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The Keos Lumbar IBFD is indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) of the spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels.

These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, anterior plate systems, and rod systems.) The device(s) is intended to be used with autogenous bone graft.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. The Keos Lumbar IBFD can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF. a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provide support to the spine for a posterior surgery.

The Keos Lumbar Intervertebral Body Fusion Devices (IBFD) are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion (IBF). They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

Keos Lumbar Intervertebral Body Fusion Devices (IBFD) are made from PEEK radiolucent material and Hydroxyapatite (HA) Enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

Surgical instruments are required for implantation of the device. The accessories are manufactured from 17-4 Stainless Steel (per ASTM F899-11), 465 Stainless Steel, Silicon, 6061 Aluminum, 300 and 400 Series Stainless Steel.

I apologize, but the provided text from the FDA 510(k) clearance letter for the Keos Lumbar IBFD does not contain any information about acceptance criteria or a study proving the device meets performance criteria for an AI/software as a medical device (SaMD).

The document is a clearance letter for a physical medical device (an intervertebral body fusion device) and focuses on its substantial equivalence to a predicate physical device. It describes:

• The device name, regulation, and product code.
• The indications for use of the physical implant.
• The materials and manufacturing of the physical implant and surgical instruments.
• A statement about "Confirmatory testing, including impaction, as well as rationales were provided to demonstrate substantial equivalence." (This refers to mechanical and material testing, not AI performance).

Therefore, I cannot provide the requested table and study details as they are absent from the provided text.

If you have a different document that describes an AI/SaMD for which you need this information, please provide that text.

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Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Keos Lumbar IBFD can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF)

Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF)

Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.

The series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The series of intervertebral body fusion devices are made from the PEEK radiolucent material and HA enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

Here's an analysis of the provided text regarding the Keos Lumbar IBFD and its acceptance criteria, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not provide specific sample sizes for the mechanical tests (Static and Dynamic Compression Tests) or the material characterization tests (XRD, FTIR, XPS). It only states that these tests were performed and the device met the acceptance criteria.

The data provenance is not specified (e.g., country of origin). Since these are material and mechanical bench tests, the concept of "retrospective or prospective" data provenance, as it typically applies to clinical studies, is not directly relevant here. These are laboratory tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The "ground truth" for these tests (mechanical and material characterization) is the established standard (e.g., ASTM F2077 for compression, ISO 17665 for sterilization) and the objective measurements derived from the tests themselves, rather than expert consensus on a clinical outcome.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation where there's subjectivity and disagreement among human reviewers to establish a consensus ground truth. The tests mentioned are objective laboratory tests.

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

An MRMC study was not conducted. This device is an Intervertebral Body Fusion Device (implantable medical device), not an AI-powered diagnostic or assistive tool for human readers. No mention of AI or human reader improvement is present.

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

This information is not applicable. The device is a physical implant, not an algorithm. Therefore, no standalone algorithm performance study was performed.

7. The Type of Ground Truth Used

The ground truth used for the nonclinical tests was primarily:

• Standardized Test Methods: Adherence to established industry standards like ASTM F2077 for mechanical testing and ISO 17665 for sterilization validation.
• Objective Measurement Data: The results of the laboratory tests (e.g., force, displacement, spectral data) compared against defined pass/fail criteria within those standards.
• Material Specifications: Compliance with material standards (e.g., ASTM F2026 for PEEK-OPTIMA and ASTM F560 for tantalum x-ray markers).

8. The Sample Size for the Training Set

No training set is mentioned or applicable. This device is a physical implant for which safety and effectiveness are shown through nonclinical (bench) testing and substantial equivalence to a predicate device, not through machine learning model training.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there was no training set.

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Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft.

Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Keos Lumbar IBFD can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF)
Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.

The series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The series of intervertebral body fusion devices are made from the PEEK radiolucent material and HA enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

The provided text details a 510(k) premarket notification for the "Keos Lumbar IBFD," an intervertebral body fusion device. While it describes the device's indications for use and a summary of nonclinical tests, it does not contain information about studies involving human readers, AI assistance, training sets, or expert ground truths as requested in the prompt. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through material and mechanical testing.

Therefore, many of the requested elements about acceptance criteria and studies cannot be extracted from this document, as they are not present.

Here's a breakdown of the information that can be extracted or inferred from the document regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The results of these studies showed that the Keos Lumbar IBFD met the acceptance criteria." However, it does not provide the specific numerical acceptance criteria or detailed numerical results for each test. It only confirms that the device passed.

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

• The document does not specify the sample size for the testing performed (e.g., number of devices tested for mechanical properties).
• The data provenance (country of origin, retrospective/prospective) is not mentioned, as these are non-clinical (mechanical) tests, not clinical studies.

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 applicable and not present. The studies performed were non-clinical mechanical tests, not studies requiring expert interpretation of medical data or images.

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

• This information is not applicable and not present, as the studies performed were non-clinical mechanical tests.

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 MRMC or comparative effectiveness study involving human readers or AI assistance was performed or reported. The document explicitly states: "No clinical tests were performed."

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

• No standalone algorithm performance study was done. This device is a physical intervertebral body fusion device, not a software algorithm.

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

• The "ground truth" for the mechanical tests would be the established scientific and engineering principles outlined in the referenced ASTM standards (e.g., F2077, F2267) and ISO standards (e.g., 17665). The tests measure physical properties against these predefined parameters. There is no biological or expert-derived "ground truth" in this context.

8. The sample size for the training set

• This information is not applicable and not present. The device is a physical implant, not an AI model requiring a training set.

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

• This information is not applicable and not present, as there is no training set for this type of device.

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