Search Results

IVA-C (ACIF):
The IVA-C Cage System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

AEON-C (ACIF):
The AEON-C Cage System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C Cage System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.

IVA-L (ALIF, PLIF, DLIF, TLIF) & AEON-L (ALIF):
The IVA-L Cage System and AEON-L Cage System are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AEON-L Cage System is designed for use with or without the bone screws, depending on the surgeon's discretion. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The IVA & AEON Cervical and Lumbar Cage System are cervical and lumbar intervertebral fusion cages that are implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The cages are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method). The cages are manufactured from titanium alloy powder per ASTM F3001 or titanium alloy per ASTM F136 or PEEK per ASTM F2026. The screws are manufactured from titanium alloy per ASTM F136. They are provided non-sterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.

This FDA 510(k) Clearance Letter is for the IVA & AEON Cervical and Lumbar Cage System, which are intervertebral body fusion devices. It is a Class II device.

Crucially, this document focuses on the substantial equivalence of a physical medical device (intervertebral cages) based on engineering performance tests, materials, and design features, not on the performance of an AI/ML software.

Therefore, most of the requested information regarding AI/ML device performance (acceptance criteria table, study details, human reader improvement, ground truth, training set, etc.) is not applicable to this specific submission.

The document states:

• "Summary of Performance Data (Nonclinical and/or Clinical):" and then lists "Non-Clinical Tests" such as Static/Dynamic Compression Bending, Static/Dynamic Compression Shear Bending, Static/Dynamic Torsion, and Subsidence, all referencing ASTM standards.
• "Clinical Tests: - N/A"

This means that the device was cleared based on non-clinical (laboratory/mechanical) testing, not on clinical performance studies involving patient data or AI/ML algorithm evaluation.

To answer your specific questions in the context of this document:

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

   • Not Applicable (N/A) for AI/ML performance.
   • For the physical device, the acceptance criteria would be defined by the referenced ASTM standards (e.g., ASTM F2077, ASTM F2267) for specific mechanical properties (e.g., strength, durability, resistance to subsidence). The document states that the "Results of the non-clinical tests indicate that the device will perform within the intended uses," implying these criteria were met, but specific numerical performance data is not provided in this public summary.

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

   • N/A for AI/ML performance.
   • For the mechanical tests, the "sample size" would refer to the number of physical devices tested to ASTM standards. This information is not provided in this summary. Data provenance is also N/A as it's not patient data.

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

   • N/A. Ground truth establishment by experts is relevant for diagnostic or AI/ML interpretation performance, not for the mechanical testing of a physical implant.

4. Adjudication method:

   • N/A. Adjudication is relevant for expert consensus in AI/ML or clinical studies.

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:

   • N/A. This is a physical implant, not an AI-assisted diagnostic tool.

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

   • N/A. This is not an algorithm.

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

   • N/A for AI/ML. For the device, the "ground truth" would be established mechanical properties as defined by the ASTM standards (e.g., material properties, structural integrity under load).

8. The sample size for the training set:

   • N/A. There is no training set as no AI/ML algorithm is involved.

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

   • N/A. There is no training set.

In summary, the provided FDA 510(k) clearance letter pertains to a surgical implant, not an AI/ML software. Therefore, the questions related to AI/ML device performance and associated studies are not applicable to this document. The clearance is based on the substantial equivalence to predicate devices and adherence to mechanical performance standards, as indicated by the non-clinical tests section.

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The IdentiTi™ II Cervical Interbody System is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi II Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The IdentiTi II Cervical Interbody System is a cervical intervertebral body fusion system designed to be inserted through an anterior surgical approach. The interbody implants are additively manufactured from titanium powder per ASTM F3001 using a powder bed fusion method. The IdentiTi II Cervical Interbody System includes the following subsystems: IdentiTi II Cervical and IdentiTi II Cervical Max Contact. The endplates of the interbody implants contain roughened surface features to mitigate the risk of expulsion. Additionally, the IdentiTi II Cervical implants are offered with a microporous/macroporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The internal lattice structure provides additional space for graft packing.

The provided FDA 510(k) clearance letter and summary concern the IdentiTi II Cervical Interbody System, which is a medical device for spinal fusion. This document does not describe an AI/ML-based medical device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as typically required for AI/ML device clearances.

The performance data section (VII. PERFORMANCE DATA) specifically lists non-clinical testing for mechanical properties, material properties, and biocompatibility, as is standard for intervertebral body fusion devices. These tests include:

• ASTM F2077 static and dynamic axial compression, compression shear and torsion
• ASTM F2267 static subsidence
• ASTM F1714 gravimetric analysis
• ASTM F1877 particle analysis
• Static push-out
• ASTM F1854 stereological analysis
• Bacterial endotoxin testing per ANSI/AAMI ST72

Since the request is to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria" as if it were an AI/ML device, and the provided text explicitly indicates it is a non-AI/ML medical device, I cannot fulfill the request directly with the given input. The information points to a traditional medical device clearance, not an AI/ML one.

To answer your question based on the provided document, I must state that the information requested (acceptance criteria for AI/ML performance, study details for AI/ML, human expert consensus, etc.) is not present because the device described is a physical intervertebral body fusion system, not an AI/ML algorithm.

The document confirms that this device is a Class II medical device (Product Code ODP: Intervertebral Body Fusion Device), and its clearance is based on substantial equivalence to predicate devices through engineering and material testing, not through AI/ML performance evaluation.

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The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - Hyper C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scollosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies at up to two contiguous levels from C2 - T1.

The EVOL® ha – Hyper C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The EVOL® ha – Hyper C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and lordotic and lordotic ande. All sizes have a central window for bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.

The provided FDA 510(k) Clearance Letter for the EVOL® ha - Hyper C Cervical Interbody Fusion System does not contain details about acceptance criteria or specific studies proving device performance against such criteria in the way you've described (e.g., related to AI/ML device performance metrics like sensitivity, specificity, MRMC studies, or ground truth establishment).

This document is a marketing clearance for a traditional medical device (an intervertebral body fusion system, which is a physical implant) and not a software-as-a-medical-device (SaMD) or an AI/ML powered device. The "acceptance criteria" and "studies" you're asking about are typically associated with the rigorous validation of diagnostic accuracy or clinical utility for AI/ML systems.

Instead, for this physical medical device, "acceptance criteria" would primarily relate to its mechanical and material performance to ensure it is substantially equivalent to a predicate device and safe/effective for its intended use. The "studies" mentioned are non-clinical (benchtop) tests to demonstrate this.

Here’s a breakdown based on the information provided, adapted to the context of a physical implant:

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

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

• Sample Size: Not specified in the document. For benchtop mechanical testing (like ASTM F2077 and expulsion testing), sample sizes are typically determined by the specific ASTM standard or internal quality protocols to achieve statistical significance for engineering parameters, but they are generally small (e.g., 5-10 devices per test condition depending on variability).
• Data Provenance: The tests are non-clinical, meaning they are laboratory/benchtop studies. There is no patient data involved (retrospective or prospective) for this type of device validation.

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. For a physical interbody fusion device, "ground truth" in the diagnostic AI sense does not apply. The "ground truth" for mechanical testing is established by the engineering specifications and performance standards defined in ASTM or similar bodies. Expert interpretation might be involved in initial design and test protocol development (e.g., biomechanical engineers), but not in establishing a diagnostic "ground truth" for a test set.

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

• Not Applicable. Adjudication methods are used to establish a consensus "ground truth" for diagnostic labels in medical imaging or pathology, often in the context of human reader studies for AI/ML devices. This is not relevant for the mechanical testing of a physical implant.

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 type of study (MRMC for AI assistance) is not applicable to a physical intervertebral body fusion system.

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

• No. This is

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The FIX-C 3D Ti ACIF System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1.

The FIX-C 3D Ti ACIF System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The FIX-C 3D Ti ACIF System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The FIX-C 3D Ti ACIF System comprises of 3D-printed porous titanium spinal cages intended to stabilize the spinal segment, restore intervertebral height, and facilitate interbody fusion in the cervical. The spinal cages are used in the anterior cervical interbody fusion (ACIF) procedures. The devices are intended to be used with supplemental spinal fixation (e.g., using anterior plate system).

The spinal cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures. The hollow geometry of the spinal cages allows them to be packed with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft.

The FIX-C 3D Ti ACF System is manufactured in a pre-designated standard size, not patient-matched. The spinal cages are available in various sizes, footprints, heights, and angles.

The FIX-C 3D Ti ACIF System is provided non-sterile. The devices must be sterilized prior to use per ISO 17665-1.

This document is an FDA 510(k) clearance letter for a medical device called the "FIX-C 3D Ti ACIF System," an intervertebral body fusion device. The request asks for details about the acceptance criteria and the study that proves the device meets them. However, the provided text primarily describes the regulatory clearance process and device characteristics, and does not contain detailed information about specific performance acceptance criteria or a clinical study that proves the device meets those criteria.

Instead, it refers to bench testing as the primary method for demonstrating equivalence.

Here's what can be extracted and what information is missing:

Information Present in the Document:

• Device Name: FIX-C 3D Ti ACIF System
• Device Type: 3D-printed porous titanium spinal cages for anterior cervical interbody fusion (ACIF).
• Regulation Number: 21 CFR 888.3080 (Intervertebral Body Fusion Device)
• Regulatory Class: Class II
• Product Code: ODP
• Intended Use/Indications for Use: For anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, confirmed by imaging, resulting in radiculopathy, myelopathy, and/or pain at C2-T1 levels. To be used with supplemental fixation systems cleared for cervical spine, autogenous and/or allogeneic bone graft. Patients should have had at least six weeks of nonoperative treatment.
• Predicate Devices: K233839 (Peridot-PT Anterior Cervical Intervertebral body fusion System), K241738 (PYXIS 3D Titanium Cervical Cage System), K212266 (FIX-C PEEK Anterior Cervical Interbody System).
• Main Study Type: Bench tests, not clinical data.
• Standards Followed for Bench Tests:
  • ASTM F2077, Standard Test Methods for Intervertebral Body Fusion Devices (Static axial compression, Static compression-shear, Static torsion, Dynamic axial compression, Dynamic compression-shear, Dynamic torsion tests)
  • ASTM F2267, Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression (Subsidence test)
• Conclusion of Bench Tests: "All test results were higher than the acceptance criteria from the [text cut off] therefore, substantially equivalent mechanical performance with the predicate device has been demonstrated."

Missing Information (and why it's missing from this FDA letter):

The FDA 510(k) summary letter is an official decision document, not the detailed study report. It summarizes the basis for clearance, including the types of tests performed and the ultimate conclusion of substantial equivalence. It generally does not include the granular details of study protocols, raw data, or specific acceptance criteria values in the public summary.

Therefore, for the specific questions asked, most of the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Acceptance Criteria: Not specified. The text only states "All test results were higher than the acceptance criteria". It doesn't list the numerical values of these criteria.
• Reported Device Performance: Not specified. The exact numerical results of the ASTM F2077 and ASTM F2267 tests are not provided. It only concludes that they met and exceeded the (unspecified) criteria.

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

• Sample Size for Test Set: Not specified. While bench tests were conducted, the number of devices or iterations tested is not mentioned.
• Data Provenance: The tests were "Bench tests" which means they are laboratory-based, not patient-derived. Therefore, there's no country of origin or retrospective/prospective distinction for the "data" in the clinical sense.

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

• Not Applicable. This device clearance is based on bench testing for mechanical performance and substantial equivalence to legally marketed predicate devices, not on a clinical ground truth established by experts.

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

• Not Applicable. This is relevant for clinical studies, especially those involving human interpretation of data, not for mechanical bench testing.

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 MRMC study was done. The document explicitly states "Clinical data is not applicable." This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool.

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

• Not Applicable. This device is an implant, not an algorithm.

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

• For the bench testing, the "ground truth" is established by the specified ASTM standards and the mechanical properties they measure (e.g., load-bearing capacity, subsidence). It's a mechanical performance "ground truth" based on established engineering standards, not clinical ground truth.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As there is no training set.

In summary, the provided FDA clearance letter focuses on establishing substantial equivalence for a physical medical device through engineering bench tests, rather than a clinical study with human readers or AI algorithms. Therefore, most of the requested information regarding clinical study methodologies, expert ground truth, and AI-specific details is not contained within this document. To obtain such granular detail on acceptance criteria and performance data, one would typically need to review the full 510(k) submission, which is generally proprietary.

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Xenco Medical CancelleX Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).

Xenco Medical CancelleX Cervical Interbody System devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. Spacers are manufactured from Titanium Alloy (TI-6AL-4V per ASTM F3001-14). The system also includes instruments manufactured using 6061 T6 Aluminum Alloy (per ASTM B211 / B221) and Stainless Steel (per ASTM F899). All system implants and instruments are provided sterile packaged and are intended for single use.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the Xenco Medical CancelleX Cervical Interbody System. It is not a study report for an AI/ML medical device.

Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device is not present in this document.

The document focuses on demonstrating substantial equivalence of a physical medical device (an intervertebral body fusion device) to existing predicate devices. It discusses:

• Device Description: Generally box-shaped with surface teeth, a central channel for autogenous bone, available in various shapes and sizes, manufactured from Titanium Alloy.
• Indications for Use: Spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease, implanted via an open, anterior approach, packed with autogenous bone, used with supplemental fixation.
• Technological Comparison: Similar design and sizing to predicates, but 3D printed from titanium with porous latticed areas, similar to an additional predicate.
• Non-Clinical Test Summary & Conclusions: Benchtop mechanical testing was performed according to ASTM standards (F2077 for static/dynamic axial compression, compression shear, and torsion; F2267 for subsidence), and expulsion testing per lab protocol. The conclusion states that the subject device has at least equivalent mechanical strength as the predicates.
• Clinical Testing: The document explicitly states, "Clinical testing was not applicable for this submission."

Since this document pertains to a physical implantable device and not an AI/ML software device, none of the specific questions regarding AI/ML device performance, acceptance criteria, or study methodologies can be answered from the provided text.

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The aprevo® Cervical ACDF Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kvphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF Interbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20 lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation.

The aprevo® Cervical ACDF-X Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X Interbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal anqulation or any use of hyperlordotic correction (>20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.

The aprevo® Cervical ACDF System, which includes the aprevo® Cervical ACDF Interbody, aprevo® Cervical ACDF-X Interbody, and the aprevo® Cervical ACDF-X (no cam) Interbody are designed to stabilize the cervical spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient-specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture for the packing of bone graft.

The aprevo® Cervical ACDF System interbodies are additively manufactured from Ti-6AI-4V ELI titanium alloy per F3001, while the screw are machined from Ti alloy per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and the instrument are provided to the end-user as single use, sterile-packed products.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device conformance. The text is a 510(k) summary for a medical device (aprevo® Cervical ACDF System) and primarily focuses on establishing substantial equivalence to predicate devices, rather than outlining specific acceptance criteria or an in-depth study with the requested details.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

1. Table of acceptance criteria and reported device performance: The document states that "All testing demonstrated substantial equivalence between the subject and predicate devices," but it does not specify what those acceptance criteria were (e.g., specific thresholds for static compression in N, or dynamic compression cycles) nor does it provide the reported performance values against those criteria. It only lists the types of tests performed (e.g., Static and Dynamic axial compression per ASTM F2077).

2. Sample sizes for test set and data provenance: This information is not present in the document.

3. Number of experts and qualifications for ground truth: This information is not present in the document. The testing described is bench testing, not clinical studies involving expert assessment of patient data.

4. Adjudication method for the test set: Not applicable as there's no mention of human-reviewed test sets for AI/software.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. The device described appears to be an implantable interbody fusion device, not an AI or imaging diagnostic software. Therefore, there would not be a study with human readers improving with AI assistance.

6. Standalone performance (algorithm only): Not applicable, as this is a physical medical device.

7. Type of ground truth used: For the bench testing, the "ground truth" would be the predetermined mechanical standards (e.g., ASTM standards) and measurements, not expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning model.

9. How ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document is a regulatory submission for a physical medical device and discusses bench testing to demonstrate substantial equivalence, not a study of an AI/software device with the characteristics you've requested.

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The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by clinical image (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine a lordotic angulation >10° are required to be used with an anterior cervical plate as the form of supplemental fixation.

The ZSFab Lumbar Interbody System is intended for lumbar interbody fusion. The devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The ZSFab Lumbar Interbody System is indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRL). Additionally, the ZSFab Lumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ZSFab lumbar Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the lumbosacral spine.

The ZSFab Cervical Interbody System includes additively manufactured interbody fusion devices for cervical implantation. The implants are designed with lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with minor axis length of 500-920μm and major axis length of 810-1390μm. The ZSFab Lumbar Interbody System includes additively manufactured interbody fusion devices for lumbar implants are designed as a solid frame that includes lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with axis lengths of 610-1000m. The endplates are featured with teeth design and stochastic lattice structures with average pore size of 620-710m. Each cervical and lumbar interbody has a bone graft window that can be packed with bone graft material. The implants are available in a variety of height, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.

This document is a 510(k) premarket notification from the FDA, approving the ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against novel acceptance criteria through a clinical validation study of an AI/software device.

Therefore, the requested information regarding acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies is not present in this document. This submission does not describe a study that validates a device's performance against defined clinical metrics or uses an AI algorithm.

The "Performance Testing" section refers to mechanical testing (e.g., static and dynamic axial compression, torsion, subsidence, expulsion) to show the physical properties of the manufactured devices are equivalent to the predicate devices. This is a common requirement for implantable medical devices to demonstrate that manufacturing changes (like a new location) do not alter the established mechanical performance of the product.

In summary, this document does not contain the information required to answer your questions about acceptance criteria, study design, and performance data for an AI/software-based medical device.

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The Gemini Cervical Fusion Cage System is indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one levels from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Gemini Cervical Fusion Cage System requires additional supplemental fixation cleared for the cervical spine. The Gemini Cervical Fusion Cage System is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment.

The Gemini Cervical Fusion Cage Systeme is an anterior cervical interbody device consisting of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is to be implanted via an open, anterior approach.

The Gemini Cervical Fusion Cage System is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The radiolucent PEEK-OPTIMA®material allows visualization of the defect site on radiography to assess bone growth and incorporates tantalum markers conforming to ISO13782 to permit verification of position. The Gemini Cervical Fusion Cage System is provided sterile via gamma irradiation for single use.Instruments are provided clean and non-sterile for steam sterilization at the user's facility.

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves a device meets acceptance criteria related to AI/ML or diagnostic performance.

The document is an FDA 510(k) clearance letter for a medical device called the "Gemini Cervical Fusion Cage System," which is an intervertebral body fusion device. The clearance is based on the substantial equivalence to a predicate device, focusing on:

• Mechanical performance: Verified through testing per ASTM F2077 and ASTM F2267, including static and dynamic axial compression, compression shear, torsional testing, and subsidence testing. The document states that "Test results meet the acceptance criteria described in ISO 23089-2 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices."
• Material: PEEK-OPTIMA® LT1 with tantalum markers, which is a common material for such implants.
• Design features: Graft windows, serrations, and comparable dimensions to the predicate.
• Sterilization: Gamma irradiation for single use.
• Intended Use and Indications for Use: Defined for anterior cervical interbody fusion procedures for cervical disc disease.

There is no mention of an AI/ML component, diagnostic performance, human readers, ground truth establishment, or any of the other criteria you listed that would be relevant to an AI/ML-driven device evaluation (e.g., MRMC studies, sample sizes for test/training sets, expert qualifications for ground truth).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the information provided.

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The GS Medical PYXIS 3D Titanium Cervical Cages indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. GS Medical PYXIS 3D Titanium Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical PYXIS 3D Titanium Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc. The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868). The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.

This FDA document is a 510(k) premarket notification for a medical device called the PYXIS 3D Titanium Cervical Cage System. It describes the device and claims substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets such criteria in the context of an AI/ML powered device, or any kind of AI/ML component at all.

The "PERFORMANCE DATA" section (page 5) simply states that "The worst-case cage of the PYXIS 3D Titanium Cage System underwent testing according to ASTM 2077, specifically static and dynamic axial compression testing, static and dynamic compression shear testing, static and dynamic Torsion testing; expulsion testing, and subsidence testing according to ASTM F2267." These are standard mechanical and structural tests for intervertebral body fusion devices, not performance metrics related to an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study details for an AI/ML device based on the provided text. The device in question is a purely mechanical implant.

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ARTFX MEDICAL Cervical PEEK Cages are made to be implanted into the appropriate vertebral section to help provide stability for spinal fusion after a diseased cervical disc producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of nonoperative treatment.

Cervical PEEK Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

Cervical PEEK Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autogenous bone. ARTFX MEDICAL Cervical PEEK Cages are to be used with supplemental fixation.

"Cervical Peek Cage" refers to a type of intervertebral cage used in spine surgery in the cervical (neck) region. ARTFX Cervical Cages cervical intervertebral devices made from PEEK Optima (per ASTM F2026) are created to be implanted into appropriate vertebral sections to help provide stability for spinal fusion after a diseased cervical disc-producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of non-operative treatment. Cervical peek cages are often used in spinal fusion surqeries.

Fusion surgeries are designed to fuse two vertebrae.

The single-use implant devices feature an open cavity in the interior geometry to accommodate autogenous bone graft and maximize bone growth, with anti-migration teeth to engage the vertebral end plates and prevent expulsion.

The ARTFX Cervical Cages are supplied sterile, single-use, and are fabricated from PEEK that conforms to ASTM F2026 for cages, and with markers and pins that are titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

ARTFX En Vivo Spinal Cervical Peek Cage has a peek cage body.

Components of the ARTFX En Vivo Spinal cage have two pins, which assist in the positive anchorage of the implant between the superior and inferior vertebral bodies, and three radiographic markers.

ARTFX Simplex Spinal XI Cervical Locking Peek Cage has a peek cage body. Components of ARTFX Simplex Spinal XI Cervical Locking Peek Cage has two titanium screws which the system is attached to the cervical spine and a titanium locking screw.

Cervical cages consist of 3 models: En Vivo Anatomical Surface, En Vivo Straight Structure, and Simplex.

This document (K240893) is a 510(k) premarket notification for a medical device called ARTFX MEDICAL Cervical PEEK Cages. It focuses on demonstrating that the new device is substantially equivalent to existing, legally marketed predicate devices.

Crucially, this document describes a physical medical implant (intervertebral cage) and its mechanical properties, not a software-based medical device that relies on algorithms for diagnostic or prognostic purposes. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of algorithms (e.g., sensitivity, specificity, human reader performance with/without AI assistance, ground truth establishment) are not applicable to this submission.

The "study" mentioned in the document refers to non-clinical mechanical testing to ensure the physical properties of the implant are comparable to the predicates, not a clinical study involving data analysis from patients or images.

Here's how the provided information relates to your questions, highlighting why most are not applicable for this type of device:

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

• Not Applicable in the traditional sense for an AI/algorithm-driven device.
• The "acceptance criteria" here relate to mechanical performance standards (e.g., load-bearing capacity, fatigue resistance) as defined by ASTM standards. The document states:
  • "Non-clinical testing including subsidence per ASTM F2267 and static and dynamic axial compression, compression-shear, and torsion per ASTM F2077 was conducted."
  • "The results showed that the performance of the proposed devices is substantially equivalent."
• A table would typically show specific force values or deformation limits from these ASTM standards, and the corresponding measured values for the ARTFX MEDICAL Cervical PEEK Cages, demonstrating they fall within the acceptable range or perform comparably to the predicate. This specific data table is not included in the provided FDA letter/summary, but the statement confirms the testing was done and met the criteria for substantial equivalence.

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 refers to mechanical testing of physical implants, not data samples for an algorithm. The "sample size" would refer to the number of physical cages tested in the lab. Data provenance is irrelevant for mechanical testing.

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 AI/algorithms, refers to the definitive correct answer for a diagnosis or measurement derived from expert consensus, pathology, or clinical outcome. For a physical implant, "ground truth" relates to the physical properties meeting engineering specifications, which is verified through standardized mechanical tests, not expert interpretation of data.

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

• Not Applicable. Adjudication is used for conflicting expert interpretations in clinical data for algorithms. Mechanical testing results are objective measurements from instruments.

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 specific to AI-assisted diagnostic devices. This submission concerns a physical implant.

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

• Not Applicable. This is specific to AI/algorithms. No algorithm is being submitted here.

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

• Not Applicable. As explained in point 3, ground truth for this device is established by adherence to engineering standards and mechanical test results (e.g., ASTM F2267, ASTM F2077), not by clinical expert consensus or pathology data.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. No training set exists for this type of device.

In summary, the provided document is a 510(k) clearance letter for a physical medical implant, not a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. Therefore, the questions posed, which are tailored for AI/algorithm-based medical devices, are largely not relevant to the information contained in this specific FDA submission. The "proof" of meeting acceptance criteria for this device rests on successful non-clinical mechanical testing that demonstrated substantial equivalence to predicate devices in terms of material properties, design, and function.

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