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The MediRod Pedicle Screw System, with or without MIS instrumentation, 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 and chronic instabilities or deformities of thoracic, lumbar. and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the MediRod Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the MediRod Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The MediRod Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws and rods manufactured from titanium alloy. All the components are available in a variety of sizes to match more closely the patient's anatomy.

This document is a 510(k) summary for the "MediRod Pedicle Screw System." It does not describe a study involving device performance metrics, accuracy, or human reader involvement in the context of AI or diagnostic systems. Instead, this document focuses on the mechanical performance testing of a physical medical device (pedicle screws) to demonstrate substantial equivalence to predicate devices for FDA clearance.

Therefore, the requested information regarding acceptance criteria for device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment, as typically applied to AI/diagnostic devices, is not available or applicable in this document.

The document states:

• Performance Testing: "Static and dynamic testing of the MediRod Pedicle Screw System was performed in accordance with ASTM F1717 (static and dynamic compression bending, and static torsion testing) and ASTM F1798 (static flexion-extension testing)."
• Conclusion: "Results of the testing demonstrate the substantially equivalent mechanical performance of the subject device."

This indicates that the acceptance criteria are based on meeting the standards set forth in ASTM F1717 and ASTM F1798 for mechanical properties, and the study "proves" the device meets these criteria by demonstrating substantial equivalence in mechanical performance to legally marketed predicate devices. However, no specific numerical acceptance criteria or reported device performance metrics (e.g., accuracy, sensitivity, specificity) are provided in the text.

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The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

LNK SPINAL FIXATION SYSTEM /OPENLOC-L SPINAL FIXATION SYSTEM: The LNK SPINAL FIXATION SYSTEM, OPENLOC-L SPINAL FIXATION SYSTEM are available in various sizes. This system is comprised of screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 6.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

ACCELFIX SPINAL FIXATION SYSTEM: The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, cross-link connectors, and hooks. The screws are available from 5.0 mm, 6.0 mm, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm diameters with working lengths ranging from 20 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

The provided text is a 510(k) summary for spinal fixation systems. It discusses the substantial equivalence of new components to previously cleared predicate devices.

Crucially, this document does not describe testing related to software or AI-powered devices, nor does it include information about the performance criteria, study design, or ground truth establishment typically associated with such devices.

The performance data section explicitly states: "The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System with the predicate device (LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System -K120270, K143363, K171813, K183168, K200790, K223565, K230245 / AccelFix Spinal Fixation System: K182544, K200794, K223565, K230245)."

Therefore, I cannot provide the requested information about acceptance criteria or a study that proves a device meets these criteria in the context of an AI/software device. The document is for a physical medical device (spinal fixation system) and relies on demonstrating substantial equivalence to predicate devices through material and design similarities, rather than performance studies with quantitative metrics, test sets, or expert reviews as would be relevant for AI.

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The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor, stenosis, and failed previous fusion (pseudoarthrosis).

The LNK SPINAL FIXATION SYSTEM, OPENLOC-L SPINAL FIXATION SYSTEM are available in various sizes. This system is comprised of screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 6.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, cross-link connectors, and hooks. The screws are available from 5.0 mm, 6.0 mm, 7.0. 7.5. 8.0. 8.5. 9.0 and 9.5mm diameters with working lengths ranging from 20 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

This 510(k) submission describes a spinal fixation system, not an AI/ML device. Therefore, the details requested about acceptance criteria and study design for AI/ML devices (e.g., ground truth, reader study, effect size) are not applicable and are not present in the provided text.

The document focuses on demonstrating substantial equivalence to predicate spinal fixation systems based on material, design, dimensions, and sterilization methods.

Here's a summary of the relevant performance data and criteria from the provided text, adapted to reflect what is actually presented:

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

The submission does not specify numerical "acceptance criteria" for performance in the way an AI/ML device would. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to legally marketed predicate devices. The reported device performance is presented as being "similar" or "identical" to the predicates across key technical characteristics.

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

This information is not applicable and not provided. The submission relies on mechanical testing data from existing predicate devices and a comparison of technical characteristics, not a clinical test set from patients.

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)

This information is not applicable and not provided. Since this is a spinal fixation system, the "ground truth" is typically established through engineering and biocompatibility testing, and comparison to existing devices, rather than expert interpretation of medical images.

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

This information is not applicable and 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

This information is not applicable and not provided. This is a medical device, not an AI/ML algorithm requiring a reader study.

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

This information is not applicable and not provided. This is not an AI/ML algorithm.

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

The "ground truth" for this type of device is demonstrated through robust engineering analysis, material characterization, and mechanical testing to ensure safety and performance, and crucially, by demonstrating substantial equivalence to predicate devices that have already met these standards. The submission explicitly states: "The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System with the predicate device (LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System -K120270, K143363, K171813, K183168, K200790, K223560 / AccelFix Spinal Fixation System: K182544, K200794, K223565)."

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/ML device that requires a training set.

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

This information is not applicable and not provided.

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