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The NOVA Minimally Invasive System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation),
4. Spinal stenosis.
5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor,
7. Pseudoarthrosis, and
8. Failed previous fusion

The NOVA Minimally Invasive System consists of cannulated polyaxial screw, straight and pre-bent rods and set screws. The components are manufactured from titanium alloy per ASTM F136. The screws range in diameter from 5.5 mm to 7.0 mm and in length from 20 mm to 70 mm. The implants are not compatible with components or metal from any other manufacturer's system. The NOVA Minimally Invasive System can be used for both percutaneous and mini-open surgery

The provided text is a 510(k) summary for the NOVA Minimally Invasive System. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device (K182416).

This document does not contain any information about acceptance criteria or a study proving the device meets those criteria for algorithmic performance. The device described is a medical implant (thoracolumbosacral pedicle screw system), not a software or AI-based diagnostic device. The "Performance Characteristics" section explicitly states: "The mechanical testing performed for the subject NOVA Minimally Invasive System with its components and the predicate devices is in accordance with ASTM F1717. There are no design change are involved for the design verification tests. The performance data for design control activities are unnecessary this time."

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as the document does not pertain to the validation of an algorithmic or AI-based device. The 510(k) submission primarily focuses on mechanical performance and substantial equivalence to an existing physical device.

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The COMET Lumbar Interbody Fusion Cage is indicated for use in intervertebral body fusion of the Spine. The COMET Lumbar Interbody Fusion Cage is inserted via a transforaminal posterior lumbar fusion procedures in skeletally mature patients with degenerative disc disease (DDD defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) and intended for use with autogenous bone graft at one or two contiguous levels of the lumbosacral spine (L2-S1). The COMET Lumbar Interbody Fusion Cage is intended to be used with supplemental fixation systems cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The COMET Lumbar Interbody Fusion Cage is a hollow, bullet-shaped PEEK cage (per ASTM F2026) with three Tantalum marker pins (per ASTM F560). It is indicated for use in skeletally mature patients for the lumbar spine intervertebral fusion. It is angulated 4°to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle.) The Cage devices are offered in a variety of different sizes with varying footprint dimensions to accommodate a multitude of anatomical needs. The implant has serrations on the top and bottom for fixation and the hollow space of the implant is intended to hold autogenous bone graft for fusion purposes. The COMET Lumbar Interbody Fusion Cage is supplied "Sterile".

The document describes a 510(k) premarket notification for the "COMET Lumbar Interbody Fusion Cage" and references a predicate device, the "SYNTHES T-PAL SPACER" (K100089). This type of submission is for medical devices and typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness or extensive AI performance studies.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies, does not directly apply in the context of this 510(k) submission.

Instead of clinical performance, the approval hinges on demonstrating:

• Identical Indications for Use.
• Similar technological characteristics, materials, and operational principles.
• Non-clinical testing to ensure the device meets established mechanical performance standards as outlined in relevant ASTM standards.

Here's a breakdown of the information that is available in the document, mapped against your request:

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

The document does not provide a table of acceptance criteria with specific numerical targets and the device's reported performance against them in the way clinical studies for AI algorithms might. Instead, it refers to non-clinical mechanical testing performed in accordance with specific ASTM standards. The "acceptance criteria" here are implied by compliance with these standards, meaning the device must withstand the forces outlined in the tests without failure.

The reported device "performance" is implicitly stated as having "provided in support of substantial equivalence," meaning it passed these tests.

The following non-clinical tests were performed:

• Static Compression per ASTM F2077
• Static Compression Shear per ASTM F2077
• Subsidence per ASTM F2267
• Expulsion
• Dynamic Compression per ASTM F2077
• Dynamic Compression Shear per ASTM F2077

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

This information is not applicable as this is a non-clinical, mechanical device submission, not an AI or diagnostic tool clinical study. The "test set" refers to physical samples of the device used for mechanical testing. The document states "The worst-case size for the COMET Lumbar Interbody Fusion Cage was conducted" for these tests, implying specific configurations of the device were tested. No data provenance in the context of patient data is relevant here.

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. Ground truth, in the sense of expert radiological or pathological labels, is not relevant for a mechanical device submission. The "ground truth" for mechanical testing is defined by the ASTM standard test methods and the physical properties observed during testing.

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

This information is not applicable. Adjudication methods are typically for subjective clinical assessments or image interpretations, which are not part of this device submission.

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 information is not applicable. No MRMC comparative effectiveness study was conducted as this is a mechanical interbody fusion cage, not an AI or imaging diagnostic device intended to assist human readers.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device, in the context of its safety and effectiveness, is established through compliance with recognized mechanical testing standards (ASTM F2077, ASTM F2267). This demonstrates that the device has appropriate structural integrity and performance characteristics for its intended physical function.

8. The sample size for the training set

This information is not applicable. This is not an AI algorithm submission, so there is no "training set."

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

This information is not applicable. There is no "training set" or ground truth for it as this is a mechanical device.

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The Facilis™ Spinal System is intended for posterior, non-cervical fixation to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion. The Facilis™ Spinal System is to be used with autograft and/or allograft.

The Facilis™ Spinal System is a system that is indicated for multiple types of spinal fusion procedures (please see Section IV). All components are made from titanium alloy Titanium-6 Aluminum-4 Vanadium (Ti-6AL-4V), a biocompatible material which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, hooks and accessory connection components. The Facilis™ Spinal Systems are supplied "Non-Steriled" and must be sterilized before use.

This document describes the Facilis™ Spinal System, a medical device, and its acceptance criteria as proven by a study.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing performed for the device. The "test set" in this context refers to the physical samples of the Facilis™ Spinal System components used for these mechanical durability tests.

• Sample Size: Not explicitly stated as a number of devices or components. It refers to "the subject Facilis Spinal System with its components and the predicate devices."
• Data Provenance: The tests were conducted according to established ASTM standards (F1717 and F1798), implying laboratory-based testing rather than clinical data from human patients. The origin of the specific tested devices is not specified beyond being the subject device and predicate devices. This would be considered prospective data generation for the purpose of demonstrating mechanical performance.

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

This information is not applicable to a mechanical performance study. "Ground truth" established by experts typically refers to clinical diagnoses or interpretations. For mechanical testing, the "ground truth" is defined by the physical properties and performance limits set forth in the ASTM standards.

4. Adjudication Method for the Test Set

This information is not applicable to a mechanical performance study. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving expert consensus on diagnoses or interpretations. For mechanical testing, the results are objectively measured against predefined criteria in the ASTM standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not the subject of this medical device submission.

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

No, a standalone performance study was not done. This submission is for a physical medical device (spinal system), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing was the acceptance criteria established by recognized industry standards (ASTM F1717 and ASTM F1798). These standards define the mechanical properties and performance requirements for spinal implant systems. The devices were tested to ensure they met these predefined physical and mechanical thresholds.

8. The Sample Size for the Training Set

This information is not applicable. This is a submission for a physical medical device. The concept of a "training set" is relevant for AI/machine learning models, not for traditional medical devices undergoing mechanical performance testing.

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

This information is not applicable for the reasons stated above.

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The NOVA Minimally Invasive System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation)
4. Spinal stenosis,
5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor,
7. Pseudoarthrosis, and
8. Failed previouis fusion

The NOVA Minimally Invasive System consists of cannulated polyaxial screws, straight and pre-bent rods, and set screws. The components are manufactured from titanium alloy per ASTM F136. The screws range in diameter from 5.5 mm to 7.0 mm and in length from 20 mm to 70 mm. The implants are not compatible with components or metal from any other manufacturer's system. The NOVA Minimally Invasive System can be used for both percutaneous and mini-open surgerv.

The provided document (K182416) is a 510(k) summary for the NOVA Minimally Invasive System, a thoracolumbosacral pedicle screw system. It focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical performance testing.

This document does NOT contain information about any study involving human readers, AI assistance, or the establishment of ground truth for a test set or training set for an AI/algorithm. The performance testing described is purely mechanical, comparing the device's physical properties to established standards and a predicate device.

Therefore, for most of your requested information (related to AI performance, human readers, ground truth, sample sizes for test/training sets, and expert qualifications/adjudication), the provided document does not contain the answer.

Here's the information that is available:

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

The document states: "The following tests were performed on the subject components per ASTM F1717: static compression bending, static torsion, and dynamic compression bending. Results of these mechanical tests demonstrate substantially equivalent mechanical performance to predicate devices."

As specific acceptance criteria (e.g., "must withstand X N of force") and exact reported performance values are not detailed in this summary, the table below provides a generalized summary based on the provided text.

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

This information is not provided. The testing was mechanical, not on human subjects or 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. This device is a pedicle screw system, and the testing was mechanical. There was no "ground truth" to be established by experts in a clinical context within this submission summary.

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

Not applicable. This was mechanical testing, not a clinical study requiring human adjudication.

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

No. This is a pedicle screw system, and the submission does not mention any AI component or MRMC study.

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

No. This is a physical medical device (pedicle screw system), not an algorithm.

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

Not applicable. The "ground truth" for mechanical testing is typically defined by engineering specifications and material properties, against which the device's performance is measured. It's not a clinical "ground truth."

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/algorithm device submission.

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

Not applicable. There is no mention of a training set as this is not an AI/algorithm device submission.

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The FacilisTM Spinal System is a non- cervical, pedicle screw system intended to provide posterior, non-cervical immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The FacilisTM Spinal System is also indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the implant fixed or attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Facilis "14 Spinal System is a system that is indicated for multiple types of spinal fusion procedures (please see Section IV). All components are made from titanium alloy Titanium-6 Aluminum-4 Vanadium (Ti-6AL-4V), a biocompatible material which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, hooks and accessory connection components. The Facilis™ Spinal Systems are supplied "Non-Steriled" and must be sterilized before use.

The provided text is for a 510(k) premarket notification for a spinal system (Facilis™ Spinal System). This document is focused on demonstrating substantial equivalence to a predicate device based on material, design, and mechanical testing, not software or AI performance.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/software device cannot be extracted from this document. This document describes the physical characteristics and mechanical testing of an orthopedic implant.

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