Search Results

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:

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.

Ask a specific question about this device

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.

This document is a 510(k) Premarket Notification from the FDA regarding the "PathLoc Lumbar Interbody Fusion Cage System." It outlines the regulatory approval process and describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to previously approved devices.

Here's an analysis of the provided information concerning acceptance criteria and study proof:

Important Note: The provided document is for a lumbar interbody fusion cage system, which is a mechanical implant. The questions posed (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance) was done," "ground truth used (expert concensus, pathology, outcomes data, etc.)" with specific numbers of experts and adjudication methods) are typical questions for the validation of AI/ML-based medical devices for image analysis or diagnostics. These types of studies are not applicable to a mechanical orthopedic implant like the PathLoc Lumbar Interbody Fusion Cage System.

The "studies" described in this document are bench testing to assess the mechanical properties and biocompatibility of the implant, demonstrating its structural integrity and safety for implantation. There are no "human readers," "AI assistance," or "ground truth based on expert consensus" in the context of this device's validation.

Therefore, many of the requested points in your prompt cannot be answered from the provided text because they pertain to a different type of medical device (e.g., AI diagnostic software) and not a physical implant.

Let's address what is available in the document:

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

The document does not provide a specific table of acceptance criteria with numerical targets and the exact reported performance values. Instead, it states:

The "acceptance criteria" are implied to be meeting or exceeding the performance of the legally marketed predicate devices and conforming to relevant ASTM standards. The detailed numerical values of these tests are not provided in this summary.

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

• Sample Size for Test Set: This refers to the number of physical samples (implants) tested in the mechanical bench studies. The document does not specify the exact number of samples tested for each mechanical test. Standard ASTM test methods typically prescribe a minimum number of samples (e.g., 5 or 6 per test condition), but this detail is not present.
• Data Provenance: Not applicable in the context of clinical patient data. This is bench testing of manufactured devices. The manufacturer is L&K BioMed Co., Ltd. from South Korea. The testing was reported as "non-clinical testing."

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. This is a mechanical device. "Ground truth" in this context is established by standardized mechanical testing methods (ASTM standards) and engineering principles, not by medical experts interpreting data like images.

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

• Not Applicable. See point 3.

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. See point 3. This device is not an AI diagnostic tool and does not involve human readers interpreting cases.

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

• Not Applicable. See point 3. This is not an algorithm.

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

• Type of "Ground Truth": For this mechanical device, the "ground truth" or standard for evaluation is:
  • ASTM Standard Methods: Compliance with the mechanical testing specifications outlined in ASTM F2077 and ASTM F2267.
  • Predicate Device Performance: Demonstrating mechanical performance (e.g., static and dynamic strength, subsidence) that is "higher or similar" to the legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of a mechanical implant. This term applies to machine learning models.

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

• Not Applicable. See point 8.

In summary, the provided document details the regulatory clearance for a physical medical implant. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for such a device primarily revolve around mechanical performance bench testing (to ensure it can withstand forces in the body without failure) and biocompatibility (to ensure it doesn't cause adverse reactions when in contact with human tissue). The questions you've posed are highly relevant for digital health devices, particularly those involving AI/ML for diagnostics or image analysis, but they do not align with the type of device described in this FDA 510(k) summary.

Ask a specific question about this device