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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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The Luna 360 Interbody Fusion System consists of the Luna 360 Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic 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 I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 360 System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant. The Luna 360 System is to be used with supplemental fixation.

The Benvenue Luna 360 System consists of the Luna 360 Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 360 System are identical to predicate interbody lumbar cages. The Luna 360 Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna 360 Implant is available in heights ranging from 8mm to 13mm in 1mm increments. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates.

The Luna 360 Implant is manufactured from polyetheretherketone (PEEK Optima LT-1), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).

The provided text describes a 510(k) premarket notification for the "Luna 360 Interbody Fusion System." This document is primarily concerned with establishing substantial equivalence to legally marketed predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically found in AI/ML medical device submissions.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, and adjudication methods is not available in the provided text, as this type of information is generally not required for this specific device type and approval pathway.

The device is an intervertebral body fusion device, not an AI/ML algorithm, and thus the concepts of "acceptance criteria" for algorithm performance, "test set," "training set," "ground truth," "MRMC studies," or "standalone performance" as they relate to AI/ML devices do not apply here.

However, the document does contain information about performance testing relevant to a medical device's physical and mechanical properties.

Here's a breakdown of the relevant information provided:

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

• Acceptance Criteria (Implicit): The implicit acceptance criterion is that the device demonstrates mechanical properties that are "substantially equivalent" to legally marketed predicate devices, particularly regarding static/dynamic compression, shear-compression, torsion, subsidence, and expulsion. The specific numerical thresholds for "acceptance" are not explicitly stated as they would be in an AI/ML performance summary, but rather implied by meeting the standards of similar devices.
• Reported Device Performance:
  • Mechanical Testing: The tests demonstrated that the Luna Interbody System is "substantially equivalent" to legally marketed predicate devices in static/dynamic compression, static/dynamic shear-compression, static/dynamic torsion testing (per ASTM F2077), static subsidence (ASTM F2267), and expulsion testing (ASTM Draft Standard F-04.25.02.02).
  • Cadaveric Testing: Performed to validate the surgical technique.
  • MR Compatibility Testing: Performed to demonstrate MR safety.

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

• Not applicable for this type of device and testing. The "test set" in this context refers to the physical devices undergoing mechanical and material testing, not a dataset of patient images or clinical outcomes.

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 this context would likely refer to engineering specifications or validated test methods, rather than expert diagnostic opinions.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 device is not an AI-assisted diagnostic tool.

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

• Not applicable.

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

• For the mechanical testing, the "ground truth" would be the established ASTM standards (F2077, F2267, and ASTM Draft Standard F-04.25.02.02) and engineering principles for mechanical performance. For MR compatibility, the "ground truth" would be established MR safety protocols.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device.

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

• Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (intervertebral body fusion system) based on substantial equivalence to existing devices, supported by a series of mechanical and material performance tests. It does not involve a clinical study or AI/ML algorithm, and therefore the specific questions related to AI/ML validation are not addressed by the text.

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