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510(k) Data Aggregation
(257 days)
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).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Compression Test performance equivalent to predicate (K112359) | Performance testing demonstrated that the Prow Fusion is 'substantially equivalent' to its predicate Prow Fusion (K112359). |
| Static Compressive Shear Test performance equivalent to predicate (K112359) | Performance testing demonstrated that the Prow Fusion is 'substantially equivalent' to its predicate Prow Fusion (K112359). |
| Static Torsion Test performance equivalent to predicate (K112359) | Performance testing demonstrated that the Prow Fusion is 'substantially equivalent' to its predicate Prow Fusion (K112359). |
| Dynamic Compression Shear Test performance equivalent to predicate (K112359) | Performance testing demonstrated that the Prow Fusion is 'substantially equivalent' to its predicate Prow Fusion (K112359). |
| Dynamic Torsion Test performance equivalent to predicate (K112359) | Performance testing demonstrated that the Prow Fusion is 'substantially equivalent' to its predicate Prow Fusion (K112359). |
| Subsidence Test performance equivalent to predicate (K112359) | Performance testing demonstrated that the Prow Fusion is 'substantially equivalent' to its predicate Prow Fusion (K112359). |
| Expulsion Test performance equivalent to predicate (K112359) | Performance testing demonstrated that the Prow Fusion is 'substantially equivalent' to its predicate Prow Fusion (K112359). |
| Dynamic Compression Test performance equivalent to predicate (K112359) | Performance testing demonstrated that the Prow Fusion is 'substantially equivalent' to its predicate Prow Fusion (K112359). |
| Particle Analysis Test performance equivalent to predicate (K112359) | Performance testing demonstrated that the Prow Fusion is 'substantially equivalent' to its predicate Prow Fusion (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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