Search Results

The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Ballista instruments are intended to be used with the 5.5 Polaris implants. The Ballista instruments when used with the Ballista cannulated screws and percutaneous rods. are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and lordosis), tumor. stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

The AccuVision Instruments, when used with the Polaris Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, The Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

This submission is a line extension to the Polaris Spinal System to add new stainless steel dominoes and washers to the system.

This 510(k) summary describes a line extension to the Polaris Spinal System, specifically adding new stainless steel dominoes and washers. The submission focuses on demonstrating substantial equivalence to existing predicate devices through mechanical testing.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

• Static Transverse Rotation (per ASTM 1798-97, reapproved 2003)
• Static Axial Slip (per ASTM 1798-97, reapproved 2003)
• Dynamic Axial Compression Bending-Fatigue (per ASTM 1717-04).
  The study verifies that the subject device is substantially equivalent to other spinal systems currently on the market and has met all mechanical test requirements based on the worst-case construct testing. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (number of devices/components tested) for each mechanical test. It refers to "worst-case construct testing" without quantifying the number of constructs or replicates.

Data provenance is not specified beyond indicating that the testing was performed, implying it was conducted by the applicant or a contracted lab. The country of origin is not mentioned, and the testing is prospective as it was performed for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for this type of device (spinal implants) is established through adherence to recognized international and national standards for mechanical testing, not expert interpretation of derived data. The "experts" are the engineers and technicians performing the tests according to the specified ASTM standards.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements against established criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices where human interpretation plays a role. This submission pertains to a mechanical medical device, and its evaluation relies on physical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable. This device is a mechanical implant, not an AI or software algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on established mechanical engineering standards, specifically ASTM 1798-97 (reapproved 2003) for static testing and ASTM 1717-04 for dynamic fatigue testing. These standards define the test methodologies and acceptance criteria for spinal systems.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this mechanical device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no training set. The "ground truth" for showing safety and effectiveness in this context relies on meeting the performance specifications of the referenced ASTM standards, which are developed and validated by experts in materials science and biomechanics.

Ask a specific question about this device

The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Ballista instruments are intended to be used with the 5.5 Polaris implants. The Ballista instruments when used with the Ballista cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

The AccuVision Instruments, when used with the Polaris Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacrabiliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

This submission is a line extension to the Polaris Spinal System to add new uniplanar screws fabricated from titanium.

Based on the provided text, the Polaris Spinal System is a medical device, and its acceptance criteria and the study proving it meets these criteria are described as follows:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly mention a "test set" in the context of clinical data for the uniplanar screws. Instead, the evaluation focuses on mechanical testing.

• Sample Size: Not specified for the mechanical tests, beyond the implication that multiple tests were performed per ASTM standards.
• Data Provenance: The mechanical testing was "conducted in accordance to ASTM 1717-04 Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model." This refers to laboratory-based mechanical testing, not human or animal study data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this submission, as the evaluation was based on mechanical testing, not clinical expert review or diagnostic performance.

4. Adjudication Method for the Test Set

This is not applicable, as there was no test set involving human assessment or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The submission is for a line extension of a spinal fixation system, focusing on mechanical equivalence.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical spinal implant system, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the mechanical testing was the specifications and performance characteristics set forth by the ASTM 1717-04 Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model, and the performance of predicate devices. The goal was to demonstrate substantial equivalence to these established standards and predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is a physical surgical implant, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Study Proving Device Meets Acceptance Criteria

The study that proves the device meets the acceptance criteria is mechanical testing performed in accordance with ASTM 1717-04 Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model.

The document states:
"Mechanical testing (conducted in accordance to ASTM 1717-04 Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model) included static compression bending, static torsion and dynamic compression bending fatigue. Based upon the mechanical testing, these screws are substantially equivalent for their intended use to other spinal systems currently on the market."

The "acceptance criteria" here are implicitly defined by achieving performance that is "substantially equivalent" to predicate devices and consistent with the established ASTM standards for the mechanical properties tested (static compression bending, static torsion, and dynamic compression bending fatigue). The study concluded that the new uniplanar screws met this "substantial equivalence" based on the mechanical test results.

Ask a specific question about this device

The Peanut™ Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients (patients who have not had physeal closure/reached skeletal maturity). This is useful for gradually correcting angular deformities in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

The Peanut™ Growth Control Plating System consists of two plate designs (arched and stepped) and solid and cannulated screws.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of a medical device such as the Peanut™ Growth Control Plating System. The document is a 510(k) premarket notification for a medical device submitted to the FDA and focuses on demonstrating substantial equivalence to previously cleared devices rather than providing performance data against specific acceptance criteria.

The submission primarily discusses:

• Device Description: The components of the Peanut™ Growth Control Plating System.
• Indications for Use: The medical conditions and patient population for which the device is intended.
• Purpose of Submission: The specific modifications being made (adding screw lengths, adding a contraindication, offering non-sterile configurations).
• Contraindications: Conditions under which the device should not be used.
• Summary of Technologies: Stating similarity to legally marketed predicate devices.
• Substantial Equivalence: Arguing that the modifications do not raise new safety or effectiveness issues and that the device is equivalent to existing cleared devices (K070823 and K031493).
• Evidence for Substantial Equivalence: Mentions "Pull-out strength testing was provided to support substantial equivalence," but no details about the acceptance criteria, study design, or results are included in this summary.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, or ground truth establishment as this information is not present in the provided text.

Ask a specific question about this device

The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal System is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The ESL Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® 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 of time.

As an intervertebral body fusion device, the ESL® Spinal System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

The ESL® Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The ESL® Spinal System may also be implanted using the Accuvision System to amount the surgeon with a minimally invasive approach for posterolateral spinal survery.

The ESL® Spinal System is a device constructed medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.

The provided 510(k) summary for the Biomet Spine ESL® Spinal System does not contain information on a study proving the device meets specific acceptance criteria in the manner typically seen for AI/ML-based devices or studies requiring performance metrics like sensitivity, specificity, or various accuracy measures.

Instead, this submission is focused on demonstrating substantial equivalence to predicate devices for a physical medical implant (intervertebral fusion device). The "study" here refers to the comparisons made to existing devices and mechanical testing, rather than a clinical performance study with specific quantitative acceptance criteria of AI/ML algorithms.

Here's a breakdown based on the provided text, addressing the points where information is available and noting where it is not applicable or not provided:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The ESL® Spinal System is a physical medical device designed for spinal applications. Its acceptance for market clearance via a 510(k) submission is based on demonstrating substantial equivalence to predicate devices already on the market, rather than meeting specific performance thresholds derived from a clinical study comparing AI outputs to ground truth.

The "study" that proves the device meets acceptance criteria primarily involves:

1. Comparison of technological characteristics (material, design, sizing, intended use, indications, principles of operation) to predicate devices.
2. Mechanical testing to ensure the device's performance is equivalent to, or better than, predicate devices for its intended use, particularly for restoring biomechanical integrity.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable in the context of this 510(k) submission, as it relates to a physical implant and not an AI/ML algorithm requiring a test set of data. The "test set" would primarily refer to the physical devices undergoing mechanical testing, but no numerical sample size for these tests is provided in this summary. Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable. "Ground truth" in the context of AI/ML refers to objective labels for input data (e.g., expert annotations on images). For a physical medical device like the ESL® Spinal System, there isn't a "ground truth" established by experts in this manner. The evaluation relies on engineering principles, material science, and mechanical testing standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or evaluations of AI/ML algorithms where multiple readers assess the same data and resolve discrepancies.

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 information is not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human reader performance for diagnostic tasks. The ESL® Spinal System is a surgical implant, not a diagnostic AI tool.

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

This information is not applicable. The ESL® Spinal System is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically defined for AI/ML performance is not applicable here. The "truth" for this device's acceptance is established through:

• Compliance with predicate device characteristics: The device's material, design, and indications must align with devices already cleared by the FDA.
• Mechanical testing standards: Performance under various load conditions to ensure structural integrity and durability. These are engineering-based "truths" rather than expert consensus on images or pathology results.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of a physical medical device.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As there is no training set, there is no ground truth established for it.

Ask a specific question about this device

The Biomet® Vision® Foot Ring System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.

Additional indications include:

• Correction of deformity .
• Revision procedures where other treatments or devices have been unsuccessful .
• Bone reconstruction procedures .
• Fusions and replantations of the foot .
• Charcot foot reconstruction and Lisfranc dislocations
• Ankle distraction (arthrodiastasis)

Device Desertification. and K052239.

This submission is a 510(k) Premarket Notification for the Biomet® Vision® Foot Ring System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data for acceptance criteria.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study that proves the device meets specific performance metrics.

Instead, the document states:

• The Biomet Trauma device is substantially equivalent to other legally marketed devices, specifically the Stryker Hoffman II Foot Ring (K041706) and the SBi RingFIX™ System (K071394).
• The "Operational principles for the device are unchanged." (from the previously cleared device)

The FDA's letter further confirms that they have "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."

In summary, none of the requested information (1-9) about acceptance criteria, study design, sample sizes, ground truth establishment, or human reader performance is present in this 510(k) summary because it is not typically required for a substantial equivalence determination for this type of device.

Ask a specific question about this device

The C-Thru™ Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used as a vertebral body replacement device, the C.Thru™ Spacers are indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The C-Thru™ Spacers are also indicated to reartial vertebral body replacement for the treatment of fractures of the thoracic and luced to purch The C-Thru™ Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged proiod,

When used as a cervical intervertebral fusion device, the C-Thru Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radia graphic studies. These patients should have had six months of non-operative treatment. The C-Thru Spacers are intended for use with supplemental fixation and autogenous bone graft to facilitate the fusion.

The C-Thru™ Anterior Spinal System consists of a spacer constructed of medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.

This document, K092336, is a 510(k) premarket notification for a medical device called the C-Thru™ Anterior Spinal System, a type of intervertebral fusion device. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies to prove effectiveness or meet novel acceptance criteria.

Therefore, the provided text does not contain information regarding traditional acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or comparative effectiveness studies in the context of AI or advanced diagnostic devices.

The document focuses on establishing substantial equivalence based on:

• Technological characteristics: Material, design, and sizing being similar to predicate devices.
• Intended use and indications: Being the same as or similar to predicate devices.
• Mechanical testing: To demonstrate that the device is substantially equivalent for its intended use to other spacers on the market.

Based on the provided text, I cannot complete the requested tables and descriptions because the document does not present a study with acceptance criteria and reported device performance in the way a diagnostic AI device or a new therapeutic device with novel claims would.

Here's why and what information is available:

Regarding Acceptance Criteria and Device Performance:

• No explicit acceptance criteria for device performance are listed. The "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence, e.g., showing mechanical properties are comparable to predicates, and that the device doesn't raise new questions of safety or effectiveness.
• No "reported device performance" in terms of clinical outcomes, sensitivity, specificity, or other diagnostic metrics are provided. The document states that "Based upon the mechanical testing, C-Thru™ Anterior Spinal System is substantially equivalent for its intended use to other spacers currently on the market," but it does not provide specific performance metrics from this testing.

Regarding Sample Sizes, Experts, and Ground Truth:

• No information is provided for sample sizes of test or training sets, data provenance, number or qualifications of experts, adjudication methods, or types of ground truth for clinical performance evaluation. This information is typical for diagnostic or AI device studies, not for a 510(k) for a spinal implant based on substantial equivalence to existing technology.
• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This is a physical implant, not an AI diagnostic assistant.
• No standalone (algorithm only) performance study was done. This is not an algorithm.

In summary, the K092336 document is about a specific type of medical device (spinal implant) and its regulatory pathway (510(k) substantial equivalence), which does not involve the kind of performance studies you are asking about, often seen with AI/diagnostic devices.

Ask a specific question about this device

The Ibex™ Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the Ibex™ is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Ibex™ Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The IbexTM 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 of time.

As an intervertebral body fusion device, the Ibex™ Spinal System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Ibex™ Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Ibex™ Spinal System may also be implanted using the Accuvision System to provide the surgeon with a minimally invasive approach for posterolateral spinal surgery.

The Ibex "Spinal Spacer is a curved device constructed of either Titanium alloy or medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.

The provided document is a 510(k) summary for the Biomet Spine's Ibex™ Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices for a medical implant, not on evaluating the performance of an AI or software as a medical device (SaMD).

Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove adherence to those criteria for an AI-powered device. The questions you've asked are typically relevant for AI/SaMD submissions, which involve clinical performance metrics and ground truth establishment.

Specifically, the document discusses:

• Device Description: The physical characteristics and materials of the Ibex™ Spinal System.
• Indications for Use: The medical conditions and anatomical locations for which the device is intended.
• Summary of Technologies: States that the technological characteristics (material, design, sizing) are similar to predicate devices.
• Substantial Equivalence: Asserts that the Ibex™ Spinal System is substantially equivalent to predicate devices based on intended use, indications, technological characteristics, principles of operation, and mechanical testing.

There is no mention of:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, accuracy).
• A study specifically designed to assess these AI performance metrics.
• Sample sizes for test or training sets for an AI.
• Data provenance, expert qualifications, or adjudication methods for ground truth in an AI context.
• MRMC studies or standalone AI performance.
• Types of ground truth for AI algorithms.

The study mentioned is "mechanical testing," which is standard for spinal implants to ensure structural integrity and biocompatibility, not for evaluating an AI's diagnostic or predictive capabilities.

Ask a specific question about this device

The 5.5 Helical Flange Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The 5.5 Helical Flange Percutaneous Instruments are intended to be used with the 5.5 Polaris implants. The Percutaneous instruments when used with the Percutaneous cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

The 5.5 Helical Flange Spinal System Mini-Open Instruments, when used with the 5.5 Helical Flange Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

This submission is a line extension to the EB1 5.5 Helical Flange Spinal System to add new 5.5 Polaris components, which may be used with the other 5.5mm components in order to build various types of spinal constructs. The new components include another style of screws in the larger diameters and a smaller diameter screw.

The provided document is a 510(k) summary for a medical device called the "EBI 5.5 Helical Flange Spinal System." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a new device's efficacy through clinical studies with acceptance criteria in the same way one might for a novel diagnostic AI.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. This document describes a traditional medical device (spinal fixation system) and its mechanical characteristics, not an AI or diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth.

However, I can extract information related to the demonstration of "substantial equivalence" which is the core of this type of submission.

Here's a breakdown of what can be extracted and what is not applicable based on the document:

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

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 document describes a mechanical device, not a diagnostic algorithm. The "test set" in this context would refer to mechanical testing (e.g., fatigue testing, static strength testing of the implants), not a clinical data set. The document states "Based upon the mechanical testing," but does not provide details on the sample size, specific tests, or provenance of the 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. Ground truth in the context of diagnostic AI refers to a definitive correct answer for a medical condition. For a spinal implant, "ground truth" would relate to the mechanical integrity and biocompatibility, which are verified through engineering tests and material science, not by expert medical interpretation of images or patient outcomes in this type of submission.

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

• Not Applicable. Adjudication methods are used in studies involving subjective interpretation, often by multiple readers, to establish a consensus ground truth. This is not relevant for the type of mechanical testing described in this 510(k) summary.

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. MRMC studies are specific to diagnostic performance, often for AI-assisted workflows. This document is for a spinal fixation system, not a diagnostic AI.

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

• Not Applicable. This is not an algorithm or AI device.

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

• The "ground truth" for a medical implant like this is typically established through adherence to recognized industry standards for mechanical testing (e.g., ASTM standards for spinal implants) and biocompatibility testing (though not explicitly detailed in this summary, it's a prerequisite for such devices). The summary mentions "mechanical testing" as the basis for substantial equivalence, implying these standards were met. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" in the way it would be for an AI diagnostic.

8. The sample size for the training set

• Not Applicable. This device is a mechanical implant, not an AI. There is no concept of a "training set" in this context.

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

• Not Applicable. As there is no training set for a mechanical implant, this question is not relevant.

Ask a specific question about this device

The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Ballista instruments are intended to be used with the 5.5 Polaris implants. The Ballista instruments when used with the Ballista cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

The Accuvision Instruments, when used with the Polaris Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

This submission is a line extension to the EBI Helical Flange System to add new 5.5 and 6.35 Polaris components in order to build various types of spinal constructs. The new components include various types of bone screws, bone hooks, plugs, rods, connectors and accessories in stainless steel.

The provided document is a 510(k) summary for the Polaris Spinal System and does not contain information regarding acceptance criteria for a device's performance based on a study, nor does it describe such a study.

This document is a regulatory submission to the FDA for a medical device (a spinal fixation system). It focuses on demonstrating "substantial equivalence" to previously approved predicate devices, primarily through technological characteristics (material, design, sizing) and principles of operation, rather than detailed performance studies with specific acceptance criteria and outcome metrics for a novel device.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the document states:

• "Based upon the mechanical testing, the Polaris Spinal System is substantially equivalent for its intended use to other spinal systems currently on the market." (page 2)

This indicates that some "mechanical testing" was performed to support the claim of substantial equivalence, but it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of 510(k) submission generally relies on comparing a new device's design and materials to existing devices and often includes bench testing (mechanical testing) to show that the new device performs at least as well as the predicates in specific mechanical properties (e.g., strength, fatigue life), but these results are typically summarized as meeting "substantial equivalence" rather than being presented as detailed clinical or algorithm performance studies.

Ask a specific question about this device

The Expandable PEEK-OPTIMA® Implant is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, The Expandable PEEK-OPTIMA® Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Expandable PEEK-OPTIMA® Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK-OPTIMA® Implant 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.

As an intervertebral body fusion device, the Expandable PEEK-OPTIMA® Implant is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Expandable PEEK-OPTIMA® Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The Expandable PEEK-OPTIMA® Implant is a rectangular, expandable device constructed of medical grade Polyetheretherketone (PEEK), for spinal applications.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) Summary for the "Expandable PEEK-OPTIMA® Implant," outlining its description, indications for use, and a claim of substantial equivalence to predicate devices, primarily based on technological characteristics and mechanical testing for equivalence, not detailed performance criteria or clinical study results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the associated details about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth information.

Ask a specific question about this device