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The CONDUIT™ Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The CONDUIT™ Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. CONDUIT™ Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The CONDUIT™ ALIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

The CONDUIT™ TLIF Cages with a microscopic roughened surface and micro and nanoscale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

The CONDUIT™ LLIF Cages with a microscopic roughened surface and micro and nano- scale features is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. CONDUIT™ LLIF Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The CONDUIT™ T/PLIF Cages with a microscopic roughened surface and micro and nanoscale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Putty must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT BG Putty must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

FIBERGRAFTIM BG Putty GPS - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Putty GPS is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Putty GPS must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT BG Putty GPS must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT BG Putty GPS is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be obtain rigid stabilization.

The GPS Cannula is intended for use only with FIBERGRAFT™ BG Putty GPS and no other products.

The CONDUIT™ Technology platform is a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal/Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The CONDUIT™ Cages are made from Ti-6A1-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous, or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion. The 3D Printed CONDUIT™ Cages have a microscopic roughened surface with micro and nanoscale features. The micro and nano features are on all surfaces of the cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure. The FIBERGRAFT™ BG Putty is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable/polymeric carrier to form a cohesive material.

The provided text does not contain typical acceptance criteria and device performance metrics, as it is a 510(k) summary for medical devices (intervertebral body fusion devices and bone graft substitutes). These summaries typically demonstrate substantial equivalence to predicate devices rather than proving specific performance against defined acceptance criteria in the same way a diagnostic AI/ML device would.

However, I can extract information related to the clinical data used to support the expanded indications, which functions as the nearest equivalent to "device performance" in this context.

Here's an analysis of the provided text, structured to address your questions. Please note that several of your requested fields (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not explicitly detailed in this type of regulatory document for these specific medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this document does not present quantitative "acceptance criteria" and "reported device performance" in the typical sense for an AI/ML diagnostic device with discrete metrics like sensitivity, specificity, or AUC. Instead, the "performance" is demonstrated through clinical data showing fusion rates and adverse event rates to support the safety and effectiveness of the device for its expanded indications. The "acceptance criteria" in this context are implicitly met if the clinical data demonstrates reasonable safety and effectiveness comparable to predicate devices for the expanded use.

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

• Sample Size (Test Set): 178 subjects. (This is the total number of subjects in the clinical data used to support the expanded indications.)
• Data Provenance:
  • Country of Origin: United States (specifically, multiple sites across CA, TX, FL).
  • Retrospective or Prospective: The text mentions "a retrospective study and two investigator-initiated studies." This indicates a mix of retrospective and potentially prospective (investigator-initiated studies often have a prospective component, though not exclusively de novo prospective trials for this type of submission).

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

This information is not provided in the document. For intervertebral fusion devices, "ground truth" would typically relate to clinical outcomes assessed by treating physicians (e.g., fusion status determined radiographically and clinically by surgeons/radiologists) rather than consensus among independent experts for a diagnostic algorithm.

4. Adjudication method for the test set

This information is not provided in the document.

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 is not applicable. The devices (intervertebral fusion cages and bone graft putty) are physical implants, not AI/ML diagnostic software that assists human readers.

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

This is not applicable. The devices are physical implants, not an algorithm.

7. The type of ground truth used

The "ground truth" is implicitly clinical outcomes data, including:

• Fusion status: Assessed radiographically and clinically (though details of how this assessment was performed for the studies are not provided).
• Adverse events: Clinical documentation of complications.

8. The sample size for the training set

This is not applicable. The clinical data mentioned is for demonstrating the performance of the physical device for expanded indications, not for training a machine learning model.

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

This is not applicable.

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The CONFIDENCE SPINAL CEMENT SYSTEM® is intended for percutaneous delivery of the CONFIDENCE™ High Viscosity Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

When the CONFIDENCE™ High Viscosity Spinal Cement is used in conjunction with the VIPER® and EXPEDIUM® Fenestrated Screw Systems, the cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VERTEBROPLASTIC Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

CONFIDENCE® Spinal Cement System: The CONFIDENCE cement is a self-curing, polymethylmethacrylate (PMMA) radiopaque bone cement. Its package includes two sterile components: a sachet containing powder polymer and an ampoule containing liquid monometer.

VERTEBROPLASTIC™ Radiopaque Bone Cement: The VERTEBROPLASTIC Radiopaque Bone Cement is a self-curing methyl methacrylate cement consisting of a powder polymer component and a liquid monomer component. The powder component is contained within a foil pouch and the liquid component in a sterile ampoule within a blister pack. The blister pack and the foil pouch are held securely on a card insert that is sealed into a peelable pouch.

The provided FDA 510(k) summary (K201831) focuses on obtaining clearance for magnetic resonance compatibility labeling for the CONFIDENCE® Spinal Cement System and the VERTEBROPLASTIC™ Radiopaque Bone Cement. The document primarily describes the non-clinical testing performed to establish MR compatibility, rather than clinical performance for their primary intended use (treatment of certain vertebral fractures).

Therefore, the requested information specifically regarding acceptance criteria and performance related to the therapeutic efficacy or diagnostic accuracy of the device is not present in this document. The study described is about the device's behavior in an MR environment.

Here's an analysis based on the provided document for the MR compatibility study:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document refers to the standard ASTM F2503 for "Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment." This standard outlines methods for testing and labeling medical devices for safe use in MRI. Specific quantitative thresholds from ASTM F2503 (e.g., maximum temperature increase, displacement force, image artifact size) are not explicitly detailed in this summary, but the general acceptance criterion is "safety in the MR environment."

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

• Sample Size: Not explicitly stated for specific tests within the summary. However, non-clinical bench testing typically involves multiple samples to ensure reproducibility and statistical confidence.
• Data Provenance: Not applicable as this was a non-clinical, bench-top study conducted in a controlled lab environment, not involving human or animal subjects or
  data from a specific country or in a retrospective/prospective manner in the traditional sense.

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

• Not applicable. This was a non-clinical engineering/physics study to measure device behavior in an MR environment, not a clinical study requiring expert diagnosis or
  interpretation to establish ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This was a non-clinical engineering/physics study. The "ground truth" (i.e., the device's behavior in an MR field) is determined by direct measurement
  against the specifications of the ASTM F2503 standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing human reader performance with medical
  AI/imaging devices, which is not the subject of this submission.

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

• Not applicable. This submission is for physical medical devices and their MR compatibility, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the MR compatibility study, the "ground truth" is defined by the technical specifications and safety limits outlined in the ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. The device performance is measured against these established engineering and safety standards.

8. The Sample Size for the Training Set

• Not applicable. This was a non-clinical bench study, not an AI or machine learning model development where training sets are used.

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

• Not applicable, as there was no training set in this non-clinical submission.

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The EXPEDIUM Verse System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Verse System is intended for noncervical pedicle fixation 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, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM Verse System is intended for noncervical pedicle fixation and nonpedicle fixation 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, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Verse System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM Verse system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM® Verse System is designed to provide intraoperative polyaxial to monoaxial conversion. It facilitates easier rod capture and provides a powerful and precise reduction mechanism. Verse is a reduced profile thoracolumbar implant for use for with wide range of patient statures. EXPEDIUM Verse is a self-contained, efficient, and intuitive instrument system that is compatible with EXPEDIUM 5.5 rods, hooks and mono screws to enhance versatility.

The provided document is a 510(k) premarket notification for the DePuy Synthes Spine EXPEDIUM® Verse Spine System. It describes the device, its intended use, and comparability to predicate devices, but does not contain information related to software or AI algorithms, nor does it provide a study that directly assesses the performance of an AI device against specific acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for AI-related studies.

The document discusses mechanical testing for the physical medical device (spinal implant system), not an AI or software device. The "Non-clinical Test Summary" and "Conclusion" sections refer to these mechanical tests.

To answer your request, I would need a document detailing the performance of an AI-based device, including its acceptance criteria and a study demonstrating its performance.

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The EXPEDIUM, VIPER, and VIPER2 Spine Systems are 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.

The EXPEDIUM, VIPER, and VIPER2 Spine System is intended for noncervical pedicle fixation and nonpedicle fixation 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 failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation 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, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM® and VIPER® and VIPER® 2 Spine Systems consist of titanium rods, pedicle screws, connectors, hooks, and extended tab implants, which are terminally sterilized via gamma radiation. Previously, these devices were commercialized as clean, non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain implants will be packaged in sterile multi-packs for customer convenience.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided 510(k) summary, there is no performance data or studies provided to establish acceptance criteria for a device's performance. This submission is for modifications to an existing spinal system (EXPEDIUM®, VIPER®, and VIPER2® Spine Systems) where the primary change is the sterilization method.

The summary explicitly states: "Performance data is not provided in this submission."

Therefore, I cannot populate the requested table or answer the specific questions related to performance studies, acceptance criteria, sample sizes, ground truth, or expert involvement because this information is not present in the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices based on identical design, materials, indications, and technology, with the only modification being the terminal sterilization method via gamma radiation. In such submissions, the FDA typically accepts the existing safety and effectiveness profile of the predicate device if the changes are deemed not to alter these fundamental aspects.

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The EXPEDIUM and VIPER/VIPER2 Spine Systems are 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.

The EXPEDIUM and VIPER/VIPER2 Spine System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation 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, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER/VIPER2 System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM and VIPER/VIPER2 PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from LI-SI in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The subject EXPEDIUM® Spine System and VIPER®/VIPER®2 Systems are pedicle screw scoliosis systems for the treatment of pediatric patients consisting of a wide range of components in a variety of geometries and sizes.

The provided document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of diagnostic accuracy or algorithmic performance.

Instead, this is a 510(k) summary for the "EXPEDIUM® Spine System, VIPER® System, VIPER®2 System," which are pedicle screw spinal systems. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, an approval pathway primarily concerned with the safety and effectiveness of a new device compared to an existing one, rather than novel performance benchmarks.

Here's a breakdown of what the document does state regarding performance:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document does not define specific performance metrics or acceptance criteria for the device's function or a study comparing it to those criteria.

2. Sample size used for the test set and the data provenance: Not applicable. No test set or data provenance for performance evaluation is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.

4. Adjudication method for the test set: Not applicable. No test set adjudication is described.

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 surgical implant (pedicle screw system), not an AI-assisted diagnostic tool, so an MRMC study is irrelevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic or AI device.

7. The type of ground truth used: Not applicable. No ground truth is mentioned.

8. The sample size for the training set: Not applicable. No training set is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set ground truth is mentioned.

Key statements from the document regarding performance:

• "No new testing was performed. Published clinical results and engineering analysis supported the expansion of indications." (Page 2, section "Performance Data")
• "The substantial equivalence justification demonstrates that the device is as effective, and performs as well as the predicate device." (Page 3, Conclusion)

In summary, this 510(k) submission relies on demonstrating substantial equivalence to predicate devices, drawing on existing clinical results and engineering analyses, rather than presenting a performance study with defined acceptance criteria for the device itself.

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The VIPER systems are 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 of deformities of the thoracic, lumbar, and sacral spine.

The VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation 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, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous, posterior approach with MIS instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation 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, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The VIPER® System is a 5.5mm rod system offered in both stainless steels and titanium materials. The system consists of monoaxial screws. polyaxial screws. uni-planar screws, and extended tab implants. They are available in various geometries and sizes to accommodate patient anatomy.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The performance data relied on Finite Element Analysis (FEA), which is a computational simulation method, not a test on physical samples in the traditional sense requiring a "test set" sample size or data provenance from a specific geographical region (country of origin). It's a predictive engineering analysis.

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

This information is not applicable/not provided. FEA uses engineering principles and material properties as its "ground truth" for simulation, not expert human interpretation of test data in the way a clinical study would. The analysis is performed by engineering professionals.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As FEA is a computational analysis, there is no "adjudication method" in the sense of reconciling human expert opinions on a test set. The results are derived directly from the simulation model.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers interpreting medical images or data, which is not relevant to the engineering rationale and Finite Element Analysis performed for this device modification.

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

Yes, in essence, a "standalone" performance evaluation was done, though not a standalone algorithm in the typical AI sense. The Finite Element Analysis (FEA) is a computational method that stands alone in evaluating the mechanical performance based on engineering models, without human intervention in the execution of the mechanical test itself. The FEA itself is the "algorithm" that provides the performance data without a human-in-the-loop for the mechanical assessment.

7. The Type of Ground Truth Used

The ground truth used for the Finite Element Analysis (FEA) would be established engineering principles, material properties (e.g., strength, stiffness of ASTM F 138, F 139 stainless steel, and F 136 titanium alloy), and validated computational models (e.g., meshing, boundary conditions, load application matching physiological conditions). There is no expert consensus, pathology, or outcomes data used as ground truth for this type of mechanical equivalence study.

8. The Sample Size for the Training Set

This information is not applicable/not provided. FEA is a simulation method, not a machine learning algorithm that requires a "training set." The models are built based on design specifications and material properties.

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

This information is not applicable/not provided. As there is no training set in the machine learning sense, there's no ground truth established for it. The "ground truth" for the FEA itself (as explained in point 7) is based on established scientific and engineering principles.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic iunction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal Svstem is intended for:

• . DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• spondylolisthesis .
• . spinal stenosis
• fracture/dislocation .
• atlanto/axial fracture with instability ●
• . occipitocervical dislocation
• revision of previous cervical spine surgery .
• . tumors

The occipital bone screws are limited to occipital fixation only.

The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.

The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TiMX®, MONARCH®, EXPEDIUM®, VIPER® and MOSS® MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.

The MOUNTAINEER OCT Spinal System consists of plates, nuts, bone screws, rods, transverse rod connectors, lateral offset connectors, head-to-head connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws, monoaxial screws, hooks and SONGER® Cables.

The MOUNTAINEER OCT System Titanium Rods (Ti-6AL-4V) are offered in both Straight and Dual Diameter designs. The Straight Rod diameter is 3.5mm and has lengths ranging from 25mm-100mm in increments of 5mm and lengths ranging from 100mm-400mm in increments of 20mm. The Dual Diameter Rods consists of 3.5 - 4.5mm, 3.5 -4.75mm. 3.5 - 5.5mm. and 3.5 - 6.35mm diameters with Rod lengths of 420mm and 600mm.

The proposed MOUNTAINEER Cobalt Chromium (Co-Cr) Rods also consist of both Straight and Dual Diameter designs. The Straight Rod diameter is 3.5mm and available in lengths ranging from 25mm to 100mm (increments of 5mm) and 120, 200, 340 and 400mm. The Dual Diameter MOUNTAINEER Co-Cr Rods consist of 3.5 – 4.5mm, 3.5 – 4.75mm, 3.5 – 5.5mm and 3.5 – 6.35mm and available in lengths of 420 and 600mm.

Other than the modifications to the material from Ti-6Al-4V to Co-Cr, no other modifications have been made. The proposed Cobalt Chromium rods are not being made to address a known recall or adverse events. These proposed components have been developed as additions to the existing MOUNTAINEER OCT Spinal System.

The MOUNTAINEER OCT Spinal System is not an AI/ML powered medical device. The information provided describes a traditional medical device (Spinal System) and its 510(k) submission. Therefore, it does not have the acceptance criteria or study details typically associated with AI/ML device performance.

The submission focuses on demonstrating substantial equivalence to a predicate device based on material change (from Titanium to Cobalt Chromium) while maintaining identical design, indications for use, and technology.

Here's an analysis based on the provided text, focusing on the available "Performance Data" which is relevant to a non-AI device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are tied to mechanical performance standards to ensure the new material (Cobalt Chromium) performs equivalently to the predicate Titanium device. The reported performance refers to the results of these tests.

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

• Sample Size: Not explicitly stated in the provided text. Mechanical testing typically involves a sufficient number of samples to achieve statistical significance for each test (static, dynamic, torsion).
• Data Provenance: The data is from "Performance data per ASTM F 1717" submitted by the manufacturer, DePuy Spine, Inc. This is prospective testing of the device itself, not retrospective patient data.

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

Not applicable. For a mechanical device, performance is established through objective, standardized physical testing (e.g., ASTM F 1717), not through expert consensus on medical images or patient outcomes. The "ground truth" is the physical properties and performance of the device under specific load conditions.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical data, especially in studies involving AI/ML where ground truth needs to be established from subjective interpretations. This submission involves objective 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 not an AI/ML powered device, and no MRMC study was conducted or is relevant for this type of device submission.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM F 1717). The measured physical properties and performance characteristics (e.g., strength, fatigue resistance) of the Cobalt Chromium rods, when compared against the established performance of the Titanium predicate device, serve as the ground truth for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device, so there is no "training set."

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

Not applicable. This is not an AI/ML powered device.

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The EXPEDIUM and VIPER Systems are 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.

The EXPEDIUM and VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation 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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation 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 failed previous fusion in skeletally mature patients.

The proposed cortical fix polyaxial screws for EXPEDIUM and VIPER System are available in various geometries and sizes.

The provided 510(k) summary (K110216) describes the DePuy Spine EXPEDIUM® and VIPER® Systems. This device is a spinal fixation system, and the submission focuses on new cortical fix polyaxial screws for these systems.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "No clinical tests were performed." Therefore, there is no information regarding a test set sample size or data provenance from a human study. The testing performed was mechanical.

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

Not applicable, as no clinical tests were performed. The "ground truth" for the mechanical tests would be the established engineering standards (ASTM F 1798-97) and the physical measurements against those standards. These would be assessed by engineers/technicians performing the tests.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical tests were performed involving human readers or interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The submission states, "No clinical tests were performed."

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

Not applicable, as this device is a physical medical implant (spinal fixation system), not a software algorithm.

7. The Type of Ground Truth Used:

For the mechanical tests performed, the "ground truth" is defined by the ASTM F 1798-97 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The device's performance was compared against the requirements and specifications outlined in this standard.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical implant, not a machine learning or AI algorithm, so there is no training set in the conventional sense. The "development" or "design" process for such a device involves engineering principles, material science, and manufacturing processes, rather than data-driven algorithm training.

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

Not applicable, as there is no training set for this type of device.

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The EXPEDIUM and VIPER Systems are 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.

The EXPEDIUM and VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation 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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation 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, kyphosis, and/or lordosis); tumor: pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The proposed closed polyaxial screws for EXPEDIUM and VIPER Spine System are available in various geometries and sizes. Manufactured from ASTM F138 implant grade stainless steel and ASTM F136 implant grade titanium alloy.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

This submission focuses on non-clinical (mechanical) testing for "EXPEDIUM® and VIPER® Systems" for spinal fixation. There were no clinical studies performed in this submission.

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

The document does not explicitly state the sample sizes for each mechanical test. However, these tests are typically conducted on multiple samples of the device components to ensure consistency and reliability. The data provenance is from non-clinical laboratory testing conducted by the manufacturer, DePuy Spine, Inc.

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

Not applicable. The ground truth for mechanical testing is established by engineering standards (ASTM F 1798-97) and measured physical properties, not by human expert interpretation.

4. Adjudication method for the test set:

Not applicable. Mechanical tests involve objective measurements against predefined engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This was a non-clinical submission for spinal implants, focusing on mechanical performance. MRMC studies are relevant for evaluating diagnostic or interpretive devices that involve human readers.

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

No. This is a hardware device (spinal implants), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable. The performance evaluated here is the standalone mechanical integrity of the device itself.

7. The type of ground truth used:

The ground truth used was objective mechanical measurements against established ASTM standards (ASTM F 1798-97) for spinal arthrodesis implants.

8. The sample size for the training set:

Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

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

Not applicable, as no training set was used.

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The EXPEDIUM Spine 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.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation 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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

The EXPEDIUM Spine System is a 5.5mm rod-based and platebased system offered in both titanium and stainless steel. The system consists of monoaxial screws, polyaxial screws, uni-planar screws, reduction screws, reduction hooks, hooks, extended tab implants, sacral extenders, lateral connectors, washers, fixed bolts, polyaxial bolts, closed screws, slotted connectors, plates, nuts, washers, drop-entry connectors, modular cross connectors, transverse rod connectors, and wires.

The proposed addition to the EXPEDIUM 5.5mm Spine System is an increased favored angle polyaxial screw. The polyaxial screw head opens posteriorly for placement of a rod which is secured to a screw by either a dual inner or unitized set screw. This additional component is available in various geometries and sizes to accommodate patient anatomy. It will be provided non-sterile.

Here's a breakdown of the acceptance criteria and study information for the K102249 submission, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a Special 510(k) submission for an addition to an existing spinal system, the EXPEDIUM® Spine System. The acceptance criteria and "device performance" (in this context, demonstrating that the new component meets the same performance standards as the predicate device) are based on mechanical non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size (number of devices/components tested) for each mechanical test. It only states that the tests were conducted in accordance with ASTM F1798-97.
• Data Provenance: The data is from non-clinical mechanical testing performed by the manufacturer, DePuy Spine, Inc., presumably in their labs. This is not patient-derived data, so terms like "country of origin" or "retrospective/prospective" are not applicable.

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

This question is not applicable to this submission. The "ground truth" for mechanical testing is established by the specified ASTM standard (F1798-97), which outlines the methodology and performance metrics. There are no "experts establishing ground truth" in the sense of clinical interpretation or diagnosis for this type of non-clinical mechanical evaluation.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication typically refers to the process of resolving discrepancies in expert opinions, often in clinical studies. For mechanical testing against an ASTM standard, the results are objectively measured and compared to the predefined criteria of the standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed."

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

This question is not applicable. This submission is for a physical medical device (spinal implant components), not a software algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device meets acceptance criteria is adherence to established mechanical testing standards (ASTM F1798-97). The performance of the new components was compared to these standards to ensure they are equivalent to the predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. This submission is for a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

This question is not applicable. As there is no training set for a machine learning model, there is no ground truth for a training set to be established.

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