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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation 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 failed previous fusion in skeletally mature patients.

Additional Component of the EXPEDIUM Spine System.

The EXPEDIUM Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This document is a 510(k) summary for the EXPEDIUM™ Spine System, specifically for additional components. It is a submission to the FDA for market clearance, not typically a publication of a clinical study with detailed performance metrics against acceptance criteria. Therefore, the information provided is limited to what's available in such a regulatory document.

Based on the provided text, a table of acceptance criteria and reported device performance from a clinical study cannot be constructed because the document does not describe acceptance criteria for diagnostic performance or a clinical study in the way typically seen for AI/software devices.

Instead, the document states:

"PERFORMANCE DATA:
Performance data were submitted to characterize the additional components of the EXPEDIUM Spine System."

This refers to engineering performance data for a physical medical device (spinal implants), not typically diagnostic performance as would be expected for an AI/software device. The FDA's 510(k) clearance in this context relies on demonstrating substantial equivalence to predicate devices, often through mechanical testing, biocompatibility, and material characterization, rather than clinical efficacy studies with ground truth.

Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods are not applicable or not present in this type of regulatory submission for a physical implantable device.

Here's an attempt to answer the questions based only on the provided text, noting where information is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable/Not provided. This document describes a physical medical device (spinal implant), not a diagnostic algorithm that would typically have a test set of data.
• Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided. Ground truth establishment by experts is typically for diagnostic or AI devices, not for the performance data of a spinal implant.

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

• Not applicable/Not provided. This relates to diagnostic image interpretation or algorithm output, not the mechanical or material performance of a spinal implant.

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/Not provided. MRMC studies are for diagnostic interpretation (often with imaging and AI assistance), which is not the subject of this 510(k) summary.

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

• Not applicable/Not provided. This document is not about an algorithm or AI device.

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

• Not applicable/Not provided. The "performance data" mentioned would likely be based on physical measurements, material properties, and mechanical tests, not a clinical ground truth as defined for diagnostic studies.

8. The sample size for the training set

• Not applicable/Not provided. This document is not about an algorithm or AI device that would have a training set.

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

• Not applicable/Not provided. This document is not about an algorithm or AI device that would have a training set with established ground truth.

Summary based on the provided text:

The provided document is a 510(k) summary for a physical medical device, the EXPEDIUM™ Spine System, an implantable spinal fixation device. The performance data mentioned refers to engineering tests and characterization (e.g., mechanical strength, biocompatibility, material properties) to demonstrate substantial equivalence to previously cleared predicate devices, not clinical efficacy or diagnostic performance. Therefore, the typical criteria and study design elements requested for an AI/software device or a diagnostic device are not present in this document.

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The indications for use for the modified devices described in this submission are the same as those for the previously cleared SWIFT Anterior Cervical Plate System. The indications are as follows:

The SWIFT™ Plus Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as pain with degeneration of the disc discogenic confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.

The SWIFT Plus Anterior Cervical Plate System consists of an assortment of plates and screws.

The SWIFT Plus Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

It looks like the text provided is a 510(k) summary for a medical device called the SWIFT™ Plus Anterior Cervical Plate System. This document outlines the device description, intended use, and materials.

However, the provided text does not contain any information regarding acceptance criteria, device performance metrics (numerical or otherwise), sample sizes for testing or training, data provenance, expert information, adjudication methods, or different types of studies (MRMC, standalone).

The "PERFORMANCE DATA:" section is present, but it only states "Performance data were submitted to characterize the SWIFT Plus Anterior Cervical Plate System." without providing any specifics. Medical device submissions like 510(k)s typically include detailed performance data, but this specific excerpt is lacking that information.

Therefore, I cannot fulfill your request for the tables and detailed information about acceptance criteria and study designs based solely on the text provided. To answer your questions, I would need a section that explicitly details the performance testing results, acceptance criteria, test methodologies, and clinical study information.

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Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects, in order to provide stabilization of the vertebral body and pain relief. Vertebroplastic™ Radiopaque Bone Cement has a low viscosity and long working and setting time

I am sorry, but the provided text is for a medical device called "Vertebroplastic™ Radiopaque Bone Cement," which is a polymethylmethacrylate (PMMA) cement used for filling spinal vertebral body defects. This is a physical product and not an AI/ML powered device. As such, the concepts of "acceptance criteria for an AI model," "sample size for test set," "ground truth," "MRMC study," or "training set" are not applicable to this document.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailed performance studies and acceptance criteria as would be found for an AI/ML device.

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The Swift Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.

The Swift Anterior Cervical Plate System consists of an assortment of plates and screws.

The Swift Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided document is a 510(k) summary for the Swift Anterior Cervical Plate System, a spinal implant. It describes the device, its intended use, and its predicate devices. However, this document does not contain explicit acceptance criteria or details of a study that proves the device meets such criteria in the format requested for AI/algorithm performance.

Instead, it primarily focuses on establishing substantial equivalence to previously cleared predicate devices for regulatory clearance. The "Performance Data" section merely states: "Performance data were submitted to characterize the Swift Anterior Cervical Plate System." This is a very general statement and does not provide specifics about the nature of the data, the tests performed, or the results against any defined acceptance criteria, as would be expected for evaluating an AI-based medical device.

Therefore, I cannot populate the requested table and answer the specific questions about "acceptance criteria," "reported device performance," "sample size," "experts," "adjudication," "MRMC study," "standalone performance," "ground truth," and "training set" based solely on the information provided in this document.

This document is for a mechanical implant and the regulatory review process primarily relies on manufacturing standards, material testing, and comparison to predicate devices, rather than clinical performance studies with specific statistical endpoints and ground truth determinations that are typical for AI/algorithmic devices.

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The Merlin Spinal System is intended for noncervical pedicle fixation and nonpedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

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I am sorry, but the provided text is a 510(k) clearance letter for the Merlin Spine System and does not contain information about acceptance criteria or a study proving the device meets them. The document outlines the regulatory approval of the device based on substantial equivalence to predicate devices, but it does not include details on performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment relevant to the questions you've asked regarding device performance and acceptance criteria.

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