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The Anova Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The Anova Containment Device is a flexible, synthetic composite implantable mesh. It includes a polyester mesh component connected by a mono-filament suture to a porous expanded polytetrafluoroethylene or "ePTFE" component. This ePTFE component is placed between the polyester mesh and the overlying soft tissues. The ePTFE component is not anchored to the disc. The Anova Containment Device is attached to the spine with four suture anchors (two fastened to the vertebra above and two fastened to the vertebra below the disc). The sutures from the anchors overlay the mesh and hold it against the vertebral body and to reinforce the mesh against pressure from the graft material.

Here's an analysis based on the provided text, outlining the acceptance criteria and the study details for the Anova Containment Device:

It's important to note that the provided text is a 510(k) summary, which is a regulatory document focused on demonstrating substantial equivalence to predicate devices, rather than a detailed scientific study report with specific performance metrics and acceptance criteria. Therefore, many of the requested points, especially those related to specific performance metrics, sample sizes for training/test sets, ground truth establishment, and expert involvement, are not explicitly stated in this type of document.

Acceptance Criteria and Device Performance

Based on the nature of a 510(k) submission, the primary "acceptance criteria" is demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is essentially that it functions similarly and addresses the same intended use.

Study Details

The provided document describes a regulatory submission (510(k)), not a clinical study in the typical sense with explicit test sets, training sets, and human reader performance measurements.

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

   • Sample Size: Not specified. The document states "evaluations based on data provided in this 510(k)," but does not detail a specific test set size or methodology for evaluating performance.
   • Data Provenance: Not specified. Given it's a premarket notification, it likely involved bench testing and potentially some animal or cadaveric studies (though not mentioned explicitly as "data provenance"). There is no mention of country of origin or whether it was retrospective or prospective in a clinical sense.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The document does not describe a process for establishing "ground truth" by experts for a test set.

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

   • Adjudication Method: Not applicable/Not specified. This type of regulatory submission does not typically involve adjudication of a test set by multiple readers.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • MRMC Study: No. This device is a physical implant (surgical mesh), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with AI assistance is not applicable.

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

   • Standalone Performance: No. This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

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

   • Type of Ground Truth: Not explicitly defined in terms of a clinical "ground truth." For a device like this, the "ground truth" would likely be established through biomechanical testing, material characterization, and potentially animal model compatibility, demonstrating the device's ability to "maintain the relative position of weak bony tissue" and its physical properties. It's not a diagnostic device with pathology or outcomes as direct ground truth for a discrete "test set."

7. The sample size for the training set:

   • Sample Size: Not applicable/Not specified. This is a physical device, and the concept of a "training set" as understood in machine learning/AI does not apply. If "training set" refers to data used during the device's development and optimization, it is not detailed in this submission.

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

   • Ground Truth Establishment: Not applicable/Not specified, as the concept of a "training set" with ground truth in the AI context does not apply here. Development involved engineering principles, material science, and possibly pre-clinical testing, but not "ground truth" as typically defined for AI/diagnostic studies.

Summary of what the document does provide:

• Device Description: A flexible, synthetic composite implantable mesh with polyester and ePTFE components, designed to be attached to the spine with suture anchors.
• Intended Use: To maintain the relative position of weak bony tissue (allografts/autografts) in spinal fusion procedures, in conjunction with rigid fixation, and not for load-bearing.
• Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence to predicate devices (K041105, K014200, K070148).
• Conclusion: The device is considered "as safe and effective" as legally marketed devices and "substantially equivalent" to the cited predicates based on the provided evaluation data.

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OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the stability of the vertebral body and does not include the vertebral endplates.

OptiMcsh is a sterile, three-dimensional surgical mesh container made of knitted polyester yarn and offered in a range of sizes. The device is packaged in double Tyvek/Mylar pouches and a cardboard carton, and terminally sterilized.

The provided document is a 510(k) premarket notification letter and summary for a surgical mesh device called OptiMesh. It does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device (e.g., performance metrics like sensitivity, specificity, accuracy against a ground truth).

Instead, this document is focused on establishing substantial equivalence to a predicate device based on intended use, materials, and configuration. The "performance data" mentioned in the "Technological Characteristic Comparisons" section likely refers to bench testing or material property tests to show the device's physical properties are safe and effective for its intended mechanical function, not a clinical performance study with human subjects or AI-driven analysis.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation.

However, I can provide what is available or infer from the document:

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

The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical outcomes (e.g., success rates, complication rates) or AI-specific metrics (e.g., accuracy, sensitivity). The "acceptance" in this context refers to the FDA finding of substantial equivalence.

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

No clinical test set or data provenance is detailed in this document. The evaluation is based on technological characteristics comparison to predicate devices, not human subject data for performance.

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

Not applicable, as no clinical test set or ground truth derived from expert review is described.

4. Adjudication method for the test set

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, this type of study is not mentioned as this device is a surgical mesh, not a diagnostic or AI-assisted interpretation device.

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

Not applicable, as this is a physical medical device (surgical mesh), not software/AI.

7. The type of ground truth used

For the purpose of substantial equivalence, the "ground truth" is established by the predicate device's characteristics and its prior regulatory approval. The safety and effectiveness of the predicate device implicitly serves as the benchmark.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device requiring a training set.

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

Not applicable.

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The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures, such as pelvic reconstruction, acetabular reconstruction, cement restriction and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel® Trabecular Metal Reconstruction system may be used with bone graft.

The Hedrocel Trabecular Metal Reconstructive System is manufactured wholly of Hedrocel porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. The devices in this line extension are wedge shaped and contoured so as to fit a variety of anatomical bone structures. The devices are available in small, medium and large sizes, with the cross-sectional dimensions being 0.52in x 0.88in for the small size; 0.58in x 0.96in for the medium size, and 0.62in x 1.06in for the large size. Each size consists of varying heights ranging from 2mm - 8mm in 2mm increments. There is a consistent inclination angle of 10 degrees along the length in all size ranges. A secondary inclination angle along the width ranges from 20-35 degrees in 5-degree increments. The resultant geometry is a bi-plane wedge. The devices have a 6mm central hole for optional bone graft placement. A tapered slot is provided for implantation instrumentation.

The provided document is a 510(k) summary for the Hedrocel Trabecular Metal Reconstructive System. It states that the device was deemed "substantially equivalent" to predicate devices without performing new testing on the subject device itself. Therefore, the information requested regarding acceptance criteria and performance studies in the prompt is not available for this specific device.

Instead, the summary refers to performance data for predicate devices (K023882 and K962468) as evidence of the subject device's anticipated performance. This means there are no specific acceptance criteria or a dedicated study described for the Hedrocel Trabecular Metal Reconstructive System in this document.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document states, "The subject device of the Hedrocel Trabecular Metal Reconstructive System was not tested. Rather previous device testing per FDA guidance documents and applicable standards were performed for the predicate devices described in K023882 and other mechanical testing reported in K962468." Therefore, no acceptance criteria or performance data for this specific device are reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available for the subject device. The document explicitly states the subject device was not tested.

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. No test set for the subject device was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for the subject device was used.

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 surgical mesh, not an AI-assisted diagnostic tool.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No specific ground truth was established for the subject device's performance through new testing.

8. The sample size for the training set: Not applicable. The device is a surgical mesh, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established: Not applicable. The device is a surgical mesh, not a machine learning model.

In summary, the 510(k) clearance for the Hedrocel Trabecular Metal Reconstructive System was based on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than new performance testing of the subject device itself.

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The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.

Hedrocel Trabecular Metal Reconstruction The System is manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. This line extension adds components with a variety of cross-sections and heights to the Hedrocel Trabecular Metal Reconstruction System.

Here's an analysis of the provided text regarding the Hedrocel Trabecular Metal Reconstructive System:

Summary of Acceptance Criteria and Study Details:

Based on the provided 510(k) summary, the device is a surgical mesh (The Hedrocel Trabecular Metal Reconstructive System) made of Hedrocel porous tantalum. The core of the submission relies on demonstrating substantial equivalence to existing predicate devices, rather than establishing specific performance acceptance criteria for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical trials or algorithm validation. The "testing" refers to mechanical performance tests of the material itself. The document mentions "mechanical test data found in MAF #920," implying laboratory-based material characterization, not patient data.
• Data Provenance: Not applicable in the context of clinical data. The mechanical test data would be lab-generated.

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

• Not Applicable. This submission focuses on demonstrating substantial equivalence through material properties and mechanical testing, not through expert-verified clinical outcomes or diagnostic accuracy.

4. Adjudication Method for the Test Set:

• Not Applicable. There is no mention of adjudication, as this wasn't a clinical performance study requiring expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is not mentioned. The submission is for a medical device (surgical mesh) and its mechanical performance, not an AI or imaging diagnostic tool that would typically involve human readers.

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

• No. This is not an AI algorithm.

7. The type of ground truth used:

• The "ground truth" for the material's performance is derived from laboratory mechanical testing that quantifies properties like strength, and comparison to existing standards and predicate device performance. It is not based on expert consensus, pathology, or outcomes data in a clinical trial setting.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The material properties are inherent to the manufacturing process and material composition.

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

• Not Applicable. See point 8.

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The MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The flat Protective Sheets with pore sizes up to 2.5mm are also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving:

• Long bones
• Flat bones
• Short bones
• · Irregular bones
• · Appendicular skeleton
• Thorax

When used alone (without traditional rigid fixation), the MacroPore OS Reconstruction System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving:

• · Tumor resections where bone strength has not been compromised
• Iliac crest harvests
• Ribs (excluding multiple segmental defects such as those found in flail chest)

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

MacroPore OS Reconstruction System is a resorbable graft containment system composed of various sized porous sheet and sleeves, non-porous sheets and associated fixation screws and tacks manufactured from polylactic acid (PLA). The MacroPore OS Reconstruction System is composed of MacroPore OS Reconstruction System Protective Sheets, MacroPore OS Reconstruction System Protective Sleeves, and MacroPore OS Reconstruction Screws and Tacks.

The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore OS Reconstruction System to the desired shape or size. MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves are fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation.

The MacroPore OS Reconstruction System Protective Sheets can be rolled into a tube or used as a flat sheet. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves can be used either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to fixate the MacroPore OS Reconstruction System and prevent dislocation.

The MacroPore OS Reconstruction System Tacks range in size from 1.7mm to 2.2mm in diameter with lengths from 3.6mm to 5.6mm and the MacroPore OS Reconstruction System Screws range in size from 2.0mm to 4.75mm in diameter with lengths from 3.35mm to 30mm. The MacroPore OS Reconstruction System Protective Sheet is provided in sheets of 25 x 25 mm to 160 x 200 mm. The MacroPore OS Reconstruction System Protective Sleeves are provided in lengths of 150mm to 5mm with inner diameters that range from 5mm up to 40mm. The MacroPore Reconstruction System Protective Sleeves are provided in circular, square, trapezoidal, and parabolic shapes. The MacroPore OS Reconstruction System Protective Sleeves are provided with and without serrated edges and / or tapered end(s) for ease of surgical installation. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves are provided with and without macroporous holes. The pore size ranges from 1.7mm to 4.0mm in diameter, with pores distributed randomly or uniformly throughout the sheet/sleeve in an offset or aligned pattern. The thickness of the MacroPore OS Reconstruction System Protective Sheets ranges from 0.5mm to 5.0mm according to the orthopedic region to be treated. The thickness of the MacroPore OS Reconstruction System Protective Sleeves ranges from 0.8mm to 5.0mm according to the orthopedic region to be treated.

The provided text describes the MacroPore OS Reconstruction System, which is a resorbable graft containment system. The document is a 510(k) summary, demonstrating "substantial equivalence" of the device to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's an analysis based on your requested information, acknowledging that many items are not applicable or not explicitly stated in this type of regulatory submission:

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

• Viscosity stayed within appropriate range after 120 minutes at 60℃ in saline (indicating brief heating during surgical prep not significant).
• As rigid and strong as predicate device after 6 months of exposure in aging studies.
• Substantially equivalent to mechanical strengths of predicate devices under indication for use conditions (tensile strength, rigidity).
• Amorphous and non-crystalline (confirmed by DSC). |

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 applicable. This submission relies on substantial equivalence to predicate devices, supported by in vitro bench testing, rather than a clinical human test set. The "test set" here refers to the samples of the device itself (MacroPore OS Reconstruction System components) used for mechanical and material characterization.
• Data Provenance: The testing was in vitro (bench testing) performed on the device components. There is no mention of country of origin for the data or whether it was retrospective or prospective, as it's not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic or image-based devices being evaluated by human interpretation. This document describes a surgical implantable device, and its equivalency is based on material properties, design, and mechanical performance demonstrated through objective laboratory tests.

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

Not applicable. Adjudication methods are typically used for clinical trials or studies involving human judgment (e.g., image interpretation). The "test set" here refers to physical device samples undergoing laboratory evaluation.

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/diagnostic device.

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

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

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

The "ground truth" for demonstrating equivalence was established by:

• Predicate Device Specifications: The material composition, design principles, indications for use, and mechanical properties of the legally marketed predicate devices (MacroPore OS Protective Sheet and Synthes Resorbable Meshes and Sheets) served as the reference or "ground truth" for comparison.
• Standardized Material and Mechanical Testing: In vitro tests (e.g., viscosity, aging studies, tensile strength, rigidity, DSC) were performed on the MacroPore OS Reconstruction System components, and the results were compared to the known or expected performance characteristics of the predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

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The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.

The Hedrocel Trabecular Metal Reconstructive System is manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. The Hedrocel Trabecular Metal Reconstructive System has oval cross-sectional geometries of 11mm by 14mm and 21mm by 32mm and is available in height options ranging from 8mm to 62mm. The superior and inferior faces of the implant are canted (included angle of 7 degrees) to provide for initial stability and to facilitate implantation.

The provided text describes a 510(k) summary for "The Hedrocel Trabecular Metal Reconstructive System," a surgical mesh device. Based on the document, here's an analysis of the acceptance criteria and study information:

This document does not provide specific acceptance criteria in terms of numerical thresholds for device performance. Instead, it relies on substantial equivalence to predicate devices and general performance testing. Therefore, I cannot generate a table comparing acceptance criteria to reported device performance as that detailed information is not present.

However, I can extract information related to the device performance study as described:

Study Information for The Hedrocel Trabecular Metal Reconstructive System:

• 1. A table of acceptance criteria and the reported device performance:
  As stated above, no explicit numerical or quantitative acceptance criteria are provided in the document. The general acceptance is implied through the "substantially equivalent" determination to predicate devices and performance testing indicating the device "will perform as indicated."

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
  The document does not specify a distinct "test set" sample size or data provenance. It mentions "Performance Data: The Hedrocel Trabecular Metal Reconstructive System was tested per FDA guidance documents and applicable standards for K010378 for use as a structural void filler in vertebral body replacement." This suggests performance testing was conducted, but details on sample size, origin, or study design (retrospective/prospective) are absent.

• 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):
  This information is not applicable and not provided in the document. This device is a physical implant, not an AI or diagnostic device that requires expert ground truth for a test set.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
  This information is not applicable and not provided.

• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
  This is not an AI-assisted device. Therefore, no MRMC comparative effectiveness study involving AI or human readers was conducted or reported.

• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
  This is not an AI algorithm. Therefore, no standalone algorithm performance was assessed.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
  For this physical medical device, "ground truth" would typically refer to the successful mechanical or biological performance of the implant in its intended use, usually assessed through in-vitro mechanical testing, pre-clinical animal studies, or clinical outcomes (though no clinical trials are explicitly mentioned for this 510(k) submission beyond "performance testing"). The document indicates that testing was done "per FDA guidance documents and applicable standards." However, the specific type of ground truth (e.g., specific pathology results, long-term outcomes) is not detailed.

• 8. The sample size for the training set:
  This is not an AI algorithm and thus does not have a "training set."

• 9. How the ground truth for the training set was established:
  This is not an AI algorithm and thus does not have a "training set."

Summary of Acceptance related to Substantial Equivalence:

The primary "acceptance" for this device is based on substantial equivalence to predicate devices. The document states:

• "A comparison of device technological characteristics and properties demonstrates that the device is substantial equivalent to the cited predicate devices."
• "The Hedrocel Trabecular Metal Reconstructive System is substantially equivalent to the cited predicate devices identified in this premarket notification."

The study that "proves" the device meets acceptance criteria (i.e., is substantially equivalent and performs as indicated) is summarized as:

• "The Hedrocel Trabecular Metal Reconstructive System was tested per FDA guidance documents and applicable standards for K010378 for use as a structural void filler in vertebral body replacement. These results indicate that the subject device will perform as indicated for use in support of weakened bony structures."

This indicates that mechanical and/or material performance testing was conducted according to regulatory standards to support its intended use and similarity to previously cleared devices, forming the basis for its 510(k) clearance.

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The NuVasive® Mesh is indicated for use in the reinforcement of weak bony tissue in orthopedic procedures.

The NuVasive® Mesh is a rhombic pattern surgical mesh device intended for the reinforcement of weak bony tissue during orthopedic surgical procedures. The implant is available in preformed round or oval cylinders, in a variety of different sizes.

The provided text does not contain information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria. The submission is a 510(k) summary for a medical device (NuVasive® Mesh), which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria.

The submission explicitly states:

• "G. Summary of Non-Clinical Tests (Not Applicable)."
• "H. Summary of Clinical Tests (Not Applicable)."
• "I. Conclusions of Non-Clinical and Clinical Tests (Not Applicable)."

This indicates that no specific non-clinical or clinical studies, as typically understood for demonstrating performance against acceptance criteria, were presented or required for this 510(k) submission. The FDA clearance was based on substantial equivalence to existing devices.

Therefore, the requested information elements cannot be extracted from the provided text.

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Indication for use is for the reinforcement of weak bony tissue in orthopedic procedures.

The Synthes SynMesh consists of both flat mesh and preformed round and oval shaped mesh cylinders. The flat mesh is intended to be customized to a design and geometry that satisfies the patients anatomical defect. In addition, rings and screws are available to reinforce the cylinders. The preformed cylinders are offered in various sizes. The mesh and preformed cylinders are manufactured from commercially pure titanium (ASTM F67). Indication for use is in reinforcement of weak bony tissue in orthopedic surgical procedures.

Here's an analysis of the provided text regarding the SYNTHES SynMesh device, focusing on acceptance criteria and the study proving it, as per your request:

Acceptance Criteria and Study for SYNTHES SynMesh (K983766)

The SYNTHES SynMesh is a Class II medical device, and its clearance was based on Substantial Equivalence to a legally marketed predicate device, the DePuy Motech Surgical Titanium Mesh (K900138). This means that a direct study proving the device meets specific performance acceptance criteria in an independent manner was not performed in this submission. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission relies on demonstrating substantial equivalence to a predicate device, rather than performing an independent clinical or bench performance test with a specific sample size. The "test set" effectively refers to the predicate device's established performance.
• Data Provenance: Not applicable for a new, independent test set. The data provenance is from the previously cleared DePuy Motech Surgical Titanium Mesh (K900138), which would have had its own supporting data at the time of its clearance.

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

• Not applicable. No "ground truth" was established for a new test set in this 510(k) submission. The FDA's review process relied on the existing clearance of the predicate device and the presented comparative data.

4. Adjudication Method for the Test Set

• Not applicable. There was no independent test set requiring adjudication in this substantial equivalence submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is typically for evaluating diagnostic or interpretive devices involving human readers. The SYNTHES SynMesh is a surgical implant; therefore, an MRMC study is not relevant to its clearance.

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

• No. This device is not an algorithm or AI-based system. It's a physical medical device.

7. The Type of Ground Truth Used

• The "ground truth," in the context of a substantial equivalence submission for a physical implant, is the established safety and effectiveness profile of the predicate device, based on its prior clearance and clinical use. No new "ground truth" was generated.

8. The Sample Size for the Training Set

• Not applicable. This concept is relevant to machine learning algorithms, which are not involved in the clearance of the SYNTHES SynMesh.

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

• Not applicable, as there is no training set for this type of device submission.

Summary of the "Study" Proving Acceptance Criteria:

The "study" in this context is a comparative analysis demonstrating that the SYNTHES SynMesh is substantially equivalent to the DePuy Motech Surgical Titanium Mesh (K900138). This involved showing:

• Identical Indications for Use.
• Identical Material Composition (commercially pure titanium, ASTM F67).
• Identical Dimensional Characteristics (same range of flat mesh size, cylinder sizes, ring sizes, and screw definitions).
• Mechanical Characteristics within Range: The hole-to-metal ratio, and thus the inferred mechanical characteristics, were shown to fall within the range of the predicate device.

The premise is that if the new device is functionally, materially, and dimensionally equivalent to a device already deemed safe and effective, then it is also safe and effective. The FDA's acceptance of this submission is based on this comparative rationale rather than a de novo clinical trial or performance study.

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