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The ARx Spinal System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the ARx Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the ARx Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.

The ARX Spinal System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARX Spinal System consists of an assortment of rods and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX Spinal System screw assembly component. The ARX Spinal System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARX Spinal System components with the components from any other system or manufacturer.

The provided text describes the 510(k) premarket notification for the ARx Spinal System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through materials and mechanical performance testing, rather than an AI/ML product. Therefore, much of the requested information regarding AI/ML device acceptance criteria and study details (like sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided document.

The document primarily addresses the mechanical and material characteristics of the ARx Spinal System.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this specific device (ARx Spinal System) are implicitly tied to the performance standards outlined in ASTM F1717 for pedicle screw systems, and the reported device performance is that it met these mechanical tests and demonstrated substantial equivalence to predicate devices. However, no specific numerical acceptance thresholds or detailed performance figures are provided in this summary.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML device. For mechanical testing, the "sample size" would refer to the number of physical devices tested, which is not specified in the document.
• Data Provenance: Not applicable in the context of an AI/ML device. This submission is about a physical spinal implant.

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

• This is not applicable as the device is a physical pedicle screw system, not an AI/ML diagnostic tool requiring expert interpretation for ground truth.

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

• Not applicable for a physical device's 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 as this is not an AI-assisted diagnostic device.

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

• Not applicable as this is a physical medical device, not an algorithm.

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

• The "ground truth" for this device would be established by established engineering principles and the performance standards outlined in ASTM F1717 for spinal implant mechanical characteristics. There isn't a "diagnostic ground truth" in the typical AI/ML sense.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

• Not applicable.

Summary of what the document DOES provide:

• Device Name: ARx Spinal System
• Device Type: Thoracolumbosacral Pedicle Screw System (physical implant)
• Regulation Number: 21 CFR 888.3070
• Regulatory Class: Class II
• Product Code: NKB
• Indications for Use: Posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ilium) in skeletally mature and pediatric patients (adolescent idiopathic scoliosis). Adjunct to fusion for stabilization and immobilization in acute/chronic instabilities or deformities.
• Materials: Titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (Co-28Cr-6Mo).
• Performance Data: Tested according to ASTM F1717 (Static Axial Compression Bending, Static Torsion & Dynamic Compression Testing) to demonstrate substantial equivalence to predicate devices.
• Predicate Devices: Life Spine Nautilus (K123373), Stryker Xia 3 Spinal System (K142381), Life Spine AR CoCr Pedicle Screw System (K200070).

In conclusion, the provided FDA clearance letter and 510(k) summary are for a traditional, physical medical device (spinal implant) and therefore do not contain the details typically required for an AI/ML-based device regarding acceptance criteria, study design, and ground truth establishment.

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The ARx Spinal System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis . It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. When used as a posterior spine thoracic/lumbar system, the ARx Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the ARx Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.

The ARx Spinal System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARX Spinal System consists of an assortment of rods and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX Spinal System screw assembly component. The ARX Spinal System implant components are made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARX Spinal System components with the components from any other system or manufacturer.

The provided text is a 510(k) premarket notification summary for a medical device, the ARx Spinal System. This type of FDA submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through a clinical study or AI/software analysis.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, especially in the context of an AI/machine learning enabled device. The "Performance Data" section specifically mentions mechanical testing (ASTM F1717 & F1798) to demonstrate substantial equivalence to a predicate device, which is typical for implantable orthopedic devices, not diagnostic or AI-powered tools.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document refers to mechanical performance testing against ASTM standards to show equivalence, not clinical performance metrics or AI algorithm performance. No acceptance criteria table or reported performance for an AI/software device is present.

2. Sample sizes used for the test set and the data provenance: Not applicable. The "performance data" refers to mechanical testing of the device itself, not a test set of data for an AI algorithm. No information on data provenance (country, retrospective/prospective) is provided as it's not relevant to this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for an AI algorithm test set is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set for an AI algorithm is mentioned.

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 document pertains to an implantable spinal system, not an AI-assisted diagnostic device.

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. There is no AI algorithm in scope for this submission.

8. The sample size for the training set: Not applicable. There is no AI algorithm described.

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

In summary, the provided FDA 510(k) clearance letter and summary are for an orthopedic implant (ARx Spinal System) and detail the process of demonstrating substantial equivalence primarily through design, materials, indications for use, and mechanical testing, not through clinical trials or performance assessments of AI/software for diagnostic purposes.

Ask a specific question about this device

The ARx Spinal System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic (4.75 systems only). It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the ARx Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (7) spinal stenosis, (8) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the ARX Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.

The ARX Spinal System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARX Spinal System consists of an assortment of rods and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX Spinal System screw assembly component. The ARX Spinal System implant components are made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARX Spinal System components with the components from any other system or manufacturer.

The provided text is a 510(k) summary for the ARx Spinal System, a medical device for spinal fixation. It details the device's characteristics and its equivalence to predicate devices, focusing on design, materials, indications for use, and mechanical performance.

However, the document does not contain information about acceptance criteria, clinical study details, sample sizes for test or training sets, expert qualifications, adjudication methods, or multi-reader multi-case studies typically associated with AI/ML device evaluations. This is a traditional medical device submission, where "performance data" refers to mechanical testing according to ASTM standards, not clinical efficacy or diagnostic accuracy as would be assessed for an AI/ML product.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and the study proving the device meets them in the context of an AI/ML device. The document focuses on demonstrating substantial equivalence through mechanical testing and comparison to predicate devices, which is a different framework than evaluating an AI/ML system's diagnostic or predictive performance.

If you are looking for information regarding acceptance criteria for a traditional implantable medical device like this, it would involve demonstrating:

• Biocompatibility: Showing the materials are safe for implantation in the human body (often by referencing existing standards and predicate devices).
• Mechanical Strength and Durability: Demonstrating the device can withstand the expected physiological loads over its intended lifespan, without fracturing or loosening. This is what the ASTM F1717 and F1798 tests address.
• Design Equivalence: Demonstrating that the design is similar enough to predicate devices such that it performs in a similar, safe, and effective manner.
• Manufacturing Quality: Ensuring the device is manufactured consistently and meets design specifications (addressed by Quality System (QS) regulation, 21 CFR Part 820, mentioned in the letter).

The "study that proves the device meets the acceptance criteria" in this context refers to the mechanical testing described:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not explicitly stated as "sample size" in the context of a clinical or data study. For mechanical testing, this refers to the number of device samples tested for each specific test (e.g., how many screws were subjected to axial compression bending). This detail is not provided in the summary.
• Data provenance: Not applicable in the context of a clinical dataset. The performance data comes from in-vitro mechanical testing conducted by the manufacturer, Life Spine, Inc.

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

• Not applicable. This is not an AI/ML device requiring expert-established ground truth on clinical data. Mechanical testing results are objective measurements from laboratory equipment.

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

• Not applicable. This is not an AI/ML device requiring expert adjudication of clinical findings.

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 not an AI-assisted diagnostic or therapeutic device.

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

• Not applicable. This is an implantable medical device, not an algorithm.

7. The type of ground truth used

• Ground truth concept: In this context, "ground truth" for mechanical performance is established by the specified ASTM standards. The devices are tested against physical parameters and benchmarks defined by these standards.
• Type: Mechanical properties (e.g., force, displacement, wear, fatigue life) measured by laboratory instrumentation according to standardized test protocols.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

In summary, the provided document is a regulatory submission for a spinal implant, focusing on its physical and material properties and substantial equivalence to existing devices, not the performance evaluation of an AI-powered system.

Ask a specific question about this device

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The ARX™ Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.

When used as a posterior spine thoracic/lumbar system, the ARXTM Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The ARX™ Spinal System includes various types and sizes of single use implantable components. When assembled, the components create a rigid structure providing stabilization and promoting spinal fusion. The system is comprised of bone screws and rods. Class I surgical instruments are utilized for the installation of the implant.

The provided text describes a medical device submission (K061600) for the ARX™ Spinal System. It details the device, its intended use, materials, and substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria for device performance in a clinical study, nor does it provide results of such a study from which "reported device performance" could be extracted.

Instead, this is a 510(k) summary submission to the FDA, where the manufacturer demonstrates substantial equivalence to legally marketed predicate devices primarily through biomechanical testing and comparison of indications for use, design, function, and materials.

Here's what can be extracted and what is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a clinical study from this document. The "criteria" for FDA clearance here is demonstrating substantial equivalence to predicate devices. This is achieved by comparing indications for use, design, function, and materials, and through biomechanical testing to ASTM F1717.
• Reported Device Performance: The document states: "Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalency." It then concludes: "The ARX™ Spinal System was shown to be substantially equivalent to previously cleared devices..." No specific numerical performance metrics are provided in this summary.

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

• Sample Size: Not applicable in the context of a clinical test set from this document. Biomechanical testing (ASTM F1717) would involve a sample of the manufactured device components rather than patient data. The sample size for the biomechanical tests is not specified.
• Data Provenance: Not applicable for patient data. The biomechanical testing would have been conducted in a lab setting.

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 not a study involving expert assessment of patient data to establish ground truth.

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

• Not applicable. This is not a study involving expert assessment of patient data.

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, an MRMC comparative effectiveness study was not done. This device is a spinal implant, not an AI diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device is a spinal implant.

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

• For the purpose of substantial equivalence, the "ground truth" is established by the performance characteristics and indications for use of the predicate devices. For the biomechanical testing, the "ground truth" would be the engineering standards defined by ASTM F1717.

8. The sample size for the training set

• Not applicable. This device does not involve a training set for an algorithm.

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

• Not applicable. This device does not involve a training set for an algorithm.

In summary, the provided document is a 510(k) premarket notification for a Class II medical device (spinal implant). It demonstrates substantial equivalence primarily through adherence to established material specifications and biomechanical testing against an ASTM standard, rather than a clinical study with detailed acceptance criteria and performance metrics for patient outcomes.

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The ARX Spinal System is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.

The ARX Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The ARX Spinal System is always to be used with supplemental internal spinal fixation. Additionally, the ARX Spinal System may be used with bone graft.

The ARX Spinal System acts as a spacer to maintain proper vertebral body spacing and anqulation following a partial or total corpectorny. The device is surgically implanted between vertebral bodies from an anterior, anterior-lateral, or lateral surgical approach. The ARX Spinal System is manufactured from MC2, a ceramic material. The ARX Spinal System is for single level anterior spinal use from T1 to L5.

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe any study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for the "Arx™ Spinal System", detailing its sponsor, trade name, classification, predicate devices, device description, and intended use. Pages 1 and 2 are a letter from the FDA confirming the substantial equivalence of the device to legally marketed predicate devices, allowing its marketing. Page 3 lists the Indications for Use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets them based on the provided text.

Ask a specific question about this device