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The Preference Pedicle Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Preference Pedicle Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis) and/or spinal deformities such as scoliosis, kyphosis or excessive lordosis.

In addition, when used as a pedicle screw fixation system, the Preference Pedicle Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the Preference Pedicle Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

Device Description

The Preference Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, hooks, connectors and rods. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-Eli) or Cobalt Chrome.

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study that demonstrates the device meets these criteria.

The document is a 510(k) summary for the "Preference Pedicle Screw System," indicating it's a submission to the FDA for market clearance. It details:

Contact Information: Trace Cawley, US Spinal Technologies.
Trade Name: Preference Pedicle Screw System.
Classification: Pedicle screw spinal system (21 CFR §888.3070), Spinal intervertebral body fixation orthosis (§888.3060), Spinal interlaminal fixation orthosis (§888.3050).
Class: II.
Product Codes: KWO, KWP, MNH, MNI.
Indications for Use: Detailed descriptions for both pedicle screw fixation and posterior, non-cervical, non-pedicle screw fixation systems in the lumbar and/or sacral spine.
Device Description: Comprised of monoaxial and polyaxial pedicle screws, hooks, connectors, and rods, manufactured from medical grade titanium alloy or Cobalt Chrome.
Predicate Device(s): US Spinal Technologies Preference Pedicle Screw System (K081296), DePuy Expedium Spine System (K073364, K041119 and K033901), and Stryker Xia Spinal System (K080928 and K060361).
Substantial Equivalence: The FDA's letter confirms substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.

Missing Information:

The document focuses on establishing substantial equivalence to previously cleared devices based on similar indications for use, design, function, and materials. It does not describe a study involving specific acceptance criteria and performance metrics in the way requested for medical device software or AI systems.

Therefore, I cannot provide the requested table or answer any of the questions (1-9) regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not present in the provided text. This device is a physical implant, and its clearance relies on established equivalence to existing devices, not typically on performance metrics derived from clinical studies with ground truth in the same way an AI diagnostic tool would.

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K Number

K081296

Device Name

PREFERENCE PEDICLE SCREW SYSTEM

Manufacturer

US SPINE

Date Cleared

2008-06-06

(30 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K041625,K062785,K080518

Intended Use

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Preference Pedicle Screw System. It focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating specific performance criteria against predefined acceptance thresholds. Therefore, much of the requested information about acceptance criteria, study details, and ground truth establishment is not available in the provided document.

Here's a breakdown of the available and unavailable information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (N/A – See comments)	Reported Device Performance	Comments
Not specified	Substantially equivalent	The document states, "The pre-clinical testing performed indicated that the Preference Pedicle Screw System is substantially equivalent to predicate devices." In a 510(k) submission for this type of device, the "acceptance criteria" for performance are often met by demonstrating that the new device performs at least as well as, and is as safe and effective as, existing legally marketed predicate devices. This typically involves mechanical and material testing to ensure it meets established standards (e.g., ASTM standards for spinal implants) and showing that its design, function, and materials are similar. The specific numerical thresholds or criteria for these tests are not detailed in this summary. The FDA's acceptance is based on this finding of substantial equivalence.

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

Sample Size for Test Set: Not specified. The document mentions "pre-clinical testing" but does not detail the number of units tested (e.g., for mechanical strength, fatigue).
Data Provenance: The testing was "pre-clinical," meaning it was likely laboratory-based (in-vitro) or potentially animal studies, but the exact location (e.g., country of origin of the data) is not specified. It is not explicitly stated if it was retrospective or prospective, but pre-clinical testing is typically prospective in its design.

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

Not Applicable. This device is a pedicle screw system, a mechanical implant. Performance is evaluated through engineering and materials testing, not typically through ground truth established by medical experts in the way an AI diagnostic device would be.

4. Adjudication method for the test set:

Not Applicable. As above, this is a mechanical device, not a diagnostic one requiring expert 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 is not an AI-assisted diagnostic device.

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

Not Applicable. This is a physical medical device (pedicle screw system), not an algorithm or AI.

7. The type of ground truth used:

Not Applicable in the traditional sense. For mechanical devices, "ground truth" would relate to engineering standards, material properties, and biomechanical performance data. For instance, the "truth" is that the device can withstand certain loads or stresses without failure according to established physical criteria. The document only broadly states "pre-clinical testing."

8. The sample size for the training set:

Not Applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not Applicable. See point 8.

In summary:

The provided document is a 510(k) summary for a physical medical device (pedicle screw system). The regulatory pathway for such devices largely relies on demonstrating substantial equivalence to already approved predicate devices through non-clinical performance testing (e.g., mechanical, material, and biocompatibility testing). It does not involve the kind of clinical study and performance metrics common for AI/ML-based diagnostic devices, which would require detailed information on acceptance criteria, ground truth, expert adjudication, and reader studies. The "performance testing" mentioned in the document refers to these pre-clinical tests, the details of which are not included in this summary but would have been part of the full 510(k) submission.

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