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The Swedge™ Pedicle Screw Fixation System is intended to provide immobilization 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudoarthrosis and failed previous fusion.

The Swedge™ Pedicle Screw Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the LS-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. It is also intended for the following indications: DDD (degenerative disc disease); trauma (i.e. fracture or dislocation); spinal stenosis; deformities (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The Swedge™ Pedicle Screw Fixation System is an implant device made from a titanium alloy (Ti-6Al-4V-ELI) and Cobalt Chrome. The subject device is to be implanted from the posterior approach. The screws are available as either solid or cannulated in diameters from 4.5mm and in lengths from 25mm – 120 mm. Titanium Alloy and Cobalt Chrome rods are available in 4.75mm – 6.0mm diameters either straight or pre-curved in lengths from 25-600 mm. Transition rods are also included with a tapered diameter from 4.75mm -5.5mm and lengths of 60mm - 600mm. The system also includes locking set screws, cross-links connectors, standard, reduction and Long polyaxial tulip heads along with the associated instrumentation to complete the procedure and implant construct.

Based on the provided text, the document is a 510(k) Premarket Notification for a medical device called the "Swedge™ Pedicle Screw Fixation System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's performance through extensive clinical studies with specified acceptance criteria and ground truth establishment in the way an AI/ML device would.

Therefore, many of the requested details, particularly those related to a study proving device performance against acceptance criteria for an AI/ML system (like sample size for test sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for training data), are not applicable to this 510(k) submission for a mechanical pedicle screw fixation system.

The "Performance Testing" section in the document describes mechanical testing, which is standard for orthopedic implants, not software or AI.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly not present or applicable for this type of device:

Acceptance Criteria and Device Performance (for a Mechanical Device)

For a mechanical device like a pedicle screw system, "acceptance criteria" revolve around established industry standards for mechanical performance (e.g., strength, fatigue, static/dynamic resistance). "Device performance" is the result of these mechanical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Testing shows that the subject Swedge™ Pedicle Screw Fixation System performs equivalent to the predicate Swedge™ Pedicle Screw Fixation System (K170045)." It does not provide specific numerical outcomes of these mechanical tests, but rather a qualitative statement of equivalence to the predicate as the performance conclusion.

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

• Sample Size: Not specified for the mechanical tests. For mechanical testing of medical implants, sample sizes are typically determined by relevant ISO/ASTM standards (e.g., typically n=5 or n=6 for static tests, and larger for fatigue tests, varying by standard and test type). However, the exact number tested is not provided in this public summary.
• Data Provenance: Not applicable in the context of "data" as clinical or imaging data. It refers to in vitro mechanical testing performed according to international standards (ASTM F1717). The location of the testing laboratory is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a mechanical orthopedic implant, not an AI/ML diagnostic or prognostic device that requires human expert review to establish "ground truth" for clinical data.

4. Adjudication Method for the Test Set

Not Applicable. No human interpretation or adjudication of clinical data is involved for this type of mechanical testing.

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

Not Applicable. MRMC studies are used to evaluate the diagnostic accuracy of AI-assisted systems compared to human readers alone. This is a mechanical device, not an AI system. Therefore, there is no effect size for human readers improving with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device is the performance against mechanical testing standards (ASTM F1717) and comparison to the established performance of the legally marketed predicate device. It is not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not Applicable. As a mechanical device, there is no "training set" in the context of machine learning. The design and manufacturing process are informed by engineering principles, material science, and prior predicate device designs for which performance is already established.

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

Not Applicable. There is no "ground truth" for a training set as this is not an AI/ML device. The design and manufacturing are based on engineering specifications and established material properties and biomechanical principles, validated by mechanical testing against industry standards and comparison to a predicate device.

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The Xia® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The Xia® Growth Rod Conversion Set may be used with any cleared Xia® 4.5 Spinal System rod construct. The Xia® Growth Rod Conversion Set is not intended for use in conjunction with staples.

The Xia® Growth Rod Conversion Set consists of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The Xia® Growth Rod Conversion Set components are manufactured from titanium alloy and are designed to interact with constructs consisting of hooks, screws, connectors, and 4.5mm diameter rods. The Xia® Growth Rod Conversion Set is intended for use only with Xia® 4.5 Spinal System fusion constructs cleared for pediatric use.

The provided text describes the Xia® Growth Rod Conversion Set, a medical device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity for an AI-powered device).

This document is a 510(k) premarket notification for a medical device (Xia® Growth Rod Conversion Set), which primarily focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the "Summary of the Performance Data" section (Page 4, Table "510(k) Summary") states:
"Engineering analysis demonstrated that introduction of the Growth Rod Conversion Set does not adversely affect performance of the Xia® 4.5 Spinal System and does not represent a new, worst case scenario. No additional performance data was provided."

This indicates that the "study" conducted was an engineering analysis to ensure the new component does not negatively impact the performance of an existing, cleared system, rather than a clinical study evaluating diagnostic accuracy or a specific set of performance metrics against acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided text. The document is about a different type of medical device review process (510(k) for a physical implantable device) that relies on substantial equivalence and engineering analysis, not diagnostic performance metrics or human reader studies.

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The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal 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 Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion
The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System, and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis. kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatic patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

1. Xia® 3 Spinal System
   The Xia® 3 Spinal System is comprised of screws, blockers, and hooks that affix rods and connectors to vertebrae of the spinal column for purposes of stabilization, or corrective action through the application of force.

2. Xia® 4.5 Spinal System
   The Xia® 4.5 Spinal System is comprised of monoaxial and polyaxial bone and reduction screws, hooks, dual staples, and blockers that affix rods, rod-to-rod connectors, and cross connectors to vertebrae of the spinal column.

The provided document is a 510(k) premarket notification for the Stryker Spine Xia® 3 and Xia® 4.5 Spinal Systems. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing or data analysis.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices for an expansion of indications for use.

Here's why and what information is available:

The document explicitly states:

• "This submission seeks to build upon predicate Xia® 3 and Xia® 4.5 Spinal Systems through expansion of indications only. Therefore, no additional performance data is necessary." (Page 6, "Summary of Performance Data")

This means the submission is not presenting new performance studies or acceptance criteria for a novel device or a significantly modified device. Instead, it's arguing that the expanded indications for the Xia® 3 and Xia® 4.5 Spinal Systems are substantially equivalent to the indications already cleared for a primary predicate device (Medtronic Sofamor Danek, CD HORIZON® Spinal System cleared under K140276) and previous versions of the Xia® systems.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document as no new performance data was deemed necessary for this submission. The device is implicitly accepted based on its substantial equivalence to predicate devices, which would have undergone performance testing during their original clearance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new performance studies were conducted for this 510(k). The document only mentions predicate device clearances.
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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a spinal fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) relies on the safety and effectiveness demonstrated by its predicate devices for its original indications and argues that the expanded indications are within the scope of what was already established for similar, legally marketed devices. It is a regulatory submission for a spinal implant, which typically doesn't involve the kind of performance studies (e.g., diagnostic accuracy, reader studies) that would generate the detailed data requested in your prompt regarding acceptance criteria, sample sizes, and expert ground truth for an AI/diagnostic device.

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The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion 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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed Previous Fusion.

The Radius® Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the Radius® Spinal system is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The Radius® Spinal System can also be linked to the XIA® Titanium Spinal System via the Ø5.5mm to Ø6.0mm Radius® rod-to-rod connector.

The Stryker Spine TRIO® Plate System is intended for posterior, noncervical (T10-S1) pedical and nonpedical fixation of the spine 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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion.

The Stryker Spine TRIO® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine TRIO® Spinal Fixation System is indicated for: 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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The TRIO® Spinal Fixation Sytem is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.

The Stryker Spine TRIO® Spinal System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segements in skeletally mature patients 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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The TRIO® + Spinal System is intended to be used in conjunction with the OSS/Diapason Rods or Opus Rods, XIA® Pre-bent Rods, and the Multi-Axis Cross Connectors.

The Stryker Spine TRIO® TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc Disease (DD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion.

The XIA® Spinal System and XIA® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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 6mm diameter rods from the DIAPASON® Spinal System and OPUS® Spinal System are intended to be used with the other components of the XIA® Titanium Spinal System. The Titanium Multi-Axial Cross Connector are intended to be used with the other components of the XIA® Titanium Spinal System.

The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor, Pseudoarthorisis; and Failed Pervious Fusion. The Ø5.5mm rods from the Stryker Spine Radius® Spinal System and the Ø6.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System. When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The XIA® 3 Spinal System for pediatic use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (DD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, the XIA® 4.5 Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical pedicle screw fixation in pediatric patients. The XIA® 4.5 Spinal System for pediatric use in intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The STRYKER Spine thoraco-lumbar spinal fixation systems, subject of this 510(k), are non-cervical, pedicle and non-pedicle fixation systems comprised of screws, rods, plates, hooks, connectors, washers and staples. The components are manufactured from either Titanium (Titanium Alloy and CP Titanium), Stainless Steel or Cobalt-Chromium-Molybdenum Alloy (Vitallium®). This Special 510(k) submission seeks clearance for sterile labeling of the listed STRYKER Spine thoraco-lumbar spinal fixation systems. All of the components of the subject devices will be sterilized by gamma radiation, a traditional sterilization method as per FDA guidance document, Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA.

This is a 510(k) Premarket Notification for sterile packaging of a range of spinal systems. The key claim is substantial equivalence to previously cleared non-sterile versions of the same devices. Therefore, the "device" in question for this submission is specifically the sterile packaging and the sterilization process, not the spinal implant itself as a medical device performing a physiological function. The "performance" being evaluated is the ability to maintain sterility and the structural integrity of the device within its packaging over its shelf life.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The document primarily discusses the sterilization process and packaging rather than clinical performance of the implant itself. Therefore, typical "test set" in the context of clinical or diagnostic AI/software devices (e.g., patient data) is not applicable here.

• Sterilization and Packaging Validation Data: The document mentions "accelerated aging data" for validating the 5-year shelf life. It does not specify the sample size for this testing, nor the country of origin or whether it was retrospective or prospective. However, these types of tests are typically prospective laboratory studies conducted in controlled environments.

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 submission is about the sterility and packaging of medical implants, not a diagnostic or clinical performance study that would require expert ground truth labeling. The "ground truth" here is the scientific validation of sterilization methods and shelf life according to recognized standards and FDA guidance.

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

Not applicable. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not relevant to this submission on sterile packaging.

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/software device and no MRMC study was conducted.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for this submission relies on:

• Scientific Validation of Sterilization: Adherence to established scientific principles and FDA guidance for sterilization (gamma radiation), demonstrating a Sterility Assurance Level (SAL).
• Accelerated Aging Data: Laboratory testing to simulate real-time aging and demonstrate that the sterile barrier packaging system maintains sterility for the stated shelf life.
• Material and Design Specification Conformity: Confirmation that the components are manufactured from specified materials and that their design, technical requirements, and intended use are identical to the non-sterile predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As this is not a machine learning or AI device, there is no training set and therefore no ground truth establishment for a training set.

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