Search Results

TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. TRYPTIK®Ti cages is used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. TRYPTIK®Ti cages is to be used 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 prior to treatment with an intervertebral cage.

The Tryptik® Ti is an anterior cervical interbody fusion device intended to provide mechanical support to the cervical spine and maintain adequate disc space until fusion occurs. The interbody device is a box-shaped spacer with a large central cavity that can receive bone graft intended to promote intervertebral fusion. The Tryptik® Ti spacers are all made from medical grade titanium alloy and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished. The Tryptik® Ti interbody spacer has a monolithic design that incorporates solid and porous structures along with superior and inferior rough surfaces intended to increase implant stability into the intervertebral space and bony integration throughout the implant. The Tryptik® Ti spacers are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile). Bacterial endotoxin testing on final, finished devices as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

This information is not contained in the provided document. The document is a 510(k) summary for a medical device (TRYPTIK®Ti Anterior Cervical Intervertebral Fusion Devices) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing of mechanical properties. It does not describe a study involving patient data, expert review, or AI performance.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (in terms of clinical outcomes or AI metrics).
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or AI improvement effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (pathology, outcomes data, etc.) for a clinical study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document only states that "Results demonstrate comparable mechanical properties to the identified predicate devices" based on non-clinical tests (Static and Dynamic Axial Compression, Static and Dynamic Shear-compression, Static and Dynamic Torsion according to ASTM F2077-18 and Subsidence according to ASTM F2267-04). It also mentions "Additionally, cadaver lab implantation trials were conducted." However, no specific performance metrics or acceptance criteria for these tests are provided in the summary.

Ask a specific question about this device

4CIS® Marlin PEEK ACIF Cage is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy in advance. The 4CIS® Marlin PEEK ACIF Cage is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.

4CIS® Marlin PEEK ACIF Cage is single component devices used to restore height of disc space by anterior approach and to facilitate cervical interbody fusion with maintaining physiological lordotic angulation of cervical spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device has three tantalum markers for ease of visualization on radiographs. The vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows bone graft material to be filled. The implant has safety proven structure and material (Poly-ether-ether-ketone, ASTM F2026) to promote biological synostosis and assures mechanical safety against load.

This FDA 510(k) summary describes a medical device, the 4CIS® Marlin PEEK ACIF Cage, which is an intervertebral body fusion device. The provided text is a regulatory filing for this device and does not contain information about software or AI performance metrics. Therefore, it is not possible to answer your questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these pertain to the evaluation of AI/software device performance, which is not discussed in this document.

The document focuses on demonstrating substantial equivalence of the physical implant device to predicate devices through mechanical testing and comparison of characteristics.

Here's a breakdown of the information that is present and why your specific questions about AI/software performance cannot be answered from this text:

Information Present in the Document:

• Device Name: 4CIS® Marlin PEEK ACIF Cage
• Intended Use: Cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at specific cervical levels (C2-C3 disc to C7-T1 disc). It is to be used with bone graft and supplemental spinal fixation systems.
• Material: Poly-ether-ether-ketone (PEEK), conforming to ASTM F2026.
• Design Features: Single component, designed to restore disc height, facilitate fusion, maintain lordotic angulation, various shapes/sizes, three tantalum markers for visualization, vertical square teeth to prevent subsidence and aid anchoring, hollow space for bone graft.
• Predicate Devices: 4CIS® Marlin ACIF Cage System (K162402) as primary; PATRIOT SPACERS: COLONIAL ACDF (K072991), TRYPTIK Ca (K091873), MATISSE Anterior Cervical Interbody Fusion Cage System (K162682) as additional.
• Performance Data (Non-Clinical): Mechanical testing was conducted in accordance with ASTM F2077-17 and F2267-04. This included static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, dynamic torsion, and static subsidence.
• Conclusion: The device is substantially equivalent to legally marketed predicate devices based on overall technology characteristics and mechanical performance data.

Why Your Questions Cannot Be Answered from This Document:

Your questions pertain to the evaluation of AI or software-based medical devices. The 4CIS® Marlin PEEK ACIF Cage is a physical medical implant, not a software or AI device. Therefore, the concept of "acceptance criteria" in the context of AI performance, "test set," "training set," "ground truth," "experts for ground truth," "adjudication," or "MRMC studies" as they relate to AI algorithms simply do not apply to this regulatory filing. The "performance data" mentioned refers solely to the biomechanical properties of the physical implant.

Ask a specific question about this device

4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy. The 4CIS® Marlin ACIF Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.

4CIS® Marlin ACIF cages are hollow, generally rectangular box shape made either from poly-ether-ether-ketone [PEEK-OPTIMA® LT1 (Invibio, Inc., West Conshohocken, PA USA) / VESTAKEEP® i4R (Evonik Industries, Essen Germany)] or Titanium alloy according to ASTM F2026(PEEK), F136(64ELI), F560(Tantalum). The cages are available in a variety of sizes and geometric options to fit the anatomical needs of a wide variety of patients. The device is filled with a bone graft material and inserted into the intervertebral body space of the cervical spine through an anterior cervical approach. As the design requirements, this cage design maintains the spacing between two vertebral bones following discectomy until fusion occurs. Each PEEK cage has three(3) x-ray markers made of tantalum for ease of visualization on the radiographs. Angled shape for lordotic curve and anatomic shape is available to allow maximum preservation of bony endplate with this system and teeth on the surfaces ensure enough contact with bony endplate, which prevents subsidence of the cage into the vertebral body when the teeth increase the anchoring and prevent slipping or expulsion.

This is a medical device 510(k) summary for the "4CIS® Marlin ACIF Cage System," an intervertebral body fusion device. The document describes the device, its intended use, and its comparison to predicate devices for substantial equivalence.

Here's an analysis of the provided text for acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for clinical performance usually seen in AI/software studies (e.g., sensitivity, specificity, AUC). Instead, it focuses on mechanical performance for this implantable device. The "Performance Specification" section states:

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

This document describes a mechanical device, not an AI/software product requiring a "test set" of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country, retrospective/prospective) are not applicable in the context of this medical device submission. The performance data comes from laboratory mechanical testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

As this is a mechanical device submission, there is no mention of experts establishing ground truth for a test set in the way it would be for an AI diagnostic algorithm. Ground truth here refers to the physical properties and performance of the device under mechanical stress, evaluated against established ASTM standards.

4. Adjudication Method for the Test Set

Again, this is not applicable as there is no "test set" in the context of clinical interpretation by experts. Mechanical testing results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and AI assistance. This submission pertains to an implantable surgical device.

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

Not Applicable. This is a physical intervertebral cage, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by Mechanical Testing Standards (ASTM F2077 and ASTM F2267). This involves objective measurements of physical properties like static and dynamic compression, torsion, subsidence, and expulsion, compared against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This isn't an AI model requiring a training set. The device's design and manufacturing processes are developed through engineering and material science, not machine learning training.

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

Not applicable. See point 8.

Ask a specific question about this device

The Qualgenix Ayers Rock Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Qualgenix Ayers Rock Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Qualgenix Ayers Rock Cervical Cage is to be used with supplemental fixation.

The Ayers Rock Cervical Cage consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Ayers Rock Cervical Cage is manufactured from PEEK OPTIMA LT1 polymer. The Ayers Rock Cervical Cage is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

The provided text describes a medical device, the Qualgenix Ayers Rock Cervical Cage, and its clearance through the 510(k) pathway. This pathway focuses on demonstrating substantial equivalence to a predicate device rather than conducting clinical trials to establish new safety and effectiveness. Therefore, the information typically requested regarding acceptance criteria based on a study, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (like MRMC) is not applicable or not provided in this type of submission for this particular device.

Here's a breakdown of the available information in relation to your request:

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

The provided document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity) for device performance in a clinical study. Instead, the device's acceptance is based on demonstrating substantial equivalence to predicate devices through preclinical testing and comparison of indications, design, and function.

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

Not applicable. The clearance is based on preclinical testing and comparison to predicate devices, not a clinical study with a "test set" of patients or data provenance in the context of clinical outcomes.

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

Not applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses or outcomes. For medical devices cleared via 510(k), especially for implants, the "truth" is established through engineering and biomechanical testing demonstrating equivalence to established devices, not expert consensus on patient data.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication in the way it's done for diagnostic algorithms.

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 implantable cervical cage, not a diagnostic AI device that would involve human readers or AI assistance in reading medical images.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for the Ayers Rock Cervical Cage is established through preclinical testing results (biomechanical and mechanical testing) demonstrating that its performance characteristics (e.g., static compression, dynamic compression, subsidence, expulsion) are equivalent to those of the predicate devices. The equivalence in design, materials (PEEK OPTIMA LT1 polymer), and intended use also serves as a critical part of the "truth" in the 510(k) context.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device 510(k) submission, as it's not an AI/algorithm-based device.

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

Not applicable, as there is no training set.

Ask a specific question about this device