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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 Prow-Fusion Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative disease (DDD). 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).

The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems). The device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Prow Fusion device.

The Prow Fusion intervertebral body fusion device must be inserted using a transforaminal approach.

The Prow Fusion Intervertbral Body Fusion Device system is comprised of two components. One component is the single-use Prow Fusion implant (intervertebral body fusion device) of various heights and the second component is a set of reusable instruments (the Prow Fusion Delivery System) used for its implantation. The implant is made from PEEK-OPTIMA® LT1 & LT2 and titanium alloy. The implant features 4 PEEK-OPTIMA® LT1 mid segments and titanium end segments. The segments has coarse surface on the superior and inferior surfaces and are attached with titanium pins.

The Prow Fusion intervertebral body fusion implant is inserted using a transforaminal approach. The proximal and the distal segments are bound together by PEEK-OPTIMA® LT2 strip. The PEEK-OPTIMA® LT2 strip is used to pull the distal seament proximally to form a ring-shaped, closed-configuration implant in the disc space.

The provided document, K130254, is a 510(k) premarket notification for the NLT SPINE Prow Fusion device. This document focuses on demonstrating substantial equivalence to a predicate device (NLT Prow Fusion K112359) rather than establishing new clinical effectiveness or safety through extensive clinical trials. Therefore, the information provided primarily pertains to bench testing to prove similar performance characteristics to its predicate, not a study involving human subjects or AI.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance data in the typical sense of a clinical study demonstrating efficacy. Instead, it relies on demonstrating substantial equivalence through mechanical and performance testing. The acceptance criterion is essentially that the Prow Fusion performs equivalently to its predicate device (K112359).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "test set" in the context of clinical data or human subjects. The performance testing refers to bench testing of the device components. The sample sizes for each type of mechanical test (Static Compression, Dynamic Compression, etc.) are not provided in this document. These would typically be detailed in separate test reports referenced or summarized.
• Data Provenance: The data provenance is from bench testing conducted by NLT SPINE. There is no information about country of origin for any human data, as no human data is presented for performance evaluation. The tests followed ASTM F2077 and ASTM F2267 standards, implying industry-standard testing methodologies.

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

Not applicable. This is a 510(k) submission for a medical implant based on substantial equivalence and bench testing, not a study involving human image interpretation or diagnostic performance where expert ground truth would be established.

4. Adjudication Method for the Test Set

Not applicable, as no human-read test set requiring adjudication is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a 510(k) submission for a modified intervertebral body fusion device, relying on bench testing to demonstrate substantial equivalence to a predicate device, not a clinical study involving human readers or AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not a submission for an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the validated mechanical properties and performance characteristics of the predicate device (K112359), as established through its own prior testing and regulatory clearance. The current device's performance is compared against these established benchmarks through bench testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable, as there is no training set mentioned.

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The NuVasive Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.

The Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Expandable Lumbar Interbody System. The Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems (e.g. pedicle screw/rod systems) that are cleared by the FDA for use in the lumbar spine.

The NuVasive Expandable Lumbar Interbody System is manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6A1-4V conforming to ASTM 1472, and Nitinol SE508 conforming to ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided document describes the NuVasive Expandable Lumbar Interbody System, a Class II medical device intended for intervertebral body fusion of the spine. The evaluation criteria for this device are based on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics for an AI system. Therefore, many of the requested categories related to AI model evaluation are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for individual tests. The document refers to various "testing" and "cadaver testing" without detailing the number of units or cadavers used.
• Data Provenance: Not explicitly stated. Nonclinical testing was performed, but the location or specific origin of materials/samples is not mentioned. This is a medical device, so the tests would be performed on engineered samples or cadaveric specimens, not retrospective or prospective patient data in the sense of an AI study.

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

• Not Applicable. This is a physical medical device clearance, not an AI or diagnostic tool where expert ground truth is established for a test set. The "ground truth" here is compliance with established ASTM standards and comparable performance to predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Testing involves objective measurements against established technical standards, not subjective expert adjudication.

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-assisted diagnostic or imaging device. Therefore, no MRMC study or AI performance evaluation was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• Technical Standards and Predicate Device Performance: The "ground truth" for this device's performance evaluation is established by:
  • ASTM International Standards: F2077 (for static and dynamic mechanical testing), F2129 (for corrosion testing).
  • Performance of Legally Marketed Predicate Devices: The "substantial equivalence" claim is based on demonstrating that the new device performs comparably to the NuVasive CoRoent® System (K071795) and NLT Spine Ltd. Prow Fusion (K112359) without introducing new worst-case scenarios.

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve an AI model requiring a training set.

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

• Not Applicable. This device does not involve an AI model requiring ground truth for a training set.

Summary of the Study:

The study described is a nonclinical performance testing regimen designed to demonstrate the mechanical and material characteristics of the NuVasive Expandable Lumbar Interbody System. The methodologies employed are based on established ASTM standards for intervertebral body fusion devices. The primary objective was to show that the subject device performs similarly to or better than two specific predicate devices already on the market (NuVasive CoRoent® System (K071795) and NLT Spine Ltd. Prow Fusion (K112359)) across various mechanical and environmental tests. The conclusion states that the device presents "no new worst-case for performance testing," thereby establishing substantial equivalence to the predicate devices in terms of safety and effectiveness. This type of clearance (510(k)) relies on demonstrating similarity to existing legally marketed devices, rather than establishing de novo safety and effectiveness through extensive clinical trials for software performance.

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