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

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

The NorthStar OCT 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.

The NorthStar OCT System can also be linked to other FDA-cleared SeaSpine/Orthofix screw systems with the use of transitional rods and/or transitional rod connectors.

The NorthStar OCT System is a posterior occipital cervical thoracic (OCT) system that consists of implants and the associated instruments used to build constructs within the body to act as a temporary or permanent posterior fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The system includes a variety of non-sterile, single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136), commercially pure titanium (Grade 2 per ASTM F67), and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537) and is comprised of polyaxial screws, rods, hooks, connectors, occipital plates, occipital screws, and set screws that can be rigidly locked together in a variety of configurations.

The NorthStar OCT System includes the associated instruments that are designed to facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants. The implants and instruments are provided in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The provided text describes the NorthStar OCT System, a posterior occipital cervical thoracic (OCT) system, and its premarket notification (510(k)) to the FDA. However, the document does not contain any information about acceptance criteria or a study proving the device meets these criteria in the context of an AI/ML-driven device.

The document discusses:

• The device's intended use and indications for use.
• Its components, materials, and overall design.
• Non-clinical mechanical testing (dynamic compression bending, static compression bending, static torsion, and dynamic torsion testing per ASTM F2706) to demonstrate substantial equivalence to predicate devices.
• A explicit statement that clinical testing was not applicable and the determination of substantial equivalence is not based on an assessment of clinical performance data.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, as the provided text pertains to a traditional orthopedic implant (hardware) that relies on mechanical testing for 510(k) clearance, not an AI/ML diagnostic or assistive device that would typically involve a test set, ground truth experts, or MRMC studies.

If you have a document describing an AI/ML device, please provide that, and I would be happy to analyze it according to your requested criteria.

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The Integra Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.

The Integra Laminoplasty System consists of titanium alloy plates and screws that are attached to the lamina after a laminoplasty procedure. Implants are available in a range of sizes and shapes, as well as in various screw hole configurations to accommodate variations in patient anatomy. The system also includes instruments to assist with implantation, and a tray for organization and storage

The provided document is a 510(k) premarket notification for a medical device called the "Integra® Laminoplasty System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a study as would be common for AI/software devices.

Therefore, many of the requested categories for AI/software studies are not applicable directly to this submission. However, I can extract the relevant information from the document regarding the device and its testing:

Device Name: Integra® Laminoplasty System
Regulation Name: Spinal interlaminal fixation orthosis (21 CFR 888.3050)
Regulatory Class: Class II
Product Code: NQW

Here's an analysis based on the provided document:

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

• Acceptance Criteria: The primary acceptance criterion for a 510(k) submission is demonstrating "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as the predicate device. For the Integra Laminoplasty System, this was demonstrated through non-clinical testing.
• Reported Device Performance: The device "demonstrated equivalent performance to the predicate systems through static testing per ASTM F2193." This implies that the mechanical properties tested under ASTM F2193 met or exceeded the performance of the predicate device(s). Specific quantitative performance metrics (e.g., tensile strength values, compression resistance values) are not provided in this summary.

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

• The document describes non-clinical testing (static testing per ASTM F2193), not a test set for an algorithm. Therefore, "sample size" here refers to the number of physical samples tested. The document does not specify the number of samples tested under ASTM F2193.
• Data Provenance: Not applicable, as it's non-clinical lab testing of physical components, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a mechanical implant; "ground truth" in the context of expert review for AI algorithms is not relevant here. The ground truth for mechanical performance is established by standardized testing methods (ASTM F2193) and engineering principles.

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

• Not applicable. This concept pertains to resolving discrepancies among expert readers in clinical image review or similar tasks for AI evaluations. This document describes mechanical testing of a medical implant.

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. The document explicitly states: "No clinical testing was required to demonstrate equivalence." Therefore, no MRMC study, or any clinical study involving human readers with or without AI assistance, was performed.

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

• Not applicable. The "Integra® Laminoplasty System" is a physical medical device (implants and instruments) for surgery, not an algorithm or AI software. Therefore, there is no "standalone algorithm performance" to evaluate.

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

• The "ground truth" for this device's performance, in the context of regulatory submission, would be its mechanical properties meeting or exceeding those of the predicate devices as determined by standardized laboratory testing (ASTM F2193). This is a physical, objective "ground truth" based on engineering standards.

8. The sample size for the training set

• Not applicable. This is not an AI/software device that requires a training set.

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

• Not applicable. As above, there is no training set for this type of device.

Summary of what the document does provide regarding acceptance criteria and performance:

The acceptance criterion for this 510(k) submission was substantial equivalence to predicate devices in areas including intended use/indications for use, technological characteristics, and performance. This equivalence was demonstrated through non-clinical static testing per ASTM F2193, showing "equivalent performance" to the predicate systems. Specific quantitative results from this testing are not included in the public 510(k) summary. No clinical testing or AI-related studies were performed or required for this submission.

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SeaSpine Spacer System – Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene:
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 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). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft (autograft) and supplemental fixation.

Cambria NanoMetalene:
Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.

Vu aPOD-L NanoMetalene:
The Integra Vu aPOD-L Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft (i.e. autograft). The Integra Vu aPOD-L Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate.
Degenerative disc disease is defined as back pain of discogenic origin, with desc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment.

Vu ePOD NanoMetalene:
When used as an intervertebral body fusion device the Vu ePOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System. Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The SeaSpine Spacer System (Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene), Cambria NanoMetalene, Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene devices are intervertebral fusion devices made from polyetheretherketone (PEEK OPTIMA LT1 per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6Al-4V ELI per ASTM F136) for radiographic visualization. The devices have a central canal for receiving autogenous bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this 510(k) is to add a 1 micrometer surface of titanium (per ASTM F67) to the exterior surface of each of these devices.

This document is a 510(k) Premarket Notification from the FDA regarding the "SeaSpine Spacer System" with various models incorporating "NanoMetalene®". This document is a regulatory approval, not a scientific study that measures device performance against acceptance criteria in the way a clinical trial or AI algorithm validation would.

Therefore, most of the information requested in your prompt (e.g., acceptance criteria, test set sample size, expert qualifications, adjudication methods, MRMC study, standalone performance, training set size, etc.) is not applicable or available within this type of document.

Here's an explanation of what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance in this document. The "acceptance criteria" here is that the device must be "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics and any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that "analysis demonstrated that the titanium surface does not negatively impact mechanical performance of the NanoMetalene subject devices when compared to the predicate devices." This is a qualitative statement of engineering analysis and non-clinical testing results, not a quantifiable performance metric against specific clinical acceptance criteria.

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

• Not Applicable. This document focuses on non-clinical testing (engineering analysis, mechanical tests). There is no "test set" in the context of clinical data or AI algorithms. The "data provenance" mentioned in the document refers to the origin of the predicate devices and the regulatory process in the USA.

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. There is no "ground truth" establishment by experts for a test set in this regulatory submission. The "ground truth" concept is typically applied to clinical or diagnostic AI evaluations.

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

• Not Applicable. No explicit "adjudication method" is described as there is no test set of clinical cases being reviewed.

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 study was not done. This device is an intervertebral body fusion device, not a diagnostic AI system or an imaging modality requiring human reader interpretation in the context of an MRMC study.

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

• No. This is a hardware medical device (an implant), not a software algorithm. Therefore, "standalone algorithm" performance is not applicable.

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

• Not Applicable / Implied by Regulatory Framework. For this type of device submission, the "ground truth" or standard for comparison is compliance with recognized engineering standards (e.g., ASTM standards for mechanical testing) and demonstrating substantial equivalence to predicate devices that have already been deemed safe and effective by the FDA. The performance is assessed against these established non-clinical benchmarks rather than clinical "ground truth" data (like pathology or outcomes) in this specific submission.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As there is no training set, this question is not relevant.

In summary: This FDA 510(k) letter and summary describe a regulatory approval process for a medical device (intervertebral body fusion device) based on proving "substantial equivalence" to existing predicate devices through engineering analysis and non-clinical testing. It is not a clinical study or AI algorithm validation with specific clinical acceptance criteria, test sets, or expert ground truth adjudication.

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The Integra® Expandable Intervertebral Body Fusion Device (IBD) System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 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). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.

The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASTM F2026), titanium (Ti-6Al-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiographic tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft. They are available in a range of sizes, and their heights can be intra-operatively expanded to the desired height to accommodate variations in surgical approach and patient anatomy. Non-expandable implants are manufactured from PEEK-OPTIMA® LT1 only with radiopaque markers. The system also includes instruments to assist with the surgical procedure/ implantation, as well as trays and caddies for organization.

This is a medical device application for an intervertebral body fusion device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML performance, is not applicable in this context.

Here's a breakdown of why the requested information cannot be provided given the input:

• Device Type: The Integra Expandable IBD System is a physical medical implant (intervertebral body fusion device) made of PEEK, titanium, and cobalt chromium. It is not a software algorithm or an AI/ML diagnostic tool.
• Regulatory Pathway: This is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices. This pathway typically relies on non-clinical (bench) testing and comparison to existing devices, rather than large-scale clinical trials or AI/ML performance studies with specific acceptance criteria like sensitivity, specificity, etc.
• Non-Clinical Testing: The submission explicitly states "Non-clinical Testing: The Integra Expandable IBD System demonstrated equivalent performance to the predicate systems through static and dynamic axial compression shear testing per ASTM F2077, with wear evaluation per ASTM F1877, subsidence testing per ASTM F2267, and expulsion testing per ASTM Draft F04.25.0202. In addition, a cadaver implantation study was conducted to demonstrate usability and graft containment/volume of the subject device."
• Clinical Testing: The submission explicitly states "Clinical Testing: No clinical testing was required to demonstrate equivalence."

Therefore, I cannot populate the table or answer the questions as they pertain to AI/ML device validation. The provided document concerns a traditional medical device demonstrating substantial equivalence through non-clinical performance standards and a cadaver study, not through a study involving AI performance metrics, readers, or ground truth as defined in an AI context.

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Integra Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions:

• 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 tumor

The device is not intended for stand-alone use.

The Integra Spinous Process System consists of an implantable spacer featuring plates of varying lengths with fixed hub diameters and set screws in order to clamp bilaterally to the spinous processes. It is a multicomponent device consisting of two plates coupled by a central hub and locked by a set screw. Each plate contains spikes for fixation to the spinous process to aid in resisting rotation after implantation. The device is available in a range of sizes to accommodate variations in patient pathology and anatomy. It is manufactured from Ti-6Al-4V ELI per ASTM F136. The device is provided non-sterile and is single use only. The complete system, including insertion and accessory instrumentation for implantation, is packaged in a tray for transportation, cleaning and sterilization.

The Integra Spinous Process System is a medical device and as such, the concept of "acceptance criteria" and "device performance" as it might apply to an AI/ML model's diagnostic accuracy is not directly applicable.

Instead, the provided text describes the device's substantial equivalence to predicate devices based on technological characteristics and performance testing.

Here's an breakdown of the information that is available, structured to align with your request where possible:

(1) A table of acceptance criteria and the reported device performance

For a medical device like the Integra Spinous Process System, "acceptance criteria" are typically related to meeting established mechanical and material standards and demonstrating equivalence to legally marketed predicate devices. "Device performance" is then evaluated against these established standards and predicate devices.

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

This information is not applicable as this is a physical medical device (implant) and not an AI/ML diagnostic system. The "test set" here refers to mechanical testing of the device itself, not clinical data or patient samples. The provenance of such mechanical testing is typically the testing lab.

(3) Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth, in the context of device performance, would be defined by the technical specifications outlined in the ASTM standards (F1717 and F1798) and the performance of the predicate devices. The "experts" would be the engineers and scientists who conducted and interpreted the mechanical tests.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth from human expert opinions. For mechanical device testing, the results are typically objectively measured against pre-defined engineering 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

This information is not applicable. This device is an implantable surgical system, not an AI-assisted diagnostic tool.

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

This information is not applicable. This is a physical medical device.

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

The "ground truth" for this device's acceptance is based on:

• Established mechanical testing standards: Specifically, ASTM F1717 and ASTM F1798, which define methods for evaluating the mechanical properties of spinal implants.
• Performance of legally marketed predicate devices: The Integra Spinous Process System's performance was compared to the performance of predicate devices (Life Spine Interspinous Fixation System, NuVasive® Spinous Process Plate System, Lanx Spinous Process Fusion Plate (SPFP), and Medtronic CD Horizon Spinous Process Plate) to demonstrate substantial equivalence.

(8) The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML model.

(9) How the ground truth for the training set was established

This information is not applicable as this is a physical medical device, not an AI/ML model.

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The Integra® Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra "Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.

The Integra® Laminoplasty System consists of plates and screws that are attached to the lamina after a laminoplasty procedure; the system is manufactured from Titanium 6Al-4V ELI per ASTM F136. Implants are available in a range of sizes and shapes, as well as in various screw hole configurations to accommodate variations in patient anatomy. The system also includes instruments to assist with implantation, and a tray for organization and storage

This 510(k) summary for the Integra® Laminoplasty System describes a medical device clearance based on substantial equivalence, rather than a study proving the device meets specific acceptance criteria through AI or clinical performance. Therefore, most of the requested information regarding AI study design, ground truth, and expert evaluation is not applicable.

Here's the information that can be extracted from the provided text, primarily focusing on the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The testing involves mechanical evaluation of the device components, not patient data.
• Data Provenance: Not applicable, as this refers to mechanical testing, not a clinical study with patient data.

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

• Number of experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F2193) and the results of the physical tests.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Not applicable. Mechanical testing results are typically measured against established engineering 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 MRMC study was done. This document describes a medical device, not an AI system. The submission explicitly states: "No clinical testing was required to demonstrate equivalence."

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used

• For the non-clinical testing: The "ground truth" is defined by the performance characteristics and requirements outlined in the ASTM F2193 standard for spinal intervertebral body fixation devices. The device's mechanical performance is compared to that of the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.

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

• Not applicable. There is no training set.

Summary of the K130830 Submission:

This 510(k) submission for the Integra® Laminoplasty System is based on substantial equivalence to existing legally marketed predicate devices. The primary evidence presented for regulatory clearance is non-clinical mechanical testing conducted according to ASTM F2193. The purpose of this testing was to demonstrate that the new device performs equivalently to the predicate devices in terms of static and dynamic mechanical properties. No clinical studies, AI performance evaluations, or expert consensus on clinical outcomes were required or performed for this clearance.

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The intended use of the Malibu System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions 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 (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),

• trauma (i.e., fracture or dislocation),

• spinal stenosis, ·

• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• tumor,

• pseudarthosis, and/or

• failed previous fusion.
  The intended use and indications of the Malibu™ Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

• degenerative disc disease (DDD) 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 or dislocation),

• spinal stenosis.

• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• tumor,

• pseudarthosis, and/or

• failed previous fusion.

The Malibu Spinal System contains titanium alloy and cobalt alloy implants and surgical tools. This submission is intended to address line extensions for spinal rods of identical material composition and dimensional specifications but with a higher tensile strength and varying uni-planar pedicle screws. Additional documentation is submitted for a reduced sterilization time for the Malibu implants within the Daytona™ Deformity System.

The Malibu™ Spinal System with the Daytona™ Deformity System is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as ground truth, training set, test set, effect size, etc.) are not applicable.

This device is a Pedicle Screw Spinal System and a Spinal Interlaminal Fixation Orthosis, which are hardware components (spinal rods and pedicle screws) used in spinal fusion procedures. The submission is a "Special 510(k)" for line extensions.

Here's the information based on the provided document:

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

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

• Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical data. The performance testing was based on mechanical testing of the devices themselves, comparing them to predicate devices.
• Data Provenance: The testing was mechanical/bench testing according to ASTM standards (F1717 and F1798) comparing the new device designs to existing predicate devices. This is laboratory-based data, not human patient data in this context.

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

• Not applicable. This is a medical device (spinal hardware) that undergoes mechanical testing, not an AI/ML device requiring expert consensus for image or clinical data.

4. Adjudication method for the test set:

• Not applicable. This is a medical device (spinal hardware) that undergoes mechanical testing, not an AI/ML device requiring adjudication of clinical or image data.

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 (spinal hardware), not an AI/ML device.

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

• Not applicable. This is a medical device (spinal hardware), not an AI/ML algorithm.

7. The type of ground truth used:

• For mechanical performance, the "ground truth" is established by the performance characteristics of legally marketed predicate devices and the requirements of recognized industry standards (ASTM F1717 and F1798). The new devices are shown to be "equivalent" in these mechanical tests to their predicates.

8. The sample size for the training set:

• Not applicable. This is a medical device (spinal hardware), not an AI/ML device.

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

• Not applicable. This is a medical device (spinal hardware), not an AI/ML device.

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This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
• trauma (including fracture or dislocation);
• spinal stenosis;
• cervical myelopathy;
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• tumor:
• pseudoarthrosis; and/or
• failed previous fusion

The Cardiff™ Anterior Cervical Plate (ACP) System is interior interbody screw fixation of the cervical spine only. The Cardiff™ ACP System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The Cardiff™ ACP System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Cardiff™ ACP System implants are manufactured from Titanium and Nitinol alloys. Fixation is provided by bone screws into the vertebral body of the cervical spine using an anterior approach.

The provided text describes a Special 510(k) submission for the Cardiff™ Anterior Cervical Plate (ACP) System. This submission is for a product line modification of an already cleared device, not an AI/ML powered medical device, and therefore does not contain information about acceptance criteria, device performance metrics, or study details typically found in submissions for such devices.

The key points from the provided text are:

• Device Type: Anterior Cervical Plate System (a physical implant for spinal fixation).
• Purpose of Submission: Special 510(k) for manufacturing process changes and addition of implant variations to an already cleared device.
• Substantial Equivalence: The submission asserts substantial equivalence to previously cleared Cardiff™ ACP System (K083338) and Sonoma™ ACP System (K032368).
• No New Clinical/Non-Clinical Testing: The document explicitly states: "No additional non-clinical testing was required to demonstrate equivalence with the previously cleared Cardiff™ or Sonoma ACP Systems." and "Engineering and Clinical rationale verified that no additional risks were introduced into the system."

Given this, I cannot provide the requested information as it pertains to AI/ML device studies (acceptance criteria, performance, sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance, training sets). This submission is for a modification to a physical implant where the changes are deemed not to alter the fundamental scientific technology and thus did not require new performance studies.

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The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine.

The SeaSpine Monopolar Probes conduct electrical stimulation to nervous tissue that may be present in close proximity of the surgical corridor to the spine. This system is not comprised of a nerve stimulator or recorder; instead it will use conventional stimulators found in the market. The SeaSpine Monopolar Probes are insulated by a biocompatible PEEK (polyetheretherketone) layer all around one or more conductive stainless steel wire(s) with the exception of the distal and proximal ends. The distal end contacts the target tissue and the proximal end connects to standard intraoperative neuromonitoring monopolar stimulator) that offers triggered electromyography (EMG) capability. Triggered EMG is a standard intraoperative practice where motor nerves are stimulated and their corresponding muscle group response is recorded, allowing for avoidance of nervous tissue during surgical approach. The proximal connector design meets the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.

The provided text describes a 510(k) submission for the SeaSpine Monopolar Probe System, which is a medical device for nerve stimulation and tissue dilation during spinal surgery. The submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way one might find for a novel diagnostic or therapeutic algorithm.

Therefore, the study design and acceptance criteria metrics requested in the prompt do not directly apply to this type of regulatory submission. The "acceptance criteria" here are effectively satisfied by demonstrating that the device is "as safe, as effective, and performs as well as or better than" the legally marketed predicate devices through engineering analysis, materials comparison, and adherence to relevant standards.

However, I will extract the available information to address the prompt's points as closely as possible within the context of this 510(k) submission.

Summary of Acceptance Criteria and Device Performance (based on Substantial Equivalence)

The "acceptance criteria" in this context are met by demonstrating substantial equivalence to the predicate devices. The "reported device performance" is essentially that it functions similarly to the predicates.

Given that this is a 510(k) submission based on substantial equivalence, the following points address what is available in the document:

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

   • This document does not describe a clinical "test set" in the traditional sense of a clinical trial for performance evaluation of an AI/ML device. The evaluation is primarily based on engineering analysis, material comparisons, and adherence to existing standards, comparing the new device to established predicate devices already on the market. Therefore, there's no sample size or specific data provenance mentioned for a test set.

2. 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. The ground truth, in this context, is the established safety and effectiveness of the predicate devices and the relevant industry standards (ISO 10993, USP Class VI, IEC 60601-1). There is no mention of experts establishing ground truth for a novel "test set" for this device.

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

   • Not applicable. No clinical test set or adjudication process is described in this 510(k) submission.

4. 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 not an AI/ML diagnostic or assistive technology and no MRMC study was conducted or is relevant to this type of device submission.

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

   • Not applicable. This is a physical medical instrument (monopolar probe) and not an algorithm or software-only device.

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

   • The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (Medtronic Xomed Stimulus Dissection Instruments (K014165) and Nuvasive Neurovision JJB System (K051718)), along with adherence to recognized performance and safety standards (ISO 10993 for biocompatibility, USP Class VI for adhesive, and IEC 60601-1 for electrical safety).

7. The sample size for the training set

   • Not applicable. This device is not an AI/ML device requiring a training set.

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

   • Not applicable. This device is not an AI/ML device requiring a training set.

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