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

The NuVasive® Camber Laminoplasty System consists of plates and screws of various sizes made from titanium alloy (ASTM F136) to provide reinforcement while expanding the spinal canal and preserving the posterior elements. Instruments required to implant the device are also available.

This document describes the FDA 510(k) clearance for the NuVasive® Camber Laminoplasty System. This is a medical device, not an AI/ML imaging device, so the typical acceptance criteria and study designs for AI/ML devices (e.g., MRMC studies, standalone performance, ground truth establishment for AI training/testing data) are not applicable here.

Therefore, the response below will describe the device-specific acceptance criteria and the methods used to prove the device meets these criteria, based on the provided text, while explicitly stating that AI/ML specific criteria were not relevant for this device.

Acceptance Criteria and Study Proving Device Meets Criteria for NuVasive® Camber Laminoplasty System

The NuVasive® Camber Laminoplasty System is a spinal implant device cleared through the FDA's 510(k) pathway. The core acceptance criterion for this pathway is demonstration of substantial equivalence to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. For devices like this, performance is primarily assessed through non-clinical, bench-top mechanical testing rather than AI/ML specific performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

• Axial Pullout (per ASTM F2193)
• Static 3-Point Bend
• Dynamic 3-Point Bend
  The results demonstrate that the subject Camber Laminoplasty System meets the same criteria as the predicate devices. |

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

• Sample Size: Not specified as "sample size" in the context of human data or imaging data. For mechanical testing, the number of test specimens (e.g., number of plates/screws tested) would typically be defined by the test standard (e.g., ASTM F2193) and internal protocols. The document does not provide the specific number of units tested.
• Data Provenance: The studies were non-clinical, bench-top tests performed by the manufacturer, NuVasive, Incorporated. The provenance is internal engineering lab testing. These tests are not retrospective or prospective in the sense of clinical studies.

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

• This question is not applicable as the device is a mechanical implant, not an AI/ML imaging device. There were no "experts" establishing ground truth in the sense of image interpretation for AI. Device performance was assessed via engineering specifications and mechanical testing standards.

4. Adjudication Method for the Test Set

• This question is not applicable for the same reasons as #3. Performance was measured objectively through mechanical tests (e.g., force, displacement), not through human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable. This describes an AI/ML imaging device study. The NuVasive® Camber Laminoplasty System is a physical medical implant. No MRMC study was conducted.

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

• This question is not applicable. This refers to AI/ML algorithm performance. The device is a mechanical implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is defined by established mechanical engineering standards and criteria relevant to spinal implants (e.g., ASTM F2193, and criteria for static and dynamic bend tests). The device had to demonstrate it met these pre-defined engineering criteria, which are derived from the biomechanical requirements for such implants. There was no clinical outcomes data, pathology, or expert consensus used as "ground truth" in the way it's used for AI/ML diagnostic devices.

8. The Sample Size for the Training Set

• This question is not applicable. There was no "training set" as this is not an AI/ML device.

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

• This question is not applicable. There was no "training set."

Summary of Relevant Information from the Document:

• Device Type: Spinal interlaminal fixation orthosis (mechanical implant).
• Regulatory Pathway: 510(k) Premarket Notification.
• Primary Evidence for Clearance: Demonstration of substantial equivalence through comparison of intended use, technological characteristics, and non-clinical performance data (mechanical testing) against legally marketed predicate devices.
• Key Tests Conducted: Axial Pullout (per ASTM F2193), Static 3-Point Bend, Dynamic 3-Point Bend.
• Conclusion: The device was found to be substantially equivalent to the predicate devices, meeting the necessary mechanical performance criteria. No clinical studies were required or conducted.

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The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1 - S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions:

· 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)

• Tumor

The Affix IIS Spinous Process Plate System is not intended for stand-alone use.

The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use.

This document is a 510(k) summary for the NuVasive® Affix IIS® Spinous Process Plate System, a medical device. It does not describe an AI/ML powered device, nor does it contain information about acceptance criteria, efficacy studies, or performance metrics in the way a diagnostic or prognostic AI algorithm would.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Indications for Use: The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device for use at a single level in the lumbosacral spine (L1-S1) to achieve supplemental fusion in conditions like Degenerative Disc Disease (DDD), Spondylolisthesis, Trauma, and Tumor. It is not for stand-alone use.
• Technological Characteristics: Comparison of design, labeling/intended use, material composition, and function to predicate devices.
• Performance Data: Nonclinical (bench) testing, including static and dynamic axial compression and static torsion, to demonstrate mechanical equivalence to predicates.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria, as it pertains to AI/ML device performance. This document is a regulatory submission for a physical medical implant, not a software-driven diagnostic or treatment planning system.

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The Spinal Simplicity Spinous Process Fusion (SPF) Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:

• · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
• · spondylolisthesis;
• · trauma (i.e., fracture or dislocation); and/or
• tumor.

The SPF-Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via an open (T1-S1) or percutaneous (L1-S1) approach.

The Spinal Simplicity Spinous Process Fusion (SPF) Plate is a minimally invasive, spinous process fusion plate designed for attachment to the posterior, non-cervical spine at the spinous processes through its bilateral locking Plates, and it is intended for use with bone graft fusion material placed within the device. The Spinal Simplicity Spinous Process Fusion (SPF) Plate consists of a Body/Post. Plates, and Fasteners that together form a construct to provide supplemental fusion and stabilization of spinal segments. The components are available in a range of sizes to accommodate varying patient anatomy. Spinal Simplicity Spinous Process Fusion (SPF) Plates are composed of titanium alloys (per ASTM F136 and ASTM F1472).

This document is a 510(k) premarket notification for a medical device called the Spinal Simplicity Spinous Process Fusion (SPF) Plate. The purpose of this notification is to demonstrate that the SPF-Plate is substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Spinal Simplicity SPF-Plate are implicitly defined by demonstrating "substantially equivalent mechanical strength" to predicate devices and functioning "as intended." The document does not provide specific numerical acceptance criteria (e.g., minimum load bearing capacity in Newtons or maximum displacement in millimeters) but rather references compliance to general performance standards and comparison to predicates.

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

The document details several types of studies but does not explicitly state a sample size for a typical "test set" as understood in AI/software evaluation. Instead, it describes mechanical tests and a surgeon survey:

• Mechanical Performance Studies:
  • No specific sample sizes (number of devices tested) are provided for the static and dynamic tests listed.
  • Data Provenance: These are laboratory-based mechanical tests (in vitro). The document does not specify the country where these tests were performed, but given the US FDA submission, it's likely they were conducted in the US or a facility recognized by the FDA for such testing.
• Cadaver Implantation Studies:
  • No specific sample size (number of cadavers or implants) is provided.
  • Data Provenance: Not specified, but generally performed in laboratories.
• Bone Block Studies:
  • No specific sample size (number of bone blocks) is provided.
  • Data Provenance: Not specified, but generally performed in laboratories.
• Survey Data from Surgeons:
  • The sample size for the survey is not explicitly stated ("survey data from surgeons outside the United States who have implanted a version of the subject device").
  • Data Provenance: Retrospective, based on real-world experience. The data originates from surgeons "outside the United States."

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

• Mechanical Tests, Cadaver Studies, Bone Block Studies: The "ground truth" for these tests is based on engineering principles and measurements. The specific number and qualifications of the engineers or technicians conducting these tests are not provided.
• Survey Data: The "experts" are the "surgeons outside the United States who have implanted a version of the subject device." The number of surgeons is not specified. Their qualifications are implied as medical doctors who perform spinal surgery, but no specific experience level (e.g., "radiologist with 10 years of experience") is given.

4. Adjudication Method for the Test Set

• Mechanical Tests, Cadaver Studies, Bone Block Studies: Adjudication is typically inherent in the testing methodology and analysis by engineers, rather than an "adjudication method" in the sense of expert consensus on qualitative observations.
• Survey Data: No formal adjudication method is described for the survey responses. It seems that the summary of observations ("none of the surgeons observed any instances of failure...") was reported directly from the survey.

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

No MRMC comparative effectiveness study is mentioned for evaluating human readers with or without AI assistance. This document pertains to a physical medical device (SPF Plate), not an AI/software device that assists human readers.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The device's "standalone" function refers to its physical capabilities when implanted.

7. Type of Ground Truth Used

• Mechanical Tests: Engineering measurements, physical properties, and objective results based on standardized test methods.
• Cadaver Studies & Bone Block Studies: Observational and measurement data related to implantation, material loss, and mechanical strength in simulated biological environments.
• Survey Data: Self-reported observations and experiences from practicing surgeons.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set in the computational sense. The design and development of the device would have involved engineering and materials science principles, potentially informed by clinical experience and predicate device analysis, but not a "training set" like an algorithm.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this physical device. The design and validation of the device rely on engineering specifications, material science, and performance testing data rather than a data-driven "training" process.

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