Search Results

The Palisade Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis; trauma, (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Palisade Pedicular Fixation System consists of titanium screws and cobalt chrome rods which allow a surgeon to build a spinal implant construct to accommodate the anatomical and physiological needs of the patient. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

This document is a 510(k) premarket notification for a medical device called the "Palisade Pedicular Fixation System." It is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to this type of submission. This document describes a mechanical device used in spinal surgery, not an AI/diagnostic device.

However, I can extract the relevant information from the document regarding the performance testing that was conducted to demonstrate the substantial equivalence of the device.

Here's an interpretation of the provided document in the context of your request, focusing on what is available:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for clinical performance, as it is a mechanical device. Instead, it relies on demonstrating mechanical equivalence to predicate devices through various ASTM standard tests. The "reported device performance" is essentially that the device passed these tests in accordance with applicable standards.

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

• Sample size: Not explicitly stated for each mechanical test. However, typically mechanical testing involves a specific number of samples (e.g., 6 or more) per test configuration as defined by the ASTM standards. This is for product samples, not patient data.
• Data provenance: Not applicable. The data is generated from laboratory mechanical testing of the device components, not from human or animal subjects.

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 mechanical testing, not a diagnostic or clinical study requiring expert ground truth.

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

Not applicable. This is mechanical testing.

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 a mechanical spinal fixation system, not an AI or diagnostic device.

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

Not applicable. This is a mechanical device.

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

Not applicable in the sense of clinical ground truth. The "ground truth" for these tests are the established performance requirements and methodologies outlined in the ASTM standards for spinal implant mechanical testing.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

Summary of the Study Discussed in the Document (Performance and Biological Testing):

The document reports on performance tests conducted in accordance with applicable standards and test methods to determine the endurance, strength, and durability of the Palisade Pedicular Fixation System.

• Tests Performed:

  • ASTM F1798
  • ASTM F1717
  • Static Compression Bending
  • Flexural Grip
  • Axial Grip
  • Static Torsion
  • Torsional Grip
  • Dynamic Compression Bending

• Conclusion regarding these tests: Spineology states that the device "passed" these tests and demonstrated substantial equivalence to the predicate devices. The exact quantitative results (e.g., specific load values, cycles to failure) are not provided in this summary document but would have been submitted to the FDA separately.

• Biological Safety Testing: "Not required as there was no change in materials from the predicate device." This implies that the materials used in the Palisade system are identical to those of legally marketed predicate devices, for which biological safety has already been established.

• Packaging and Sterilization Testing: "Not required as there was no change to the sterile barrier system, sterilization method, sterilization parameters, or sterility assurance level (SAL) from the predicate device." This indicates that these aspects of the device delivery are the same as those previously cleared predicate devices.

In essence, this document demonstrates substantial equivalence of a new mechanical spinal fixation device to existing, legally marketed devices by showing it has the same intended use, indications for use, fundamental scientific technology, biological safety, packaging, and sterilization method, supported by mechanical testing that confirms similar performance characteristics as defined by international standards.

Ask a specific question about this device

The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and nonpedicle fixation (T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

• . degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• . spondy lolisthesis,
• . trauma (i.e., fracture or dislocation),
• . spinal stenosis,
• . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• . tumor;
• . pseudoarthrosis, and
• failed previous fusion .
  When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
  The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
  The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
  When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks and iliac connectors. The expansion of indications for the Firebird Spinal Fixation System is proposed for the inclusion of adolescent idiopathic scoliosis alone, and not other indications for a pediatric population.
A subset of the Firebird Spinal Fixation System and Phoenix MIS System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.5mm to 7.5mm and lengths ranging from 25mm to 60mm.

The provided document is a 510(k) summary for the Orthofix Firebird Spinal Fixation System. This type of regulatory submission (510(k)) is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel device or a PMA.

Therefore, the document does not contain information about acceptance criteria and a study proving a device meets them in the way a diagnostic AI device or a novel therapeutic device would. Instead, it focuses on demonstrating equivalence to existing devices based on design, materials, indications for use, and mechanical performance.

I will attempt to extract the closest equivalents to your requested information where possible, based on the context of a 510(k) submission.

Analysis of the Provided Document Regarding Acceptance Criteria and Device Performance

The Orthofix Firebird Spinal Fixation System is a Class III Preamendment Device (Pedicle screw spinal system) for which the manufacturer is seeking 510(k) clearance. A 510(k) clearance means the device is "substantially equivalent" to predicate devices. This type of submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed device. It typically does not involve traditional clinical studies with acceptance criteria for device classification as one would expect for a novel device or an AI/diagnostic product.

Therefore, many of the requested points below are not directly applicable or quantifiable from this document.

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

   Not applicable in the context of this 510(k) submission. The performance assessment is focused on "substantial equivalence" to predicate devices, primarily through mechanical testing and engineering analysis rather than specific clinical acceptance criteria.

   The document states:
   "Previous mechanical testing of the system included static and dynamic compression bending testing and static torsion testing per ASTM F1717-04 and finite element analysis."

   While these tests have criteria for compliance with the standard, the document does not present a table of these criteria alongside specific device performance data. The conclusion drawn is that the device is substantially equivalent based on these results.

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

   Not explicitly stated for the mechanical testing mentioned. When mechanical testing is performed, the "sample size" refers to the number of physical devices or components tested. The data provenance is not specified.

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. Mechanical testing does not involve "experts" establishing ground truth in the way a diagnostic study would. The standards for mechanical testing (e.g., ASTM F1717-04) define the methods and parameters.

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

   Not applicable. Mechanical testing does not involve adjudication.

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 a spinal fixation system, not a diagnostic or AI-powered device.

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

   Not applicable. This is a spinal fixation system, not an algorithm.

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

   For mechanical testing, the "ground truth" is defined by the physical properties and performance limits set by engineering standards (e.g., ASTM F1717-04). For the expansion of indications (specifically for adolescent idiopathic scoliosis), the document mentions: "Published clinical results and engineering analysis supported expansion of indications." This implies that existing clinical literature for similar predicate devices, combined with engineering analysis (which would include the mechanical testing), served as the basis for justifying the expanded indications. Outcomes data or expert consensus from previously published studies might have indirectly informed this, but no new study for this submission is detailed.

8. The sample size for the training set

   Not applicable. This is a spinal fixation system, not a machine learning model requiring a training set.

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

   Not applicable. This is a spinal fixation system, not a machine learning model.

Summary regarding the Firebird Spinal Fixation System and 510(k) process:

The K130932 submission for the Firebird Spinal Fixation System is a 510(k) premarket notification. The core of this submission is to demonstrate substantial equivalence to existing predicate devices. This is achieved by showing that the device:

• Has the same intended use.
• Has the same basic technological characteristics (design, materials: titanium alloy per ASTM F136 and cobalt chrome per ASTM F1537, as with predicates).
• Performs as safely and effectively as the predicate devices.

The "proof" the device meets acceptance criteria in this context relies on:

• Mechanical Testing: Static and dynamic compression bending, and static torsion testing per ASTM F1717-04.
• Finite Element Analysis (FEA).
• Comparison to existing predicate devices: K081684, K082797, K100044, K093926, K122901 (Orthofix Inc.), K113666 (Stryker Spine), K091445 (Medtronic Sofamor Danek USA), K994121 (Synthes Spine), K121630 (K2M, Inc.), K111492 (Medtronic Sofamor Danek USA).

The document states: "Previous testing performed on this device indicates that the Firebird Spinal Fixation System is substantially equivalent to predicate devices." and "Published clinical results and engineering analysis supported expansion of indications." This means the mechanical performance met relevant engineering standards, and the safety and efficacy for the expanded indications (specifically pediatric adolescent idiopathic scoliosis) were supported by existing clinical literature and the device's engineering characteristics being similar to already approved predicate devices.

Ask a specific question about this device