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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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