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The Kodiak Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the Kodiak Lumbar Spacer System. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the Kodiak Lumbar Spacer System.

The Kodiak Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.

The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6A1-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.

The provided text describes the 510(k) premarket notification for the "Kodiak Lumbar Spacer System," an intervertebral body fusion device. This document is a regulatory submission for a medical device that does not involve Artificial Intelligence (AI).

The requested information pertains to studies proving device performance with AI, such as acceptance criteria for AI model performance, sample sizes for AI training and test sets, expert adjudication methods for AI ground truth, and AI-assisted reader studies. Since the Kodiak Lumbar Spacer System is a physical implant and not an AI-powered diagnostic or therapeutic tool, this document does not contain any of the information requested about AI device performance studies.

The "Performance Data" section lists several types of mechanical tests performed on the device in accordance with ASTM standards (e.g., Static Compression, Dynamic Compression, Subsidence, Expulsion). These tests are standard for orthopedic implants to demonstrate their structural integrity and function, but they are not related to AI performance.

Therefore, I cannot provide the requested information because the provided document does not discuss an AI device or its performance studies.

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The F3D Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment.

The F3D Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The CoreLink F3D Cervical Stand-Alone Interbody Fusion System is a collection of additively and subtractively manufactured implants and associated instruments for surgical site preparation and implantation. The subject cages are additively manufactured from Ti-6Al-4V per ASTM F3001. The subject screws are machined from Ti-6Al-4V per ASTM F136. The F3D Cervical Stand-Alone Interbody Fusion System includes additively manufactured interbody spacers. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a trapezoidal column to provide surgical stabilization of the spine. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft.

The acceptance criteria and study proving the device meets these criteria can be inferred from the provided FDA 510(k) summary for the F3D Cervical Stand-Alone Interbody Fusion System.

It's important to note that this document is a 510(k) summary for a medical device (interbody fusion system), not an AI/ML software device. Therefore, the questions related to AI/ML specific performance metrics (like human reader improvement with AI, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, etc.) are not applicable to this submission. The "device" in question here is a physical implant, and its performance is assessed via mechanical testing, not clinical imaging or diagnostic accuracy.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" and "reported device performance" are based on a series of non-clinical mechanical tests, demonstrating structural integrity and functional suitability. The specific quantitative acceptance criteria (e.g., minimum load bearing capacity, maximum displacement) are not explicitly stated with numerical values in this summary. Instead, the document states that the testing shows the device is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: This refers to the number of physical devices or components tested. The summary does not specify the sample size (number of units tested) for the mechanical tests.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. For a physical device, the "data" comes from engineering testing conducted under controlled laboratory conditions, likely at a testing facility. The document implicitly indicates this by listing "Empirical Testing Corp." as the contact for the submitter.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. Ground truth in this context is established by engineering standards (ASTM standards) and physical measurements from mechanical testing, not by expert human interpretation of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" in the sense of reconciling multiple human interpretations for ground truth. Testing follows defined ASTM protocols.

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 not an AI/ML software device.

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

Not applicable. This is not an AI/ML software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is derived from:

• Established ASTM (American Society for Testing and Materials) standards: F2077 (for static/dynamic axial compression, compression-shear, torsion), F2267 (for subsidence). These are widely accepted engineering standards for testing spinal implant devices.
• Physical measurements and material properties: Conformance to material standards (ASTM F3001, ISO 5832-3, ASTM F136 for Ti-6Al-4V).
• Benchmarking against predicate devices: Performance is compared to "legally marketed predicate devices" to demonstrate substantial equivalence, implying that the predicates' performance serves as a comparative "truth" for acceptable safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device using a training set. The device is designed and manufactured based on engineering principles and materials science, then tested.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no AI/ML training set for this physical implant.

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The Innovasis AXTiTM Titanium Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The AXTi™ Titanium Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AXTi implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

The Innovasis AXTi™ Titanium Stand-Alone ALIF System features a sterile packaged single use implant and associated reusable instrumentation for preparation of the surgical site and implantation of the device provided. The instruments and fixation screws are provided in storage trays for organization and steam sterilization.

The AXTi Titanium Stand Alone ALIF features all titanium (6Al 4V ELI) implant body and bone screws for fixation. The implant is a stand-alone anterior intervertebral body fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The implant body is provided sterile.

The interior of the device will be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

The device is intended to support restoration of the sagittal balance.

It is intended to be used with all three internal fixation bone screws and will not require additional supplementary fixation for implants with a lordotic angle less than 20°.

Implants with a lordotic angle ≥20° are indicated for use with supplementary fixation, such as the Excella® Spinal System.

It is intended for use with the standard anterior (ALIF) approach

The provided text describes a 510(k) premarket notification for a medical device, the AXTi™ Titanium Stand-Alone ALIF System, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding the acceptance criteria or a study that proves a device meets AI/Machine Learning performance acceptance criteria.

The "Performance Data" section explicitly states "(Non-clinical)-Performance testing per ASTM F2077-14 and F2267-04 for Static Axial Compression. Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear, Subsidence and Expulsion testing indicates that the AXTi Titanium Stand-Alone ALIF is substantially equivalent to the predicates." This refers to mechanical and physical performance testing of the intervertebral fusion device itself, not the performance of an AI or Machine Learning algorithm.

Therefore, I cannot populate the requested table or answer the questions related to AI/Machine Learning performance, ground truth, expert review, or MRMC studies based on the provided input. The document describes a physical medical device, not an AI-powered one.

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The CoreLink® M3™ Stand-Alone Anterior Lumbar System is a standalone interbody fusion system indicated for use 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 radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The device may be used with supplemental fixation.

Hyperlordotic implants (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non- operative treatment prior to treatment with the devices.

The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, then additional supplemental fixation in the lumbar spine must be used to augment fixation.

The CoreLink® M3™ Stand-Alone Anterior Lumbar System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The CoreLink® M3TM Stand-Alone Anterior Lumbar System consists of an interbody cage, locking plate, and three (3) bone screws. System components are manufactured from either titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3 or additively manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F3001. The 8°, 15°, and 20° lordotic cages may be used as a standalone system. The M3 Stand-Alone Anterior Lumbar System M3 Stand-Alone Anterior Lumbar System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

This document is a 510(k) Premarket Notification from the FDA regarding the CoreLink® M3™ Stand-Alone Anterior Lumbar System. It does not describe an AI/ML medical device and therefore does not contain information typically associated with acceptance criteria and study designs for such devices (e.g., performance metrics like sensitivity/specificity, ground truth establishment by experts, or MRMC studies).

The "performance data" section refers to non-clinical mechanical testing of the interbody fusion device, not performance related to algorithms or human reader improvement.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about AI/ML device performance, acceptance criteria, or related study details.

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