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The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is indicated for the use with Medtronic CD Horizon™ SOLERA™ Spinal System which is intended for posterior, lumbar and sacral fixation 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, curvatures (i.e. scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System consists of pre-bent spinal rods compatible for use with the Medtronic CD Horizon™ SOLERA™ Spinal System. The SAS PI Rod System is manufactured from either titanium alloy or cobalt chrome.

The CD Horizon™ Spinal System consists of a variety of shapes and size of rods, screws, CROSSLINK® Plates, and connecting components which can be rigidly locked into avariety of configurations, with each construct being tailor-made for the individual case.

This looks like a 510(k) clearance letter for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study of the device's performance against specific acceptance criteria for AI/software-as-a-medical-device (SaMD).

The provided text discusses a "Spinal Alignment Solutions Pelvic Incidence (PI) Rod System," which appears to be a physical medical device (pre-bent spinal rods) intended for use with an existing spinal system (Medtronic CD Horizon™ SOLERA™ Spinal System). It is not a software-based or AI-driven device.

Therefore, the prompt's request for:
1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

...are not applicable to the content provided. The document describes a traditional medical device submission, where "Performance Testing" refers to mechanical testing (or the absence thereof, as noted in this case, due to substantial equivalence) rather than clinical performance or AI algorithm validation.

The key statement in the document regarding "Performance Testing" is:

"When used with the Medtronic CD Horizon™ SOLERA™ Spinal System the subject SAS PI Rods have the same fundamental scientific technology, indications for use, intended use, materials, manufacturing processes, and levels of attachment as the predicate CD Horizon™ SOLERA™ Spinal System devices. The subject device does not introduce a new worst case condition and therefore, no additional mechanical testing was performed."

This indicates that the clearance was based on the substantial equivalence principle, asserting that the new device is so similar to an already cleared device that no new performance studies (mechanical or otherwise) were deemed necessary by the FDA. The "acceptance criteria" for a traditional mechanical device would typically involve meeting specific mechanical strength or fatigue standards, but these are not detailed here because the pre-bent rods are considered equivalent to the existing predicate rods.

In summary, as the provided text pertains to a physical medical device (spinal rods) and a 510(k) submission based on substantial equivalence, it does not contain the information requested about acceptance criteria, study design, ground truth, or expert involvement typically associated with the validation of AI/SaMD devices.

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The Infinity™ OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:

• Traumatic spinal fractures and/or traumatic dislocations.
• Instability or deformity.
• Failed previous fusions (e.g. pseudarthrosis).
• Tumors involving the cervical spine.
• Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT Rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and VertexTM Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert and Vertex™ Reconstruction System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) reguires the use of MAS Crosslink™ at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offiset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

The PASS OCT spinal system is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT spinal system is also 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 tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the PASS OCT spinal system may be connected to the PASS LP spinal system with the dual diameter rods. Refer to the PASS LP spinal system package insert for a list of the PASS LP spinal system indications of use.

The Infinity™ OCT System and PASS OCT Spinal System (including UNID™ OCT Patient-Specific Rods) are posterior systems, which consist of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations.

The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, Cobalt-chromium molybdenum alloy Co-Cr28Mo6 according to ISO 5832-12 and ASTM F1537.

The purpose of this submission is to add titanium alloy and cobalt chrome 3.5/4.75 mm transition rods to the line of UNID™ OCT Patient-Specific Rods. The subject rods are designed and manufactured for one specific patient and are compatible with Infinity™ OCT System and PASS OCT Spinal Systems (cranially) and the CD Horizon Spinal System (caudally). The UNID™ OCT Patient-Specific Rods must be used during surgery for this patient only and must not be reused (single use only).

This document describes a spinal system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for AI/ML models is not applicable and cannot be extracted from the provided text.

The document pertains to the 510(k) premarket notification for the "Infinity™ OCT System and PASS OCT Spinal System," which are posterior cervical screw systems intended to provide immobilization of spinal segments. The purpose of the specific submission is to add titanium alloy and cobalt chrome 3.5/4.75 mm transition rods to the line of UNiD™ OCT Patient-Specific Rods.

The "Performance Data (Non-Clinical Test Summary)" section mentions that "Medicrea has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices." The tests performed were "static and dynamic compression bending, and static torsion" per ASTM F1717, to confirm the compatibility of the caudal 4.75 mm portion of the subject rods with the CD Horizon Spinal System. This describes mechanical testing of a medical device, not a study of an AI/ML algorithm.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

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

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

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

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation' attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The subject CD HORIZON® Solera™ Spinal System offers dual rod multi-axial screws (DRMAS) that have an opened head. The subject screws offer the ability to place two rods in parallel. The subject DRMAS are provided sterile.

The provided text is a 510(k) summary for the Medtronic CD HORIZON® Spinal System. It describes the device's indications for use, comparison to predicate devices, and performance data from mechanical testing and biocompatibility assessments.

However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document describes a spinal implant system, not a software or AI/ML device. The "performance data" section refers to mechanical testing (Static Compression, Static Torsion, Compression Fatigue, Axial Grip, Axial Torsional Grip, Flexion Extension Fatigue) and biocompatibility of the physical implant components, not performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI/ML device.

Therefore, the requested information specifically related to acceptance criteria and studies proving an AI/ML device meets them, along with details about sample sizes, data provenance, ground truth establishment, expert qualifications, and MRMC studies, cannot be extracted from this document.

The document primarily focuses on demonstrating substantial equivalence of a physical medical device (spinal system) to predicate devices through material properties and mechanical performance.

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When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw 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 tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with KYPHON® HV-R Fenestrated Screw Cement, the CD HORIZON® Fenestrated Screws are 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 tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON® Fenestrated Screws augmented with KYPHON HV-R® Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. KYPHON HV-R® Fenestrated Screw Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. KYPHON HV-R® Fenestrated Screw Cement will be provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.

2. The CD HORIZON® Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON® LEGACY™ and CD HORIZON® SOLERA™ implants contained in the CD HORIZON® Spinal System. The CD HORIZON® Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON® Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These screws are provided non-sterile.

The provided document is a 510(k) premarket notification for the KYPHON HV-R® Fenestrated Screw Cement and CD HORIZON® Fenestrated Screw Set. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study with specific metrics like sensitivity, specificity, or reader performance.

Therefore, many of the requested details about acceptance criteria, study design for performance measurement, ground truth, and expert involvement are not available in this type of regulatory document.

However, I can extract information regarding performance data and the overall conclusion.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Applicable. The document explicitly states "Clinical data and Non-Clinical testing were provided in support of substantial equivalence of the subject device." This indicates that the performance data was used to demonstrate that the new device is as safe and effective as the predicate devices, rather than meeting predefined acceptance criteria for diagnostic performance metrics (like sensitivity/specificity) for a specific task (e.g., detecting a condition). The performance data cited would likely be mechanical properties, biocompatibility, or other engineering parameters relevant to medical devices, not diagnostic accuracy.

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

• Not Available. The document does not specify test set sample sizes or data provenance. The "clinical data" mentioned would typically be focused on patient outcomes and safety profiles compared to predicate devices, not on a "test set" for an AI algorithm's performance.

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 device is a medical implant and bone cement system, not an AI diagnostic tool. Therefore, there is no "ground truth for a test set" in the context of expert review for diagnostic accuracy as there would be for an AI algorithm. Ground truth, if applicable in a clinical study for an implant, would relate to patient outcomes, imaging results post-procedure, or pathology reports after explantation, which are typically assessed by treating physicians or pathologists, not necessarily a panel of experts specifically for "ground truth establishment" in the way it's described for AI.

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

• Not Applicable. As explained above, this is not an AI diagnostic device and therefore, adjudication methods for a test set based on expert review are not relevant to this 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

• Not Applicable. This is a medical device (cement and screws), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described in this document.

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

• Not Applicable. This is not an algorithm or AI system.

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

• Outcomes Data/Substantial Equivalence to Predicates: While not framed as "ground truth" for an AI, the "Performance Data" and "Clinical Data and Non-Clinical testing" would have relied on various forms of data to demonstrate safety and effectiveness. For implants, this typically includes:
  • Mechanical Testing Data: Demonstrating the physical properties (strength, fatigue, etc.) of the cement and screws.
  • Biocompatibility Testing: Ensuring the materials are safe for implantation.
  • Clinical Outcomes Data: Potentially from studies comparing the device to existing treatments, or from safety monitoring, though detailed clinical trial results are not provided in a 510(k) summary. The primary "ground truth" here is often the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. This is a medical device, not an AI model requiring a training set.

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

• Not Applicable. This is a medical device, not an AI model.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical "AI performance study" framework, it does describe its substantial equivalence to predicate devices based on presented data.

Device(s) being reviewed:

• KYPHON HV-R® Fenestrated Screw Cement
• CD HORIZON® Fenestrated Screw Set

Predicate Devices:

• KYPHON® HV-R® Bone Cement (K150460)
• CD HORIZON® Spinal System (K042025 and K113174)

Basis of Substantial Equivalence (implied "performance criteria" for a 510(k) device):
The substantial equivalence is based on demonstrating that the new device has the same intended use, similar technological characteristics, and comparable performance to the legally marketed predicate devices. The document explicitly states:

• KYPHON HV-R® Fenestrated Screw Cement: "identical in composition, method of manufacture and sterilization to the primary predicate Kyphon® H-VR® Bone Cement... The only differences between the subject and predicate cement are the method in which the cement is delivered and that the subject cement is limited to patients with advanced stage tumors..."
• CD HORIZON® Fenestrated Screw Set: "have the same or similar indications, intended use, fundamental scientific technology, and are manufactured from similar materials as the pedicle screws found in the following FDA cleared CD HORIZON® Spinal System applications... The primary difference is the subject screws contain fenestrations which allow PMMA cement to flow in a controlled manner through the screw and into the targeted pedicle."

Conclusion:
"Based on the provided performance data, the subject KYPHON® HV-R Fenestrated Screw Cement is substantially equivalent to the KYPHON® HV-R® Bone Cement (K150460, SE 04/28/15) and the CD HORIZON® Fenestrated Screw Set is substantially equivalent to the CD HORIZON® Spinal System (K042025 (SE 08/25/2004) and K113174 (SE 11/21/2011))."

Performance Data Mentioned:
"Clinical data and Non-Clinical testing were provided in support of substantial equivalence of the subject device." (Details of this data are not provided in this summary.)

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The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all the following indications: 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), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista/Ballista II instruments are intended to be used with Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: 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), deformity or curvature (i.e., scoliosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.

The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

The Polaris Spinal System is a non-cervical spinal fixation device. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos and various cross connectors. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This submission is a line extension to Polaris Spinal System to add other styles of multiaxial screw, including a screw with translating feature, and to provide the Polaris Spinal System sterile packed.

The provided document describes a 510(k) summary for the Biomet Spine Polaris Spinal System - Translation Screw, which is a non-cervical spinal fixation device.

Here's an analysis 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 does not specify a "test set" in the context of clinical data for algorithmic performance. The testing performed was mechanical testing of the device hardware.

• Test Set Sample Size: Not applicable in the context of clinical data or algorithm performance.
• Data Provenance: Not applicable. The "data" comes from physical mechanical tests conducted on the device components.

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

Not applicable. Ground truth, in the context of algorithm performance, typically refers to expert-validated clinical diagnoses or outcomes. This submission focuses on mechanical performance data of a physical medical device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert opinions for clinical ground truth. Mechanical testing has well-defined pass/fail criteria per ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is a physical spinal fixation system, not an AI or imaging diagnostic tool.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the mechanical testing was the established pass/fail criteria defined by ASTM 1717-11a standard test methods for static and fatigue testing of spinal implant constructs in a vertebrectomy model.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI algorithm requiring a training set.

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

Not applicable, as there is no training set for a physical device.

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