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The Acro Composites Interbody System is intended for interbody fusion. The devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and are to be used with supplemental fixation cleared for the implanted level.
The Acro Composites cervical devices are intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The cervical devices are indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate.
The Acro Composites lumbar devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The lumbar devices are indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The hyperlordotic implants (≥ 20°) should be used with anterior supplemental fixation.

The Acro Composites Interbody System includes interbody fusion devices for cervical and lumbar implantation manufactured from AcroPek – a carbon fiber reinforced PEKEKK polymer (CFRP) material. The implants are designed as a solid frame to provide surgical stabilization of the spine. Each interbody incorporates a central cavity that can be packed bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. The implants are sold sterile.

The provided document is a 510(k) summary for the Acro Composites Interbody System, a medical device for spinal fusion. It details the device's indications for use, materials, and a declaration of substantial equivalence to predicate devices. However, this document does not describe an AI or software device study. It describes the mechanical performance testing of an intervertebral fusion device to demonstrate its safety and effectiveness.

Therefore, most of the information requested in your prompt, which pertains to AI/software device studies (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth for AI), is not present in the provided text.

Based on the information provided, here's what can be extracted:

1. Table of acceptance criteria and the reported device performance:

Note: The reported device performance is stated as "The mechanical test results demonstrate that the Acro Composites Interbody System performance is substantially equivalent to the predicate devices" and that it aligns with the specified ASTM standards. Specific numerical values for acceptance criteria or performance are not provided in this summary.

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

• Sample Size: Not specified in the document. Mechanical testing typically involves a specific number of samples for each test type (e.g., several devices for compression, shear, and torsion).
• Data Provenance: Not specified. These are laboratory-based mechanical tests, not clinical data from patients.

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. This is not an AI/software device and does not involve human expert interpretation for "ground truth". The "ground truth" here is compliance with engineering standards (ASTM).

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

• Not applicable. (See answer to point 3).

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/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/software device.

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

• The "ground truth" in this context is compliance with established engineering and biocompatibility standards, specifically:
  • ASTM F2077 (Standard Test Methods for Static and Dynamic Axial Compression, Compression-Shear, and Torsion Testing of Spinal Implants)
  • ASTM F2267 (Standard Test Method for Measuring Load Between Parallel Platens for Intervertebral Body Fusion Devices)
  • ASTM F1876 (PEKEKK resin material standard)
  • ASTM B562 (Gold wire material standard)
  • ASTM F899 (Medical grade stainless steel material standard)

8. The sample size for the training set

• Not applicable. This is not an AI/software device and does not involve a "training set."

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

• Not applicable. (See answer to point 8).

Summary of what the document IS about:

The document describes the submission of a 510(k) premarket notification for the Acro Composites Interbody System. The intent is to demonstrate "substantial equivalence" to existing, legally marketed predicate devices. This equivalence is primarily shown through:

• Identical Intended Use: Interbody fusion for cervical and lumbar spine.
• Similar Technological Characteristics: Basic design (structural column), material (reinforced polymer), and sizes comparable to predicate systems.
• Performance Data: Mechanical testing (static & dynamic axial compression, compression-shear, torsion, and subsidence) was performed according to ASTM F2077 and F2267 standards. The results demonstrate that the device's performance is substantially equivalent to the predicate devices and meets these standards.

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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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