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The Matrix HA PEEK Cervical Implant System is intended for spinal fusion procedures at multiple contiguous levels (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Matrix HA PEEK cervical implant system is intended to be used with a supplemental fixation system.

Additionally, the use of hyperlordotic devices (lordotic angle greater than 8°) are intended to be used exclusively with anterior supplemental fixation.

Matrix HA PEEK Cervical IBF devices are manufactured from Hydroxyapatite (HA) filled Polyetheretherketone (PEEK). The specific material is PEEK-OPTIMA HA Enhanced manufactured by Invibio. The Matrix HA Cervical IBF Devices superior and inferior surfaces have ridges designed to interface with the vertebral endplates to help resist rotation and migration. Tantalum (ASTM F560) or titanium (ASTM F136) rods are located at the extremes of the Matrix HA Cervical IBF Devices to allow for radiological confirmation of the device positioning. The anterior face of each interbody has a recessed horizontal slot encapsulating a 6/32 threaded thru hole which is to be used to interface with the inserter. Each device has a uniform wall thickness of 2.5mm.

Matrix HA PEEK Cervical IBF Devices are available in multiple configurations to coincide with the surgical approach and patient needs: parallel, 7° thru 20° lordotic angle and convex. The Matrix HA PEEK Cervical IBF Devices are open rectangular devices with curved lateral walls and rounded edges. The devices are open with cavities to facilitate bony ingrowth.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "MATRIX HA PEEK Cervical IBF System."

The document primarily covers:

• The FDA's decision of substantial equivalence for the device to a predicate device.
• Regulatory information and requirements for the manufacturer.
• Indications for Use of the device.
• A 510(k) summary, including:
  • Sponsor/Manufacturer details.
  • Device trade and common names, classification.
  • Predicate device.
  • Device description (material, design features).
  • Intended Use (reiterating the indications).
  • Technological Characteristics (stating they are identical to the cleared device).
  • Non-clinical Testing (referencing testing per ASTM F2077-18 for mechanical function and properties, and establishing substantial equivalence).
  • Conclusion of substantial equivalence.

There is no mention of an AI-powered device, acceptance criteria related to software performance, test set details, expert ground truth establishment, MRMC studies, or standalone algorithm performance. The testing mentioned (ASTM F2077-18) is for the mechanical properties of an intervertebral body fusion device, not for the performance of a diagnostic or therapeutic AI system.

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The Matrix HA PEEK Cervical Implant System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Matrix HA PEEK Cervical Implant System is intended to be used with a supplemental fixation system.

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I am sorry, but the provided text only contains an FDA 510(k) clearance letter for a medical device (Matrix HA PEEK Cervical Implant System). It outlines the device's classification, regulation, and indications for use.

The document does not contain any information about the acceptance criteria, study design, or performance data for a device that relies on AI or machine learning. Therefore, I cannot extract the details requested in your prompt regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test and training sets, data provenance.
• Number of experts for ground truth establishment and their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

This document pertains to a physical implant system, not a software device or AI-driven system requiring such detailed performance validation against acceptance criteria as might be expected for an AI/ML medical device.

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The SMG Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:

· degenerative disc disease (as defined by neck pain of discogenic origin with

degeneration of the disc confirmed by patient history and radiographic studies),

• · spondylolisthesis,
• · trauma (i.e. fractures or dislocations),
• tumors.
• · deformity (defined as kyphosis, lordosis, or scoliosis),
• · failed previous fusion (pseudoarthrosis)
• · spinal stenosis.

The SMG Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6Al-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, two-level, three-level, four-level fusion configurations (13~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and selfdrilling threaded. This device is provided as non-sterile.

This is a 510(k) premarket notification for a medical device, the SMG Anterior Cervical Plate System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive studies with detailed acceptance criteria as one might find for a PMA or de novo submission for a novel AI/ML device.

Therefore, the information you've requested regarding acceptance criteria for device performance in a clinical setting, sample sizes for test and training sets, expert qualifications, and adjudication methods (typical of AI/ML device evaluations) is not present in this document.

Here's an analysis based on the provided text, addressing what information is available:

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

The document does not provide specific quantitative "acceptance criteria" for clinical performance that would typically be seen for an AI/ML device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and performance data.

The "reported device performance" is in the context of bench testing:

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

This information is not applicable/not provided. The assessment for this device is based on mechanical bench testing and comparison to existing predicate devices, not clinical data sets or test sets as would be used for an AI/ML device.

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/not provided. Ground truth in the context of expert review for clinical performance is not part of this 510(k) submission.

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

This information is not applicable/not provided. Adjudication methods are relevant for clinical studies with subjective interpretation, which is not the basis of this 510(k).

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/not provided. The device is a physical anterior cervical plate 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/not provided. The device is a physical implant, not an algorithm.

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

This information is not applicable/not provided. The "ground truth" equivalent for this type of device is its ability to meet engineering specifications and withstand mechanical forces, as demonstrated through bench testing and comparison to established predicate devices.

8. The sample size for the training set

This information is not applicable/not provided. Training sets are relevant for AI/ML models, not for physical medical implants like an anterior cervical plate system.

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

This information is not applicable/not provided.

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The Cervical Implant is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended via an open, anterior approach and packed with autogenous bone graft. The Cervical Implant is intended to be used with supplemental fixation system.

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The provided document is an FDA 510(k) clearance letter for the Sapphire Cervical Implant System. This letter is for a medical device (an implant), not an AI/Software as a Medical Device (SaMD) product. Therefore, the questions related to AI/SaMD performance, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this document.

The document confirms that the Sapphire Cervical Implant System is substantially equivalent to legally marketed predicate devices. The "Indications for Use" section (page 2) describes its intended purpose and target patient population.

Therefore, I cannot provide the requested information as the document does not contain data or information related to the acceptance criteria and study proving performance for an AI/SaMD product.

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The A-Wedge Anterior Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. A-Wedge Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The A-Wedge Anterior Interbody System (A-Wedge AIS) was developed for the stabilization of the lumbar spinal column. The body of the device is a rounded-trapezoidal shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. A-Wedge AIS implants are available in two lordotic configurations (6° and 11°) of various heights to restore lumbar lordosis and the associated sagittal balance. SMG A.I.S. implants have three titanium alloy x-ray markers. The A-Wedge AIS device is single-use only.

Materials: Medical grade PEEK (ASTM F2026) machined from Orthoplastics Vertepeek extruded bar stock (FDA master file MAF #1820). Orthoplastics Vertepeek is fabricated from Evonik Degussa medical grade Vestakeep | PEEK granules (FDA master file MAF # 1688). ELI grade titanium alloy (Ti-6Al-4V per ASTM F136) for radio opaque markers.

Function: A-Wedge AIS devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.

This document is a 510(k) Pre-Market Notification for a medical device called the "A-Wedge Anterior Interbody System". It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria in the context of AI/software performance. Therefore, most of the requested information regarding AI/software performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and stand-alone performance is not applicable to this type of regulatory submission.

The document focuses on the mechanical and material performance of a physical implant.

Here's an analysis based on the provided text, addressing the relevant points and noting where information is not applicable:

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

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

• Sample Size for Test Set: Not applicable. This document refers to mechanical testing of physical implants, not an AI/software test set. The number of physical units tested is not specified in this summary but would be part of the detailed test reports referenced (e.g., ASTM standards).
• Data Provenance: Not applicable in the context of clinical or AI data. The mechanical testing was performed in accordance with FDA Guidance and ASTM standards.

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 is not a study involving human experts or ground truth in the sense of clinical annotations for AI. Mechanical tests are typically performed by engineers/technicians following standardized protocols, and their "ground truth" is the physical measurement against set thresholds.

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

• Not applicable. No adjudication is mentioned as this is mechanical testing, not a clinical or AI performance evaluation.

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 not an AI-powered device or a study involving human readers.

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

• Not applicable. This is a physical intervertebral body fusion device, not an algorithm.

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

• Ground Truth: For mechanical testing, the "ground truth" is the established quantitative performance requirements defined by industry standards (ASTM F2077, F2267, and draft F04.25.02.02) and FDA guidance for intervertebral body fusion devices. The device's performance is measured against these objective, verifiable thresholds.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device; therefore, there is no training set mentioned.

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

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

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