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The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radios. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device with compatible allograft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion, is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

AFT is intended for use as a bone void filler in the extremities, spine, intervertebral disc space, and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury. When used in intervertebral body fusion procedures, AFT must be used on its own with an intervertebral body graff containment device cleared by FDA for use with a bone void filler.

The OptiMesh Multiplanar Expandable Interbody Fusion System is an intervertebral body graft containment device that is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

AFT Allograft Filler Tube is composed of human demineralized bone matrix, human nondemineralized bone, and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.

The provided text describes a 510(k) premarket notification for the "OptiMesh Multiplanar Expandable Interbody Fusion System" with the addition of "AFT Allograft Filler Tube" as a compatible allograft. It outlines the purpose of the submission, device descriptions, indications for use, technological characteristics, and non-clinical/clinical testing. However, the document does not provide specific acceptance criteria or detailed study results in the format requested.

The FDA 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific, quantifiable acceptance criteria with a detailed study report. The non-clinical and clinical data presented here are used to support this claim of substantial equivalence.

Based on the provided text, I can infer some aspects and highlight what is not present:

Inferred Information:

• Acceptance Criteria (Implied): The implied acceptance criteria revolve around demonstrating that the OptiMesh device with AFT performs comparably to the predicate device and the reference devices in terms of mechanical performance and biological impact, without introducing new safety or effectiveness concerns. This means that:
  • Mechanical performance of OptiMesh + AFT should be "as intended" and comparable to the reference device and ISO 23089-2 data.
  • Biological impact of AFT should be comparable to the reference bone graft.
  • Biocompatibility, pyrogenicity/endotoxin, sterilization, packaging, and shelf-life should be acceptable and comparable.
  • The risk profile should not be altered, and new safety/effectiveness issues should not arise.
• Study Proving Acceptance Criteria: The study used to demonstrate this is primarily a critical engineering and clinical comparison to a bone graft used in a prospective, multi-center, non-randomized, FDA and IRB approved performance goal clinical investigation.

Information NOT present explicitly in the document:

• Specific quantifications of acceptance criteria.
• A table of acceptance criteria and reported device performance with numerical values.
• Sample sizes used for the test set (e.g., number of patients/data points in the clinical investigation for comparison).
• Data provenance (country of origin, retrospective/prospective for the comparison study). While it mentions a "prospective" clinical investigation for the reference bone graft, it doesn't specify if the comparison itself involved new prospective data or a retrospective analysis of the existing investigation's data.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details (effect size, human reader improvement). This type of study is more common for diagnostic imaging AI than for interbody fusion systems.
• Standalone algorithm performance (algorithm only without human-in-the-loop). This is a physical device, so "standalone algorithm performance" is not applicable in the typical AI/software sense.
• Type of ground truth used (pathology, outcomes data, etc.) beyond "clinical data" and "performance goal clinical investigation."
• Sample size for the training set. There's no mention of a "training set" in the context of an AI/machine learning model. This submission is for a physical medical device.
• How the ground truth for the training set was established. (Not applicable for this type of device submission).

Given these limitations, here is the best possible answer based only on the provided text, heavily inferring the "acceptance criteria" based on the substantial equivalence claims:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance:
* Sample Size: Not specified in the given text.
* Data Provenance: The clinical data for comparison comes from a "prospective, multi-center, non-randomized, FDA and IRB approved performance goal clinical investigation" involving a reference bone graft. The country of origin is not specified but it's an FDA-approved study, implying it was likely conducted in the US or under FDA oversight for data acceptability.

3. Number of experts used to establish the ground truth for the test set and their qualifications:
* Not specified. The clinical investigation mentioned for comparison would have medical professionals involved, but the text does not detail the "ground truth" establishment process by experts in the context of this submission.

4. Adjudication method for the test set:
* Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
* No, an MRMC study is not mentioned. This type of study is typically for evaluating diagnostic imaging systems where human readers interpret medical images. This submission is for a physical interbody fusion system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No, this concept is not applicable. The device is a physical medical implant, not an AI algorithm.

7. The type of ground truth used:
* The term "ground truth" is not explicitly used in the context of a dataset for algorithmic evaluation. However, for the clinical performance comparison, the "performance goal clinical investigation" likely established clinical outcomes (e.g., fusion rates, pain reduction, adverse events) as the de facto "truth" against which the subject device's performance (via comparison to a reference bone graft) was evaluated.

8. The sample size for the training set:
* Not applicable. This submission is for a physical medical device, not an AI/machine learning model that would require a training set.

9. How the ground truth for the training set was established:
* Not applicable, as there is no training set for an AI model.

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The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radios. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device with compatible allograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

The OptiMesh Multiplanar Expandable Interbody Fusion System is an intervertebral body graft containment device that is a non-rigid, implanted spinal device designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

The OptiMesh Lordotic device incorporates an asymmetrical dual chamber mesh with a larger chamber in the anterior portion of the disc space than in the posterior. Due to the asymmetry of the two mesh chambers when filled, the implant is designed to result in a lordotic shape.

The provided document is a 510(k) summary for the OptiMesh Multiplanar Expandable Interbody Fusion System. This document does not describe a study involving an AI/CADe device, human readers, or a test set with ground truth established by experts.

Instead, this document describes a medical device (an intervertebral body fusion system) and its mechanical and design properties. The non-clinical testing performed focuses on benchtop performance ASTM testing and risk assessment to demonstrate equivalence to a predicate device.

Therefore, I cannot provide the requested information, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, or adjudication methods, as these concepts are not applicable to the information presented in this 510(k) summary.

In summary, the provided document does not contain information about an AI/CADe device study to fulfill the prompt's requirements.

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OptiMesh 500E is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal or tibial plateau in hip stem and total knee replacement.

OptiMesh 500E is not intended for use in spinal indications.

OptiMesh 500E is an implantable PET device indicated for use as a cement restrictor in the femur and tibia. OptiMesh 500E is manufactured from polyethylene terephthalate (PET). The device is provided pre-loaded, for ease of handling, on a disposable holder made of stainless steel. The device is available in a variety of different sizes to suit the individual pathology and anatomical conditions of the patient.

The provided text describes a 510(k) premarket notification for a medical device called OptiMesh 500E Cement Restrictor. This document establishes that the device is substantially equivalent to legally marketed predicate devices. However, it does not include information about specific acceptance criteria and a study proving those criteria are met in the way typically found for AI/ML-based devices with quantitative performance metrics.

The document is for a physical medical device (cement restrictor) and its clearance is based on substantial equivalence to existing predicate devices, not on meeting specific performance acceptance criteria from a clinical study with quantitative outcomes.

Therefore, the requested information elements related to AI/ML device performance (like sample size for test set, provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details) are not applicable to this type of device submission as described in the provided text.

Here's an analysis of what is available:

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

• Acceptance Criteria: The primary "acceptance criterion" for this type of device, as per the document, is demonstrating substantial equivalence to existing predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
• Reported Device Performance: Instead of performance metrics from a clinical study, the "performance" demonstrated is that the device is identical in materials and similar in configuration and principles of use to predicate devices. Configurational differences were addressed through testing, which found "no new questions of safety or effectiveness."

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

• Not applicable. This is a physical device submission focused on substantial equivalence through material and design comparison, supported by internal testing (not clinical trials with human participant test sets).

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 as typically defined for AI/ML models is not relevant here.

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 is not an AI-assisted device.

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

• Not applicable. This is a physical device.

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

• For this type of device, the "ground truth" would be related to engineering specifications, material properties, and mechanical performance demonstrated through non-clinical testing, rather than clinical outcomes or diagnostic accuracy. The text indicates "configurational differences... were addressed through testing," which implies mechanical or bench testing.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires training data in that sense.

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

• Not applicable.

In summary, the provided document relates to a traditional medical device (cement restrictor) seeking 510(k) clearance based on demonstrating substantial equivalence to already cleared predicate devices. The study that "proves" the device meets acceptance criteria primarily involves bench testing and comparison to predicate device specifications rather than clinical study data and performance metrics typically associated with AI/ML or efficacy trials.

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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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