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The TELIX K Interbody System is intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1).

Patients should have six months of non-operative treatment prior to surgery.

These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone.

These implants are intended for use with Biedermann Motech supplemental internal fixation products.

The TELIX K Interbody System is intended for use as an intercorporal fusion cage in the lumbar region (L2-L5) and sacral region (S1). Therefore, the system includes the following implants:

The TELIX K Interbody System is comprised of slightly curved implants in lengths of 28, 32 and 36mm and heights ranging from 7 to 17mm.

Devices that are 7mm in thickness are only available with 0-degrees of lordosis and all other implants possess 5-degrees of lordosis.

The implants are introduced via a TLIF approach using autogenous bone. The TELIX K Interbody System must only be implanted in combination with supplemental fixation.

The implants of the TELIX K Interbody System are single-use only and the system is provided non sterile.

This document is a 510(k) premarket notification for a medical device (TELIX K Interbody System), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against detailed acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" (especially points 2, 3, 4, 5, 6, 7, 8, 9 which relate to data, ground truth establishment, and clinical studies) are not applicable or not present in this type of regulatory submission. This document describes a physical intervertebral body fusion device, not an AI or algorithm.

Here's an analysis based on the provided text, addressing only the applicable points:

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

Based on the document, the "acceptance criteria" are derived from relevant ASTM standards for intervertebral body fusion devices, and the "reported device performance" refers to the results of mechanical bench testing.

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

• Sample Size: Not explicitly stated for specific tests, but implies a sufficient number of samples were tested to meet ASTM standard requirements for substantiation.
• Data Provenance: Not applicable in terms of patient data. The data is from mechanical bench testing of the device components.

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

• Not applicable. This relates to mechanical testing against standards, not expert-derived ground truth on patient data.

4. Adjudication method for the test set:

• Not applicable. This relates to mechanical testing governed by standardized protocols, not human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This document refers to a physical implant and mechanical testing, not a diagnostic or AI-assisted device.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used:

• For the mechanical bench testing, the "ground truth" is defined by the acceptance limits and methodologies of the ASTM standards (ASTM F2077-14 and ASTM F2267-04).

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is a physical device subject to mechanical testing, not an AI/algorithm.

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

• Not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.

Summary based on the document:

The provided document describes a 510(k) premarket notification for a physical medical device, the TELIX K Interbody System. The intent of this submission is to demonstrate substantial equivalence to an already legally marketed device, primarily through non-clinical bench testing to ensure mechanical performance aligns with established standards for intervertebral body fusion devices.

The "acceptance criteria" are implied by the referenced ASTM standards (ASTM F2077-14 and ASTM F2267-04), which dictate the performance requirements for such implants regarding static compression, dynamic compression, torsion, compression-shear, and subsidence. The study conducted was non-clinical bench testing, specifically mechanical tests. No clinical trials or studies involving human patients were performed or deemed necessary for this 510(k) submission ("No clinical tests were performed."). Therefore, concepts like data provenance from patient studies, expert consensus, MRMC studies, or training sets for AI algorithms are not relevant to this specific regulatory submission.

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