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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 K&J 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-T1 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 K&J IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who 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 K&J IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage consists of PEEK+Tantalum which is identical to its predicate devices. The design, material composition and manufacturing are same as the predicate.

This document is a 510(k) summary for the K&J IVA PEEK Cage. It asserts substantial equivalence to a previously cleared device (K162220).

Therefore, there is no acceptance criteria or study that proves this specific device meets acceptance criteria presented in this document. The manufacturer explicitly 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 K162220. No testing is required."

To answer your request, one would need to review the 510(k) submission for the predicate device, DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (K162220), as that is where the original performance data and substantial equivalence arguments would have been presented.

Based on the provided text for K212038:

1. A table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or performance data for this specific device are provided because it is considered identical to a predicate device.
2. Sample size used for the test set and the data provenance: Not applicable. No performance testing was conducted for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance testing was conducted for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance testing was conducted for this device.
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 a medical implant (intervertebral body fusion device), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical implant (intervertebral body fusion device), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No performance testing was conducted for this device.
8. The sample size for the training set: Not applicable. This is a medical implant and not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable. This is a medical implant and not an AI/ML device that requires a training set.

Ask a specific question about this device