Search Results

The Exactech Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Exactech Acapella One Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

The Acapella One Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features a chamber intended to be filled with autogenous bone graft material. The Acapella One Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate). Acapella One Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Exactech Octane-A implants (K082270). The material used to construct the anchors is titanium alloy Ti-6AI-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants. The radiographic markers are composed of tantalum per ASTM F560, which also has a long history of safe and effective use in orthopedic implants. The Acapella One Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.

The provided document is a 510(k) summary for a medical device called the Exactech® Acapella™ One Cervical Spacer System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness through extensive clinical studies with acceptance criteria for device performance. Therefore, the information typically requested in your prompt (e.g., acceptance criteria for a diagnostic device, details of a study proving a device meets these criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, and ground truth establishment methods) is not present in this document.

The document describes material and mechanical testing to demonstrate substantial equivalence, not clinical performance against predefined acceptance criteria for a diagnostic or AI-driven device.

Here's an breakdown based on the information that is available in the document:

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

• No specific acceptance criteria are listed in the typical sense of a diagnostic or AI device (e.g., sensitivity, specificity, AUC).
• The "performance" is demonstrated through non-clinical mechanical testing, showing the device functions as intended and is substantially equivalent to predicate devices.
• The tests performed are: Static Compression, Static Compression Shear, Static Torsion, Subsidence (Anchors Deployed and Not Deployed), Expulsion (Anchors Deployed and Not Deployed), Dynamic Compression, Dynamic Compression Shear, Dynamic Torsion, and Wear. The document states these tests "demonstrated equivalent performance to cited predicates under the same test conditions," but does not provide numerical results or specific acceptance thresholds for these tests within this summary. The standards referenced (e.g., F2077, F22674, F1877) would contain the details of the test methodologies and potentially acceptance criteria, but these are not reproduced in the 510(k) summary.

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

• Not applicable. This document describes mechanical, non-clinical testing of a physical implant device, not a study involving human data or a test set in the context of an AI/diagnostic device.

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. See point 2.

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

• Not applicable. See point 2.

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. This is not a diagnostic device or an AI-assisted device.

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

• No. This is not an algorithm or AI device.

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

• Not applicable in the AI/diagnostic sense. The "ground truth" for this device's evaluation is its mechanical performance against established ASTM standards and equivalence to predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable. See point 8.

In summary, the provided document is a 510(k) submission for a non-active, implantable medical device. Its purpose is to demonstrate "substantial equivalence" to existing legally marketed devices, primarily through engineering and biocompatibility considerations, rather than clinical performance data against specific acceptance criteria relevant to AI or diagnostic tools.

Ask a specific question about this device