Search Results

Ask a specific question about this device

Ask a specific question about this device

The Dakota LP Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Dakota LP Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

The Dakota LP Anterior Cervical Interbody Fusion System includes cervical interbody fusion spacers to provide mechanical support of the cervical spine until fusion of the treated level occurs. The Dakota LP Anterior Cervical Interbody Fusion System implants are offered in a variety of sizes to accommodate patient anatomical needs and are manufactured from Ti-6Al-4V ELI per ASTM F3001 (cages) and Magnolia PEEK per ASTM F2026 with Tantalum per ASTM F560 (cages) with or without commercially pure titanium coating per ASTM F67.

N/A

Ask a specific question about this device

EFFORTMED 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 autograft/autologous bone graft. Patients should have received at least six (6) months of prior non-operative treatment. EFFORTMED CERVICAL PEEK CAGES are to be used with supplemental fixation.

The EFFORTMED LUMBAR PEEK CAGES are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/autologous bone graft to facilitate fusion for each spinal region.

The EFFORTMED ORIZABA CERVICAL CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The EFFORTMED COTOPAXI LUMBAR CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The ORIZABA and COTOPAXI CORPECTOMY CAGES are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

ORIZABA and COTOPAXI CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.

The EffortMed spinal interbody cage system includes cervical intervertebral body fusion (IBFD), transforaminal lumbar interbody fusion (TLIF), and posterior lateral interbody fusion (PLIF) devices. The cervical cage models are the EffortMed Pacaya Cervical PEEK Cage and Masaya Augmented Cervical PEEK cage. The lumbar cage models are the EffortMed TLIF PEEK Cage, Effortmed TLIF PEEK Cage 4° Angled, Effortmed PLIF PEEK Cage, EffortMed PLIF PEEK Cage 5° Angled, and EffortMed Expandable PLIF PEEK Cage. The system was designed to restore height and lordotic angle in the spine. The main role of the cages is to help maintain the cleared disc space stable and intact, until a healthy bony fusion occurs between the adjoining vertebrae. To help achieve this, the inner chamber of the cage body is filled with bone graft before implantation.

The system also includes cervical and corpectomy cages (identified as used in cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to, tumors, fractures, and infections. The corpectomy cage models are the EffortMed Orizaba Cervical Corpectomy cage and EffortMed Cotopaxi Lumbar Corpectomy cage.

N/A

Ask a specific question about this device

BEE HA cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of 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 more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE HA cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

The subject BEE HA cage is an anterior cervical interbody fusion device. BEE HA cage is manufactured from PEEK-OPTIMA™ HA Enhanced. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Additionally, the device contains four (4) titanium alloy (Ti6Al4V per ASTM F136) pins to provide imaging visibility for device positioning.

BEE HA cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form.

BEE HA cage is intended for single use only and is provided sterile, using gamma irradiation.

The purpose of this traditional 510k is to expand the size range offerings for the previously cleared BEE HA.

N/A

Ask a specific question about this device

The Latitude-C AM™ Interbody Spacer is indicated for spinal fusion procedures at one or more levels in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The Latitude-C AM™ Interbody Spacer is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Cyclops™ Anterior Cervical Plate System.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C AM™ Interbody Spacer in the cervical spine.

The DeGen Medical Latitude-C AM™ Cervical Interbody Fusion System is an additively manufactured anterior cervical interbody fusion system for anterior cervical fusion procedures. Latitude-C AM™ cervical spacers are comprised of a single component that is additively manufactured. Latitude-C AM™ spacers are available in the following configurations; lordotic, anatomic, and symmetric. The superior and inferior sides of the endplates of the spacer feature porous surfaces to facilitate fusion and mitigate subsidence and expulsion and feature a central aperture to constrain bone graft. Latitude-C AM™ spacers include various depths, widths, heights, and angles of lordosis. Latitude-C AM™ spacers are additively manufactured from Puri-Ti™ unalloyed titanium.

N/A

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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

Ask a specific question about this device

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.

Ask a specific question about this device