Search Results

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).

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.

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 (Ti6Al4V-Eli) or Cobalt Chrome.

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:

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.

Ask a specific question about this device