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DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created from traumatic injury to the bone. The Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process.

The DSM Calcium Phosphate Cement is a line extension to the current DSM Calcium Phosphate Cement product line, which introduces the 1cc size and a new packaging configuration. DSM Calcium Phosphate Cement is an injectable, sculptable, drillable, fast self-setting bone substitute. DSM Calcium Phosphate Cement is composed of calcium phosphate, which converts to hydroxyapatite in vivo, and bovine collagen powder. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form and is packaged in a female luer syringe. An empty male luer syringe is provided to allow for syringe-to-syringe mixing of the powder with saline at the required powder-to-liquid ratio. DSM Calcium Phosphate Cement is supplied sterile by gamma irradiation and is non-pyrogenic.

This document is a 510(k) premarket notification for the DSM Biomedical Calcium Phosphate Cement. It describes a line extension of an existing product, specifically a new 1cc size and packaging configuration. The submission aims to demonstrate substantial equivalence to the predicate device (DSM Biomedical Calcium Phosphate Cement, K173362).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Non-Clinical Bench Testing (Material, Mechanical, Physical): The document does not specify the exact sample sizes for each type of bench testing (e.g., injectability, setting time, compressive strength). It just states that "Material characterization and performance testing... was completed." The provenance is likely internal testing by DSM Biomedical.
• Biocompatibility Testing: The number of samples for each biocompatibility test (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Subacute Systemic Toxicity, Pyrogenicity) is not specified. Provenance is likely contract labs performing testing according to ISO 10993 standards.
• Performance Animal Testing: The test set used an "ovine critical sized femoral defect model." The number of animals in the DSM + saline group and the Hydroset predicate group is not explicitly stated, but the percentages imply multiple subjects, and statistical variations (e.g., "± 2%") would necessitate a reasonable sample size for statistical significance. This appears to be a prospective animal study specifically designed for this submission or product line.

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

• Bench Testing: Ground truth for bench testing is established by recognized standards (FDA Guidance Document, ASTM F1185, USP , AAMI ANSI ST72: 2019, ISO 11607-1, ISO 11137-1/2, ISO 10993 series, ISO 22442-2/3). Experts are likely engineers and scientists within DSM Biomedical or independent testing laboratories with expertise in these standards. Their specific number and qualifications are not detailed.
• Animal Study: The animal study compared the device to a predicate and an empty defect control. The "ground truth" here is the biological response (new bone formation, implant remaining) observed in the ovine model. The evaluation of these outcomes would typically involve veterinary pathologists and/or histologists; however, their specific number and qualifications are not mentioned.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for human reviewers in a clinical context. The "adjudication" for bench and animal testing is inherent in the standardized methodologies and objective measurements.

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 MRMC comparative effectiveness study was mentioned. This device is a bone void filler, not an AI-powered diagnostic or assistive technology for human readers.

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

This question is irrelevant for the DSM Biomedical Calcium Phosphate Cement, as it is a medical device material/implant and not an algorithm or AI product.

7. The Type of Ground Truth Used

• Bench Testing: Ground truth established through objective measurements against pre-defined performance specifications derived from recognized standards (ASTM, ISO, USP, FDA guidance).
• Biocompatibility Testing: Ground truth established through biological response assays compared against established criteria for acceptable biocompatibility (based on ISO 10993 series).
• Animal Study: Ground truth for "performance" (new bone formation, implant remaining) was established by histological and quantitative analysis of tissue samples from the ovine femoral defect model.

8. The Sample Size for the Training Set

This product is not an AI/ML algorithm requiring a training set. This question is not applicable.

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

This question is not applicable, as there is no training set for this device.

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The DSM Biomedical Dental Bone Graft Plus is indicated for:

• Augmentation or reconstructive treatment of the 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 the 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)

The DSM Biomedical Dental Bone Graft Plus is a non-pyrogenic porous bone mineral and collagen matrix for use in periodontal, oral, and maxillofacial surgery. The DSM Biomedical Dental Bone Graft Plus is composed of anorganic porcine bone granules combined with bovine collagen to form small cylinders. The device is provided in sizes ranging from 100 - 500mg. DSM Dental Bone Graft Plus is supplied sterile by gamma irradiation and is for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding the "DSM Biomedical Dental Bone Graft Plus." It concerns the substantial equivalence of this new device to a predicate device, not the results of a clinical study demonstrating the device's performance against predefined acceptance criteria for a new AI/software medical device.

Therefore, I cannot provide the requested information as the document does not contain:

1. Acceptance criteria and reported device performance (table): The document discusses the equivalence of a bone graft material to a predicate, focusing on material properties, indications for use, and a demonstration in an animal model. It does not present quantitative performance against specific clinical acceptance criteria typically seen for AI/software medical devices (e.g., sensitivity, specificity, AUC).
2. Sample size and data provenance for a test set: The document mentions an "animal study" but does not detail the sample size (number of animals or cases in a test set), nor does it describe data provenance in terms of country of origin or retrospective/prospective nature, as would be relevant for clinical data in AI/software evaluation.
3. Number and qualifications of experts for ground truth: This is relevant for AI/software devices whose ground truth is often established by expert consensus. This document pertains to a physical bone graft material, and the ground truth for an animal study would be based on histological or imaging analysis, not expert interpretation of outputs of an AI algorithm.
4. Adjudication method for the test set: Not applicable for a physical medical device.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is a study design specifically for evaluating the impact of AI assistance on human reader performance, which is not relevant for a bone graft material.
6. Standalone (algorithm only) performance: This is for software, not a physical device.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): While animal study results (likely histological or imaging evidence of bone formation) serve as ground truth for the performance of the bone graft, the nature of "ground truth" establishment for AI/software (e.g., expert reads, pathology reports) is not present.
8. Sample size for the training set: This refers to AI/machine learning models, which are not discussed in this document.
9. How ground truth for the training set was established: Also refers to AI/machine learning models.

The document primarily focuses on establishing "substantial equivalence" of the new bone graft material to an existing one, based on:

• Non-clinical testing data: Mechanical and physical testing, biocompatibility testing (ISO standards), and pyrogenicity testing.
• Animal Testing: A canine intrabony defect animal study comparing the new device to the predicate device to evaluate bone healing.

In essence, this document is a regulatory submission for a physical medical device, not a performance study report for an AI/software medical device.

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DSM Biomedical Calcium Phosphate Cement with Microspheres is indicated to fill bony voids or gaps of the sketal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement with Microspheres is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement with Microspheres cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement with Microsheres resorbs and is replaced by bone during the healing process.

DSM Biomedical Calcium Phosphate Cement with Microspheres is an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement with Microspheres is composed of calcium phosphate which converts to hydroxyapatite in vivo, bovine collagen powder, and PLGA microspheres. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement with Microspheres is supplied sterile by gamma irradiation and is non-pyrogenic.

The provided text is a 510(k) Summary for the DSM Biomedical Calcium Phosphate Cement with Microspheres, describing its design, indications, and the basis for substantial equivalence to a predicate device. It details the tests performed to demonstrate safety and performance but does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria specifically in the context of an AI/ML device.

The document discusses material characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study for a medical device that fills bony voids. It compares the characteristics of the proposed device with a predicate device (Stryker® Injectable Cement).

Therefore, I cannot provide the requested information for an AI/ML device, as the provided text pertains to a traditional medical device (bone void filler) and does not mention any AI/ML components or related studies (like MRMC studies, standalone AI performance, or expert consensus for AI ground truth).

To answer your request, the input text would need to be a 510(k) summary for an AI/ML medical device.

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DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The DSM Biomedical Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The DSM Biomedical Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process.

DSM Biomedical Calcium Phosphate Cement as an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement is composed of calcium phosphate which converts to hydroxyapatite in vivo, and bovine collagen powder. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement is supplied sterile by gamma irradiation and is non-pyrogenic.

The provided text is a 510(k) summary for the DSM Biomedical Calcium Phosphate Cement. It states that the device is substantially equivalent to a predicate device based on various criteria, including performance data. However, the document does not contain the level of detail requested in the prompt regarding acceptance criteria, specific reported device performance values, sample sizes for test or training sets, expert qualifications, or adjudication methods for studies.

The document primarily focuses on establishing substantial equivalence to a predicate device (Stryker® Injectable Cement K060061) through comparisons of:

• Indications for Use
• Material Composition
• Technological Characteristics
• Performance Characteristics

It mentions that "material characterization, including chemical and material physical characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study have been conducted to evaluate the performance characteristics and biological safety." It also states these were completed in accordance with FDA Guidance Document, "Resorbable Calcium Salt Bone Void Filler Device and ASTM F1185 Standard Specification for Composition of Hydroxylapatite for Surgical Implants."

An "ovine bilateral femoral defect animal study" was performed to evaluate bone healing.

Therefore, many of the specific details requested cannot be extracted from this document.

However, I can provide a summary of what is mentioned concerning performance and the basis for substantial equivalence:

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

The document does not provide a table with quantitative acceptance criteria and corresponding reported device performance values. It states that tests were conducted according to FDA guidance and ASTM standards, implying that the device met the requirements of those standards.

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

• Test Set Sample Size: Not explicitly stated for any of the tests.
• Data Provenance: The animal study was an "ovine bilateral femoral defect animal study." This suggests an animal model study, not human subject data.

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

Not applicable, as this is related to a medical image analysis or diagnostic device, which this bone void filler is not. The ground truth for performance would be based on the physical, chemical, and biological measurements from the lab and animal studies.

4. Adjudication method 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/imaging device.

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

Not applicable. This is not an AI/imaging device.

7. The type of ground truth used

For the performance of the material:

• Physical and chemical characterization data (e.g., setting time, mechanical strength, composition, resorption rate – though specific values are not listed).
• Biocompatibility test results (cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, hemocompatibility, subacute toxicity, implantation).
• Viral inactivation study results.
• Residual chemical assessment results.
• Bone healing evaluation from the ovine animal study (comparison to predicate).

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

Summary of Device Performance (as described in the document, without specific values):

The document concludes that "The bench, animal, and biocompatibility testing demonstrates that DSM Biomedical Calcium Phosphate Cement is substantially equivalent to the predicate device." This implies that the device met the performance requirements necessary to establish substantial equivalence based on the completed tests.

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DSM Biomedical Dental Bone Graft is indicated for:

• Augmentation or reconstructive treatment of the 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 the 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)

The DSM Biomedical Dental Bone Graft is a non-pyrogenic porous bone mineral matrix for use in periodontal, oral, and maxillofacial surgery. It is produced by removing organic components from porcine bone. The composition of DSM Biomedical Dental Bone Graft meets the requirements of ASTM F 1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is provided as cancellous granules approximately 0.25 - 1.0mm in size. It is supplied sterile by gamma irradiation and is for single use only.

The provided text is a 510(k) summary for the DSM Biomedical Dental Bone Graft. It describes the device, its indications for use, and a comparison to a predicate device (Bio-OSS®). However, this document does not contain the acceptance criteria or a study proving that an AI device meets acceptance criteria.

Instead, it pertains to a traditional medical device (a dental bone graft material) and focuses on demonstrating substantial equivalence to a predicate device through material characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device's performance based on the provided text. The document does not describe an AI device.

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DSM Biomedical Porcine Pericardium Dental Membrane is indicated for:

• simultaneous use of GBR-membrane and implants
• 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
• guided tissue regeneration procedures in periodontal defects.

The DSM Biomedical Porcine Pericardium Dental Membrane is a resorbable porcine pericardium derived extracellular matrix barrier membrane for guided tissue and bone regeneration in dental applications. The device is manufactured using a standardized, controlled, multistage process. The origin of all animals is the United States of America. It is provided as a lyophilized sheet in sizes 15 mm x 25 mm, 20 mm x 30 mm, and 30 mm x 40 mm, which may be hydrated with saline or blood. It can be easily trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane is easily drapeable while maintaining suture tear resistance. It is supplied sterile by ethylene oxide and is for single use only.

The DSM Biomedical Porcine Pericardium Dental Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. Animal studies have shown that DSM Biomedical Porcine Pericardium Dental Membrane is resorbed within 2 to 9 weeks.

This document is a 510(k) summary for the DSM Biomedical Porcine Pericardium Dental Membrane, seeking substantial equivalence to a predicate device (Bio-Gide® K042197).
The provided text does not contain detailed acceptance criteria or a study design in the format typically used for evaluating the performance of AI/ML-based medical devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating the substantial equivalence of a physical medical device (a resorbable membrane) to a predicate device.

However, I can extract the relevant information from the document to answer your questions based on the type of device and study described.

Here's the breakdown of the "acceptance criteria" and "study" as presented in this context:

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

In the context of this 510(k), "acceptance criteria" are not reported as specific numerical thresholds for diagnostic performance. Instead, the acceptance criteria are implicitly that the subject device (DSM Biomedical Porcine Pericardium Dental Membrane) performs similarly or equivalently to the predicate device (Bio-Gide®) across various characteristics, including in vivo performance.

The reported device performance is that the subject device achieved similar new bone formation to the predicate device in an animal model, even with faster degradation.

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

• Test Set (In vivo animal study): "A canine intrabony defect animal study" was performed.
  • Sample Size: Not explicitly stated as a number of animals or defects.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but it is an in vivo animal study, which is prospective by nature. The origin of the animals for the device material itself is the "United States of America."

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)

• Ground Truth for In vivo Study: The ground truth for the animal study (new bone formation) was established through "histopathology evaluations."
  • Number of Experts: Not specified.
  • Qualifications of Experts: Not specified, but implied to be pathologists or histologists capable of evaluating tissue samples for new bone formation.

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

• Adjudication Method: Not specified. It's likely that histopathology evaluations are conducted by a single qualified expert unless discrepancies arise, at which point an internal expert consensus or review might be employed.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical barrier membrane, not an AI/ML diagnostic software. The comparison was device-to-device (subject device vs. predicate device) in an animal model, not AI vs. human readers.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

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

• Ground Truth Type: For the in vivo animal study, the ground truth for evaluating new bone formation was established by histopathology evaluations.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "characterization" and "bench tests" are akin to pre-market testing for a physical product, not machine learning model training.

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

• Training Set Ground Truth: Not applicable, as there is no training set for an AI/ML model for this device.

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The DPR Cable is intended for:

• Spinal applications include sublaminar and intraspinous process wiring for trauma applications.
• Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
• Sternotomy indications including the "rewiring" of osteomized sternums.
• Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
  The device is intended for single patient use only.

The DPR Cable is a flexible, multi-strand ultra-high molecular weight polyethylene (UHMWPE) cerclage cable. The device is intended to provide stabilization of bony segments.
The DPR Cable is made of woven ultra-high molecular weight polyethylene fibers which incorporate bismuth trioxide (Bi₂O₃). The addition of bismuth trioxide allows for radiographic visualization both during and after surgical procedures. The device is supplied sterile in double-layer packages. The DPR Cable is intended for single patient use only. DPR Cable is MR safe.

The provided text is a 510(k) Premarket Notification for a medical device called the "DPR Cable." This document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than detailing a clinical study with acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested details regarding acceptance criteria, study design for proving device performance (especially for an AI/algorithm), ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies do not apply to this type of regulatory submission for this medical device.

The document discusses biomechanical testing to show equivalence in performance characteristics to predicate devices, but this is not an AI/algorithm study.

Here's an attempt to extract relevant information, highlighting where the requested details are not applicable based on the provided text's context as a 510(k) for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating equivalence to predicate devices through biomechanical testing, rather than explicit criteria for an AI's accuracy or clinical performance. The table in the document (Page 5) compares the technological characteristics and certain performance metrics with the predicate device.

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Medeor Matrix Wound Dressing is indicated for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds.

Medeor Matrix Wound Dressing is intended for one time use.

Medeor Matrix Wound Dressing, Acellular Dermal Matrix is a resorbable porcine dermisderived dressing intended for the management of topical wounds. The device is sterilized by electron beam irradiation and supplied hydrated in a double layer package. The device is a prescription device for single use only.

This document describes the Medeor Matrix Wound Dressing, a resorbable porcine dermis-derived dressing for topical wounds. However, it is a 510(k) summary for a medical device that is not an AI/ML device.

The provided document does not contain information about a study proving that an AI device meets acceptance criteria. It is a regulatory submission for a physical wound dressing and primarily focuses on demonstrating substantial equivalence to a predicate device based on its material, technological, and performance characteristics, as well as biocompatibility testing.

Therefore, I cannot fulfill the request to provide information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the provided content.

The information primarily concerns the biocompatibility and physical performance of the wound dressing, not the performance of an AI/ML algorithm.

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Meso Tendon Matrix is indicated for use in sports medicine procedures for the reinforcement and repair of soft tissue where weakness exists including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. Meso Tendon Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. Meso Tendon Matrix is supplied sterile and for one time use.

Meso Tendon Matrix is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine mesothelium tissue. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.

Here's an analysis of the acceptance criteria and supporting studies for the Meso Tendon Matrix device, based on the provided text:

This document is a 510(k) summary for a medical device (Meso Tendon Matrix) seeking substantial equivalence to a predicate device (Medeor Matrix). The acceptance criteria are primarily demonstrated through equivalence to the predicate, rather than meeting specific performance thresholds against a diagnostic "ground truth" as would be the case for a diagnostic AI device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility: The text does not specify the sample size for each test conducted under ISO 10993-1:2009. These typically involve standardized protocols where sample size is determined by the specific test method (e.g., number of cell cultures, animals per group).
• Biomechanical Testing: Not specified.
• Animal Implant Studies: Not specified.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing and studies conducted by DSM Biomedical or contracted testing facilities. Given the nature of these tests, it's prospective testing.

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

This type of device (surgical mesh) does not involve a "ground truth" established by experts in the sense of a diagnostic interpretation (e.g., radiologists reviewing images). Instead, acceptance criteria are based on objective, standardized scientific and engineering tests (biocompatibility, mechanical properties) and animal model outcomes for tissue response. The "ground truth" is established by the validated methods of these scientific tests themselves and the comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations. The "adjudication" is essentially the comparison of the test results to predefined acceptance criteria or to the predicate device's characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI or diagnostic imaging device. An MRMC study is not relevant here.

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

Yes, in the sense that the device's inherent properties (biocompatibility, mechanical strength, in vivo tissue response) were tested independently without a "human-in-the-loop" component. The device itself is not an algorithm, so this question is interpreted as the device's performance being evaluated in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance is established through:

• Compliance with International Standards: For biocompatibility, adherence to ISO 10993-1:2009.
• Objective Engineering Measurements: For biomechanical properties (tensile strength, burst, tear, suture retention).
• Observed Biological Response: In animal implant studies, observing normal tissue healing and remodeling.
• Comparison to Predicate Device: The primary "ground truth" for regulatory clearance is substantial equivalence to the Medeor Matrix (K103787) across material, intended use, principles of operation, and technological characteristics.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set. The "training" in a broad sense would be the research and development phase where materials were selected and manufacturing processes optimized, but this is not a data-driven "model training" process.

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

Not applicable for the same reason as above.

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Meso Bilayer Surgical Mesh is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g. hiatal, femoral, paracolostomy, umbilical.) Meso Bilayer Surgical Mesh is supplied sterile and for one time use.

Meso Bilayer Surgical Mesh is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine tissue and a synthetic absorbable polymer. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.

The provided text describes the regulatory submission for the "Meso Bilayer Surgical Mesh" and its comparison to a predicate device. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic AI device or a device with a human-in-the-loop component.

This document is a 510(k) summary for a surgical mesh, which is a medical device for tissue reinforcement. The studies mentioned (biocompatibility, biomechanical bench testing, characterization testing, and in vivo performance testing) are for evaluating the physical and biological properties of the mesh itself, showing its equivalence to a predicate device. They are not studies related to diagnostic accuracy, AI performance, or human reader effectiveness.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met for an AI device. The document is about a different type of medical device.

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