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The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is interior fixation to the cervical spine C2-C7. The specific clinical indications include:

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

The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for IMPEACE-UNI and one, two, three, and four level procedures for IMPEACE. Main plate is available from 13mm to 46mm for IMPEACE-UNI and 10mm to 112mm for IMPEACE. Screws are available in lengths from 12mm to 20mm for IMPEACE-UNI and 10mm to 20mm in 2mm increments for IMPEACE. The screws have either a 4.5mm or 5.1mm diameter for IMPEACE-UNI and 4.0mm or 4.5mm diameter for IMPEACE. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium allow (Ti-6Al-4V ELI) that conforms to ASTM F136.

This document is a 510(k) premarket notification for the IMPEACE and IMPEACE-Uni Anterior Cervical Plate System. It explicitly states that no performance testing was required for this submission. The basis for substantial equivalence is that the subject device is identical to a previously cleared predicate device (Huvexel - FORTIS and HANA Anterior Cervical Plate System, K173099).

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, expert panels, adjudication, MRMC studies, standalone performance), or how ground truth was established, as no such studies were conducted or provided in this documentation.

The document states:

• "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K173099. No testing is required."
• "The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is identical to the predicate device and is as safe and effective as the Huvexel - FORTIS and HANA Anterior Cervical Plate System."

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The Medynus IVA (ACIF) PEEK Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The Medynis IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S 1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Medynus IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine. All the devices are non-sterile, single use - cages of multiple footprints, heights and lordosis options to fit the anatomical needs of a wide variety of patients and are made from PEEK and Tantalum. They have anti-migration features on the superior and inferior surfaces and can be packed with autograft to facilitate fusion.

The provided text describes a 510(k) premarket notification for a medical device called the Medynus IVA PEEK Cage. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new performance testing or clinical studies.

Therefore, the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not applicable to this submission.

Here's why and what can be extracted from the document:

• No Acceptance Criteria or Performance Study: The document explicitly states: "The subject and predicate devices are identical and therefore, no performance testing is necessary to demonstrate substantial equivalence. Submission is only transferring name of a system that has already been cleared under K162220. No new testing was provided." This means there was no new study performed to generate device performance data against specific acceptance criteria.
• Substantial Equivalence: The foundation of this submission is that the Medynus IVA PEEK Cage is identical to a previously cleared predicate device (DIO Medical IVA PEEK Cage, K162220) in terms of intended use, indications, technological characteristics, and principles of operation. The FDA clears the new device based on the established safety and effectiveness of the predicate device.

Given this, I can fill in the table and explain why the other sections are not applicable:

1. Table of Acceptance Criteria and the Reported Device Performance

Explanation: As stated in the document, "no performance testing is necessary to demonstrate substantial equivalence" because the device is identical to a previously cleared predicate device. Therefore, there are no new acceptance criteria or reported device performance from a new study generated for this 510(k) submission. The safety and effectiveness are based on the predicate device's prior clearance.

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 new test set or data was used for a performance study. The submission relies on the established performance of the predicate device.

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 new test set or ground truth establishment was required for this substantial equivalence submission.

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

Not applicable. No test set was used.

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 device is an intervertebral body fusion cage, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Not applicable. No ground truth needed to be established for this submission as it relies on the predicate device's established safety and effectiveness.

8. The sample size for the training set

Not applicable. This device is a physical implant, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

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The Goblin and Goblin LS Pedicle Screw Systems are intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications:

• · 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 stenosis;
• · Curvatures (i.e., scoliosis, kyphosis and/or lordosis);
• · Tumor and pseudarthrosis

The Goblin and Goblin LS Pedicle Screw Systems are top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms. The implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F136. Various sizes of these implants are available.

The provided text is a 510(k) summary for the "Goblin and Goblin LS Pedicle Screw Systems." It describes a traditional medical device (pedicle screw systems for spinal fixation), not an AI/ML medical device. Therefore, the acceptance criteria and study information typically provided for AI/ML device validation (e.g., sample size for test/training sets, adjudication methods, expert qualifications, MRMC studies, standalone performance, ground truth establishment) are not applicable and are not present in this document.

The performance data section for this device focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices, specifically:

• Non-clinical testing performed in accordance with ASTM F1717:
  • Static compression
  • Dynamic compression
  • Static Torsion

This type of testing evaluates the mechanical integrity and performance of the physical implants, which is standard for pedicle screw systems.

Therefore, it is impossible to extract the requested information regarding acceptance criteria and studies that prove an AI/ML device meets those criteria from the provided document. The document concerns a hardware medical device.

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