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The ShurFit CpTi-HA Coated Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. ShurFit Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non- operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

The ShurFit Anterior Cervical Interbody Fusion (ACIF) System consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is implanted from the anterior approach and packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured from medical grade polyetheretherketone as described by ASTM F2026, specifically PEEK Optima LT1. The cages are included without a coating (already cleared K083118) or with a CpTi-HA (Commercially Pure Titanium -Hydroxyapatite) coating (this submission).

I am sorry, but the provided text is a 510(k) summary for a medical device (ShurFit CpTi-HA ACIF Interbody Fusion System). It describes the device, its indications for use, and a comparison to predicate devices, including a brief summary of non-clinical tests performed.

However, this document does not contain information about:

• Acceptance criteria
• A study that proves the device meets acceptance criteria.
• Reported device performance values against specific criteria.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for the training set.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and mechanical testing according to established ASTM standards for interbody fusion devices and coatings. It details what tests were performed on the device and its coating (e.g., Static Axial Compression, Static Tensile Bond Strength), but not the specific quantitative results or how those results compare to pre-defined acceptance criteria for a "study that proves the device meets the acceptance criteria."

Therefore, I cannot fulfill your request for the specific details you've asked for based on the provided text. This document is a regulatory submission for device marketing clearance, not a clinical study report or a detailed performance validation study report.

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The Ascendant™ Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Ascendant™ Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The Ascendant™ Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with CP titanium coating and tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous bone graft material.

The Ascendant™ Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate).

The provided text is a 510(k) premarket notification for a medical device called the "Ascendant™ Cervical Spacer System." This document is for a spinal implant, not an AI/ML powered medical device or a diagnostic device. Therefore, the information required to answer the prompt, such as acceptance criteria for performance metrics like sensitivity, specificity, or AUC, as well as details about training/test sets, ground truth establishment, expert adjudication, or MRMC studies, is not present in this document. The document describes mechanical performance testing for the device's physical properties.

However, I can extract the information related to the device's mechanical performance and present it as acceptance criteria and reported performance, even though it doesn't align with the type of acceptance criteria typically expected for AI/ML devices.

Here's the information derived from the document:

1. Table of acceptance criteria and the reported device performance:

Note: The document broadly states "The results of this non-clinical testing show that the strength of the Cervical Spacer System, Ti Coated is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Specific numerical acceptance values or reported outcomes are not provided in this summary, only the conclusion that the device's strength is sufficient.

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

This information is not applicable to the mechanical testing described. Mechanical tests typically use a certain number of physical samples of the device, not a "test set" in the context of data or images. The document does not specify the number of device samples used for each test. Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of mechanical testing.

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

This information is not applicable. The "ground truth" for mechanical performance is determined by the physical properties of the material and design, measured against engineering standards (e.g., ASTM standards), not by human expert opinion.

4. Adjudication method for the test set:

This information is not applicable, as ground truth is based on engineering standards and physical measurements, not on human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a physical spinal implant; it is not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable as the device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is the established mechanical engineering standards (e.g., ASTM F2077, ASTM F1854-09, ASTM F1044-05, ASTM F1147-05, ASTM F1160-05, ASTM F1978-00) for intervertebral body fusion devices. The device's performance is measured against these standards to demonstrate its "sufficient strength" and substantial equivalence to predicate devices.

8. The sample size for the training set:

This is not applicable as the document describes mechanical testing of a physical device, not an AI/ML model.

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

This is not applicable as the document describes mechanical testing of a physical device, not an AI/ML model.

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The Plasmapore® XP Spinal Implant System are indicated 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 involved levels. These patients may have had previous non-fusion surgery at the involved spinal level(s). The Plasmapore® XP Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The Plasmapore® XP Spinal Implants can be used individually or in pairs. The Plasmapore® XP Spinal Implant System is also intended for use with autogenous bone graft.

Patients must have undergone a regiment of non-operative treatment prior to being treated with the device.

The Plasmapore® XP Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK – Optima (per ASTM F2026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have titanium alloy (TiAl6V4) radiographic markers per ISO 5832-3.

The provided document, K132421, describes the 510(k) premarket notification for the Plasmapore® XP Spinal Implant System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about clinical studies with human participants, AI algorithms, or related ground truth establishment, expert consensus, or multi-reader multi-case studies.

Therefore, the following information is extracted directly from the provided text, and many of the requested sections related to AI performance, human user studies, and ground truth are not applicable or not present in this type of submission.

Acceptance Criteria and Device Performance

The device's premarket submission is based on demonstrating substantial equivalence to existing predicate devices through a series of non-clinical, laboratory performance tests. The acceptance criteria are implicitly that the Plasmapore® XP Spinal Implant System "meets or exceeds the performance of the predicate devices" for the tested parameters.

Study Details

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

   • This submission describes non-clinical (laboratory) testing of the device, not a human clinical study or AI algorithm test set. Therefore, there is no "test set" of patient data in the context of an AI algorithm or clinical trial. The "samples" would typically refer to physical device specimens tested in a laboratory. The document does not specify the number of device samples used for each test.
   • Data Provenance: Not applicable as it refers to non-clinical laboratory testing. The testing was performed by Aesculap, an American company (or its affiliates under the Aesculap brand), suggesting the data originates from their internal testing or third-party labs.

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. Ground truth in this context is established by standardized laboratory testing methods (ASTM and ISO standards) and the physical properties/performance of the device specimens, rather than human expert interpretation of data.

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

   • Not applicable. This pertains to non-clinical laboratory testing.

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 submission concerns a physical medical device (spinal implant), not an AI-assisted diagnostic or interpretative system.

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

   • Not applicable. This submission concerns a physical medical device, not an AI algorithm.

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

   • The "ground truth" for this device's performance is derived from standardized physical and mechanical testing protocols (ASTM and ISO standards) applied to device specimens in a laboratory setting. The acceptability is determined by meeting or exceeding the performance thresholds of the predicate devices under these controlled conditions.

7. The sample size for the training set:

   • Not applicable. This is not an AI algorithm. There is no "training set" in this context.

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

   • Not applicable. This is not an AI algorithm.

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