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RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to fusion for the following indications: degenerative 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 stcnosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor: pscudarthrosis: and/or failed previous fusion.

Except for hooks, when used as an anterolatcral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pediale screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consist of pedicle screws, rods, locking set screws, hooks. rod connectors and transverse connectors.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this submission is to add 6.35mm implants to the system.

This FDA submission describes a spinal fixation system, not an AI/ML powered device. As such, the typical acceptance criteria and study designs for AI/ML devices (like accuracy, sensitivity, specificity, and MRMC studies) are not applicable.

The submission focuses on establishing substantial equivalence to previously marketed devices based on design features and material properties. The primary way this device meets its "acceptance criteria" is by demonstrating it is as safe and effective as existing, legally marketed spinal systems.

Here's an analysis based on the provided document, addressing the original prompt's categories where applicable for a non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of clinical "test sets" for AI/ML performance. For mechanical testing, the "worst case components" were selected for testing, implying a representative sample of components or configurations were tested to cover the range of mechanical properties. The specific number of components or implants tested is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data provenance. The mechanical test data would be generated in a laboratory setting (likely within the company or a certified testing facility).

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

• Not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic tool requiring expert interpretation of outputs to establish ground truth. Substantial equivalence for this device is based on technical comparisons and mechanical testing against recognized standards.

4. Adjudication method for the test set

• Not applicable. There is no "adjudication" in the sense of reconciling clinical interpretations for this type of device. The determination of "worst case" for mechanical testing would be an engineering assessment.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a spinal implant.

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

• No, a standalone algorithm performance evaluation was not done. This device is a physical medical implant, not a software algorithm.

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

• For mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F1717) and successful performance within those standards, demonstrating adequate strength and durability.
• For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML "training set."

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

• Not applicable. As there is no AI/ML component, there is no "training set" or ground truth for it.

Summary regarding the device's "acceptance":

The Range Spinal System gained FDA clearance (K141147) by demonstrating substantial equivalence to predicate devices already on the market. This means the FDA concluded that the new device is as safe and effective as the existing devices. The key elements for this determination were:

• Design and Material Comparison: The new components (6.35mm implants) were found to be "substantially the same" in design features and materials (Titanium Alloy and Cobalt Chrome per ASTM/ISO standards) as predicate devices.
• Mechanical Performance: The "worst case components" of the system were previously tested against established standards (ASTM F1717) for static compression bending, static torsion, and dynamic compression. The proposed new implants were determined by engineering analysis not to represent a "new worst case," implying they perform comparably or better than previously tested components and meet the required mechanical integrity.
• Intended Use: The indications for use are consistent with those of the predicate devices.

Essentially, the "study" for this device was a combination of engineering analysis and mechanical testing against industry standards, alongside a direct comparison of its technical characteristics and intended use to already cleared predicate devices.

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The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (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, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Everest Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

The provided text describes a 510(k) summary for the Everest Spinal System, which is a medical device. As such, the concept of "acceptance criteria" and "device performance" as it pertains to medical image analysis, AI algorithms, or diagnostic tools with quantifiable metrics like sensitivity, specificity, or AUC, is not directly applicable in this context.

Instead, for a spinal fixation system like the Everest Spinal System, "acceptance criteria" are typically met through demonstrating substantial equivalence to predicate devices based on design, materials, function, and mechanical performance. The "study" that proves the device meets these criteria is typically a mechanical testing study.

Here's an analysis based on the provided text, reinterpreting the request for a device like this:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the traditional sense for this type of mechanical device. The "test set" would be the collection of components and configurations of the Everest Spinal System that underwent mechanical testing. The specific number of devices or test repetitions for each mechanical test (static compression bending, static torsion, dynamic compression) is not provided in this summary.
• Data Provenance: The mechanical tests were performed by K2M, Inc. to compare against predicate device performance. This is typically internal testing conducted according to recognized industry standards (ASTM F1717). This is a prospective evaluation of the new device components. The "country of origin of the data" would be the United States, where K2M is located.

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

• Not applicable. For mechanical testing of a spinal fixation system, "ground truth" is established by adherence to recognized international mechanical testing standards (e.g., ASTM F1717) and the physical measurements obtained during the tests. It does not involve human expert interpretation in the way radiological images would.

4. Adjudication Method for the Test Set

• Not applicable. This concept relates to reconciling discrepancies in human expert interpretations (e.g., in diagnostic studies). Mechanical testing results are determined objectively by instrumentation and adherence to test protocols, not through human 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 study type is relevant for diagnostic devices (especially those involving AI or human interpretation of images/data). The Everest Spinal System is a physical implant, not a diagnostic tool or an AI-assisted system.

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

• Not applicable. This device does not involve an algorithm or AI. Its performance is purely mechanical.

7. The Type of Ground Truth Used

• Objective Mechanical Measurements and Standard Compliance: The "ground truth" is defined by the objective physical measurements (e.g., load, displacement, cycles to failure) obtained during mechanical testing on the device components, compared against the established performance characteristics of predicate devices and the requirements of the ASTM F1717 standard.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of a mechanical medical device like this, as it does not involve machine learning or AI.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set, this question is irrelevant for the Everest Spinal System.

In summary: The "study" proving the device met acceptance criteria was a mechanical testing study comparing the new components of the Everest Spinal System against predicate devices according to ASTM F1717 standards. The success criterion was that the new components performed "equally to or better than" the predicate devices in static compression bending, static torsion, and dynamic compression, and that their design and materials were substantially equivalent.

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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.

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