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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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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 Soft Tissue Augmentation Resorbable (STAR) Matrix is intended to support localized gingival augmentation to increase keratinized tissue.

STAR Matrix is indicated for:

• Covering of implants placed in immediate or delayed extraction sockets;
• Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.

The Soft Tissue Augmentation Resorbable Matrix (STAR Matrix) is a cross – linked, resorbable membrane engineered from highly purified Type I collagen fibers derived from Porcine Achilles Tendon for use in periodontal, oral, and maxillofacial surgery. STAR Matrix is composed of two structures: a smooth outer layer that acts as a barrier membrane and a porous matrix layer to allow cell invasion and tissue ingrowth. The product is oriented so that the porous layer is in contact with the host tissue bone/bone graft or periosteum to facilitate tissue integration. The product is provided sterile, non-pyrogenic, and for single use only. Product is provided in various sizes where it can be easily trimmed for appropriate fit and sutured into place during surgery.

The provided document is a 510(k) summary for a medical device (Soft Tissue Augmentation Resorbable Matrix - STAR Matrix) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report for software as a medical device (SaMD) or AI/ML-driven devices.

The document primarily covers:

• Description of the device: A resorbable membrane for gingival augmentation.
• Comparison to predicate devices: Highlighting similarities and differences in technical characteristics.
• Performance data: Primarily non-clinical (in vitro, animal, biocompatibility, sterilization, shelf life).
• No clinical studies were required to determine substantial equivalence for this device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria because the document does not describe such a study. The information requested (acceptance criteria table, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is typically found in documentation for the validation of AI/ML-based medical devices or devices demonstrating clinical efficacy/safety through trials, which is not the nature of this 510(k) submission.

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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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Mineral Collagen Composite Bioactive Extra Moldable 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, 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.

For spine application Mineral Collagen Composite Bioactive Extra Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.

Mineral Collagen Composite Bioactive Extra 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 osteroconductive, 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 anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material of all organic components from bovine bone. The anorganic bone mineral meets ASTM F1581 standard specifications for the composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meeting ASTM F1538 standard specifications for malantation. 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.

The provided 510(k) summary for the "Mineral Collagen Composite Bioactive Extra Moldable" device indicates that no new acceptance criteria or specific studies proving the device meets these criteria were conducted for this submission (K231942).

Instead, the submission relies on the substantial equivalence to predicate devices (K221735 and K182074) and states that the performance data, including sterilization, pyrogenicity, biocompatibility, and animal testing results, remain the same as those previously submitted for the predicate devices. No new clinical studies were required.

Therefore, many of the requested details about acceptance criteria and study particulars for this specific submission are not explicitly provided because the device's performance is asserted to be equivalent to previously cleared devices, and thus relies on their past demonstrations of meeting acceptance criteria.

However, based on the information provided, we can infer some details:

1. Table of Acceptance Criteria and Reported Device Performance:

Since new performance criteria are not explicitly stated for this submission, the "acceptance criteria" here refer to the standards that the predicate devices met, which are then carried over to the current device due to substantial equivalence.

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

• Sample Size for Test Set: Not applicable for this submission as no new testing was conducted to establish acceptance criteria for K231942. The "test set" and corresponding sample sizes would have been part of the predicate device submissions (K221735 and K182074). The document states, "In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device and remains the same as that submitted for the primary predicate device (K221735) and the secondary predicate device (K182074)."
• Data Provenance: Not specified for this submission, as it relies on previous submissions. It's not stated whether the original predicate studies were retrospective or prospective, or their country of origin.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable as no new specific ground truth establishment for a test set was detailed for this submission.

4. Adjudication Method for the Test Set:

• Not applicable as no new specific test set and adjudication method were detailed for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was NOT done. The device is a "Resorbable Calcium Salt Bone Void Filler Device," which is a physical implant, not an AI or imaging diagnostic device that would typically involve human reader studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

• No, a standalone performance study was NOT done. This is not an algorithmic or AI device.

7. Type of Ground Truth Used:

• Not explicitly defined for this submission in the context of a new test set. For the predicate devices, the "ground truth" for demonstrating performance would likely involve histopathology (for bone ingrowth and resorption in animal studies), material characterization data (for biocompatibility and physical properties), and microbiological testing (for sterility).

8. Sample Size for the Training Set:

• Not applicable as this is a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable as this is a physical medical device, not a machine learning model.

In summary, this 510(k) relies entirely on the demonstration of substantial equivalence to previously cleared predicate devices, asserting that the change (improved moldability) does not alter the fundamental performance as previously established. Therefore, no new primary studies to define and meet acceptance criteria were conducted or reported in this specific submission.

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Mineral Collagen Composite Bioactive Moldable 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, 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.

For spine applications, Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.

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 anorganic 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-pvrogenic, and for single use only.

The provided text is a 510(k) summary for the Mineral Collagen Composite Bioactive Moldable device. This document describes a medical device seeking regulatory clearance, not an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical testing (biocompatibility, sterilization, pyrogen, packaging, shelf life, and animal studies). Clinical studies were explicitly not required for this determination.

Here's an attempt to answer the questions based on the provided document, highlighting where the requested information is not applicable:

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

The document does not specify quantitative acceptance criteria in a table format for performance. Instead, it relies on demonstrating that the device performs substantially equivalently to its predicate and reference devices, particularly for the expanded indications for use.

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

• Animal Study: The document mentions "a rabbit femoral condyle critical-sized defect model." It does not specify the number of rabbits or exact sample size used for this study.
• Data Provenance: The studies mentioned (biocompatibility, sterilization, pyrogen, packaging, shelf life) were completed under the original submission (K182074). The animal study appears to be part of the current submission, likely conducted for the expanded indications. The country of origin and whether the data was retrospective or prospective is not specified, but animal studies are typically prospective.

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

This information is not applicable as this is not an AI/ML device requiring human expert annotation for ground truth. Ground truth for a bone void filler would typically be established through histological analysis of tissue regeneration in the animal model. The document does not specify who conducted such analyses or their qualifications.

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

Not applicable for this type of device and study.

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/ML device that assists human readers.

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

Not applicable. This is not an AI/ML algorithm.

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

For the animal study, the "ground truth" for assessing device performance would primarily be based on pathology/histology of bone regeneration and integration within the rabbit femoral condyle defects, comparing the test device to the reference device. The document states "The results demonstrate performance substantially equivalent to the reference device with regards to the expansion of the indications for use," implying such an assessment was made.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

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Fibrillar Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.

Fibrillar Collagen Wound Dressing may be used for the management of exudating wounds such as:

• Pressure ulcers
• Venous stasis ulcers
• Diabetic ulcers
• Acute wounds, for example trauma and surgical wounds
• Partial-thickness burns

The Fibrillar Collagen Wound Dressing is an absorbent microfibrillar collagen matrix intended for the management of moderately to heavily exudating wounds and the control of minor bleeding. When interacting with the wound fluid, the product immediately begins to absorb the exudates. The Fibrillar Collagen Wound Dressing is applied directly to the secreting wound and protects the wound bed and delicate new tissue. In addition, the product, being comprised of microfibrillar collagen, has intrinsic hemostatic properties, which can be used to control minor bleeding.

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

This document does not contain an AI/ML device, and therefore does not have acceptance criteria or study information relevant to AI/ML performance. Instead, it is a 510(k) premarket notification for a Fibrillar Collagen Wound Dressing, claiming substantial equivalence to a predicate device.

The document discusses:

• Regulatory information: FDA approval, regulatory class, product code, general controls, and compliance with various parts of the Code of Federal Regulations.
• Indications for Use: For the management of moderately to heavily exudating wounds and control of minor bleeding, applicable to pressure ulcers, venous stasis ulcers, diabetic ulcers, acute wounds (trauma, surgical), and partial-thickness burns.
• Device Description: An absorbent microfibrillar collagen matrix that absorbs exudates, protects the wound bed, and has intrinsic hemostatic properties.
• Comparison to Predicate Device (K030921): Shows identical indications for use, material (collagen), biocompatibility, sterility, pyrogenicity, and single-use/reuse characteristics.
• Nonclinical Tests: The submission included summary-level information demonstrating compliance with design controls and risk analysis. Specific tests mentioned are:
  • Cytotoxicity (L929 MEM Elution, ISO 10993-5)
  • Sensitization (Guinea Pig Maximization, ISO 10993-10)
  • Intracutaneous Reactivity (Rabbits, ISO 10993-10)
  • Acute Systemic Toxicity (Mice, ISO 10993-11)
  • Pyrogenicity (Rabbit Pyrogen Study, USP )
  • Additional in-vivo implantation and subchronic toxicity testing of the predicate device was leveraged.
• Conclusion: The device is substantially equivalent to its legally marketed predicate based on the design control process and non-clinical studies.

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Porcine Mineral Collagen Composite is intended to be used for bone grafting in periodontal, oral and maxillofacial surgeries.

Porcine Mineral Collagen Composite is indicated for:

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

Porcine Mineral Collagen Composite is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal. oral and maxillofacial surgery. The device is composed of anorganic bone mineral granules derived from porcine cancellous bone and collagen from porcine Achilles tendon in compressed, formaldehyde-crosslinked, preformed sponge matrices designed to fit the size of the defect upon hydration. The product is supplied sterile, non-pvrogenic and for single use only.

The product is available in the following shape and sizes:

This document describes the performance data for a medical device called "Porcine Mineral Collagen Composite" in the context of its 510(k) premarket notification to the FDA. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence through various performance tests rather than against explicit numerical "acceptance criteria" in the way one might see for an AI algorithm's sensitivity/specificity. However, the outcomes of these tests effectively serve as the criteria for acceptance to demonstrate equivalence to the predicate device.

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

• Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of guinea pigs for sensitization, number of mice for acute systemic toxicity) are not explicitly stated in the summary. The tests were performed in vitro (e.g., L929 MEM Elution) and in vivo (e.g., Guinea Pig Maximization, Rabbit Intracutaneous Reactivity, mice for systemic toxicity, canine for implantation).
• Bench Testing: Sample sizes for each bench test are not specified. These tests are inherently in vitro.
• Animal Testing (Canine Study): The sample size (number of canines) for the intrabony defect model is not specified. The study was in vivo, involving implantation at 4, 8, and 13 weeks. Its provenance is not stated (e.g., specific country or institution), but it's an animal study conducted to demonstrate performance.
• Data Provenance: The document does not explicitly state the country of origin for the data for any of the studies, nor does it explicitly classify them as "retrospective" or "prospective" as one would for human clinical trials. However, given the nature of the studies (biocompatibility, bench, animal), they would generally be considered prospective studies designed to evaluate the device.

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

This level of detail is not provided for most tests.

• Animal Testing (Canine Study): Radiographic, Micro CT, Histology, and Histomorphometry analyses were conducted. While these analyses require expert interpretation (e.g., veterinary pathologists, radiologists), the number of experts and their specific qualifications are not specified in this summary. The "ground truth" here is derived from the scientific measurements and observations from these analyses compared to a predicate device and sham control.
• For in vitro and other standardized tests (e.g., cytotoxicity, pyrogenicity), the "ground truth" is typically the result of the standardized test itself, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable or specified for the types of tests conducted. These are not studies requiring human expert adjudication of ambiguous cases, as would be common for AI in medical imaging. The studies focus on objective measurements and established biological responses.

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. This type of study (MRMC for AI assistance) was not performed because:

• The device is a medical implant (bone graft material), not a software or AI-driven diagnostic tool.
• "Clinical performance data was not required to determine substantial equivalence" (Page 8), meaning human clinical trials comparing device performance or AI assistance were not deemed necessary for this 510(k) submission.

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

No. This question is also specifically relevant for AI algorithms. The "Porcine Mineral Collagen Composite" is a physical device, so the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.

7. The Type of Ground Truth Used:

The ground truth for the performance evaluation of this device is established through a combination of:

• Standardized Test Results/Reference Values: For biocompatibility tests (e.g., non-cytotoxic, non-mutagenic), specific thresholds or qualitative outcomes defined by recognized standards (ISO, USP) serve as the ground truth.
• Predicate Device Equivalence: For many bench tests (e.g., mineral content, calcium to phosphate ratio, porosity, pH), the "ground truth" is similarity to the legally marketed predicate devices, as the goal is to demonstrate substantial equivalence.
• Pathological/Histological Findings: In the canine intrabony defect model, ground truth is derived from objective measurements (e.g., radiographic density, Micro CT analyses) and expert evaluation of tissue samples (histology, histomorphometry) for parameters like tissue reaction, new bone formation, etc.

8. The Sample Size for the Training Set:

This device does not involve a "training set" in the context of machine learning or AI models. Therefore, this question is not applicable.

9. How the Ground Truth for the Training Set was Established:

As there is no training set for an AI model, this question is not applicable. The device's characteristics are inherent to its manufacturing process and tested through established laboratory and animal study protocols.

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Porcine Mineral Collagen Composite Moldable is indicated for:

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

Porcine Mineral Collagen Composite Moldable is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal, oral and maxillofacial surgery. The device is composed of 90% anorqanic bone mineral granules derived from porcine cancellous bone and 10% collagen from porcine Achilles tendon in a composite matrix. The product is supplied sterile, non-pyrogenic and for single use only.
Porcine Mineral Collagen Composite Moldable is provided in a block form and is available in three sizes, 0.5cc, 1.0cc, and 2.0cc.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device Name: Porcine Mineral Collagen Composite Moldable (K201859)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating substantial equivalence to predicate devices (K140714 and K033815, K110600, K122115) through a series of non-clinical tests. The criteria used are the standards and expected outcomes for these tests.

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

The document does not explicitly state numeric "sample sizes" in terms of "test sets" for many of the individual tests beyond the animal study.

• Animal Study (Implantation/Toxicity/Performance): The text mentions "Implantation in Canine Intrabony Defect Model" and "performance of the device in a canine one-wall intrabony defect model." It refers to "the subject device, reference device and sham negative control." While it doesn't give an exact number of dogs or defects, it implies experimental groups were used for comparison.
• Biocompatibility Tests: These tests typically use standardized biological samples (e.g., L929 cells for cytotoxicity, guinea pigs for sensitization, rabbits for irritation, mice for acute systemic toxicity). The specific sample numbers for each of these tests are not provided but are generally dictated by the referenced ISO standards.
• Bench Testing: These tests assess material properties and are performed on samples of the device and predicate/reference devices. Specific sample numbers (e.g., how many units were tested for mineral content, density, pH) are not specified.
• Data Provenance: The studies are described as non-clinical (in vitro, bench, and animal testing). The country of origin for the data is not specified, but the use of international standards (ISO, ASTM, USP) suggests these are likely standardized laboratory tests. The nature of these tests is prospective within the context of the study design for each specific test, as the device was manufactured and then subjected to these evaluations according to pre-defined protocols.

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

• Not applicable in the conventional sense. This is a non-clinical device submission for a bone grafting material. The "ground truth" for these tests refers to the established scientific principles, standardized test methods (like ISO, ASTM, USP), and documented performance of predicate devices. There wouldn't be "experts" establishing a "ground truth" for a test set in the same way clinical image interpretation requires expert radiologists. The "truth" is determined by the objective measurements and observations defined by the test protocols and standards.
• For the Animal Testing, the "ground truth" for efficacy (performance) would be established by objective measurements (Radiographic, Micro CT, Histology, Histomorphometry analyses) performed by trained scientists/pathologists in accordance with the study protocol. Their qualifications are not specified but would typically involve veterinary expertise, histology pathology, and imaging interpretation.

4. Adjudication Method for the Test Set

• Not applicable. As this is a non-clinical submission relying on objective measurement and comparison to predicate devices and standards, there is no "adjudication" in the sense of resolving conflicting interpretations by multiple human readers. The results of the tests (e.g., non-cytotoxic, similar mineral content, substantially equivalent performance in canines) are based on pre-defined criteria within the test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a submission for a medical device (bone grafting material), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• No. As explained above, this device is a physical bone grafting material, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

• Standardized Test Outcomes: Adherence to established international standards (ISO, ASTM, USP) for biocompatibility, material properties, sterility, etc. The results are compared against the pass/fail criteria or expected values defined by these standards.
• Comparison to Predicate Device Performance: Demonstrating that the subject device's performance (e.g., physical, chemical, biological characteristics, and performance in animal models) is "substantially equivalent" to legally marketed predicate devices. This is achieved by showing similar results across various tests.
• Histopathology/Imaging (for Animal Study): For the animal study, the ground truth for biological response and bone regeneration comes from objective analyses like radiography, Micro CT, histology, and histomorphometry of tissue samples, interpreted by experts in these fields.

8. The Sample Size for the Training Set

• Not applicable. This submission describes the evaluation of a manufactured medical device. There is no concept of a "training set" in the context of machine learning for this type of product. The device itself is the product being tested, not an algorithm that learns from data.

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

• Not applicable. Since there is no "training set," the establishment of its ground truth is not relevant.

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Mineral Collagen Composite Bioactive Moldable combined with either autogenous bone marrow or autograft with saline is indicated for bony voids or gaps, that are not intrinsic to the stability of the bony structure; Mineral Collagen Composite Bioactive Moldable can also be used with autograft as a bone graft extender.

The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., 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.

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 anorganic 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 deep flexor Achilles tendon.

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

The provided text is a 510(k) Summary for a medical device called "Mineral Collagen Composite Bioactive Moldable." It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets them.

Here's why and what's missing:

• Acceptance Criteria and Reported Device Performance: This document states that in vivo and in vitro testing was conducted to demonstrate substantial equivalence, and "The results of the animal study demonstrate performance substantially equivalent to the predicate device Vitoss BA and performance substantially equivalent to autograft when used as an autograft extender." However, it does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., bone formation percentage, fusion rates, mechanical strength) or provide tables comparing the device's performance against these criteria. It only makes a general statement of "substantially equivalent."

• Sample Size for Test Set and Data Provenance: The document mentions "posterolateral spine fusion rabbit model" for the in vivo study, but does not specify the sample size (number of rabbits or test articles) used in this test set. It also doesn't explicitly state the country of origin or whether the data was retrospective or prospective, though animal studies are typically prospective.

• Number of Experts and Qualifications for Ground Truth: This information is not present in the document. Ground truth for animal studies often involves histological analysis by veterinary pathologists, but this detail is missing.

• Adjudication Method: This information is not present in the document.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not mention an MRMC study. The study described is an animal in vivo study comparing the device to a predicate and autograft, not a human reader study.

• Standalone (Algorithm Only) Performance: This device is a physical bone graft matrix, not an algorithm. Therefore, a "standalone algorithm performance" assessment is not applicable.

• Type of Ground Truth Used: For the animal study, the ground truth would likely be based on histological analysis and potentially imaging (e.g., X-rays, micro-CT) assessed by experts (e.g., veterinary pathologists, radiologists). While not explicitly stated, this is standard for such studies.

• Sample Size for Training Set: Since this is a physical device and not an AI/ML algorithm, there is no "training set" in the context of an algorithm's development. The "training" for the device would be its manufacturing process.

• How Ground Truth for Training Set Was Established: As above, this concept is not applicable to a physical medical device.

In summary, while the document confirms that studies were conducted to support the device's substantial equivalence, it lacks the detailed breakdown of acceptance criteria, specific performance metrics, sample sizes, and expert involvement that your request specifies for AI/ML or diagnostic device evaluations. The information provided is typical for a 510(k) summary for a physical implantable device, focusing on material composition, biocompatibility, and in vivo performance relative to predicates.

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