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The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine. The system is intended to be used with autogenous or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

The Stable-C Interbody System is an anterior cervical interbody device comprised of a cage (lordotic angles of 0 , 6°, and 12°) made from Ti-6Al-4V per ASTM F3001 and two fixation anchors made from Ti-6-Al-4V ELI per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text is a 510(k) premarket notification FDA letter for a medical device called the "Stable-C Interbody System." This document primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices.

It does NOT describe a study involving an AI/Medical Device that uses machine learning, nor does it provide details about acceptance criteria and performance data in the context of an algorithm's accuracy or effectiveness.

The "Performance Data" section in the document refers to mechanical testing of the physical implant device to prove its structural integrity and safety, not the performance of an AI algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, details of a study proving algorithm performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from the provided text because it is not relevant to an AI/ML medical device.

To answer your request, I would need a document describing the validation and performance of an AI/ML-based medical device.

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The VerteFIT™ Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFIT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFIT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

VerteFIT Corpectomy Cages are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include central PEEK cores and titanium-coated PEEK endcaps which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endcaps can be intraoperatively assembled to best fit patient anatomy requirements. Each endcap has a central axial chamber to allow autogenous bone graft or allograft to be packed inside of the spacer. Unidirectional teeth on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. VerteFIT endcaps (superior and inferior) have slots to accommodate VerteBRIDGE anchoring plates.

This document describes the VerteFIT™ Corpectomy Cage System, a vertebral body replacement device. The provided text outlines the device's indications for use and non-clinical performance data, but it does not describe an acceptance criteria table, a study proving device adherence to acceptance criteria, nor does it contain information typically associated with studies of AI/ML devices (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

The information provided pertains to the non-clinical performance data which focuses on mechanical testing to demonstrate substantial equivalence to predicate devices, rather than clinical performance data or AI/ML-specific study details.

Here's a breakdown of the available information based on your request:

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

• Acceptance Criteria: Not explicitly stated in a table format. The document implies compliance with standards and guidance documents, such as "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s., May 3, 2004" and various ASTM standards (F2077, F2267, F2129).
• Reported Device Performance: The document states that "Mechanical testing was conducted... to demonstrate substantial equivalence to the predicate system(s)." Specific numerical performance results or whether these results "met" an explicit acceptance criterion are not detailed in this summary.

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. The document refers to mechanical testing, not clinical studies involving patient data.
• Data Provenance: Not applicable. No patient data or clinical data is mentioned.

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 is a mechanical device, and "ground truth" as typically understood in AI/ML clinical studies is not relevant. Mechanical testing relies on engineering standards and measurements.

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

• Not applicable. No form of adjudication is mentioned as it's not a clinical study involving human interpretation.

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 document pertains to a physical medical device (spinal implant), not an AI/ML diagnostic or assistive device. No MRMC study or human reader performance is mentioned.

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

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

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

• Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering specifications and performance within defined limits of the ASTM standards mentioned.

8. The sample size for the training set

• Not applicable. There is no AI/ML component; therefore, no training set.

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

• Not applicable. There is no AI/ML component; therefore, no training set ground truth.

Summary of Non-Clinical Performance Data (as provided):

• Tests Conducted:
  • Static & dynamic compression (ASTM F2077)
  • Static & dynamic shear compression (ASTM F2077)
  • Static & dynamic torsion (ASTM F2077)
  • Subsidence (ASTM F2267)
  • Cage and anchor expulsion (F-04.25.05.02)
  • Corrosion testing (ASTM F2129)
• Purpose: To demonstrate substantial equivalence to predicate device(s) based on mechanical performance.
• Clinical Performance Data: "Clinical testing was not required to demonstrate substantial equivalence."

This document focuses on the regulatory clearance for a physical medical device through a 510(k) pathway, which typically involves demonstrating substantial equivalence to a legally marketed predicate device, often through non-clinical performance testing and comparison of technical characteristics, rather than extensive clinical efficacy studies or AI/ML performance evaluations.

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The Irix-C Cervical Integrated Fusion System is a stand-alone cervical fusion device intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies).

Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral fusion device.

The Irix-C Cervical Integrated Fusion System is a stand-alone intervertebral fusion device designed to restore biomechanical height and act as an aid in fusion of the cervical spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The Irix-C implant will be manufactured in either a composite construction of titanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580.

The intervertebral fusion device is intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The device is then secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6AI4V) per ASTM F136.

The devices are available in various sizes, and screws are offered in multiple lengths to adjust for variations in patient anatomy. The single-use implants are provided clean and non-sterile. These devices are intended to be sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.

A series of manual surgical instruments, provided clean and non-sterile, intended to assist with the insertion and placement of the implants, is included in an instrument tray, which is used for instrument sterilization and storage.

The system does not contain software/firmware.

This document is a 510(k) premarket notification for a medical device called the "Irix-C Cervical Integrated Fusion System." It is a submission to the FDA seeking clearance to market the device.

Based on the provided text, the device is an intervertebral body fusion device intended for spinal fusion procedures. It is classified as a Class II device with product code OVE.

Crucially, this document states: "No substantial technological changes were made to the existing Irix-C System, nor were any new components added to the Irix-C System. The only change is the expanded Indications for Use. Therefore, no additional testing was required or performed."

This means there is NO EVIDENCE OF A STUDY to prove the device meets acceptance criteria related to its performance for this particular 510(k) submission. Instead, the submission relies on the substantial equivalence principle, arguing that the device is equivalent to previously cleared predicate devices for its expanded indications for use.

Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as no such study is described in this document for the current submission.

However, I can extract the proposed Indications for Use (the acceptance criteria in terms of clinical application) for the device and clarify why no performance study was conducted.

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

As stated above, this 510(k) submission did not involve new performance testing. The "acceptance criteria" for this submission are essentially the expanded "Indications for Use," which are compared to predicate devices for substantial equivalence, rather than being demonstrated through new performance data.

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. No new performance study (test set) was conducted for this 510(k) submission.

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 new performance study requiring expert ground truth establishment was conducted.

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

• Not applicable. No new performance study requiring adjudication was conducted.

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 physical implant, not an AI/software device. The submission explicitly states "The system does not contain software/firmware."

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

• Not applicable. This device is a physical implant, not an AI/software device.

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

• Not applicable. No new performance study requiring ground truth was conducted. The ground for substantial equivalence is based on comparisons of design, materials, and established indications for use of predicate devices.

8. The sample size for the training set

• Not applicable. No new performance study (training set) was conducted as there is no algorithm or AI component.

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

• Not applicable. No new performance study (training set) was conducted.

Summary of the document's approach:

The manufacturer, X-Spine Systems, Inc., submitted a 510(k) for their Irix-C Cervical Integrated Fusion System. The core of this submission is substantial equivalence to existing predicate devices. They are seeking to expand the device's "Indications for Use" to include:

• The use of allograft (in addition to autograft) as bone graft material.
• An expanded anatomical region for use, specifically including level C2 (whereas the previous clearance was for C3-T1 inclusive).

The document explicitly states that no new performance data or testing was required or performed because "No substantial technological changes were made to the existing Irix-C System, nor were any new components added to the Irix-C System. The only change is the expanded Indications for Use."

They argue that the expanded indications are not "unique" and are already covered by other legally marketed devices, thus demonstrating substantial equivalence.

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