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The MonoPoly Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis).

When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

The MonoPoly Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

This document describes a medical device, the MonoPoly Pedicle Screw System, and its regulatory filing, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, the provided text is a 510(k) summary and associated FDA correspondence, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. This means the manufacturer is asserting their device is as safe and effective as existing legally marketed devices, rather than establishing de novo performance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and performance studies. The "Performance Testing" section explicitly states: "The pre-clinical testing performed indicated that the MonoPoly Pedicle Screw System is substantially equivalent to predicate devices." This implies the testing was comparative in nature against existing devices, not against a predefined set of acceptance criteria for a new device.

Here's a breakdown of what is and is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not present. The document does not define specific performance acceptance criteria (e.g., in terms of strength, fatigue life, or other biomechanical properties). It also does not report specific quantitative performance data for the device against such criteria. The "Performance Testing" section only states that the testing indicated substantial equivalence to predicate devices.

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

• Not present. The document does not describe a clinical "test set" for performance evaluation in the way you're asking. The testing mentioned is "pre-clinical," likely referring to mechanical or biomechanical bench testing. No sample sizes for any test sets are provided, nor is any information about data provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable. Ground truth is generally relevant for diagnostic or AI-driven devices where a human expert's judgment is used to label data. This document describes a mechanical implant, not a diagnostic device.

4. Adjudication Method:

• Not applicable. See point 3.

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

• Not applicable. This type of study is used for diagnostic imaging devices to assess human reader performance with and without AI assistance. The MonoPoly Pedicle Screw System is a surgical implant.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This is a mechanical implant, not an algorithm or AI system.

7. Type of Ground Truth Used:

• Not applicable. See point 3.

8. Sample Size for the Training Set:

• Not applicable. A "training set" is relevant for machine learning algorithms. This document describes a physical medical device.

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

• Not applicable. See point 8.

Summary from the provided text:

The MonoPoly Pedicle Screw System is a Class III spinal implant comprising various screws, rods, and connectors made from titanium alloy. It is intended to aid in spinal segment immobilization and stabilization as an adjunct to fusion for various spinal conditions. The pre-clinical testing indicated substantial equivalence to four predicate devices: Cross Medical Synergy VLS System (K974749), U&I Optima Xia System (K031585), GSS Medical GS System (K053573), and Signus Medical OvalTwist System (K061577). The document does not provide details of specific performance criteria or a study demonstrating the device meets such criteria, as its 510(k) clearance path relies on equivalence to existing devices.

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The NUBIC™ Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to LS) and is intended for use with supplemental internal fixation.

The NUBIC™ may be implanted singularly or in pairs.

The supplemental internal fixation systems that may be used with the NUBIC™ Spinal Implant include, but are not limited to, SIGNUS CONKLUSION System, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).

Not Found

The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document is a 510(k) premarket notification letter from the FDA to Signus Medical, LLC. for the NUBIC™ Spinal Implant. It states that the device is substantially equivalent to a predicate device based on similarities in functional design, indication for use, principles of operation, materials, and performance characteristics.

The letter explicitly mentions:

• Device Name: NUBIC™ Spinal Implant
• Regulation Number: 21 CFR 888.3060 (Spinal intervertebral body fixation orthosis)
• Regulatory Class: II
• Product Code: MQP
• Indications for Use: To replace a vertebral body resected or excised due to tumor or trauma/fracture in the thoracolumbar spine (T1-L5), used with supplemental internal fixation.
• Predicate Device: RABEA™ cleared under K043316.
• Basis for Substantial Equivalence: Similarities in functional design, indication for use, principles of operation, materials, and performance characteristics. It also states the NUBIC™ is "Implanted using the same surgical techniques and equipment; Used in conjunction with the same types of supplemental internal fixation systems; The same manufacturing environment; The same sterilization process; and The same packaging configurations."

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study details.
6. Standalone (algorithm only) performance study details.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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The Conklusion Pedicle Screw System, including hooks, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

The ConKlusion Pedicle Screw System is a spinal system that consists of a variety of hooks, screws, rods, connectors, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using posterior approach.

The provided text describes a 510(k) premarket notification for the ConKlusion Pedicle Screw System. The acceptance criteria and the study proving the device meets them are focused on mechanical and functional safety for an orthopedic implant, rather than the performance of an AI or diagnostic device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The text indicates that "All testing was conducted in accordance with ASTM F1717." While it states the device met or exceeded "all product specifications," the specific quantitative acceptance thresholds for each test (e.g., minimum load to failure, maximum deflection, number of cycles survived) are not detailed in this summary.

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

• Sample Size for Test Set: The sample size for each functional and mechanical test (compression bending, tensile bending, torsion, and compression bending fatigue) is not specified in the provided document. The document only states "Functional and Mechanical testing of the subject device consisted of three static mechanical tests and one dynamic test to evaluate the spinal implant assemblies."
• Data Provenance: The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission. No country of origin for the data is explicitly mentioned, but the submitter is SIGNUS Medical, LLC, based in Chanhassen, MN, USA, and the FDA is the reviewing body, suggesting a US-based context for the testing. The testing is retrospective in the sense that it was completed prior to the submission for market clearance.

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

• This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is established by the specifications and standards (ASTM F1717) and the physical measurements of the device's performance under stress, pressure, and fatigue, not by expert human interpretation.

4. Adjudication Method

• This question is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation (e.g., medical imaging reads) requires consensus or tie-breaking mechanisms. In mechanical testing, results are objectively measured against predefined engineering specifications.

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

• No, an MRMC comparative effectiveness study was not done. This type of study assesses the performance of human readers, sometimes with and without AI assistance, on a set of cases. The ConKlusion Pedicle Screw System is a physical orthopedic implant, and its performance is evaluated through mechanical testing, not through human reader interpretation of cases.

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

• Not applicable. This question pertains to AI algorithms. The device described is a physical pedicle screw system, not an algorithm. Its "standalone performance" refers to its mechanical integrity and function as tested in a lab.

7. The Type of Ground Truth Used

• The ground truth used for the device's performance evaluation is based on defined engineering specifications and compliance with recognized industry standards (ASTM F1717). These standards dictate specific test parameters and success criteria for spinal implant assemblies. The "ground truth" is that the device must meet or exceed these physical, measurable requirements.

8. The Sample Size for the Training Set

• This question is not applicable as the described study is for a physical medical device and its mechanical properties, not an AI or machine learning model 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 and study.

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The PEEK Tetris™ Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The PEEK Tetris™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the PEEK Tetris™ Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).

The PEEK Tetris™ Spinal Implant is a hollow, rectangular frame with lateral fenestrations. The upper and lower aspects of the implants are open and the walls feature spikes, which assist in the positive anchorage and seating of the implants between the superior and inferior vertebral bodies. The frame is forged from PEEK which is radiolucent and incorporates Titanium alloy marker pins so the device can be located within the body. The PEEK Tetris™ Spinal Implant is available in a variety of sizes and a wedge shaped option. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition.

The provided text describes a 510(k) submission for the PEEK Tetris™ Spinal Implant and focuses on demonstrating its substantial equivalence to a predicate device, the Titanium Tetris™.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific numerical performance results. Instead, it relies on demonstrating comparable functional and performance characteristics to the predicate device through testing. The key acceptance criterion is that the PEEK Tetris™ must perform equivalently or superiorly to the Titanium Tetris™ regarding its intended use as a vertebral body replacement.

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

The document states: "Representative samples of the device underwent testing to demonstrate comparable functional and performance characteristics to the predicate device."

• Sample Size: "Representative samples" implies a test set was used, but the exact number of devices or experimental units is not specified.
• Data Provenance: The document does not specify the country of origin for the data. It's safe to assume the testing was conducted in a controlled lab environment. It is a prospective study in the sense that the testing was performed specifically for this 510(k) submission.

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

This type of information is not applicable to this submission. The device is a physical medical implant, and its "performance" for regulatory purposes is evaluated through mechanical testing, material characterization, and comparison to a predicate device, not through expert assessment of clinical outcomes or images in a diagnostic context. Ground truth, in this context, would be established by direct physical measurements and material properties obtained from laboratory tests, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers (e.g., radiologists interpreting images) where conflicting interpretations need to be resolved. For mechanical testing of an implant, the results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. An MRMC study is relevant for AI-powered diagnostic or decision-support systems that influence human interpretation. The PEEK Tetris™ is a surgical implant and does not involve AI assistance or human readers in its direct use or regulatory evaluation for this 510(k).

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

This is not applicable. The PEEK Tetris™ is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for evaluating the PEEK Tetris™ (in comparison to the predicate) would be based on:

• Physical and Mechanical Testing: Direct measurements of properties like strength, stiffness, fatigue resistance, and geometric conformity.
• Material Characterization: Verification of the PEEK material composition and its properties.
• Biocompatibility Standards: Compliance with established biocompatibility standards, demonstrated by analogy to other legally marketed devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical implant. Training sets are relevant for machine learning algorithms.

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

This is not applicable for the same reason as point 8.

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The TETRIS™ Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5).

The TETRIS™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixations systems that may be used with the TETRIS™ Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).

The TETRIS™ Spinal Implant is a hollow, rectangular frame with lateral fenestrations. The upper and lower aspects of the implants are open and the walls feature spikes, which assist in the positive anchorage and seating of the implants between the superior and inferior vertebral bodies. The frame is forged from a titanium alloy (Ti6Al4V).

The TETRIS™ Spinal Implant is available in a variety of sizes and a wedge shaped option. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition. The TETRIS™ may be used individually or paired based on anatomy and amount of bone resected by the surgeon. When using two implants, care should be taken not to mix flat and wedged shaped devices.

The provided text describes a 510(k) premarket notification for a medical device called the TETRIS™ Spinal Implant. The information focuses on regulatory approval and substantial equivalence to predicate devices, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories are not applicable.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The study involved mechanical testing, not a clinical test set with human data.

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

Not applicable. The ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on medical images or patient outcomes.

4. Adjudication Method

Not applicable. This was mechanical testing, not an assessment requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

Not applicable. This submission concerns a physical medical implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI algorithm. The device itself is a standalone implant.

7. The Type of Ground Truth Used

The ground truth used was based on mechanical engineering standards and validated testing protocols as outlined in the "Guidance for Spinal System 510(k)s."

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm requiring a training set. The device's design and manufacturing rely on established engineering principles and materials science.

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

Not applicable. As above, this is not an AI algorithm.

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The RABEA™ Cement Restrictor is intended to be used in orthopedic surgeries, such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

The RABEAT™ Cement Restrictor is a hollow, PEEK rounded rectangular frame with fenestrated surfaces on all sides and 1mm toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.

The provided text describes a 510(k) submission for the RABEA™ Cement Restrictor Device. It outlines the device's functional and safety testing, concluding that it is substantially equivalent to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics in a quantitative manner as requested by the prompt.

Therefore, many of the requested sections regarding the study and acceptance criteria cannot be extracted from this document.

Here's a breakdown of what can be inferred/stated based on the provided text, and what cannot:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds or quantitative targets.
• Reported Device Performance: The document only states: "The results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device." No specific performance metrics (e.g., strength, durability, failure rates) are provided.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.
• Retrospective/Prospective: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This is not applicable as the study described is for a cement restrictor device, not an AI/diagnostic algorithm where expert ground truth is typically established.

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

• Not applicable for this type of device 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 a physical medical device, not an AI-assisted diagnostic tool.

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.

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

• For this type of device, "ground truth" would likely be based on engineering specifications and physical testing standards rather than expert consensus on diagnostic images or pathology. However, the specific type of ground truth is not detailed in the provided text, other than it involved "examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications."

8. The sample size for the training set

• Not applicable as this is a physical medical device, not an AI algorithm that requires training data.

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

• Not applicable for the same reason as above.

Summary Table of Available Information based on the provided text:

Conclusion from the document:

The study involved "Functional and Safety Testing" consisting of "examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications." The conclusion was that "The results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device," leading to the determination of substantial equivalence to predicate devices. The document does not provide the specific quantitative acceptance criteria or the detailed results of these tests.

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