FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The TriFix Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.

The Tri-Fix Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The posterior Tri-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The posterior Tri-Fix System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

Device Description

The TrFix Washerless Plate system is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, plates, and accessory connection components.

AI/ML Overview

The provided text describes a 510(k) summary for the Tri-Fix Washerless Plate system. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a previously cleared device, not on clinical performance metrics like sensitivity, specificity, or reader studies. Therefore, many of the requested categories (such as experts, adjudication, effect size, standalone performance, ground truth types, and training set details) are not applicable to this type of submission.

Here's an analysis based on the information provided:

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

Acceptance Criteria	Reported Device Performance
Equivalence to previously cleared components	Biomechanical testing according to ASTM F1717 demonstrated that the new component (nut) is substantially equivalent to previously cleared components of the TriFix system.
	Both static and fatigue compression tests were completed.

2. Sample size used for the test set and the data provenance

The study was a biomechanical test, not a clinical study involving human patients. The "sample size" refers to the number of constructs tested.

Test Set Sample Size: Not explicitly stated in terms of a specific number of constructs, but implied as sufficient to conduct "both static and fatigue compression tests."
Data Provenance: Not applicable in the sense of country of origin for patient data, as this was a biomechanical engineering test. It was a non-clinical, in-vitro study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a biomechanical engineering test, not a clinical study requiring expert ground truth for diagnostic accuracy. The "ground truth" was the physical performance of the device under stress, measured against engineering standards.

4. Adjudication method for the test set

Not applicable. This was a biomechanical test with objective physical measurements, not a test requiring human adjudication of results.

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 a surgical implant, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a physical surgical implant, not an algorithm.

7. The type of ground truth used

The ground truth for this non-clinical study was the biomechanical performance of the device components when tested against established industry standards (ASTM F1717) for static and fatigue compression.

8. The sample size for the training set

Not applicable. As a biomechanical engineering study to demonstrate substantial equivalence, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There was no training set for this biomechanical engineering study.

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K Number

K011830

Device Name

TRI-FIX SPINAL FIXATION SYSTEM

Manufacturer

ENDIUS, INC.

Date Cleared

2001-07-23

(41 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The TriFix Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.

The Tri-Fix Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar. and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The posterior Tri-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The posterior Tri-Fix System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with mateautins and of the disc confirmed by history and radiographic studies), deformities (scoliosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.

Device Description

The Tri-Fix Spinal System is a system that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, plates, and accessory connection components.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Tri-Fix Spinal Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel AI diagnostic device would.

Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific performance metrics with acceptance criteria) are not applicable to this document as it pertains to a traditional medical device (spinal fixation system) seeking 510(k) clearance based on equivalence to an existing device, not a novel AI/software medical device.

However, I can extract information related to the device's technical specifications and the comparison made to the predicate device, which serves as the "study" demonstrating its suitability for market.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are generally implicit in demonstrating substantial equivalence to the predicate device. The primary performance metric mentioned is Stiffness Range from Biomechanical Test Results.

Acceptance Criteria / Comparison Point	Tri-Fix Spinal System Performance	Predicate Device (ISOLA Spinal System) Performance (Benchmark)
Indications for Use	See above (detailed in 7.7)	Identical
Materials	Titanium	Stainless Steel or Titanium
Product Labeling	Instructions for use and box labeling including all necessary warning statements	Instructions for use and box labeling including all necessary warning statements
Packaging/Sterilization	Non-sterile, single use only	Non-sterile, single use only
Biomechanical Test Results (Stiffness Range)	Within the range of ISOLA	Outside the range of TriFix (This means the TriFix system's stiffness range is shown to overlap or fall within the acceptable range demonstrated by the ISOLA system, even if the ISOLA's overall range might be broader and include values outside the TriFix's specific range.)

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

Not applicable in the context of a 510(k) for a spinal fixation system. This document does not describe a clinical study with a "test set" of patient data or samples. The "test set" here refers to the biomechanical testing conducted on the device components.
The biomechanical tests would have involved a certain number of device samples, but the specific sample size for these engineering tests is not provided in this summary.
Data Provenance: The biomechanical testing would have been conducted by the manufacturer (Endius, Inc.).

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

Not applicable. This relates to clinical data analysis, which is not the focus of this 510(k) summary for a spinal implant. Biomechanical testing relies on engineering standards and measurement rather than expert interpretation of a "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set

Not applicable. This applies to clinical interpretation or consensus, not biomechanical engineering tests.

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

No, an MRMC study was not done. This type of study is specifically relevant to diagnostic imaging devices or AI-driven decision support systems where human readers interpret cases. This document concerns a physical implant.

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

No, this is not applicable. The Tri-Fix Spinal Fixation System is a physical medical device, not an algorithm or software. It does not have standalone "algorithm-only" performance.

7. The Type of Ground Truth Used

For the biomechanical testing, the "ground truth" would be established by standardized engineering test methods and established biomechanical properties (e.g., stiffness thresholds) relevant to spinal fixation systems. The predicate device's performance (ISOLA Spinal System's stiffness range) serves as the primary benchmark for the "ground truth" of acceptable performance.

8. The Sample Size for the Training Set