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NEO Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach.

The indication for use is Degenerative Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment.

The NEO Cage System™ is an intervertebral fusion device with bone graft intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The cages are intended to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage implants may be implanted via an open posterior approach.

The Neo Cage System™ consists of cages of different lengths, sizes and lordotic angles to adapt to a variety of patient anatomies. The size and form of the devices is adjusted to the morphology of the body and the surgical technique. The cages of the Neo Cage system are made of titanium alloy (Ti6Al4V) according to ISO 5832-3 or ASTM F3001 and are supplied sterile. The system includes the relevant instruments which are either single use only and delivered sterile or reusable. The Instruments are to be used for the implantation of the above mentioned medical devices.

This document is a 510(k) Premarket Notification from Neo Medical S.A. to the FDA for their NEO Cage System™. It outlines the device's indications for use, description, and a summary of the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices.

Let's break down the requested information based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the typical sense of a clinical study for a new AI/software medical device where performance metrics (e.g., sensitivity, specificity) are directly tied to specific thresholds.

Instead, this 510(k) submission focuses on non-clinical testing to demonstrate substantial equivalence for a physical medical device (an intervertebral body fusion device). The "acceptance criteria" are implied by the standards and successful completion of the tests, and the "reported device performance" is that the device met these standards.

Here's an interpretation based on the provided "Summary of testing":

Regarding the study that proves the device meets acceptance criteria:

The "study" in this context is the comprehensive set of non-clinical performance testing summarized, not a traditional clinical trial or AI model validation study. The document explicitly states: "Clinical Evaluation: Clinical studies were not required, based upon review an evaluation of scientific literature, comparison with similar devices and non-clinical performance data."

Therefore, many of the specific questions about an AI/software device's validation are not applicable here.

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

• Sample Size: Not applicable in the sense of patient data for an AI/software test set. The "samples" would be the physical devices or materials used for the various non-clinical tests (e.g., a certain number of cages for mechanical testing, sterile samples for SAL validation, material extracts for biocompatibility). The document doesn't specify these quantities but successful completion implies sufficient sampling per the referenced standards.
• Data Provenance: Not applicable for patient data. The testing was conducted by Neo Medical S.A. (Switzerland) and its affiliated labs (likely contract labs based on the testing types). The tests followed international standards (ISO, ASTM).

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)

• Experts: Not applicable in the context of establishing ground truth for medical image interpretation or similar.
• The "Usability" study involved "orthopedic surgeons," who are experts in their field, to confirm the suitability of the instruments and system. This is an expert-based review of the physical device and its surgical use, not ground truth for a diagnostic algorithm.

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

Not applicable. There is no "test set" in the context of human interpretation that would require adjudication. The non-clinical tests are objective measurements against defined standards.

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 for a physical intervertebral fusion device, not an AI or imaging diagnostic device. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm.

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

• The "ground truth" for this device is the adherence to internationally recognized standards (ISO, ASTM) and successful performance in rigorous non-clinical laboratory tests (e.g., materials characterization, mechanical strength, sterility, biocompatibility).
• For the "Usability" study, the "ground truth" was the expert opinion/confirmation of orthopedic surgeons regarding the suitability of the system.

8. The sample size for the training set

Not applicable. 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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Neo Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach.

The indication for use is Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The NEO Cage System™ is an intervertebral fusion device with autogenous bone graft intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The cages are intended to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage implants may be implanted via an open posterior approach.

The Neo Cage System™ consists of cages of different lengths, sizes and lordotic angles to adapt to a variety of patient anatomies. The size and form of the devices is adjusted to the morphology of the body and the surqical technique. The cages of the Neo Cage system are made of titanium alloy according to ISO 5832-3 or ASTM F3001 and are supplied sterile. The system includes the relevant instruments which are single use only and delivered sterile. The Instruments are to be used for the implantation of the above mentioned medical devices.

This document is a 510(k) premarket notification for a medical device (Neo Cage System™), which is a regulatory submission to the FDA. It does not include data from a study proving a device meets acceptance criteria, an MRMC study, or AI performance data.

The document states: "Clinical Evaluation: Clinical studies were not required, based upon review and evaluation of scientific literature, comparison with similar devices and non-clinical performance data."

Therefore, I cannot provide details on the specific points requested regarding acceptance criteria and performance studies (e.g., sample size for training/test set, expert ground truth establishment, MRMC studies, standalone performance), as these were not part of this 510(k) submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through:

• Mechanical Testing: Performed according to ASTM F2077 and F2267, and ISO 17853, covering static and dynamic compression, shear, torsion, subsidence, and wear testing.
• Biocompatibility: Evaluated per ISO 10993-1, including chemical analysis (ISO 10993-18) and cytotoxicity (ISO 10993-5).
• Sterilization Validation: Per ISO 11137-2 (VDmax25 method) for a SAL of 10-6.
• Pyrogenicity: LAL-Test results

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The NEO Pedicle Screw System™ is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical firation for the following indications: 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, tumor, pseudarthrosis, and/or failed previous fusion.

The NEO Pedicle Screw System™ consists of pedicle screws and connecting rods which differ in length and diameter. The system includes the relevant instruments which are single use, disposable and delivered sterile. All components and instruments are sterilized by gamma irradiation.

The screws are offered in diameters of 5.0 - 7.0 mm and lengths of 35 - 55 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 - 100 mm, straight rods in lengths from 30 - 300 mm and the special-bent rod in either 30 or 40 mm length. All spinal implant components are made of titanium alloy (Ti6Al4V Eli) in accordance with ASTM F136. The screws are color coded for better identification of the different diameters. The screws are double threaded, cannulated, fenestrated and selftapping.

This document pertains to the 510(k) premarket notification for a medical device called the "NEO Pedicle Screw System™." This submission is for a Class II medical device, and as such, it focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving a totally new level of device performance through extensive clinical trials.

Therefore, the information typically sought regarding acceptance criteria and studies proving the device meets those criteria (especially in the context of device performance metrics like accuracy, sensitivity, specificity, or human-AI reader performance improvements) is not present in this type of regulatory submission.

Here's why and what information IS available:

1. Nature of the Device: The NEO Pedicle Screw System™ is an orthopedic implant (pedicle screws and rods) used for spinal fixation. Its primary function is mechanical support. Unlike diagnostic AI software, its performance is not measured by diagnostic accuracy or an effect size on human reader improvement.
2. Regulatory Pathway (510(k)): The 510(k) pathway for Class II devices primarily requires demonstration of "substantial equivalence" to a predicate device already on the market. This is achieved by showing that the new device has:
   • The same intended use as the predicate.
   • The same technological characteristics as the predicate, OR
   • Different technological characteristics, but these do not raise new questions of safety and effectiveness, AND the device is as safe and effective as the predicate.
3. Focus of Testing: The testing detailed in this document is primarily non-clinical and focuses on:
   • Material properties: Biocompatibility (ISO 10993-1), chemical analysis.
   • Mechanical performance: Static and dynamic axial compression, static torsion (in accordance with ASTM F1717), showing comparability to other marketed systems.
   • Sterilization: Validation (ISO 11137-2), pyrogenicity.
   • Packaging: Shelf life (ISO 11607-1), transport studies.
   • MRI Compatibility: Magnetic field interactions, heating, artifacts (ASTM F2052-15, F2182-11a, F2119-07).
   • Usability: WetLab study with orthopedic surgeons.

Therefore, I cannot provide the requested information about acceptance criteria for AI performance, MRMC studies, or specific effect sizes, as this device is a mechanical implant and not an AI/diagnostic software.

However, I can extract the information relevant to the types of studies conducted for this specific device:

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

For this device, the "acceptance criteria" are not based on diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are based on meeting established standards for mechanical performance, biocompatibility, sterility, and durability, demonstrating "comparability" and "substantial equivalence" to predicate devices. The document implies that the device met these standards, as it received 510(k) clearance.

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable in the context of diagnostic AI. For mechanical and biological testing, sample sizes are dictated by the specific ASTM/ISO standards referenced (e.g., number of test specimens for mechanical strength, number of samples for sterility validation), but these specifics are not provided in this summary. Data provenance is implied to be from the manufacturer's own internal testing and external certified labs commissioned by the manufacturer. It is not clinical data (retrospective or prospective) in the sense of patient data.

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

• Not applicable for this type of device. "Ground truth" in the context of AI diagnostic performance relies on expert consensus or biopsy/pathology. Here, the "truth" for mechanical performance is defined by adherence to engineering standards (ASTM, ISO), and human experts (orthopedic surgeons) were involved in a "WetLab study" for usability, but not to establish "ground truth" for a diagnostic test.

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

• Not applicable. This refers to methods for consolidating expert opinions in diagnostic studies, which is not relevant here.

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

• No. An MRMC study is for evaluating human performance with and without AI assistance for diagnostic tasks. This device is a surgical implant, not a diagnostic AI.

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

• Not applicable. This refers to the performance of an AI algorithm alone.

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

• For this device, "ground truth" is established by:
  • Engineering standards and specifications: For mechanical strength (ASTM F1717), sterility (ISO 11137-2), biocompatibility (ISO 10993-1), MRI compatibility (ASTM F2052-15, F2182-11a, F2119-07), and packaging (ISO 11607-1).
  • Functional verification: For the monoaxial mode and overall usability (WetLab confirmation by surgeons).
  • Published scientific literature: Used for clinical evaluation to demonstrate equivalence to predicate devices, as "Clinical studies were not required."

8. The sample size for the training set:

• Not applicable. This term is relevant for machine learning models.

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

• Not applicable. This term is relevant for machine learning models.

In summary, the provided document describes a regulatory submission for a physical medical device (spinal implant) through the 510(k) pathway. The evidence presented focuses on ensuring the device is safe and effective as a mechanical and biological component, rather than as a diagnostic tool or AI algorithm.

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