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The coflex-IF is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

The coflex-IF system is an implant system for interspinous fixation within lumbar interbody fusion surgery. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.

The purpose of this Special 510(k) is to add a notch in the posterior portion of the U-shaped body. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

Here's a breakdown of the acceptance criteria and study information for the coflex-IF device, based on the provided FDA 510(k) summary:

• Note: This document is a 510(k) summary for a spinal implant (coflex-IF), which is a physical medical device, not a software or AI-based diagnostic device. Therefore, many of the requested categories (like sample size for test/training sets, experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types for AI models) are not applicable to this type of submission. The information provided focuses on engineering and mechanical testing for substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

Study Information (Where applicable, based on a physical medical device)

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

   • Sample Size: Not explicitly stated as "sample size" in the context of human subjects or data, but "The worst case device" was tested. This refers to a manufactured physical device chosen as representative of the most challenging conditions or configurations.
   • Data Provenance: Not applicable in the context of human data. The testing is described as mechanical performance testing of the device itself.

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

   • Not applicable. Ground truth for a physical device's mechanical performance is established through standardized engineering tests (e.g., ASTM F 1717-13) and comparison to the predicate device, not expert consensus on human data.

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

   • Not applicable. Mechanical testing results are objective measurements of physical properties, not subject to human adjudication in the way clinical diagnostic interpretations would be.

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 is a physical spinal implant, not an AI software/diagnostic device.

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

   • Not applicable. This is a physical spinal implant, not an AI algorithm.

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

   • For mechanical performance, the "ground truth" is defined by the standards set by ASTM F 1717-13 and the established performance of the predicate device. The goal is substantial equivalence, meaning the new device performs acceptably within the same safety and effectiveness parameters as the legally marketed predicate.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI model requiring a training set of data. Device design and manufacturing parameters are based on engineering principles and material science, not machine learning.

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

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

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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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The Axle Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to 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); and/or tumor. The Axle Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.

The Axle Interspinous Fusion System consists of plates and inserts of various sizes that are used to provide supplemental stabilization of the spinous processes to support fusion. The svstem components can be assembled in a variety of configurations so that adaptations can be made to take into account pathology and individual patient anatomy. The systems components are manufactured using standard manufacturing processes of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and Invibio PEEK Optima LT-1 in accordance with ASTM F2026 -Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclaye in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the Autoclave manufacturer.

The provided text describes a 510(k) premarket notification for the Axle™ Interspinous Fusion System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish novel performance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and AI-specific metrics is largely not applicable to this document.

Here's an breakdown of why and what information can be extracted based on the provided text:

General Context of the Document:

This is a 510(k) submission, specifically a "Special 510(k): Device Modification." This means X-spine Systems, Inc. is seeking to market a modified version of an already cleared device. The primary goal of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. This is typically achieved through comparison of design, materials, manufacturing processes, and sometimes non-clinical performance testing (bench testing), rather than large-scale clinical trials.

Missing Information (and why):

Most of the requested information (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth, etc.) is relevant for studies conducted to establish the de novo efficacy or safety of a new and novel device, particularly those involving AI/ML components for diagnostic or prognostic purposes. The Axle Interspinous Fusion System is a mechanical implant, and its 510(k) submission does not involve AI or these types of clinical study methodologies.

Information Extracted from the Document:

Despite the above, I can provide a limited answer based on the provided text, focusing on what is relevant to a 510(k) for a mechanical device:

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

For a mechanical implant like the Axle Interspinous Fusion System, "acceptance criteria" and "reported device performance" are typically defined by engineering standards and successful completion of specified mechanical tests, demonstrating equivalence to the predicate device. The document states:

Self-correction/Clarification: The document doesn't explicitly list numerical "acceptance criteria" (e.g., "must withstand X N of compression"). Instead, it states that the device was tested using specific ASTM standards and additional tests. The acceptance for a 510(k) is that the device performs comparably to the predicate device under these tests, thereby demonstrating "substantial equivalence." The document concludes that the modified device "substantially meet[s] the performance criteria established by the cleared parent device," implying it met the unstated performance thresholds benchmarked against the predicates.

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

• This information is not provided as the device is a mechanical implant primarily evaluated through bench testing. The "test set" here refers to the physical samples of the device undergoing mechanical scrutiny, not a clinical data set. There is no mention of country of origin or retrospective/prospective data collection as it's not a clinical study in that sense.

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/provided. "Ground truth" in the context of mechanical testing refers to the physical properties and performance characteristics of the materials and device components. Experts in this field would be engineers and material scientists interpreting the results of mechanical tests, but their number and specific qualifications are not detailed in this 510(k) summary.

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

• This information is not applicable/provided. Adjudication methods are typically for subjective clinical assessments or image interpretations, not for 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

• This information is not applicable. The Axle Interspinous Fusion System is a surgical implant, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted, nor is AI involved.

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

• This information is not applicable. As stated, this is a mechanical implant with no AI component.

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

• The "ground truth" for this device's evaluation is primarily engineering specifications and measurements from mechanical (bench) testing against established ASTM standards and comparable performance to the predicate devices.

8. The sample size for the training set

• This information is not applicable/provided. The concept of a "training set" is relevant for machine learning models, which are not involved here.

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

• This information is not applicable/provided for the same reasons as #8.

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The VertiFlex® Spinous Process Fixation 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 (defined as back pain of discogenic origin with degenerationof the disc confirmed by history and radiographic studies); spondylolisthesis; Irauma (i.e., fracture or dislocation); and/or tumor. The VertiFlex® Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.

The VertiFlex® Spinous Process Fixation (SPF) Plate is a one-piece bilateral locking plate device which attaches to the posterior non-cervical spine by securely grasping two adjacent spinous processes. The SPF Plate is available in multiple sizes to accommodate different anatomical requirements, and it is composed entirely of titanium 6AL-4V allov. The SPF Plate may be implanted by either conventional surgical methods, or via minimally-invasive techniques. Proprietary manual instrumentation for implantation of the SPF Plate is available for both conventional and minimally-invasive surgical procedures.

The provided text describes the VertiFlex® Spinous Process Fixation Plate, a medical device for spinal fixation. It details the device's indications for use, comparison to predicate devices, and a summary of non-clinical tests. However, it explicitly states, "No clinical testing was conducted to support this submission."

Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics from clinical trials, a test set, ground truth, expert involvement, or AI-related data, is not available in the provided text.

Based on the document, here's 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 criteria from a specific clinical study for device performance. The "acceptance criteria" for regulatory submission seems to be substantial equivalence to predicate devices, based on design, materials, indications, and non-clinical performance.
• Reported Device Performance:
  • Non-Clinical Tests: The device demonstrated "substantial equivalence... in terms of performance" to a commercially available predicate through tests conducted in accordance with ASTM F1717-12 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), static pull-off testing in synthetic bone, and static dissociation testing. Specific performance values (e.g., load limits, displacement) are not provided.

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

• Not applicable. No clinical test set data is provided. The non-clinical tests likely used test samples of the device and synthetic bone models.

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. No clinical test set and thus no ground truth established by medical experts for device performance are mentioned.

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

• Not applicable. No clinical test set is mentioned.

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. This device is a mechanical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant to its regulatory pathway as described.

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

• No. This device is a mechanical implant. The concept of "standalone algorithm performance" is not applicable.

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

• Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate devices against which the VertiFlex® plate was compared for substantial equivalence.

8. The sample size for the training set

• Not applicable. No machine learning or AI training set is mentioned as this is a mechanical device.

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

• Not applicable. No machine learning or AI training set is mentioned.

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The SP-Fix™ Spinous Process Fixation 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 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), and/or tumor. The SP-Fix™ Spinous Process Fixation Plate is intended for use with bone graft material and is not intended for stand-alone use.

The SP-Fix™ Spinous Process Fixation Plate consists of plates, rods and barrels that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. SP-Fix™ implants are composed of titanium alloy (per ASTM F136) and PEEK radiolucent polymer (per ASTM F2026).

The provided text is for a 510(k) summary for the SP-Fix™ Spinous Process Fixation Plate, a medical device. It does not describe or include an AI device or a study involving AI. Therefore, I cannot provide information regarding acceptance criteria and studies that prove an AI device meets acceptance criteria.

The information provided pertains to the mechanical testing of a physical medical device to demonstrate its substantial equivalence to predicate devices, which is a standard regulatory pathway for non-AI medical devices.

Here's what I can extract from the provided text about the device and its testing:

Regarding the specific questions about AI device studies:

Since this document describes a physical medical device and its mechanical testing for regulatory clearance, the following points are not applicable and cannot be answered based on the provided text:

• Sample size used for the test set and the data provenance: Not relevant for mechanical testing of a physical device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for mechanical testing.
• Adjudication method for the test set: Not relevant for mechanical testing.
• 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 relevant for a physical medical device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant for a physical medical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not relevant for mechanical testing. The "ground truth" for mechanical testing is typically engineering specifications and performance benchmarks derived from predicate devices or industry standards.
• The sample size for the training set: Not relevant as there is no AI model being trained.
• How the ground truth for the training set was established: Not relevant as there is no AI model being trained.

The document states that mechanical testing was performed to demonstrate substantial equivalence. This type of testing involves subjecting the device to various physical forces and measuring its response, not analyzing data with an AI algorithm.

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