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The Coligne GII Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The GII Spinal Fixation System is intended for use in the non-cervical posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft and/or allograft, the GII Spinal Fixation System is intended for use or more of the following; (1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal stenosis, (6) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Coligne GII Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma.

This system is intended to be used with autograft. Pediatic pedicle screw fixation is limited to a posterior approach.

The GII Spinal Fixation System is a top loading polyaxial pedicle screw, which, when used with rods and crosslinks, results in a multiple component, posterior system. All the components are available in a variety of sizes to match the patient's anatomy more closely.

This document outlines the FDA's 510(k) premarket notification clearance for the Coligne GII Spinal Fixation System. The focus of the 510(k) submission is to add flexStaas pedicle screws to the existing system.

Based on the provided text, the device in question is a Spinal Fixation System, and the "study" referred to is a non-clinical test summary to demonstrate that the new component (flexStaas pedicle screws) meets performance criteria compared to predicate devices. There were no clinical studies performed.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the flexStaas pedicle screws of the GII Spinal Fixation System met or exceeded acceptance criteria for two specific non-clinical tests. However, the specific quantitative acceptance criteria values are not explicitly stated in this document. Only the types of tests and the outcome ("met or exceeded") are provided.

Note: The document only provides a qualitative summary of the non-clinical test results. The actual quantitative acceptance criteria and the measured performance values would be detailed in the full test reports, which are not included in this FDA clearance letter.

Study Information (Non-Clinical)

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

   • Sample Size: Not explicitly stated for the non-clinical tests. The number of samples for dynamic flexion-extension and torsional strength tests is typically specified in the test protocols, but not in this summary.
   • Data Provenance: The tests were performed "in support of this Special 510(k)". It is implied that these tests were conducted by the manufacturer, Coligne AG, or a contracted testing facility. The country of origin of the data is not specified beyond the company being located in Zurich, Switzerland. The tests are prospective in the sense that they were performed to support the submission.

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

   • Not Applicable. This was a non-clinical, mechanical testing study, not a study involving expert review of medical images or patient outcomes. The "ground truth" for mechanical tests is defined by established engineering standards (ASTM F1798) and material properties.

3. Adjudication method for the test set:

   • Not Applicable. This was a non-clinical, mechanical testing study. Adjudication methods like 2+1 or 3+1 are used for human reader studies or when establishing ground truth from multiple expert opinions.

4. 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. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted. This device is a mechanical implant, not an AI-assisted diagnostic tool.

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

   • Not Applicable. This is a mechanical device, not an algorithm. Standalone performance refers to the accuracy or performance of an AI algorithm independent of human intervention.

6. The type of ground truth used:

   • For the non-clinical tests, the "ground truth" is based on established engineering standards (specifically ASTM F1798 for dynamic testing) and material property specifications (e.g., strength requirements for medical implants). It's not a medical "ground truth" like pathology or clinical outcomes.

7. The sample size for the training set:

   • Not Applicable. The document describes a mechanical device requiring non-clinical testing, not a machine learning model that would have a training set.

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

   • Not Applicable. As no training set was involved (this is a mechanical device), no ground truth for a training set needed to be established.

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The ostaPek Interbody Fusion Cages system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the sacro-lumbar spine (L2-S1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ostaPek Interbody Fusion Cages are placed via an anterior, posterior or lateral approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ostaPek Interbody Fusion Cages are to be used with supplemental fixation cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The ostaPek Interbody Fusion Cages system consists of four families of cages used with four surgical approaches: the Erriva® ELIF/TLIF Cage (Extraforaminal Lumbar Interbody Fusion/ Transforaminal Lumbar Interbody Fusion), the Gemitra® TLIF Cage, the PLIF Cage (Posterior Lumbar Interbody Fusion) and PLIF Bullet Cage, and the ALIF Cage (Anterior Lumbar Interbody Fusion). All device configurations are available in multiple sizes to adequately fit patient anatomical variations. They all have bone graft windows, ridges or teeth to resist migration, and x-ray markers.

This document is a 510(k) Premarket Notification for a medical device called "ostaPek Interbody Fusion Cages." It is not a document about an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria, study design for AI evaluation, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document indicates that the device's substantial equivalence was demonstrated through non-clinical testing and comparison to predicate devices, and explicitly states: "No clinical studies were performed."

The request asks for details specific to the evaluation of an AI/ML medical device, which are not applicable to the traditional medical device clearance process described in this document.

Therefore, I cannot provide the requested information based on the provided text.

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Trabis® is a vertebral body replacement system indicated for use in the cervical spine (from C2 to T1 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. Trabis® is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft, as an adjunct to fusion. Trabis® is 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The devices included in this submission are a subset of the devices that were included in the OstaPek® VBR System, cleared in K072326. The only difference between the Trabis® and the K072326 subset is that the Trabis® VBR are intended for the use in the cervical spine, whereas the devices cleared in K072326 were cleared for use in the thoracolumbar spine. Therefore, the purpose of this 510(k) is to modify the Indications for Use for the subject Trabis®.

The document provided is a 510(k) summary for the Trabis® vertebral body replacement system. It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical (mechanical) testing and a retrospective clinical study.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Reported Device Performance

For medical devices, "acceptance criteria" are generally established to demonstrate that the device performs as intended and is safe and effective. In a 510(k) submission, this often means demonstrating substantial equivalence to a legally marketed predicate device. The primary acceptance criteria for the Trabis® device, as inferred from the "Non-clinical Test Summary" and "Conclusions: Non-clinical and Clinical" sections, are related to its mechanical performance and clinical outcomes being comparable to predicate devices.

Study Details:

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

   • Test Set Sample Size: "Ninety-three patients were treated with the Trabis® after cervical corpectomy of one or more levels for different reasons." So, N=93 patients.
   • Data Provenance: The study was "retrospectively reviewed." It was conducted at "three centers." The country of origin is not explicitly stated in the provided text.

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

   • The document does not specify the number of experts used to establish the ground truth or their qualifications. It mentions "analyzing the outcome and radiological findings," which implies some form of assessment, but not who performed it or how consensus was reached.

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

   • The document does not provide any information on the adjudication method used for the test set.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical vertebral body replacement system, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable to this submission.

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

   • No. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.

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

   • The ground truth appears to be based on "outcome and radiological findings" from the retrospective review of patient cases. This implies a combination of clinical assessments and imaging interpretations. The specific details of how these "findings" were adjudicated or confirmed (e.g., against pathology, long-term outcomes) are not detailed.

7. The sample size for the training set:

   • The document describes a retrospective clinical study for performance evaluation, not an AI/algorithm-based device that would typically have a separate "training set." Therefore, no training set sample size is mentioned.

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

   • Not applicable, as there is no mention of a training set for an algorithm.

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The ACIF system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACIF implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACIF implants are to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to surgery.

The coLigne ACIF system are used to maintain disc space distraction in skeletally mature adults requiring anterior cervical interbody fusion (ACIF). This system includes two design configurations: ACIF oscar, and ACIF oscar dome. The implants are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of bone graft.

This document is a 510(k) Premarket Notification for a medical device called ACIF (Anterior Cervical Interbody Fusion) system. It outlines the device's characteristics, intended use, and substantial equivalence to previously cleared devices, a requirement for FDA clearance for Class II medical devices.

Here's an analysis of the provided text to address your specific questions regarding acceptance criteria and the study that proves the device meets them:

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

Based on the provided text, the ACIF device is not an AI/Software as a Medical Device (SaMD). It is a physical intervertebral body fusion device. Therefore, the concept of "acceptance criteria" and "device performance" as typically applied to AI-powered diagnostic or predictive tools (e.g., sensitivity, specificity, AUC) does not apply in this context.

Instead, the acceptance criteria for this device are related to its physical, mechanical, and biological properties and its substantial equivalence to existing predicate devices.

Here's a table summarizing the relevant "performance" and "acceptance criteria" as described for this physical device:

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

• Sample Size for Test Set: Not applicable in the context of an AI/SaMD test set. For this physical device, the "test set" refers to the specific physical prototypes or batches of the device that underwent non-clinical mechanical testing. The document does not specify the number of individual devices tested, which is typical for a 510(k) summary focused on demonstrating equivalence through standard test methods.
• Data Provenance: The data comes from non-clinical bench testing performed by or for the manufacturer (coLigne, AG, based in Switzerland). It is not patient data, nor is it retrospective or prospective in the sense of a clinical trial.

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. The "ground truth" for a physical device like this is established by recognized engineering standards (e.g., ASTM F2077, ASTM F2267) and the results of established mechanical testing methodologies. There are no "experts" in the sense of clinical interpreters establishing ground truth as there would be for an image-based AI algorithm. The expertise lies in engineering and materials science to design and conduct these tests.

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

Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses for AI/SaMD test sets. For a mechanical device, the test results are quantitative (e.g., force, displacement), measured by calibrated equipment, and interpreted against predetermined thresholds or comparative data from predicate devices.

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. An MRMC study is relevant for AI/SaMD devices where human readers (e.g., radiologists) use AI assistance to improve their diagnostic accuracy. This device is a physical implant, not an AI diagnostic tool.

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

No. This concept is for AI/SaMD devices. The "performance" of this device is its mechanical integrity and ability to facilitate fusion, which is not an "algorithm."

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

As explained in point 3, the "ground truth" for demonstrating the safety and effectiveness of this physical device is based on accepted engineering standards (e.g., ASTM F2077, ASTM F2267) and direct comparative mechanical testing against a well-characterized predicate device. The goal is to show the new device performs equivalently in a mechanical sense.

8. The sample size for the training set

Not applicable. This device is not an AI/SaMD that requires a "training set" for machine learning.

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

Not applicable, as there is no training set for this type of medical device.

In summary: The provided document describes a physical implantable device, not an AI/SaMD. Therefore, many of the questions asked (especially those related to "test sets," "ground truth experts," "MRMC studies," and "training sets") are not applicable to this type of device and its regulatory clearance process. The "study" that proves the device meets acceptance criteria consists of non-clinical, benchtop mechanical testing designed to demonstrate substantial equivalence to legally marketed predicate devices, not clinical trials or AI performance evaluations.

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