(32 days)
PathLoc Lumbar Interbody Fusion Cage System is indicated for intervertebral body 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). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. PathLoc Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The PathLoc Lumbar Interbody Fusion Cage System implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.
- PathLoc – TM / BluEX-TM are to be implanted via transforaminal and posterior approach.
The provided FDA 510(k) clearance letter for the PathLoc Lumbar Interbody Fusion Cage System focuses on the mechanical testing and material composition of the device, rather than a clinical study evaluating its performance with human readers or AI assistance. Therefore, many of the requested criteria, particularly those related to AI algorithm performance, multi-reader multi-case (MRMC) studies, ground truth establishment for image datasets, and training/test set details for AI, are not applicable to this submission.
This document describes a medical device (an intervertebral body fusion cage) which is a hardware implant, not an AI/Software as a Medical Device (SaMD). The acceptance criteria and "study" described are focused on bench testing (mechanical performance) and material biocompatibility to prove substantial equivalence to existing predicate devices.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance (Mechanical Testing)
The "acceptance criteria" for this device are based on demonstrating mechanical performance that is either superior or equivalent to the predicate device and in compliance with specified ASTM standards. The "study" proving this involves a series of bench tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Bench Test Standard) | Specific Test Description | Reported Device Performance |
|---|---|---|
| ASTM F2077-18 | Static Axial Compression | Met pre-defined criteria; showed higher or similar mechanical value than predicate. |
| Static Compression-Shear | Met pre-defined criteria; showed higher or similar mechanical value than predicate. | |
| Static Torsion | Met pre-defined criteria; showed higher or similar mechanical value than predicate. | |
| Dynamic Axial Compression | Met pre-defined criteria; showed higher or similar mechanical value than predicate. | |
| Dynamic Compression-Shear | Met pre-defined criteria; showed higher or similar mechanical value than predicate. | |
| ASTM F2267-04 (Reapproved 2018)/F 2077-18 | Static Subsidence | Met pre-defined criteria; showed higher or similar mechanical value than predicate. |
| Overall | "Met all pre-defined acceptance criteria and, in tests where it was compared to either PathLoc Lumbar Interbody Fusion Cage System the predicate or reference device, was found to not represent a new worst case." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of devices or units. For mechanical bench testing, sample sizes are typically defined by the ASTM standards (e.g., n=5, n=6, etc.) but are not detailed in this summary. It would be a sample of the manufactured devices.
- Data Provenance: The "data" here refers to the mechanical test results from manufactured devices. This is not "data" in the sense of patient images or clinical outcomes. The device is manufactured in South Korea. The testing would have been conducted in a lab environment. The provenance is internal bench testing, not patient-derived data, and is not retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This is a hardware device; its performance is measured by mechanical properties according to engineering standards, not by human interpretation of images or clinical outcomes requiring expert consensus. The "ground truth" is established by the specified ASTM test methods.
4. Adjudication Method for the Test Set:
- Not applicable. As the "test set" is physical devices undergoing mechanical tests, there is no human adjudication process involved as there would be for, e.g., image interpretation. The machines measure and report data directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC study is relevant for evaluating the performance of AI (or human readers) in interpreting medical images. This device is a physical implant, not an imaging or diagnostic AI tool.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) was Done:
- Not applicable. This is a hardware device, not an algorithm or software. "Standalone performance" here is interpreted as the device's mechanical performance in isolation, which is precisely what the bench tests measure.
7. The Type of Ground Truth Used:
- Engineering/Material Standards and Predicate Device Performance: The "ground truth" for this device's performance is its ability to meet predefined mechanical specifications outlined in ASTM standards and to demonstrate substantial equivalence (i.e., not inferior performance) to the predicate device. It's about physical properties, not clinical "truth" from patients.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of this traditional hardware device clearance. This term (training set) relates to machine learning models.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for a machine learning model, this question is irrelevant to this device submission.
In summary: The FDA 510(k) clearance for the PathLoc Lumbar Interbody Fusion Cage System relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device in terms of design, materials, and mechanical performance. The framework of questions about AI algorithm performance, clinical ground truth establishment, and training/test datasets is not applicable to this type of medical device submission.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.