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The Alpine Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 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 S1) with removal of the implants after the attainment of a solid fusion.

The Alpine Pedicle Screw System is a spinal system that consists of screws, rods, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using a posterior approach.

The provided text describes a medical device, the Alpine Pedicle Screw System, and its mechanical testing. However, it does not contain information about acceptance criteria and the study that proves the device meets those criteria in the format requested, which implies clinical or diagnostic performance metrics.

The document is a 510(k) summary for a spinal implant, focusing on its substantial equivalence to predicate devices based on design, materials, and mechanical performance. The "acceptance criteria" mentioned relate to mechanical testing standards for spinal implants (ASTM F1717 and F1798), not clinical performance or diagnostic accuracy.

Therefore, I cannot populate the table or provide the detailed information requested regarding clinical study design, sample sizes, expert qualifications, or ground truth for diagnostic AI.

Here's a summary of what is available in the provided text regarding device performance:

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

Important Note: The provided document is a 510(k) summary for a mechanical implant. The "acceptance criteria" and "device performance" here refer to mechanical properties and biocompatibility, not diagnostic accuracy or clinical outcomes that would typically involve AI models, expert readers, or ground truth derived from pathology or outcomes data.

Regarding the other requested information (which is not present in the provided text):

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

• Not applicable / Not provided. This document details mechanical testing, not a clinical or diagnostic study with a test set of data.

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 / Not provided.

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

• Not applicable / Not provided.

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 / Not provided. This is a mechanical implant, not an AI-assisted diagnostic tool.

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

• Not applicable / Not provided.

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

• Not applicable / Not provided. For mechanical testing, the "ground truth" is adherence to established ASTM standards.

8. The sample size for the training set

• Not applicable / Not provided.

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

• Not applicable / Not provided.

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The Active "10 Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-11) with removal of the implants after the attainment of a solid fusion mass. The Active ™ Anterior Cervical Plate System is intended for use under the following indications:

· Degenerative disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

• · Spondylolisthesis
• · Trauma (i.e., fracture or dislocation)
• · Spinal stenosis
• · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

• Tumor

• Pseudoarthrosis

• · Failed previous fusion

The Active " Anterior Cervical Plate System is a fixation system designed to allow for settling of the bone graft during fusion. Plates are provided in various lengths to accommodate fusions from 1 to 4 Ievels. Fixed and variable angle locking unicortical screws are provided in lengths of 12, 14, 16, and 18mm and diameters of 4mm and 4.5mm.

The provided text describes the 510(k) summary for the "Active Anterior Cervical Plate System" (K073500), a medical device intended for spinal fixation. This submission focuses on establishing substantial equivalence to previously marketed predicate devices, primarily through mechanical performance testing and comparison of technological characteristics.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data or patient samples. The evaluation of this device is based on mechanical performance attributes per ASTM F1717. For such testing, the "sample size" would refer to the number of devices or components tested. This information is not provided in the given text.

Similarly, the data provenance (country of origin, retrospective/prospective) is not applicable as the study described is a mechanical engineering test, not a clinical study involving human subjects or their data.

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

This information is not applicable. The "ground truth" for mechanical testing is typically established by the specifications of the ASTM F1717 standard and the results of the physical tests themselves. It does not involve human expert consensus in the way clinical studies do.

4. Adjudication Method for the Test Set

This is not applicable for mechanical performance testing. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where human interpretation or consensus is required to establish ground truth or resolve discrepancies in evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

This information is not applicable. The submission describes a spinal fixation system, which is a physical implant, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

This is not applicable. The device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily mechanical performance standards (ASTM F1717). The device's performance was compared to existing predicate devices based on these standards.

8. The Sample Size for the Training Set

This information is not applicable as the evaluation is based on mechanical performance testing, not a machine learning model that requires a "training set."

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

This is not applicable for the same reasons as #8.

Summary of the Study and Device Performance:

The study described for the Active Anterior Cervical Plate System is largely a technical and mechanical performance evaluation to demonstrate substantial equivalence to legally marketed predicate devices. The primary "study" involved:

• Comparison of Technological Characteristics: The device's features (augmenting stability, segmented plate for screw translation, use of titanium alloys, compression application) were compared and found to be substantially equivalent to features present in various predicate devices.
• Mechanical Testing per ASTM F1717: The device underwent mechanical performance testing according to the ASTM F1717 standard. The results of this testing demonstrated that its mechanical attributes were "substantially equivalent" to those of the predicate devices.

The FDA's review concluded that the device is substantially equivalent to predicate devices for its stated indications for use, primarily based on these comparative analyses and mechanical testing. No clinical studies with human participants, expert consensus for diagnosis, or AI performance evaluations are mentioned in this 510(k) summary.

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The LowTop Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 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 S1) with removal of the implants after the attainment of a solid fusion.

The LowTop System is intended for posterior, non-cervical pedicle fixation for the following indications:
Spondylolisthesis
Trauma (i.e., fracture or dislocation)
Spinal stenosis
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
Tumor
Pseudoarthrosis
Failed previous fusion

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 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 S1) with removal of the implants after the attainment of a solid fusion.

The LowTop Pedicle Screw System is a spinal system that consists of screws, rods, connectors and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using a posterior approach.

The LowTop Pedicle Screw System is a spinal implant system. The provided text describes the device's mechanical testing, which served as the study to demonstrate it met the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

   Test Type	Acceptance Criteria (Standard)	Reported Device Performance
   Static Compression Bending	ASTM F1717	"performed as designed and met, or exceeded, all product specifications"
   Static Torsion	ASTM F1717	"performed as designed and met, or exceeded, all product specifications"
   Dynamic Compression Bending	ASTM F1717	"performed as designed and met, or exceeded, all product specifications"

2. Sample Size and Data Provenance:

   • The document does not specify the exact sample sizes used for each mechanical test.
   • The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. This was a laboratory study of a medical device, not a clinical trial with patient data.

3. Number of Experts and their Qualifications (for ground truth):

   • Not applicable. This device is hardware that underwent mechanical testing against engineering standards, not an AI or diagnostic device that requires expert-established ground truth from clinical data.

4. Adjudication Method (for ground truth):

   • Not applicable, as this was a mechanical testing study against established engineering standards rather than a clinical study requiring consensus among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done. This is a mechanical device, and such studies are typically for AI-powered diagnostic or interpretive tools.

6. Standalone Performance Study:

   • Yes, the "standalone" performance in this context refers to the device's mechanical integrity as an independent unit. The mechanical testing itself, conducted on the device, represents its standalone performance.

7. Type of Ground Truth Used:

   • The "ground truth" for this device's performance was the specifications and requirements outlined in the ASTM F1717 standard for spinal implant constructs.

8. Sample Size for the Training Set:

   • Not applicable. This is a mechanical device, not an algorithm that requires a training set.

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

   • Not applicable. There was no training set for this type of device.

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