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The Rexious Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Rexious Spinal Fixation System is intended for use as a posterior, non-pedicle system indicated for 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; pseudoarthrosis; and failed previous fusion.

The Rexious Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and transverse (cross) linking mechanisms.

The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Rexious implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.

This document is a 510(k) summary for the Rexious Spinal Fixation System. It explicitly states that no performance testing was required for this submission. The basis for clearance is that the device is identical to previously cleared predicate devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be provided from the given text because such studies were not conducted for this specific submission.

The relevant section from the document is:

• Performance Data: "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 K100765, K113324, K111362, and K173131. No testing is required."

This means the device's acceptance was based on its substantial equivalence to a previously cleared device, not on new performance data demonstrating it meets specific acceptance criteria through a new study.

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The BALTEUM™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The BALTEUM™ Lumbar Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the thoracolumbar spine (T1-L5) either through an antero-lateral, or lateral approach and to the lumbar/lumbosacral spine (L1-S1) through an anterior approach. The system includes instrumentation which assists in the surgical implantation of the device.

The provided FDA 510(k) summary for the BALTEUM™ Lumbar Plate System describes a spinal implant and therefore does not concern an AI/ML powered medical device. As such, the requested information regarding acceptance criteria, study details, and AI/ML model performance is not applicable to this document.

The document focuses on non-clinical testing for substantial equivalence to predicate devices, which is typical for traditional hardware implants.

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The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach.

Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device.

The AEON-C™ Stand Alone System includes PEEK interbodies and titanium interbodies, which utilize a titanium alloy locking mechanism that is either integrated in an anterior fixation plate or within the interbody. Both PEEK interbodies and titanium interbodies, with or without fixation plates, are to be anchored to patient anatomy via two (2) titanium alloy bone screws. The implant design includes multiple footprints, heights and lordosis options and the screw design includes multiple diameters and lengths, to fit a variety of patient anatomies.

The provided text describes the 510(k) summary for the HUVEXEL Co., Ltd's AEON-C™ Stand Alone System. This is a medical device for orthopedic surgery, specifically for intervertebral fusion, and the information presented is related to its mechanical performance and substantial equivalence to existing devices, not an AI/ML algorithm.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, sample size for training set, and ground truth for training set) are not applicable to this type of device and study.

However, I can provide the acceptance criteria and reported device performance from a mechanical testing perspective, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Description of the Study that Proves the Device Meets Acceptance Criteria:

The study conducted to demonstrate the AEON-C™ Stand Alone System meets acceptance criteria was a non-clinical performance testing study. This study aimed to show that the subject device is substantially equivalent to legally marketed predicate devices.

Specifics of the Study:

• Type of Study: Non-clinical (mechanical) testing.
• Standards Followed: The testing was performed in accordance with ASTM F2077 (Standard Test Methods for Determining Durability of Intervertebral Body Fusion Device Materials and Constructs in a Corpectomy Model) and ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression).
• Tests Performed:
  • Static & Dynamic compression
  • Static & Dynamic compression shear
  • Static & Dynamic Torsion
  • Subsidence
  • Expulsion
• Objective: To demonstrate that the AEON-C™ Stand Alone System is as safe, as effective, and performs as well as, or better than, the legally marketed predicate devices.
• Conclusion: The non-clinical tests demonstrated that the device is substantially equivalent to the predicate devices.

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

• Test Set Sample Size: Not applicable. This was mechanical testing of the device, not a study involving patient data or a "test set" in the context of AI/ML. The sample size would refer to the number of physical devices tested, but this detail is not provided in a 510(k) summary for mechanical testing as it is assumed to be adequate for the standards.
• Data Provenance: Not applicable, as this refers to mechanical testing results, not clinical data or data from a specific country of origin.

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. Ground truth as defined in this request (expert consensus, pathology) is relevant for clinical or diagnostic AI/ML studies. This study is mechanical performance testing against established engineering standards. The "ground truth" here is the performance metrics defined by the ASTM standards.

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

• Not applicable. Adjudication methods are used in studies where human judgment is involved in establishing ground truth for a clinical or diagnostic outcome. This was mechanical 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:

• Not applicable. This applied to AI/ML devices, not a physical intervertebral fusion device.

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

• Not applicable. This applies to AI/ML algorithms. The device itself is described as a "Stand Alone System" in the sense that it is a physical implant, but not in the context of an AI algorithm operating independently.

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

• Mechanical Performance Standards: The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards (e.g., ASTM F2077, ASTM F2267) and substantial equivalence to predicates as demonstrated through comparative mechanical testing and material characterization.

8. The sample size for the training set:

• Not applicable. This applies to AI/ML algorithms, not mechanical device testing.

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

• Not applicable. This applies to AI/ML algorithms, not mechanical device testing.

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The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannualated form to accommodate patient anatomy. The three design types of the subject device are:

1. Standard Thread Screw (with and without slots)
2. Lag Screw (with and without slots) and
3. Washer Screw (with slots)

The provided text is a 510(k) premarket notification for the UNITY Sacroiliac Joint Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the way a diagnostic AI might.

Therefore, many of the requested fields regarding acceptance criteria and study details for an AI-based device are not directly applicable or available in this document. The document describes mechanical performance testing and biocompatibility.

Here's an analysis based on the provided text:

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

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

The document does not specify the exact sample sizes used for the mechanical tests. It states that "Three motion and stress tests were performed" and lists four tests, implying a set of samples for each test type. The data provenance is implied to be from the manufacturer (Huvexel Co., Ltd. in South Korea) through their testing activities. The nature of these tests (mechanical stress and motion) is inherently prospective as new devices would be manufactured and tested.

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)

This field is not applicable. The device is a physical implant, not a diagnostic AI system requiring expert interpretation for ground truth. The "ground truth" for the mechanical performance is defined by the standards and the physical properties observed during testing.

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

This field is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical device testing. The assessment of mechanical performance is based on adherence to engineering standards and observed physical behavior.

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 field is not applicable. The UNITY Sacroiliac Joint Fixation System is a physical implant, not an AI-assisted diagnostic tool.

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

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

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

For biocompatibility, the ground truth is established by referencing the prior FDA clearance of the Rexious Spinal Fixation System (K111362) which used similar materials, manufacturing processes, and sterilization. This is a form of historical data/pre-established safe use.

For mechanical testing, the ground truth is established by engineering standards (ASTM F2193-14 and ASTM F543-17) which define acceptable ranges and behaviors for the specified tests. The "functioned as intended" and "stability observed as expected" implies meeting these standards.

8. The sample size for the training set

This field is not applicable. The device is a physical implant, not an AI model requiring a training set.

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

This field is not applicable. The device is a physical implant, not an AI model.

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