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The SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplement fixation is used.

As an intervertebral body fusion device designed for use with autograft, the SIBD Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).

Patients should be skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap® Implant Systems device.

The Aesculap® Implant Systems SIBD Spinal System is an implantable spinal device manufactured from polyetheretherketone (PEEK) with tantalum markers. The implant is secured to vertebral bodies by four titanium screws inserted through the anterior screw holes. The implants are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy.

The provided text describes a medical device, the Aesculap® Implant Systems SIBD Spinal System, and its clearance process. However, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and a study proving device performance.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria for a new, novel device. The "performance data" section primarily refers to mechanical testing.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it refers to mechanical testing standards and states that the device is "safe and effective."

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

This information is not present in the provided document. The performance data discussed is related to mechanical testing, not a clinical test set on 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)

This information is not present. The document doesn't describe a clinical study involving experts establishing ground truth for a test set.

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

This information is not present. No clinical test set with adjudication is described.

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

There is no mention of an MRMC study or AI in this document. This device is a physical spinal implant, not an AI/software device.

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

This information is not applicable/present. This is a physical implant, not an algorithm.

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

For the mechanical testing, the "ground truth" would be the parameters defined by the ASTM F2077/F2267 standards. For the overall device, the "ground truth" for FDA clearance is its substantial equivalence to existing predicate devices, implying similar safety and effectiveness profiles as established by the predicate devices' past performance and regulatory history. There is no specific, independent "ground truth" derived from patient data described for this 510(k) submission.

8. The sample size for the training set

This information is not present. There is no "training set" in the context of this 510(k) summary for a physical implant.

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

This information is not present/applicable.

Summary of what the document shows:

The document provides a 510(k) summary for a spinal implant system. The primary method for demonstrating its "safety and effectiveness" and meeting "acceptance criteria" (though not explicitly called that) is by showing:

• Substantial Equivalence: The device is similar in materials, design, and intended use to several already FDA-cleared predicate devices.
• Mechanical Testing: The device successfully passed standard mechanical tests (ASTM F2077/F2267) relevant to spinal implants.

This type of submission typically relies on non-clinical data and comparison to predicates, rather than extensive, new clinical performance studies with defined acceptance criteria and ground truth derived from patient data.

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