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CopiOs™ BVF, in combination with autologous bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (ie, extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs™ BVF is intended to be gently packed into the void or gap and will resorb during the course of the healing process.

CopiOs™ BVF is a synthetic bone graft material consisting of mineralized, lyophilized collagen that has been formed into three-dimensional pads of various sizes for surgical implantation. The CopiOs™ BVF product sponge consists of dehydrothermally (DHT) cross-linked bovine dermal collagen mixed with calcium phosphate salt. The pads are approximately 67% mineral by weight. The fibrous collagen mixed with the calcium phosphate salt is cast into sponges as described in this application. The average porosity of the product was determined to be 93.39%, which allows for favorable conditions for cell migration and adherence to the collagenous matrix. Further, the calcium phosphate provides the mineral required for osteogenesis and the specific CopiOs™ BVF formulation provides a pH environment conducive for osteoinduction.

The provided text describes a 510(k) premarket notification for the CopiOs™ Bone Void Filler (BVF). The study supporting its substantial equivalence is a comparative animal study.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" in the form of specific thresholds for success. Instead, it frames the performance in terms of "substantial equivalence" to a predicate device (HEALOS). The performance claims are qualitative comparisons.

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

• Test Set Sample Size: The document mentions a "comparative rabbit radial defect study." The exact number of rabbits or defect sites used in this study (the "test set" for performance evaluation) is not specified in the provided text.
• Data Provenance: The study was a "comparative rabbit radial defect study," indicating animal data. The country of origin is not explicitly stated, but the sponsor is based in Minneapolis, Minnesota. The study would be considered prospective in nature, as it's an experimental design to evaluate the device.

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

The document does not provide information on the number or qualifications of experts involved in establishing the ground truth for the rabbit study. Histological analysis or imaging interpretation, which would likely involve experts, is implied for assessing bone regeneration and resorption, but details are absent.

4. Adjudication method for the test set

The document does not specify an adjudication method for the test set.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, nor is this device an AI-based system. This question is not applicable to the provided information.

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

This question is not applicable as the device is a medical implant (bone void filler), not an algorithm or AI system.

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

For the "comparative rabbit radial defect study," the ground truth for evaluating bone regeneration and resorption would likely be based on histopathology (microscopic examination of tissue samples) and potentially imaging analysis (e.g., radiography, micro-CT) of the radial defects. This would constitute a form of objective, scientific assessment.

8. The sample size for the training set

This device is not an AI/ML algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable. The "training" for this device's development would involve biological research and materials science, not data training.

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

As in point 8, the concept of a "training set" and its ground truth in the context of AI/ML is not applicable to this bone void filler device.

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When used as a pedicle screw fixation system in skeletally mature patients, the DYNESYS Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the DYNESYS Spinal System is indicated for use in patients:

• Who are receiving fusions with autogenous graft only; a)
• b) Who are having the device fixed or attached to the lumbar or sacral spine; and
• c) Who are having the device removed after the development of a solid fusion mass.

The DYNESYS® Spinal System consists of four pedicle screws, two cords and two spacers in a symmetric, bilateral arrangement. The pedicle screws are placed lateral to the facet joints with two screws in the cephalad position and two screws in the caudad position. The superior-inferior distance between the pedicle screws is maintained with the spacers. The cord passes through the eye of the pedicle screw heads and through the centers of the spacers.

This document is a 510(k) Pre-Market Notification for the DYNESYS® Spinal System. It is an application for regulatory clearance, claiming substantial equivalence to a predicate device, rather than a clinical study report describing acceptance criteria and device performance. Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify quantitative acceptance criteria or report performance metrics from a study designed to meet such criteria. It states that "Establishment of equivalence is based on similarities of intended use, design, and performance characteristics" to the predicate device.

2. Sample size used for the test set and the data provenance:
Not applicable. This document does not describe a clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This document does not describe a clinical study with a ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This document does not describe a clinical study with adjudication.

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 is for a medical device (spinal system), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This document is for a medical device (spinal system), not for an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. This document does not discuss a clinical study with ground truth. The basis for clearance is substantial equivalence to a predicate device.

8. The sample size for the training set:
Not applicable. This document describes a medical device, not a machine learning model that would have a training set.

9. How the ground truth for the training set was established:
Not applicable. This document describes a medical device, not a machine learning model.

Additional relevant information from the document:

• Device Name: DYNESYS® Spinal System
• Intended Use: "When used as a pedicle screw fixation system in skeletally mature patients, the DYNESYS Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis)."
• Predicate Device: Silhouette™ Spinal Fixation System (K980288)
• FDA Limitation: The FDA added a limitation to the labeling: "The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established." This indicates that while the device was found substantially equivalent for specified uses, potential broader uses were explicitly excluded without further proof.

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The Spine-Tech™ Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The Spine-Tech™ Cement Restrictor is NOT intended for any spinal indications.

The Spine-Tech™ Cement Restrictor is a threaded, hollow cylinder that is manufactured from PEEK Optima LT1 with carbon fiber. This device is intended to be used in conjunction with PMMA cement.

The provided text describes a 510(k) premarket notification for a medical device (Spine-Tech™ Cement Restrictor), focusing on its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria, detailed study designs, or performance metrics typically found in clinical trials or validation studies for AI/algorithm-based devices.

Therefore, most of the requested information cannot be extracted from this document.

Here's an assessment based on the provided text, indicating what information is not available:

1. Table of acceptance criteria and the reported device performance:

• Not available. This document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than setting or meeting specific performance acceptance criteria from a study.

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

• Not available. No test set or data provenance from a study is mentioned. The clearance is based on comparison to predicate devices, not specific performance data from a clinical or analytical study.

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

• Not available. No ground truth establishment for a test set is mentioned.

4. Adjudication method for the test set:

• Not available. No test set or adjudication method 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/Not available. This device is a physical medical implant (cement restrictor), not an AI or imaging diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

• Not applicable/Not available. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not available. No ground truth for a study is mentioned. The "ground truth" for 510(k) clearance is often the historical performance (safety and efficacy) of the predicate device(s).

8. The sample size for the training set:

• Not available. No training set is mentioned as this is not an AI/algorithm device.

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

• Not available. No ground truth for a training set is mentioned.

Summary based on the document:

The Spine-Tech™ Cement Restrictor received 510(k) clearance based on demonstrating substantial equivalence to two predicate devices:

1. RPX™ Titanium Cement Restrictor Device (K020344)
2. Medtronic Sofamor Danek Cement Restrictor PEEK Optima™ LT (K010528)

Equivalence was established based on:

• Similarities of intended use: Both the subject device and predicates are intended for use as cement restrictors in orthopedic surgeries (e.g., femoral canal and tibial plateau in hip stem and total knee replacement).
• Design similarities: All are cement restrictors. The subject device is a threaded, hollow cylinder manufactured from PEEK Optima LT1 with carbon fiber.
• Physical characteristics similarities: Implied by the design and material, without specific physical characteristic data provided in this summary.

The FDA added a warning that the device is not intended for any spinal indications, and its safety and effectiveness when implanted in the spine have not been established. This indicates an assessment of where the device could potentially be used but its safety and efficacy are not proven for that specific use.

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The Trinica Select™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Trinica Select Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter

Plates are offered in one-level, two-level, and four-level fusion configurations (22 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.

The provided document is a 510(k) summary for the Trinica Select Anterior Cervical Plate System. It describes a medical device and its substantial equivalence to predicate devices, rather than a study evaluating device performance against acceptance criteria for an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available in this document.

The document states:

• Summary of Non-Clinical Tests: "Based on risk analysis, appropriate testing was conducted to evaluate the impact of the changes to ensure that the modified device meets established criteria and that identified potential risks were mitigated. Results of the testing demonstrated that the modified device meets established criteria."
• Conclusions Drawn From Testing: "Testing of the Trinica Select Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the devices and that the design modifications do not affect device safety and effectiveness."

However, it does not specify what these established criteria are, what the reported device performance was against these criteria, or provide any details about the study design that would allow me to populate the requested table and answer the specific questions about sample sizes, ground truth, experts, or comparative effectiveness.

This document focuses on demonstrating substantial equivalence for a physical medical device (an anterior cervical plate system) based on material, design, and non-clinical performance testing (likely mechanical testing under loads), rather than clinical performance or the performance of an AI/ML algorithm.

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The Spine-Tech Silhouette Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

When used as a hook and sacral screw system, the Spine-Tech Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for sacral/iliac attachment only, screws of the Spin-Tech Silhouette Spinal Fixation System are intended for sacral/iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Spine-Tech Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitates the biological process of the spine. This system is intended for posterior use in the thoracic, lumbar and sacral regions of the spine. Implants of this system consist of hooks and/or screws, polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors, both fixed and variable. All implants in this system are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V), conforming to ASTM F-136.

The implants of this system are for single use only. An implant should never be reused after being removed from the body or sterilized after coming into contact with body fluids or tissues.

The provided document is a 510(k) summary for the Spine-Tech Silhouette™ Spinal Fixation System. It describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, it does not contain information regarding specific acceptance criteria, a formal study demonstrating the device meets those criteria, or details about a test set, ground truth, or expert involvement typically associated with AI/software device evaluations.

Instead, this document focuses on a medical device (spinal implant system) rather than a software or AI-based diagnostic/predictive device. The "testing" mentioned refers to biomechanical testing of the physical implants.

Therefore, many of the requested categories are not applicable to the content provided.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not specify quantitative acceptance criteria in terms of performance metrics commonly associated with software/AI (e.g., sensitivity, specificity, AUC). The performance reported is that the physical device components showed "equivalent mechanical performance" to predicate devices.

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

• Sample Size for Test Set: Not applicable. The "testing" refers to biomechanical tests on device components, not a clinical test set from human data for an AI/software.
• Data Provenance: Not applicable. The biomechanical testing would have been conducted in a lab setting, not using human data from a specific country or in a retrospective/prospective manner.

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

• Number of Experts: Not applicable. Ground truth, in the context of AI/software, refers to clinically verified labels or outcomes. For biomechanical testing, the "ground truth" would be established by engineering standards and measurements, not clinical experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there is no clinical test set or ground truth adjudication process described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, this type of study is typically conducted for diagnostic imaging devices where human readers interpret medical images, often with AI assistance. This document describes a physical spinal implant system.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable, as this is a physical medical device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the biomechanical testing, the "ground truth" would be the established engineering and materials science standards for spinal implants (e.g., ASTM F-136 for titanium alloy, specifications for load-bearing, fatigue, etc.). This is a physical or engineering "ground truth," not a clinical ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document is not about an AI/ML model, so there is no training set in that sense. The design and manufacturing processes are informed by engineering principles and possibly prior iterations, but not a "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model. The design and manufacturing of the physical device components are based on established engineering and medical device standards.

Summary of Document's Focus:

The K980288 document is a premarket notification for a physical medical device. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, primarily through comparison of materials, design, function, and biomechanical testing. It does not involve software or artificial intelligence, and therefore, the requested information pertaining to AI/software validation studies is not present.

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The Spine-Tech Bone Harvester is indicated for the cutting and collection of morselized autogenous bone graft from the anterior or posterior iliac crest, tibia or femur.

This device is intended to cut and collect finely morselized autogenous bone graft for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include; spinal fusion, joint arthrodesis, total joint replacement, fracture repair, maxillofacial reconstruction and tumor removal.

All components of the Spine-Tech Bone Harvested are intended for single use only.

The Spine-Tech Bone Harvester consists of two cutting head/collection tube sizes, Hudson or Hall fitting adapter for power use, trocar and plunger. The cutting heads and trocar are constructed from stainless steel. The collection tube and adapter are constructed from medical grade polycarbonate. The plunger is constructed from acetal copolymer.

After cutting and collection of morselized bone graft, the cutting head is removed from the collection tube with the trocar and bone is pushed out of the collection tube with the plunger.

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and study details.

Based only on the provided text, it's immediately clear that the device is a physical medical instrument (bone harvester), not a software or AI-driven diagnostic device. Therefore, many of the requested points, such as those related to AI assistance, ground truth establishment for AI models, and sample sizes for training sets, are not applicable to this type of submission.

The 510(k) summary for a Class I device like the Spine-Tech Bone Harvester focuses on demonstrating substantial equivalence to predicate devices and verifying basic safety and performance, rather than complex clinical efficacy studies typically seen for higher-risk devices or novel technologies.

Acceptance Criteria and Study Details for Spine-Tech Bone Harvester

Given the nature of the device (a Class I surgical instrument), the "acceptance criteria" discussed in the 510(k) are related to materials, design, and basic functional performance, rather than diagnostic accuracy metrics like sensitivity or specificity. Similarly, the "study" referred to is primarily bench testing and internal quality assurance, not clinical trials with patient populations or expert reviews.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated. The "test set" here refers to the actual devices or components tested during bench and quality assurance. This would typically involve a sample from manufacturing lots. The specific number of units tested is not provided in this summary.
• Data Provenance: The "testing" described is internal bench testing and quality inspection. Therefore, the data would be internally generated by Spine-Tech, Inc. There is no mention of specific country of origin for this testing data, nor whether it was retrospective or prospective (as these terms usually apply to clinical data, not manufacturing verification).

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

This information is Not Applicable to this type of device and submission. "Ground truth" and "experts to establish ground truth" are concepts relevant to diagnostic devices, particularly those involving image interpretation or clinical judgment. For a bone harvester, "ground truth" would relate to its ability to physically cut and collect bone, which is verified through engineering tests, not expert consensus on diagnoses.

4. Adjudication method for the test set:

This information is Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among multiple experts interpreting data, typically in diagnostic studies. For mechanical device testing, the results are objectively measured (e.g., dimensions, cutting efficiency, material strength) against pre-defined specifications, not subject to subjective expert interpretation requiring adjudication.

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 and discussions of AI assistance are relevant for AI/ML-driven diagnostic devices, not for a manual surgical instrument like a bone harvester.

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

This information is Not Applicable. This concept applies to AI/ML software. The Spine-Tech Bone Harvester is a physical instrument requiring user operation.

7. The type of ground truth used:

The "ground truth" for this device's performance would be:

• Engineering Specifications: Successful completion of bench tests (e.g., material strength, cutting efficiency, dimensional accuracy) against pre-defined engineering and design specifications.
• Adherence to Standards: Compliance with relevant material and biocompatibility standards (e.g., ASTM standards mentioned).
• Substantial Equivalence: Demonstrated equivalence in material, design, and function to legally marketed predicate devices, implying that if the predicate is safe and effective, the new device, being equivalent, also is.

8. The sample size for the training set:

This information is Not Applicable. "Training set" refers to data used to train AI/ML models. This device is a manual surgical instrument; there is no AI model involved.

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

This information is Not Applicable, for the same reason as point 8.

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