defects.

Geistlich Bio-Gide® Compressed is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Forte is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Perio is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

• augmentation or reconstructive treatment of the alveolar ridge;
• filling of periodontal defects;
• filling of defects after root resection, apicoectomy, and cystectomy;
• filling of extraction sockets to enhance preservation of the alveolar ridge;
• elevation of the maxillary sinus floor;
• filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
• filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation.
Geistlich Bio-Gide® is provided in the following sizes: 13 x 25 mm, 25 x 25 mm, 30 x 40 mm, 40 x 50 mm.

Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.

Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.

Geistlich Bio-Gide® Forte is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Forte membrane is available in five different sizes, 13 x 25 mm, 25 x 25 mm, 20 x 30 mm, 30 x 40 mm, and 40 x 50 mm.

Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.

Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

The provided FDA 510(k) clearance letter and associated S510(k) summary documents describe a class II medical device, Geistlich Bio-Gide and its variants, which are resorbable bilayer membranes and bone grafting materials. This submission is for a determination of substantially equivalent to a predicate device.

Crucially, this document is focused on demonstrating substantial equivalence based on material characteristics, manufacturing processes, and performance data for the device itself (a physical membrane and bone grafting material), not on the performance of an AI/ML powered device.

Therefore, most of the requested information regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and effect sizes for AI assistance are not applicable to this type of medical device submission. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing conducted to confirm the physical and biochemical properties of the new device are equivalent to the predicate device, especially after changes to supplier and manufacturing processes.

Here's an attempt to extract relevant information and note the inapplicable sections based on your request:

Acceptance Criteria and Device Performance (for a physical medical device)

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

Since this is not an AI/ML device, the acceptance criteria are not typically expressed in terms of accuracy, sensitivity, or specificity. Instead, they are based on physical, chemical, and biological properties demonstrating equivalence to a predicate device. The performance data provided is primarily comparative to the predicate.

The "analysis" column in the provided tables consistently states "The material of construction is identical," "The sizes offered are identical/similar," etc., implying the acceptance criterion is indeed identity or substantial similarity to the predicate.

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

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of an AI/ML model. The performance data consists of various physical, biochemical, and experimental tests. The number of samples for each specific test (e.g., number of membranes for tensile strength testing) is not provided.
• Data Provenance: Not specified regarding country of origin. The studies are described as "in vitro and in vivo biocompatibility," "sterilization," "shelf-life," "bench," and "clinical performance studies" leveraged from previous predicate device submissions (e.g., K212463, K171643). These are likely a mix of lab-based and potentially historical clinical data. It is not specified if these are prospective or retrospective studies; however, given they are leveraged from previous clearances, they would be historical for this specific submission.

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 is not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in that manner. The "ground truth" for a resorbable membrane involves objective physical, chemical, and biological measurements, and comparison to established standards and predicate device characteristics, not expert consensus on image interpretation.

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

• Not Applicable. No human adjudication method is described or relevant for the physical and chemical performance tests conducted on this medical device.

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-assisted 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 algorithm. Its "standalone" performance refers to its intrinsic physical and chemical properties.

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

• Not Applicable / Different Context. The "ground truth" for this device's performance is established by:
  • Objective Measurements: Results of standardized physical and biochemical tests (e.g., SEM, porosity, tensile strength, DSC, solubility, degradation, molecular weight, hydration capacity, suture pull-out force).
  • Regulatory Standards: Compliance with ISO and ASTM standards (e.g., ISO 10993-1, ISO 11137 series, ISO 22442-3, ASTM F2450-18, ASTM F2150-19, ASTM F2212-20).
  • Predicate Device Data: Comparison and leveraging of performance data (biocompatibility, sterilization, shelf-life, bench, clinical) from previously cleared predicate devices. The claim is substantial equivalence, meaning it performs as safely and effectively as the legally marketed predicate.

8. The sample size for the training set

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

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

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary of the Study Proving Device Meets Acceptance Criteria (in this context):

The "study" conducted for the Geistlich Bio-Gide product family in this 510(k) submission primarily consists of a comprehensive battery of non-clinical performance tests combined with the leveraging of existing performance data from previously cleared predicate devices. The purpose of these tests was to demonstrate that modifications (e.g., new slaughterhouse, non-significant manufacturing changes) did not alter the fundamental safety and effectiveness of the device, making it substantially equivalent to its predicates.

The non-clinical tests included:

• Physical and Biochemical Testing: SEM (surface morphology), porosity, tensile strength, DSC (onset temperature), suture pull-out force, solubility, enzymatic degradation, SDS-PAGE (molecular weight distribution), and hydration capacity. For Geistlich Bio-Gide Forte and Compressed, handling properties were also evaluated.
• Other Experimental Testing: Viral safety according to ISO 22442-3:2007.

These tests, performed on the modified devices, aimed to show that their properties were consistent with a product that would continue to perform as intended and as safely and effectively as the predicate devices. The acceptance criteria were implicitly that the new devices exhibit equivalent performance characteristics to the cleared predicate devices, as supported by these various in vitro and experimental studies and referencing past clinical data from the predicates.

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TYBR Collagen Gel is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.

TYBR Collagen Gel is a naturally-derived collagenous semi-permeable barrier device that conforms to the application site and degrades within 30 days. The TYBR Collagen Gel includes a blue color additive to aid with visualization. The applicator provides controlled delivery of the collagen gel to support uniform coverage at the desired location.

I'm sorry, but the provided FDA 510(k) Clearance Letter for TYBR Collagen Gel does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/software-based medical device.

The document describes a physical medical device (collagen gel) and its performance testing, which includes:

• Cadaveric simulated use testing: To assess biomechanical effects and risk of improper gel application (loading for tendon sliding and gliding).
• Animal performance studies (chicken flexor tendon repair model): To evaluate tendon rupture strength, histopathology, gross pathology (adhesion scoring), and range of motion compared to a predicate device.

This type of testing is relevant for a biomedical material, not for an AI device. The questions you've asked (about sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance, etc.) are specific to the validation of AI/machine learning algorithms in medical imaging or diagnostics, which are not present in this document.

Therefore, I cannot extract the requested information from the provided text.

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The Préime DermaFacial with Collagen+ Applicator is intended to relieve minor muscle aches and pain, relieve muscle spasms, temporarily improve local blood circulation, temporarily improve the appearance of cellulite.

Not Found

I apologize, but the provided FDA 510(k) Clearance Letter for the "Préime DermaFacial Collagen+" device does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The letter is a formal notification of substantial equivalence for a medical device (an electrosurgical cutting and coagulation device) based on its intended use to relieve minor muscle aches and pain, muscle spasms, improve local blood circulation, and temporarily improve the appearance of cellulite.

It details:

• The device name and regulation information.
• The legal basis for its clearance (substantial equivalence to predicate devices).
• Applicable regulations and requirements (e.g., general controls, Quality System regulation, UDI Rule).
• Contact information for FDA.
• The specific Indications for Use.

It does NOT include:

• Any performance specifications or acceptance criteria (e.g., sensitivity, specificity, accuracy, or any performance metrics related to its stated indications).
• Details of any clinical or non-clinical studies conducted to demonstrate its performance against such criteria.
• Information on sample sizes, data provenance, expert qualifications, ground truth establishment, or any aspects of a statistical study design.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text, as this information is not present. This type of detail is typically found in a separate study report or a more comprehensive FDA submission document, not within the clearance letter itself.

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Bovine Dermis Collagen Dermal Matrix 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• . Trauma wounds (abrasions, lacerations, and skin tears)
• Draining wounds
• Partial thickness burns

Bovine Dermis Collagen Dermal Matrix is an absorbent, porous, collagen matrix engineered from purified collagen derived from bovine dermal tissue. Bovine Dermal Matrix should be applied directly to the wound, covering the entire wound surface.
Bovine Dermis Collagen Dermal Matrix is supplied sterile, non-pyrogenic and for single use only.

The Collagen Matrix, Inc. Bovine Dermis Collagen Dermal Matrix (K243071) is a medical device. The provided text outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence for regulatory purposes.

Here's an analysis of the acceptance criteria and study information, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a go/no-go fashion with numerical targets for clinical performance. Instead, it compares the subject device to predicate devices across various technical characteristics. The implicit acceptance criterion is that the subject device's performance is either equivalent to or better than the predicate devices, or that any differences do not raise new questions of safety or effectiveness.

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

• Test Set Sample Size: The document does not specify a "test set" in the context of clinical or performance data with a specific number of cases or patients. The studies described are in vitro characterization tests, biocompatibility tests, and a viral inactivation study. These are conducted on samples of the device itself or in laboratory settings, not on patient data.
• Data Provenance: Not applicable in the context of clinical patient data. The studies are laboratory-based and conducted on the manufactured device.

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. The studies are not clinical studies requiring expert ground truth for interpretation of patient data. They are lab tests for material properties, biological safety, and viral inactivation.

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

Not applicable. This pertains to clinical studies involving human readers and adjudicated outcomes, which are not described here.

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. The document describes laboratory-based testing of a dermal matrix, not a diagnostic AI device requiring human reader analysis.

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

Not applicable. This pertains to AI algorithm performance studies, which are not described here.

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

Not applicable in the human clinical sense. For the in vitro tests (Absorbency, pH, Thermal Transition Temperature, Density, Crosslinking Agent Residual Content, Pyrogenicity), the "ground truth" would be established by validated analytical methods and reference standards. For biocompatibility, it would be based on established international standards (e.g., ISO 10993 series) and their respective endpoints. For viral inactivation, it would be based on virological assays.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

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LUOFUCON® Silver Collagen Dressing is intended for the management of wounds that include: Full thickness and partial thickness wounds Pressure ulcers venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers First and second degree burns Donor sites and other bleeding surface wounds Abrasions Trauma wounds healing by secondary intention Dehisced wounds Surgical wounds Dehisced surgical wounds

LUOFUCON® Silver Collagen Dressing is comprised of bovine collagen and silver chloride intended for the management of wounds. Silver chloride is present to prevent bacteria colonization within the dressing. An in-vitro antibacterial effectiveness test showed that the dressing is effective against bacteria. LUOFUCON® Silver Collagen Dressing is a sterile, single use, pliable, absorbent and biodegradable wound dressing. In the present of the wound exudate LUOFUCON® Silver Collagen Dressing transforms into a soft, conformable gel sheet, maintains a physically moist environment, to protect the wound and support natural healing. LUOFUCON® Silver Collagen Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings.

The provided text is a 510(k) summary for a medical device (LUOFUCON® Silver Collagen Dressing) and describes its substantial equivalence to a predicate device. It details the device's characteristics, indications for use, and various tests performed to demonstrate its safety and performance. However, it does not explicitly state "acceptance criteria" as a set of quantified thresholds for performance, nor does it describe a study specifically designed to prove all elements of acceptance criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (Puracol® Plus Ag MicroScaffold™ Wound Dressing), rather than defining and meeting specific, quantifiable acceptance criteria. The tests conducted are primarily to show that the subject device performs similarly to the predicate and meets general safety and performance standards for wound dressings.

Therefore, many of the requested fields cannot be directly extracted from the provided text in the manner specified. I will answer based on the information that is available, and indicate where information is not provided.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance outcomes. Instead, it states that "The results of the testing confirm that the subject device meets all product performance requirements for the intended use and demonstrates substantial equivalence to the predicate device."

Here's an attempt to infer and summarize based on the provided "Performance Test-bench" section and the comparison table. It's important to note that the specific numerical acceptance criteria for each test are not provided in this document.

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

• Sample size: Not specified. The document mentions "a series of bench tests" and "an in-vitro antibacterial effectiveness test" but does not provide the number of samples or specimens used for each test.
• Data provenance: Not specified. The tests appear to be laboratory-based ("bench tests," "in-vitro") conducted by the manufacturer or a contracted lab. There is no mention of country of origin of data or whether it was retrospective or prospective in the context of clinical data, as this is a pre-market submission based on non-clinical testing.

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

Not applicable. This device is not an AI/software device that requires expert adjudication for ground truth. The "ground truth" for these tests would be the established scientific and engineering principles for material properties, sterilization efficacy, and biological safety, as defined by international standards (e.g., ISO, FDA guidance).

4. Adjudication method for the test set

Not applicable. See #3.

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 device is a wound dressing, not an AI-assisted diagnostic or therapeutic device involving human readers.

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

Not applicable. See #5.

7. The type of ground truth used

For the non-clinical tests described:

• Sterility: Established by documented validation methods (ISO 11137-1/-2) demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶.
• Shelf-life: Established by real-time aging tests compliant with FDA guidance.
• Biocompatibility: Established by adherence to ISO 10993-1 standards and FDA guidance, with specific tests conducted (Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, etc.).
• Performance (Physical/Chemical): Established by standard laboratory testing methodologies for properties like appearance, size, loss on drying, tensile strength, free swell absorption, pH value, and silver content.
• Antibacterial effectiveness: Established by an in-vitro test.
• Animal-Derived Materials Safety: Established by compliance with FDA guidance and ISO 22442 standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. See #8.

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ABCcolla® Collagen ADM Scaffold is intended to be used for management of wounds. including venous ulcers, pressure ulcers, chronic vascular ulcers, diabetic ulcers, tunneled undermined wounds (donor site/ grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), first and second-degree burns, draining wounds.

ABCcolla® Collagen ADM Scaffold is a decellularized porcine collagen biomaterial from porcine dermis. When applied on a wound, this product helps absorb wound exudates and maintain a moist wound environment.

This document is a 510(k) premarket notification for the ABCcolla® Collagen ADM Scaffold, a medical device for wound management. The core of the submission is to demonstrate the substantial equivalence of the new device to a legally marketed predicate device, ABCcolla® Collagen Matrix (K162348), and a reference device, Cook® ECM Powder (K152033).

Based on the provided text, the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" are not related to an AI/ML-driven device's performance in terms of diagnostic accuracy or a clinical study in humans with a traditional statistical endpoint and acceptance criteria. Instead, the "acceptance criteria" for this specific device (a collagen scaffold for wound management) are primarily focused on benchmarking against a predicate device to demonstrate "substantial equivalence" as required by the FDA 510(k) pathway. The "study" here refers to the pre-clinical testing and characterization that demonstrates the new device has similar technological characteristics and performance to the predicate device, and any differences do not raise new questions of safety or effectiveness.

Here's an interpretation of the requested information based on the provided document:

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

For a 510(k) submission, "acceptance criteria" are not typically framed as specific performance metrics and thresholds like sensitivity/specificity for an AI device. Instead, the acceptance is based on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by comparing various characteristics.

Here's a table based on the "Substantial Equivalence Comparison Table" in the document, interpreting "acceptance criteria" as demonstrating "sameness" or "differences that do not raise new questions of safety/effectiveness" compared to the predicate/reference devices:

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RejuvaKnee is intended for use in surgical procedures for the reinforcement and repair of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the RejuvaKnee must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.

RejuvaKnee reinforces soft tissue and provides a reasonable scaffold that is replaced by the patient's own soft tissue. The RejuvaKnee is not a prosthetic device and is not intended to replace normal body structure.

The RejuvaKnee™ Collagen Meniscus Implant is comprised primarily of bovine Type I collagen (nominally 99%) derived from meniscus. The device is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue.

RejuvaKnee is supplied sterile and is intended for single use.

This is a 510(k) summary for the RejuvaKnee™ Collagen Meniscus Implant.
The device is a resorbable scaffold made of bovine Type I collagen intended for the reinforcement and repair of medial meniscal defects. It is compared to the Ivy Sports Medicine Collagen Meniscus Implant (K170364) as a predicate device.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison of features between the RejuvaKnee™ Collagen Meniscus Implant and its predicate. Acceptance criteria are implied by the reported values and the claim of substantial equivalence to the predicate.

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THE Graft Collagen is recommended for:

• Filling of extraction sockets to enhance preservation of the alveolar ridge.

THE Graft Collagen, composed of porcine derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. The bone mineral matrix is similar to physical and chemical aspects of the mineralized matrix of human bone. Hydrated collagen components have viscosity that facilitates for blending of the bone mineral matrix. With this characterization, it can be trimmed and/or molded to the various shapes of defects. THE Graft Collagen is sterilized using gamma irradiation and recommended for the patient who needs filling of bone defects and bone augmentation.
THE Graft Collagen is available in various sizes.
Block (Height x Length x Width)
3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5x 10 mm, 7 x 7x 7 mm
THE Graft Collagen contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen in a block form. The Graft Bone Substitute (K173188) is a porous bone mineral matrix available in cancellous granules made of porcine bone. Granules serve as a scaffold for new bone, and collagen holds the granules not to break away from the implanted site and facilitates handling.

Description of the Device

The device, "THE Graft Collagen," is a bone grafting material composed of a porcine-derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. It is designed to be trimmed and molded to fit various defect shapes and comes in block form in different sizes (e.g., 3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5 x 10 mm, 7 x 7 x 7 mm). It contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen. The granules act as a scaffold for new bone, while the collagen helps hold the granules together and facilitates handling. The device is sterilized using gamma irradiation.

Indications for Use

THE Graft Collagen is recommended for:

• Filling of extraction sockets to enhance preservation of the alveolar ridge.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for "THE Graft Collagen" are based on demonstrating substantial equivalence to its predicate devices, K122894 Bio-Oss® Collagen (primary predicate) and K173188 The Graft Bone Substitute (reference predicate), through non-clinical performance testing. The reported device performance aligns with these criteria, confirming substantial equivalence.

Study Details

Due to the nature of this submission being a 510(k) premarket notification for a Class II medical device (Bone Grafting Material) that primarily relies on demonstrating substantial equivalence to predicate devices, the detailed information typically found in clinical trials for AI/software devices (e.g., explicit test set sample sizes, data provenance for clinical images, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or large-scale training set details) is not applicable or not provided in the document.

The "study" that proves the device meets acceptance criteria consists of:

1. Bench Testing: Performed on the device itself to evaluate physicochemical properties (Ca/P ratio, residue on ignition, heavy metal, pH, compressive strength).
2. Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including various in vitro and in vivo tests.
3. Sterilization Validation: Performed according to ISO 11137.
4. Shelf-Life Study: A real-time aging study in accordance with ISO 11607.
5. Control of Animal Origin Materials Validation: Performed according to ISO 22442-2 and ISO 22442-3.
6. Comparative In-Vivo Study: An animal study comparing the performance of the subject device to the primary predicate device in a beagle mandibular intraoral model.

Here's the breakdown of the specific points requested, based on the provided document:

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

2. Sample sized used for the test set and the data provenance:

   • In-Vivo Study (Beagle Mandibular Intraoral Model): The specific number of animals (beagles) used in the study is not explicitly stated, nor is the country of origin of the study. It is an animal implant study used for performance comparison.
   • Bench, Biocompatibility, Sterilization, Shelf-Life, Animal Origin Control tests: Sample sizes for these tests are not provided in this summary but would be standard for material and safety testing of medical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and study. The ground truth in the animal study would be based on scientific and pathological assessments (histology, histomorphometry, Micro-CT) performed by qualified scientific personnel (e.g., veterinarians, pathologists, histotechnicians), but their specific number and qualifications are not detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of animal study and material testing conducted. Data analysis would involve measurements and interpretations by individual experts or teams, rather than a consensus-based adjudication process for diagnostic labeling.

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 bone grafting material, not an AI/software device involving human readers or interpretation of diagnostic images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

   • In-Vivo Study: The "ground truth" was established through histology, histomorphometry, and Micro-CT analyses in a beagle mandibular intraoral model, assessing new bone formation, integration, and other tissue responses. This combines pathological assessment with quantitative imaging analysis.
   • Other tests: Ground truth for bench performance, biocompatibility, sterilization, and shelf-life is based on established scientific and regulatory standards (e.g., ISO, USP) and laboratory measurements.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

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LUOFUCON® Collagen Particles is intended for the management of wounds including:

• · Full thickness and partial thickness wounds
• · Pressure (stage I-IV) and venous ulcers
• · Ulcers caused by mixed vascular etiologies
• · Venous stasis and diabetic ulcers
• · 1st and superficial second-degree burns
• Cuts
• Abrasions
• · Surgical wounds

LUOFUCON® Collagen Particles is a native bovine collagen wound dressing that is sterile, white to off-white, absorbent and resorbable powder. LUOFUCON® Collagen Particles maintains a moist wound environment to support wound healing.
LUOFUCON® Collagen Particles can be applied to a wound either in the dry state or pre-hydrated with sterile saline, and can be used in conjunction with other suitable secondary dressings indicated for wound management. The device is intended for one time use.
LUOFUCON® Collagen Particles is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.

This is a 510(k) Premarket Notification for a medical device (LUOFUCON® Collagen Particles, a collagen wound dressing) seeking substantial equivalence to a legally marketed predicate device. The information provided in this document focuses on demonstrating substantial equivalence for a collagen wound dressing, not an AI/Software as a Medical Device (SaMD).

Therefore, the specific criteria you've asked for, such as "acceptance criteria for an AI/SaMD study," "sample size for the test set," "number of experts for ground truth," "MRMC study," "standalone AI performance," and "training set details," are not applicable to this type of medical device submission.

This document demonstrates substantial equivalence through:

1. Comparison to a Predicate Device (K171645): Showing that the subject device has similar indications for use, technological characteristics (material, animal source, physical structure, biodegradability, mode of action), and manufacturing processes.

   • Acceptance Criteria: Substantial equivalence based on these comparisons.
   • Device Performance: The detailed comparison table (Table 1) outlines the similarities and minor differences. The document explicitly states: "LUOFUCON® Collagen Particles has the similar indications for use, and very similar technological characteristics to the predicate device(K171645). Both devices are 100% collagen and are designed as powder form, Tyvek packaging, single-use, sterile product. Their main production process includes drying, grinding, and irradiation sterilization. The subject and predicate devices employ the same mode of action in that both devices contain an absorbent nature that maintains a moist wound environment to support wound healing."

2. Non-Clinical Data/Information: Providing data on sterilization, shelf-life, biocompatibility, and performance bench tests to ensure safety and performance.

   • Acceptance Criteria: Meeting relevant ISO standards (ISO 11137-1/-2 for sterilization, ISO 10993-1 for biocompatibility, ISO 22442 for animal-derived materials safety) and demonstrating that the device meets performance requirements.
   • Device Performance:
     • Sterilization and Shelf-Life: "LUOFUCON® Collagen Particles is sterilized using Gamma radiation to a sterility assurance level of 10-6." and "a real-time aging test was conducted to demonstrate the shelf-life of LUOFUCON® Collagen Particles."
     • Biocompatibility: "The results showed that LUOFUCON® Collagen Particles meets biocompatibility requirements of the ISO 10993-1 standard and FDA Guidance, and it raised no new safety concerns for biocompatibility to the predicate device."
     • Performance Test-bench: "Test results confirm that the subject device meets all product performance requirements and demonstrates substantial equivalence to the predicate device." Specific tests conducted include: Appearance, Weight, Sieving rate, Loss on drying, Free swell absorption, pH value, Heavy metal, Hydroxyproline assay, Endotoxin content, Sterility, In-Vitro degradation.
     • Animal-Derived Materials Safety: "the requirements of safety is compliant with FDA quidance document-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) and ISO 22442 standards."

In summary, for this specific submission of a collagen wound dressing, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device through detailed comparison and non-clinical testing, rather than performance metrics for an AI algorithm.

The document does not contain any information related to AI/SaMD testing, human reader studies, or ground truth establishment in the context of an AI system.

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Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

In the posterolateral spine and intervertebral disc space, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender. When used in intervertebral body fusion procedures, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.

The anorqanic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine Achilles tendon.

The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.

This is a 510(k) premarket notification for a medical device called "Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix". The document confirms FDA clearance and discusses the device's indications for use and substantial equivalence to previously cleared devices.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the traditional sense of a performance study with defined metrics for the device itself.

The document focuses on establishing substantial equivalence to predicate devices. This means that the FDA has determined the new device is as safe and effective as a legally marketed device that does not require premarket approval.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• No "AI" or "Algorithm": This is a bone graft matrix, a physical medical device. It's not a software device or an AI-powered system, so concepts like "AI assistance," "human-in-the-loop," "ground truth," "training set," "test set," "experts," or "adjudication methods" are not applicable.
• Focus on Substantial Equivalence: The "study" mentioned is not a performance study against acceptance criteria for an AI or software device. Instead, it refers to the comparison of the subject device to predicate devices to demonstrate substantial equivalence.

However, I can extract the relevant information regarding the "study" (in the context of demonstrating substantial equivalence) and the "performance" as described:

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

Since this is not a software/AI device with performance metrics like sensitivity, specificity, or accuracy, a traditional acceptance criteria table is not present. The "performance" is primarily described by its material composition and functional characteristics, and its equivalence to predicate devices.

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 is not a study assessing performance of a diagnostic or AI device using a test set of data. The "testing" refers to non-clinical assessments, material characterization, and comparison to predicate devices, not data-driven performance metrics against a "test set."

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 is not a study requiring expert-established ground truth for a test set.

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. This document is not about AI assistance or human reader performance.

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)

Not applicable. The "ground truth" for this device's safety and effectiveness is established by its demonstrated equivalence in material, design, and performance characteristics to previously cleared predicate devices through non-clinical testing (e.g., material testing, sterilization validation, biocompatibility) and the absence of new safety/effectiveness concerns.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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