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The FIX-C PEEK ACIF SA System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level 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 stand-alone interbody cages must be used with internal screw fixation. The FIX-C PEEK ACIF SA System is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate 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 non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The FIX-C PEEK ACIF SA System consists of a stand-alone interbody fusion device with internal screw fixation. The FIX-C PEEK ACIF SA System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.

The FIX-C PEEK ACIF SA System is comprised of a PEEK interbody cage and screws. The PEEK interbody cage is made from medical-grade polyetheretherketone (PEEK) which is radiolucent and contains radiopaque titanium clips made from medical-grade titanium alloys. The titanium clip assembled in the PEEK cage includes a Zero-Step Mechanism designed to prevent the screw from disengaging or loosening from the cage. The PEEK materials conform to ASTM F2026, and the titanium alloys materials conform to ASTM F1136.

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

This FDA 510(k) clearance letter is for a medical device (an intervertebral body fusion device), not a software or AI-powered device. Therefore, the information provided does not include the details about acceptance criteria, study design (sample sizes, expert adjudication, MRMC studies, ground truth establishment, etc.) that would be relevant for an AI/software-based medical device.

The clearance letter focuses on establishing substantial equivalence to previously cleared predicate devices based on:

• Indications for Use: The FIX-C PEEK ACIF SA System is indicated for anterior cervical interbody fusion procedures, which is compared to the predicate device's indications.
• Technological Characteristics: The device materials (PEEK, titanium), design features (internal screw fixation, Zero-Step Mechanism), and sterilization methods are described and implicitly compared to predicates.
• Non-Clinical Testing (Bench Tests): This is the primary "study" mentioned. The device underwent mechanical bench tests to ensure its structural integrity and performance are comparable to established standards and the predicate device.

Here's a breakdown of the information that is and is not provided in the context of your request for AI/software device evaluation:

Information Provided in the Document (Relevant to a mechanical device):

1. Acceptance Criteria & Reported Device Performance:

   • Acceptance Criteria: "All test results were higher than the acceptance criteria from the reference literature." (Specific numeric criteria not detailed, but implied to be based on ASTM standards).
   • Reported Device Performance: "All test results were higher than the acceptance criteria... Therefore, substantially equivalent mechanical performance with the predicate device has been demonstrated." (No specific quantitative results are provided in the clearance letter itself, only the conclusion of meeting criteria.)

   Table (As much as can be constructed from the text):

   Acceptance Criteria	Reported Device Performance
   Performance higher than "reference literature" values for ASTM F2077 (Static axial compression, Static compression-shear, Static torsion, Dynamic axial compression, Dynamic compression-shear, Dynamic torsion) and ASTM F2267 (Subsidence)	All test results were reported as "higher than the acceptance criteria."
   Substantial equivalence to predicate device in mechanical performance	Substantial equivalence demonstrated.

2. Sample Sizes and Data Provenance:

   • Not applicable in the AI/software sense. This refers to physical bench testing of device units. The number of units tested is not specified.
   • Data provenance is "bench tests conducted for the subject device" (manufacturer).

3. Experts for Ground Truth, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth:

   • Not applicable: These concepts are entirely relevant to evaluation of diagnostic/AI software performance based on clinical image interpretation or patient data, not for the mechanical performance testing of an interbody fusion device.
   • The "ground truth" for this device's performance would be the physical measurements and results obtained from the bench tests, compared to engineering standards.

4. Training Set Sample Size and Ground Truth Establishment (Training Set):

   • Not applicable: There is no "training set" in the context of a mechanical device. These refer to the data used to train machine learning models.

Summary regarding your specific questions NOT answered by this document (because it's a mechanical device, not AI/software):

• Sample sized used for the test set and the data provenance: Not clinical data, but bench test data. Specific number of samples tested is not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No (not an algorithm).
• The type of ground truth used: Bench test measurements against engineering standards (not expert consensus, pathology, or outcomes data in the clinical sense).
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Conclusion:

This FDA 510(k) clearance letter details the regulatory approval of a physical medical implant based on its compliance with established mechanical safety and performance standards (ASTM F2077, ASTM F2267) and substantial equivalence to existing devices. It does not provide the type of performance metrics, study designs, or data provenance relevant to the validation of an AI/software medical device.

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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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Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

The Peridot-TD Anterior Cervical Intervertebral body fusion 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 Peridot-TD Anterior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)

The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The Peridot-TD Cages are intervertebral fusion device manufactured from poly-ether-ether-ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The Peridot-TD Cages have a 0.5 ~ 1.0micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cages holders are made of titanium alloy as per ASTM F136.

The Peridot-TD Cages intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).

Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) Systems.

Each system features a full breadth of sizes, footprints, heights and angles.

The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screw and rod system, anterior plate and screw system, or lateral plate and screw system).

The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.

The hyperlordotic lumbar cages (>20 degree) should be an anterior plate system as the form of supplement fixation.

The device is supplied with its specific instruments. The device must be used in combination with the dedicated instruments supplied. The specific instruments are supplied dedicated tray and non-sterile.

The provided document is a 510(k) premarket notification for a medical device called the "Peridot-TD Spacer system" and "Anterior cervical interbody fusion - ACIF". This submission is for additional models with added sterilization methods to a previously cleared 510(k) (K230708).

The document does not contain information about software performance, AI assistance, or human reader studies. It focuses on the mechanical performance and substantial equivalence of an intervertebral body fusion device. Therefore, many of the requested criteria cannot be extracted from this document.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted according to ASTM standards for mechanical properties. The "acceptance criteria" are implied by the successful completion of these tests, demonstrating substantial equivalence to the predicate device. Specific numerical "reported device performance" values or explicit criteria are not provided in this summary, only that the "worst-case devices were tested".

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

This document discusses in vitro mechanical testing, not a clinical test set with patient data. Therefore, the concept of data provenance (country of origin, retrospective/prospective) is not applicable in the way it would be for a diagnostic AI device. The sample size for the mechanical tests is not explicitly stated, although it mentions "worst-case devices were tested," implying a representative selection.

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

Not applicable. This document describes mechanical testing of a physical medical device, not a diagnostic device requiring expert review for ground truth.

4. Adjudication method for the test set

Not applicable. This document describes mechanical testing of a physical medical device.

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 is for a physical intervertebral body fusion device and does not involve AI assistance or human readers.

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

Not applicable. This document is for a physical intervertebral body fusion device and does not involve an algorithm.

7. The type of ground truth used

For mechanical testing, the "ground truth" is typically defined by the specified ASTM standards and the expected mechanical properties of the materials and design. Failure criteria for these tests would serve as the ground truth.

For the clinical indications for use, the document states that cervical disc degeneration and/or spinal instability are "confirmed by imaging studies (radiographs, CT, MRI)" and degenerative disc disease by "patient history and radiographic studies." This implies a combination of imaging and clinical assessment as the basis for patient selection for the device.

8. The sample size for the training set

Not applicable. This document is for a physical medical device and does not involve a training set for an algorithm.

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

Not applicable. This document is for a physical medical device and does not involve a training set for an algorithm.

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The GS Medical QUASAR Stand-alone ACIF System is 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. The GS Medical QUASAR Stand-alone ACIF System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. When the GS Medical QUASAR Standalone ACIF System is used with all the titanium alloy screws for which the implant is designed it does not require supplemental fixation. When used with fewer screws the implant should be used in conjunction with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The subject device, the QUASAR Standalone ACIF System cages are designed for restoring the height of the intervertebral space after resection of the disc while also providing biomechanical stability with the addition on an integrated plate. This integrated plate allows for the user to bypass using an additional plate as seen with traditional ACIF spacers. The QUASAR Standalone ACIF System devices consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The supplementary fixation screws are used along with the subject device cage and plate.

The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with Titanium alloy plates (Ti-6Al-4V) and supplementary screws made up of Titanium alloy (Ti-6Al-4V).

The provided text describes a medical device, the "QUASAR Standalone ACIF System," and its clearance by the FDA. However, it does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) clearance letter for an intervertebral body fusion device, which is a physical implant used in spinal surgery, not an AI/ML diagnostic or therapeutic system. The "Performance Data" section (F) describes mechanical testing of the implant (e.g., static and dynamic axial compression, shear, torsion, expulsion, and subsidence testing) against ASTM standards, which are physical engineering standards for device performance, not clinical performance metrics for AI.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the given input because the input describes a non-AI/ML medical device.

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Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

The Peridot-TD Anterior Cervical Intervertebral body fusion 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, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Antervertebral body fusion 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 Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)

The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The Peridot-TD Cages are intervertebral fusion device manufactured from poly-ether-ether-ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The Peridot-TD Cages have a 0.5 ~ 1.0micron thick surface coat of commercially pure (CP) titanium per ASTM F67.

And some cages holders are made of titanium alloy as per ASTM F136.

The Peridot-TD Cages intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).

Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) Systems.

Each system features a full breadth of sizes, footprints, heights and angles.

The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screw and rod system, anterior plate and screw system, or lateral plate and screw system). The implant cages are supplied sterilized.

The hyperlordotic lumbar cages (>20 degree) should be an anterior plate system as the form of supplement fixation.

The device is supplied with its specific instruments. The device must be used in combination with the dedicated instruments supplied. The specific instruments are supplied dedicated tray and non-sterile.

This is a 510(k) premarket notification for a medical device (Peridot-TD Spacer system), not a study demonstrating AI performance. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance metrics is not present in the provided text.

The document describes the device, its intended use, and indicates that performance testing has been conducted according to ASTM standards to demonstrate substantial equivalence to predicate devices. However, it does not provide specific acceptance criteria values or detailed performance data from these tests. It also does not mention any AI component or associated studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert qualifications, or AI-related study outcomes as these are not discussed in the provided regulatory document.

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The GS Medical CYGNUS-C Standalone ACIF System is 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. The GS Medical CYGNUS-C Standalone ACIF System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. The GS Medical CYGNUS-C Standalone ACIF System is to be used with two titanium alloy screws which accompany the implant and does not require supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The CYGNUS-C Standalone ACIF System cages are designed for restoring the height of the intervertebral space after resection of the disc while also providing biomechanical stability with the addition on an integrated plate. This integrated plate allows for the user to bypass using an additional plate as seen with traditional ACIF spacers. The CYGNUS-C Standalone ACIF System devices consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Subject device also contains supplementary fixation screw. The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with a titanium alloy (Ti-6Al-4V) plate and X-ray (radioopaque) markers made of tantalum. The supplementary screws are made up of titanium alloy (Ti-6Al-4V).

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification summary for a medical device (CYGNUS-C Standalone ACIF system), which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a clinical or performance study with detailed acceptance criteria.

Therefore, I cannot provide the requested information. The document primarily discusses:

• Device Description and Intended Use: For cervical spinal fusion.
• Predicate Devices: Used for comparison to establish substantial equivalence.
• Technological Characteristics: Materials and design.
• Performance Data (Mechanical Testing): States that the device underwent testing according to ASTM standards (ASTM 2077, ASTM F2267) and "the results met all acceptance criteria." However, it does not specify what those acceptance criteria were nor the detailed results of the tests.
• Biocompatibility: Based on predicate devices.
• Conclusion: Substantial equivalence.

There is no mention of a human-in-the-loop study, MRMC study, expert ground truth establishment, or training/test set details related to AI/algorithm performance, as the device described is a physical implant, not an AI-powered diagnostic tool.

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The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 weeks of non-operative treatment prior to treatment with Hexanium® ACIF system. This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.

The Hexanium® ACIF is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the device as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® ACIF is available in 2 sagittal profiles (lordotic 6º and convex 6°), heights of 5-12 mm, and 3 footprints (15x12mm, 17x14mm, and 19x15mm). The Hexanium® ACIF screws are self-drilling and available in lengths of 10, 12, 14, and 16mm and diameters of 3.50 and 3.80mm. Hexanium® ACIF is provided sterile. The Hexanium® ACIF system includes a set of reusable surgical instruments. The purpose of this Special 510(k) application is to propose minor modifications to the currently cleared surgical instruments. There are no modifications being proposed for the implantable components of the system

This is not an AI/ML medical device. This is a medical device for intervertebral body fusion. Thus the acceptance criteria for AI devices do not apply here.

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The Medynus IVA (ACIF) PEEK Cage 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 disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system 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 with an intervertebral cage.

The Medynis IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S 1, 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 I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Medynus IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine. All the devices are non-sterile, single use - cages of multiple footprints, heights and lordosis options to fit the anatomical needs of a wide variety of patients and are made from PEEK and Tantalum. They have anti-migration features on the superior and inferior surfaces and can be packed with autograft to facilitate fusion.

The provided text describes a 510(k) premarket notification for a medical device called the Medynus IVA PEEK Cage. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new performance testing or clinical studies.

Therefore, the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not applicable to this submission.

Here's why and what can be extracted from the document:

• No Acceptance Criteria or Performance Study: The document explicitly states: "The subject and predicate devices are identical and therefore, no performance testing is necessary to demonstrate substantial equivalence. Submission is only transferring name of a system that has already been cleared under K162220. No new testing was provided." This means there was no new study performed to generate device performance data against specific acceptance criteria.
• Substantial Equivalence: The foundation of this submission is that the Medynus IVA PEEK Cage is identical to a previously cleared predicate device (DIO Medical IVA PEEK Cage, K162220) in terms of intended use, indications, technological characteristics, and principles of operation. The FDA clears the new device based on the established safety and effectiveness of the predicate device.

Given this, I can fill in the table and explain why the other sections are not applicable:

1. Table of Acceptance Criteria and the Reported Device Performance

Explanation: As stated in the document, "no performance testing is necessary to demonstrate substantial equivalence" because the device is identical to a previously cleared predicate device. Therefore, there are no new acceptance criteria or reported device performance from a new study generated for this 510(k) submission. The safety and effectiveness are based on the predicate device's prior clearance.

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

Not applicable. No new test set or data was used for a performance study. The submission relies on the established performance of the predicate device.

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 test set or ground truth establishment was required for this substantial equivalence submission.

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

Not applicable. No test set was used.

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 an intervertebral body fusion cage, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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 algorithm.

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

Not applicable. No ground truth needed to be established for this submission as it relies on the predicate device's established safety and effectiveness.

8. The sample size for the training set

Not applicable. This device is a physical implant, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

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The K&J IVA (ACIF) PEEK Cage 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 disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system 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 with an intervertebral cage.

The K&J IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who 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 I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The K&J IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage consists of PEEK+Tantalum which is identical to its predicate devices. The design, material composition and manufacturing are same as the predicate.

This document is a 510(k) summary for the K&J IVA PEEK Cage. It asserts substantial equivalence to a previously cleared device (K162220).

Therefore, there is no acceptance criteria or study that proves this specific device meets acceptance criteria presented in this document. The manufacturer explicitly states: "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K162220. No testing is required."

To answer your request, one would need to review the 510(k) submission for the predicate device, DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (K162220), as that is where the original performance data and substantial equivalence arguments would have been presented.

Based on the provided text for K212038:

1. A table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or performance data for this specific device are provided because it is considered identical to a predicate device.
2. Sample size used for the test set and the data provenance: Not applicable. No performance testing was conducted for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance testing was conducted for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance testing was conducted for this device.
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 a medical implant (intervertebral body fusion device), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical implant (intervertebral body fusion device), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No performance testing was conducted for this device.
8. The sample size for the training set: Not applicable. This is a medical implant and not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable. This is a medical implant and not an AI/ML device that requires a training set.

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The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 weeks of non-operative treatment prior to treatment with Hexanium® ACIF system. This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.

The Hexanium® ACIF is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the device as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® ACIF is available in 2 sagittal profiles (lordotic 6° and convex 6°), heights of 5-12 mm, and 3 footprints (15x12mm, 17x14mm, and 19x15mm). The Hexanium® ACIF screws are self-drilling and available in lengths of 10, 12, 14, and 16mm and diameters of 3.50 and 3.80mm. Hexanium® ACIF is provided sterile.

This is a 510(k) premarket notification for a medical device (Hexanium® ACIF, an intervertebral body fusion device) seeking substantial equivalence to a predicate device, not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study design, ground truth, sample sizes for training/test sets, expert adjudication, and MRMC studies is not applicable in this context.

The document states:

• "No clinical data has been presented." This means no human study was performed to assess the performance of the device in patients.
• "The following non-clinical tests were conducted: static and dynamic axial compression, static and dynamic shear compression, static and dynamic torsion testing according to ASTM F2077, subsidence testing according to ASTM F2267, and expulsion testing. Results demonstrate comparable mechanical properties to the predicate device." This indicates the performance data relates to mechanical properties tested in a lab setting, not clinical performance or AI/ML algorithm performance.

The acceptance criteria for this device would be based on these mechanical tests demonstrating equivalence to the predicate device, generally through meeting established ASTM standards. The "performance data" section states that the device demonstrated "comparable mechanical properties to the predicate device," which implies it met the acceptance criteria for these physical tests.

Since this is a traditional medical device submission and not an AI/ML device, the detailed requirements for AI/ML performance studies (like MRMC, standalone performance, ground truth establishment, expert qualifications, etc.) are not relevant here.

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