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It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1. The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
   a. Patients having fractures of the thoracic and lumbar spine.
   b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2. The ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
3. In addition, the ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The ZODIAC Polyaxial Pedicle Screw System, when used as a laminar hook and bone screw system is intended for:
   a. Patients having fractures of thoracic and lumbar spine.
   b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The ZODIAC Polyaxial Pedicle Screw System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti6Al-4V ELI (ASTM F 136). System rods are available in titanium alloy or commercially pure titanium, CP Grade 4 (ASTM G67). The ZODIAC Polyaxial Pedicle Screw System is designed to facilitate optimal screw and rod placement.

The provided text describes a medical device, the ZODIAC Polyaxial Pedicle Screw System, and its clearance through the 510(k) pathway. This pathway establishes substantial equivalence to already marketed predicate devices, primarily through performance data demonstrating comparable safety and effectiveness.

However, the 510(k) summary does not contain the level of detail requested for a typical AI/software device study (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, standalone performance). This is because the ZODIAC system is a mechanical implant, and its performance evaluation relies on different methodologies, primarily mechanical and dynamic testing, rather than clinical efficacy studies with human readers or AI algorithms.

Therefore, many of the specific questions cannot be answered from the provided document. I will extract what information is present and indicate where the requested information is not available.

Acceptance Criteria and Device Performance (Based on Provided Text)

The "acceptance criteria" for a mechanical device like the ZODIAC system are met by demonstrating structural integrity and comparable mechanical performance to predicate devices. The document focuses on demonstrating substantial equivalence rather than listing specific numerical acceptance criteria.

Missing Information: Specific numerical thresholds for mechanical strength, fatigue life, or other mechanical properties that would constitute "acceptance criteria" are not provided in this 510(k) summary. These would typically be found in detailed test reports, not the summary itself.

Study Details (Based on Provided Text)

1. Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing. The "test set" would refer to the number of devices or components tested. This number is not specified in the 510(k) summary. The data provenance would be from laboratory testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing of implantable devices, "ground truth" is established through physical measurement and engineering analysis, not expert interpretation of data relevant to AI performance.

3. Adjudication method for the test set: Not applicable. Mechanical testing results are objective measurements and do not typically require adjudication in the way clinical diagnostic interpretations do.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in interpretation, which is not the function of a pedicle screw system.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not applicable. The device is a mechanical implant, not an algorithm.

6. The type of ground truth used: For mechanical performance, the ground truth is derived from direct physical measurements (e.g., load-to-failure, cycles to fatigue) obtained in laboratory settings according to established industry standards or internal protocols.

7. The sample size for the training set: Not applicable. As a mechanical device, there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by engineering principles and prior device experience, not by a data-driven training set.

8. How the ground truth for the training set was established: Not applicable. See point 7.

Summary of Non-Applicability:

The requested detailed information regarding acceptance criteria, study sample sizes, expert ground truth, and AI-specific study methodologies (MRMC, standalone performance, training sets) is largely not applicable to the ZODIAC Polyaxial Pedicle Screw System as described in this 510(k) summary. This is because it is a physical medical implant, and its regulatory clearance relies on demonstrating substantial equivalence through mechanical and dynamic testing against predicate devices, rather than clinical efficacy studies involving diagnostic interpretations or AI performance. The provided text indicates that mechanical and dynamic testing was performed and that the results demonstrated comparability to predicate devices.

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The Alpha Mirage® Top Tightening Spinal System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Alpha Mirage® Top Tightening Spinal System are dependent in part on the configuration of the assembled device and the method of attachment to the spine and are listed in Indications for Use Statement.

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1. The Alpha Mirage® Top Tightening Spinal System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
   a. Patients having fractures of the thoracic and lumbar spine.
   b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2. The Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
3. In addition, the Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The Alpha Mirage® Top Tightening Spinal System, when used as a laminar hook and bone screw system is intended for:
   a. Patients having fractures of thoracic and lumbar spine.
   b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The Alpha Mirage® Top Tightening Spinal System is a spinal fixation system comprised of various types and sizes of components that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems, the Alpha Miraqe® Top Tightening Spinal System is comprised of 1) bone screws and hooks for attachment to the spine, 2) longitudinal rods that are attached to the bone screws and hooks directly/indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.

The purpose of this 510(k) is to provide for commercially pure titanium rods, which allows surgeons to manipulate the rod prior to implantation without compromising the structural strength of the construct.

The provided text describes a 510(k) summary for the Alpha Mirage® Top Tightening Spinal System. It details the device's description, intended use, indications for use, and a comparison to a predicate device. The primary purpose of this 510(k) is to introduce commercially pure titanium rods as part of the system.

However, the document does not describe an AI/ML device, nor does it contain information relevant to AI/ML acceptance criteria or studies. Instead, it discusses the substantial equivalence of device components (titanium rods) to previously cleared components through mechanical and dynamic testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them based on the provided text. The document is for a traditional medical device (spinal fixation system) and its performance data refers to mechanical and biocompatibility testing, not AI/ML model performance.

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It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1. The Alpha Mirage® Top Tightening Spinal System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
   a. Patients having fractures of the thoracic and lumbar spine.
   b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, deqenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2. The Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumore and failed previous fusion (pseudoarthrosis).
3. In addition, the Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The Alpha Mirage® Top Tightening Spinal System, when used as a laminar hook and bone screw system is intended for:
   a. Patients having fractures of thoracic and lumbar spine.
   b. Patients having thoracolumbar deformity (i.e., idioscoliosis, · neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The Alpha Mirage® Top Tightening Spinal System is a spinal fixation system comprised of various types and sizes of components that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems, the Alpha Mirage® Top Tightening Spinal System is comprised of 1) bone screws and hooks for attachment to the spine, 2) longitudinal rods that are attached to the bone screws and hooks directly/indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.

The provided text is a 510(k) summary for a medical device (spinal system) and letters from the FDA. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/software performance or diagnostic accuracy.

The "Performance Data" section ([1] on page 2) explicitly states: "Mechanical and dynamic testing of the Alpha Mirage® Top Tightening Spinal System constructs was performed as described in 510(k) applications K951846 and K930515. The test results demonstrated that the mechanical performance and biocompatibility characteristics are at least comparable to, if not better than, those of the predicate device."

This indicates that the "performance data" refers to mechanical and biocompatibility testing for a physical spinal implant system, not a software device or AI algorithm with performance metrics like sensitivity, specificity, or AUC. The FDA letter ([2] on page 2) also classifies the device under regulations for physical spinal fixation devices, not software as a medical device.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or software function.
2. Sample size used for a test set, data provenance, ground truth establishment, or expert involvement for AI/software evaluation.
3. Any information about MRMC comparative effectiveness studies or standalone algorithm performance.

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The Deltaloc Anterior Cervical Plate System is indicated for use in the anterior cervical spine (C2-C7); patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.

The Deltaloc Anterior Cervical Plate System consists of plates and screws that are used for attachment to the anterior cervical spine. Plates are offered in a variety of sizes with varying numbers of screw holes to accommodate single to quadruple level fusions. Plates are shaped with both radial and lordotic curvature and contain a deformable tab at each screw hole to capture the screws to the plate, preventing screw digression. Screws are offered in two diameters and four lengths per diameter. All screws are also available so that their angle relative to the plate is fixed or variable.

The plates of the Deltaloc Anterior Cervical Plate System are manufactured from commercially pure titanium and the screws are manufactured from titanium alloy (Ti-6Al-4V).

This document is not a study; it is a 510(k) premarket notification for the Deltaloc Anterior Cervical Plate System. A 510(k) notification aims to establish substantial equivalence to a predicate device already on the market, rather than proving device performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document.

However, I can extract the information that is available:

1. A table of acceptance criteria and the reported device performance
This document, being a 510(k) notification, does not provide specific performance criteria or a table comparing them to reported device performance. It focuses on demonstrating substantial equivalence to a predicate device.

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. This is a premarket notification for a medical device (cervical plate system), not a study involving a test set of data.

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. This is a premarket notification for a medical device (cervical plate system), not a study involving expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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 a physical implant (cervical plate system), 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 physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable.

8. The sample size for the training set
Not applicable.

9. How the ground truth for the training set was established
Not applicable.

Information that is available from the document:

• Device Name: Deltaloc Anterior Cervical Plate System
• Manufacturer: Alphatec Manufacturing, Inc.
• Intended Use/Indications: For use in the anterior cervical spine (C2-C7) in patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.
• Predicate Device: Synthes CSLP (Cervical Spine Locking Plate) System
• Basis for Approval: Substantial equivalence to the predicate device in design, function, materials used, and indications for use.
• Materials: Plates from commercially pure titanium, screws from titanium alloy (Ti-6Al-4V).

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The Alphatec External Fixation System is indicated for limb salvage from traumatic injury; fracture treatment (i.e., long bone fracture, including the tibia, femur, humerus, radius, and ulnar bones); reconstruction of extremities with deformity and dysfunction; limb lengthening; arthrodesis; and pelvic fractures.

The Alphatec External Fixation System Compression/Distraction (CD) Rod consists of a CD rod that is available in two lengths and a CD rod to rod connector. These components are designed to be used in conjunction with the Alphatec External Fixation System and the Alphatec Wire External Fixation System which were the subject of prior premarket notifications. The additional use of the CD rod with the systems listed adds the capabilities of limb lengthening during fracture fixation. The CD rod and CD rod to rod connector are manufactured from titanium alloy (Ti-6Al-4V).

The provided document is a 510(k) Pre-Market Notification for the Alphatec External Fixation System Compression/Distraction Rod. This document is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device.

It does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

Instead, it focuses on:

• Device Description: What the device is made of and how it works.
• Intended Use: The medical conditions the device is designed to treat.
• Substantial Equivalence: A comparison of the device to existing, legally marketed devices to show it is as safe and effective.
• FDA Clearance: The official letter from the FDA stating that the device is substantially equivalent.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in this type of regulatory document for a mechanical medical device.

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The Pylon Intramedullary Nail System is indicated for internal fixation of tibial or femoral fractures including low subtrochanteric fractures, transverse fractures, oblique and spiral fractures, segmental fractures, comminuted fractures, high supracondylar and spiral fractures with bone loss, stabilization for bone transport or lengthening and shortening, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the bone shaft, nonunions, malunions, metaphyseal/diaphyseal junction fractures, and acute bone lengthening and shortening.

The Pylon Intramedullary Nail System consists of intramedullary rods and screws for fixation inside the canal of the tibia or femur. The rods are cylindrically shaped and either made of a solid or cannulated construct, depending on the outer diameter of the rod. Rods are available in a variety of diameters and lengths and have holes located in the proximal and distal ends for fixation to bone by means of bone screws. Bone screws are also available in a multitude of diameters and lengths. An end cap is available that screws into the proximal end of the nails to prevent bone ingrowth which may hamper the attachment of extraction instrumentation. All components of the Pylon Intramedullary Nail System are manufactured from titanium alloy (Ti-6Al-4V).

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the "Pylon Intramedullary Nail System."

The document is a 510(k) Pre-market Notification for a medical device. This type of submission to the FDA focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed study results on the device's performance against specific acceptance criteria.

The information provided only includes:

• Device Identification and Description: Pylon Intramedullary Nail System, its components, and materials.
• Intended Use/Indications: A list of fracture types and conditions for which the device is intended.
• Manufacturer Information.
• Substantial Equivalence Claim: The device is stated to be substantially equivalent to ACE AIM Titanium Nails.
• FDA Clearance Letter: Confirming the substantial equivalence determination and allowing marketing.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from this document.

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External Fixation is useful in many areas of orthopedic surgery. Following are the major categories of application:

• 1. Limb salvage from traumatic injury.
• 2. Fracture treatment (i.e. long bone fracture, including the tibia, femur, humerous, radius, and ulnar bones).
• 3. Reconstruction of extremities with deformity and dysfunction.

4. Arthrodesis.
   The surgeon must carefully evaluate the purpose for external fixation in the individual patient if the treatment is to be successful. Consideration should be given to the following factors necessary for the successful application of an external fixator. Fracture osteotmy stability, soft tissue viability, adjacent function or injury, and functional demands of the patient.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the Alphatec Wire External Fixation System. This type of document declares "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as a device already on the market.

It is important to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence, not necessarily on presenting a comprehensive study with acceptance criteria and a detailed performance study in the way a Premarket Approval (PMA) application would.

Therefore, the specific information requested in your prompt regarding acceptance criteria, sample sizes, expert qualifications, and detailed study methodologies is not explicitly present in the provided FDA letter or its enclosed "Indications for Use" statement. The letter refers to the "510(k) premarket notification" as containing the description of the device and how it was deemed substantially equivalent. The detailed study data would be within that notification, not in the FDA's summary letter itself.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the FDA letter. For a 510(k), compliance with predicate device characteristics and relevant standards (e.g., mechanical strength, biocompatibility) would be assessed. The letter does not specify quantitative acceptance criteria or reported device performance metrics in a tabular format.

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

This information is not provided in the FDA letter. 510(k) submissions typically include bench testing, and sometimes animal or limited clinical data if necessary to demonstrate equivalence or address specific safety concerns. The letter does not detail any such specific study data.

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

This information is not provided in the FDA letter.

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

This information is not provided in the FDA letter.

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 is not applicable to the Alphatec Wire External Fixation System, which is a physical orthopedic device, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not have been performed.

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

This is not applicable as it's a physical device, not an algorithm.

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

This information is not provided in the FDA letter. For a 510(k) for a physical device, substantial equivalence is often based on design, materials, and performance characteristics compared to a predicate, as well as adherence to relevant standards. The "ground truth" would implicitly be the established safety and efficacy of the predicate device under its intended use.

8. The sample size for the training set:

This information is not provided in the FDA letter. As this is a physical device, there would not be a "training set" in the context of machine learning or AI development.

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

This information is not provided in the FDA letter. Again, this concept is not directly applicable to a physical medical device.

In summary, the provided FDA letter for the Alphatec Wire External Fixation System is a declaration of substantial equivalence based on a 510(k) submission. It does not contain the detailed study data, acceptance criteria, or performance metrics in the format you've requested. Such information would be contained within the larger 510(k) submission document itself, which is not provided here. The letter confirms that the device is deemed substantially equivalent to legally marketed predicate devices for the stated "Indications for Use" (limb salvage, fracture treatment, reconstruction of extremities, arthrodesis). The approval assumes compliance with good manufacturing practices and other general controls.

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Ask a specific question about this device