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EDEN ControlCath is used for delivery of drugs that have been indicated for the epidural space.

EDEN ControlCath consists of a flexible catheter, steering handle, and a port for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The port facilitates the connection of syringes to deliver therapeutic agents by physicians as appropriate to their diagnosis. It is supplied sterile and it is for single use.

The provided text is a 510(k) summary for a medical device called "EDEN ControlCath." This document details the device's characteristics, intended use, and its comparison to a predicate device to demonstrate substantial equivalence.

However, the provided text DOES NOT contain information regarding:

• Acceptance criteria beyond "test criteria" for various bench tests.
• Specific device performance metrics that meet these criteria.
• Study design for proving acceptance criteria, particularly regarding clinical studies or AI model performance. The document explicitly states, "Clinical testing was not required for this submission."
• Sample sizes used for test or training sets for AI models.
• Data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone AI performance, or how ground truth was established, as these are typically relevant for AI/ML-based medical devices or diagnostics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate conventional medical device through bench testing and material comparisons, not an AI/ML device.

To answer your request based on the provided text, I can only state the following:

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

The document mentions that various properties were tested based on referenced standards, and "All the test results support substantial equivalence to the predicate devices." However, it does not provide specific numerical acceptance criteria (e.g., "tensile strength > X N") or measured device performance values. It broadly states that the device "passed the test criteria."

2. Sample sized used for the test set and the data provenance:
The document does not specify sample sizes for any of the bench tests or material evaluations. It refers to "bench test results" generally. It does not involve patient data, so concepts like "country of origin" or "retrospective/prospective" are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is not an AI/ML diagnostic tool, and its evaluation relies on established engineering and materials testing standards, not expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no human adjudication process described for the non-clinical bench 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:
No. This is not an AI-assisted device, and no MRMC study was conducted or required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical epidural catheter, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on compliance with international standards for medical devices (e.g., ISO, ASTM) through various physical and chemical bench tests (tensile strength, leakage, biocompatibility, etc.) and comparison to a legally marketed predicate device.

8. The sample size for the training set:
Not applicable. There is no training set mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. There is no training set involved.

In summary, the provided FDA 510(k) summary is for a traditional medical device (an anesthesia conduction catheter), not an AI/ML-driven product. Therefore, the detailed questions about AI model performance, data sets, and expert ground truth establishment are not addressed in this document.

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The EDEN Spinal Fixation MIS System is intended to provide immobilization of the posterior, noncervical spine as an adjunct to fusion in skeletally mature patients 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, pseudarthrosis, and/or failed previous fusion.

The EDEN Spinal Fixation MIS System can be used in an open approach and a percutaneous approach.

The purpose of this special 510(k) submission is to add MIS components and instruments to the previously cleared EDEN Spinal Fixation System. The EDEN Spinal Fixation MIS System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The EDEN Spinal Fixation MIS System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI- 4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the EDEN Spinal Fixation MIS System. The EDEN Spinal Fixation MIS System will also offer a wide variety of instruments that range from bone awls to occipital screwdrivers. These instruments will be made from various grades of stainless steel with aluminum alloy being used in a few handles. All items are supplied "NON-STERILE" and must be sterilized prior to use. The orthopedic instruments are Class I, 510k exempt, and discussed here for informational purpose only.

This FDA 510(k) summary is for a spinal fixation system, not an AI/ML powered medical device. Therefore, the information requested about acceptance criteria, study data, expert ground truth, MRMC studies, and standalone algorithm performance used in the context of AI/ML devices is not applicable to this document.

The document discusses non-clinical tests based on various ASTM and ISO standards for spinal implants, focusing on mechanical properties and biocompatibility. It concludes substantial equivalence to a predicate device based on these engineering tests, not a clinical study involving human or AI interpretation of medical data.

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The EDEN Spinal Fixation System is intended to provide immobilization and stabilization of the posterior, non- cervical spine as an adjunct to fusion in skeletally mature patients 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, pseudarthrosis, and/or failed previous fusion.

The EDEN Spinal Fixation System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The EDEN Spinal Fixation System is a pedicle screw and rod system intended for immobilization and stabilization of the spine as an adjunct to fusion. The EDEN Spinal Fixation System consists of pedicle screws, rods, cross links, and set screws that can be used via percutaneous surgical approach. The components are available in a variety of designs and sizes in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136). The implants will be provided non-sterile.

The EDEN Spinal Fixation System also offer a wide variety of instrument that range from bone awls to screwdrivers.

They are made of various grades of stainless steel and aluminum alloys. All the items are supplied non-sterile and must be sterilized prior to use.

This document, an FDA 510(k) Premarket Notification review, pertains to the EDEN Spinal Fixation System. It does not describe an AI medical device or a study proving that an AI medical device meets specific acceptance criteria in the manner requested.

Therefore, I cannot extract the information required to populate the table and answer the questions about AI device performance, sample sizes, ground truth establishment, or human-in-the-loop studies. The document focuses on the substantial equivalence of a physical medical device (spinal fixation system) to a predicate device based on material, design, and non-clinical mechanical testing, rather than the performance of an AI algorithm.

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The EDEN Peek Cage - PLIF Type is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involvedlevel(s).This device is to be used with autogenous bone graft. The EDEN Peek Cage System is 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.

The EDEN Peek Cage - ACIF Type 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 weeks of non-operative treatment with an intervertebral cage.

The EDEN Peek Cage is offered in various device configurations based on based on surgical approach and patient anatomy, and consist of:

Cervical Interbody Fusion Device (ACIF Type) which may be implanted as a single device via an anterior approach.

Lumbar Interbody Fusion Device (PLIF Type) which can be implanted Bi-laterally via a posterior approach.

• · As a single device via an Anterior approach;(ACIF Type)
• · Bi-laterally via a posterior approach:(PLIF Type)

The EDEN Peek Cage is made of polyether ether ketone (VESTAKEEP® i4 R) that conforms to ASTM F2026 and they have tantalum markers (ASTM F560) to assist the surgeon for proper placement of the device. The subject devices are offered gamma sterile.

The provided text describes a medical device submission (K201793) for the "EDEN Peek Cage," an intervertebral body fusion system, to the FDA. The document focuses on regulatory approval, particularly establishing "substantial equivalence" to predicate devices. It does not contain information about acceptance criteria, device performance, or a study to prove the device meets acceptance criteria in the context of AI/machine learning.

The non-clinical testing section (Section 8) lists:

• Sterilization validation testing
• 36-month shelf life validation
• Mechanical tests (static and dynamic axial compression, static and dynamic torsion per ASTM F2077, and subsidence per ASTM F2267)

These are standard engineering and material tests for intervertebral fusion devices, not studies of AI/machine learning performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets them for an AI/ML device based on the provided text. The document is a 510(k) summary for a physical medical implant, not an AI/ML diagnostic or therapeutic device.

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