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The PROW FUSION-L is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 through S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION-L device is intended to be used with autogenous bone graft and a supplemental spinal fixation system that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems).

PROW FUSION-L is lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. PROW FUSION-L is provided in different sizes to fit the anatomical needs of a wide variety of patients. PROW FUSION-L is manufactured from titanium alloy per ASTM F136 and Polyetheretherketone per ASTM F 2026. The device contains an expandable mechanism that allows it to achieve its final footprint in situ. PROW FUSION-L is to be filled with autogenous bone graft material.

Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae. The devices require the use of commercially available supplemental spinal fixation systems.

This document describes a 510(k) premarket notification for the "PROW FUSION-L" intervertebral body fusion device. A 510(k) is a submission to the FDA demonstrating that the device is at least as safe and effective as a legally marketed predicate device. This type of submission generally does not require clinical trials with acceptance criteria and statistical performance metrics in the same way a PMA (Premarket Approval) would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, and MRMC studies is not applicable to this 510(k) submission.

Instead, the submission relies on the concept of substantial equivalence to a predicate device, demonstrated primarily through mechanical testing.

Here's the summary of what is provided:

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

• Not Applicable. As this is a 510(k) for substantial equivalence, formal acceptance criteria in the context of clinical performance (sensitivity, specificity, etc.) are not presented. The "acceptance" is based on the mechanical test results demonstrating equivalence to the predicate and compliance with relevant ASTM standards.

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

• Test Set Sample Size: Not specified in terms of human subjects or clinical cases. The "test set" here refers to the physical devices subjected to mechanical testing. The number of devices tested for each mechanical test (static and dynamic axial compression, compression-shear, subsidence, expulsion, wear particle assessment) is not explicitly stated.
• Data Provenance: The mechanical testing was conducted to demonstrate substantial equivalence to the predicate device and compliance with ASTM standards. The submission originates from NLT SPINE Ltd. in Kfar-Saba, Israel. The context suggests that the testing was performed in a lab setting rather than involving human data.

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. Ground truth in the context of clinical expert consensus is not relevant for this type of submission focused on mechanical equivalence. The "ground truth" for mechanical testing is adherence to predefined engineering specifications and performance within established ASTM standards.

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

• Not Applicable. Adjudication methods are relevant for clinical studies where expert review is needed for diagnoses or outcomes. This document describes mechanical testing.

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. No MRMC or clinical comparative effectiveness study involving human readers or AI is mentioned, as this is a mechanical device, not an imaging or AI diagnostic tool.

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

• Not Applicable. This is a physical intervertebral body fusion device, not an algorithm or AI system.

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

• For the mechanical performance data, the "ground truth" is adherence to established ASTM (American Society for Testing and Materials) standards and demonstrating performance similar to the predicate device. The specific standards cited are ASTM F2077 (for static and dynamic axial compression, static and dynamic compression-shear) and ASTM F2267 (for subsidence).

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of a machine learning algorithm for this physical device.

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

• Not Applicable. As there is no training set for an algorithm, this question is not relevant.

In summary, the PROW FUSION-L device gained market clearance via a 510(k) submission based on:

• Substantial Equivalence: To several predicate devices including Life Spine, Longbow Spacer System (K133717).
• Mechanical Performance Data: Consisting of static and dynamic axial compression, static and dynamic compression-shear (according to ASTM F2077), subsidence (according to ASTM F2267), and additional expulsion and wear particle assessment testing.
• Compliance with Guidance: Per "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007.

The "study" that proves the device meets the criteria is a set of mechanical tests designed to show that the device performs functionally and structurally equivalent to its predicate.

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Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon):

The Choice Spine Lumbar Spacer System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1 in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

When used as a vertebral body replacement device, the Choice Spine Intervertebral Body Device is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Choice Spine VEO™ Lateral Access & Interbody Fusion System:

The Choice Spine VEO™ Lateral Access & Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.

Choice Spine Interbody Fusion System:

The Choice Spine Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

This submission includes three lumbar implant families. The device description for each family is listed below.

Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon):

The Choice Spine Lumbar Spacer System consists of interbody fusion devices (specifically, SABRE, SHARK™, HORNET™ & HARPOON™ Lumbar Spacers) comprised of polyetheretherketone (PEEK - Optima®) with tantalum markers (ASTM F2026 and ASTM F560) or Ti-6AI-4V ELI (ASTM F136). The spacers have a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet shaped anterior surface. They are available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements. These implants are delivered via a posterior or transforaminal approach.

Choice Spine VEO™ Lateral Access & Interbody Fusion System:

The Choice Spine VEO™ Lateral Access & Interbody Fusion System is a multicomponent system including instrumentation made of stainless steel. Aluminum. and Radel R and implants made of tantalum (ASTM F560) and PEEK Optima® (ASTM F2026) or Ti-6Al-4V ELI (ASTM F136). The implants are delivered via lateral approach.

Choice Spine Interbody Fusion System:

The Choice Spine Interbody Fusion System is a family of implants intended to aid in spinal fixation of the lumbar spine. This system includes implants made of Zeniva ZA-500 PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti-6Al-4V ELI (ASTM F136), which are delivered via anterior or anterolateral approach.

The provided document is a 510(k) summary for several intervertebral body fusion devices. This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, the document does not contain the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth establishment, or multi-reader multi-case studies for a device's performance.

The document primarily focuses on:

• Indications for Use: What conditions the devices are intended to treat.
• Device Description: The materials and general design of the implants.
• Comparison to Predicate Devices: An assertion that the new devices are substantially equivalent to previously cleared devices.
• Non-Clinical Testing: A statement that "no new non-clinical testing is needed" due to the design being the same if manufactured from Titanium instead of PEEK.

In the context of a 510(k) submission for these types of devices, the "acceptance criteria" are typically related to demonstrating substantial equivalence through a comparison of technological characteristics and intended use, often supported by non-clinical performance data (e.g., mechanical testing to ASTM standards), rather than clinical performance metrics like sensitivity, specificity, or reader improvement with AI.

Therefore, I cannot extract the requested information from this document. The document specifically states: "no new non-clinical testing is needed," implying that the performance was considered sufficiently similar to the predicate devices based on design and material changes, and thus no new study specifically proving acceptance criteria for device performance was required or submitted as part of this 510(k).

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