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The IRIX-A™ Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The IRIX-A™ System is intended to be used with autograft and/or allograft comprised of cancellous bone graft material, and is to be used with three titanium alloy screws included as part of the system.

Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

The IRIX-A™ Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The IRIX-A™ implant is manufactured from both titanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580.

The device is secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes, and screws are offered in multiple lengths to adjust for variations in patient anatomy. The spacers of the IRIX-A™ System are supplied clean and STERILE. The screws and accompanying instruments of the IRIX™-A System are provided clean and non-sterile.

The system does not contain software/firmware or electrical equipment.

The provided document is a 510(k) Pre-market Notification from the FDA for a medical device called the IRIX-A™ Lumbar Integrated Fusion System. This submission focuses on establishing substantial equivalence to existing predicate devices, rather than a clinical study evaluating the device's diagnostic performance against specific acceptance criteria for AI/software-based devices. Therefore, much of the requested information regarding acceptance criteria for device performance in a clinical context, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not applicable or not present in this type of regulatory document.

However, I can extract information related to the performance data provided within this 510(k) summary for non-clinical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states the device "meets or exceeds the performance of the predicate device" for these tests, implying that the acceptance criteria are based on the performance of the predicate device as established through the same ASTM standards and FDA recommendations.

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

• Test set sample size: Not applicable. This document describes non-clinical mechanical testing, not a clinical study involving a test set of data.
• Data provenance: Not applicable. The testing is described as "Nonclinical testing" and performed on the device itself.

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

• Not applicable. Ground truth for clinical data is not relevant to this non-clinical mechanical testing.

4. Adjudication method for the test set:

• Not applicable.

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-based diagnostic device, nor a comparative effectiveness study involving human readers.

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

• Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:

• For the non-clinical performance data: The "ground truth" or reference for performance is the established performance characteristics of the predicate device under the specified ASTM standards and FDA recommendations for static and dynamic compression, subsidence, and expulsion.

8. The sample size for the training set:

• Not applicable. This product does not involve machine learning or a "training set."

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

• Not applicable.

Summary based on the provided document:

The IRIX-A™ Lumbar Integrated Fusion System is a physical medical device (intervertebral body fusion device), not an AI/software-based diagnostic tool. The regulatory submission (510(k)) aims to demonstrate substantial equivalence to legally marketed predicate devices. This is achieved through non-clinical performance testing (mechanical/physical tests) rather than clinical studies involving patient data and diagnostic performance metrics like sensitivity, specificity, or reader studies.

The performance data supplied focuses on:

• ASTM F2077: Static and dynamic compression testing
• ASTM F2267: Subsidence
• Expulsion testing as recommended by FDA

The conclusion is that the subject device "meets or exceeds the performance of the predicate device" for these tests, indicating that its mechanical integrity and function are comparable or superior, and it "does not introduce any new risks." The predicate device itself acts as the benchmark for establishing acceptable performance under these tests.

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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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