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The Tyche® Pedicle Screw System is a non-cervical, pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, The Tyche® Pedicle Screw System 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 and chronic 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 (pseudarthrosis).

The Tyche Pedicle Screw System is made up of muti-axial and standard screws, rods, locking cap, adjustable cross connectors. This system's intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. All components are made from medical grade titanium alloy (Ti-6Al-4V-ELI) by such as ASTM F136. The products are supplied clean and "NON STERILE".

The medical device in question is the Tyche® Pedicle Screw System. The provided text focuses on its 510(k) submission for substantial equivalence, primarily detailing its design, materials, indications for use, and a comparison to predicate devices, rather than an acceptance criteria and study proving performance in the traditional sense of a clinical or software-based diagnostic device.

Therefore, the information for some requested sections, particularly those related to clinical performance, ground truth, and expert evaluation, is not available in the provided document. The performance data discussed is exclusively bench testing.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a spinal implant, the "acceptance criteria" are typically defined by recognized standards for mechanical performance, and "device performance" refers to the results of testing against these standards.

*Note: The document states that testing was "performed in accordance with" ASTM F 1717-04, implying that the device met the requirements of this standard, which defines the acceptance criteria for mechanical performance of such implants. However, the specific quantitative results (e.g., actual load values, cycles survived) are not explicitly detailed in this summary; they are likely in the "mechanical testing report" mentioned in Appendix IV, which is not provided here.

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

• Sample size for test set: Not explicitly stated regarding the number of devices or constructs tested. The testing was conducted on "the worst case Tyche" pedicle screw system structure."
• Data provenance: Not applicable in the context of clinical data. This refers to bench testing performed on manufactured devices.

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

Not applicable. Ground truth for mechanical bench testing is established by the test setup and instrumentation measuring physical properties according to the ASTM standard. This does not involve expert clinical assessment or image interpretation.

4. Adjudication method for the test set

Not applicable. This concept (e.g., 2+1, 3+1) is relevant for studies involving human interpretation or clinical endpoints, not for mechanical bench 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. This device is a mechanical implant, 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 device is a mechanical implant, not an algorithm.

7. The type of ground truth used

The ground truth for the "performance data" (bench testing) is based on mechanical properties and failure analysis as defined by the ASTM F 1717-04 standard. This standard simulates in-vivo conditions for spinal implants and assesses their structural integrity and strength.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device that requires a training set.

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

Not applicable. As above, no training set is relevant for this type of device.

In summary, the provided 510(k) summary for the Tyche® Pedicle Screw System details its design, materials, indications, and substantial equivalence to predicate devices based on mechanical bench testing against an ASTM standard. It does not include information pertaining to clinical studies, human performance, or AI-related assessments.

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PolyBone® Dental is indicated to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is specifically for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filing of cystic defects; filling of extraction site; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors; cysts or other osseous defects; and substitute for autogenous of allergenic bone grafts. PolyBone® Dental is a bone graft substitute that resorbs and it is replaced with bone during the healing process.

PolyBone® Dental is a synthetic resorbable calcium phosphate bone grafting material which consists of 100% beta-tricalcium phosphate. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The multidirectional interconnected porosity ranges from 7585% with a 200500 um pore size. Mechanism of PolyBone Dental's bone regeneration works by bone cells resorbing dicalciumphosphate dihydrate (DCPD, brushite), which is a conversion material of ß tricalcium phosphate.

This document describes a 510(k) submission for a device called "PolyBone® Dental". The submission focuses on establishing substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics. Therefore, many of the requested details are not available in the provided text.

Here is the information that can be extracted or inferred:

1. Table of acceptance criteria and the reported device performance

No explicit acceptance criteria or quantitative performance metrics are provided in the document. The submission's goal is to demonstrate "substantial equivalence" to predicate devices, focusing on similar technological characteristics, components, indication for use, chemical properties, and performance properties.

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

Not applicable. This is a 510(k) submission based on demonstrating substantial equivalence, not a clinical trial with a test set of patient data from specific geographical locations.

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

Not applicable. Ground truth for a test set is not discussed as this is not a study assessing diagnostic or prognostic performance based on patient data.

4. Adjudication method for the test set

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This device is a bone grafting material, 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 device is a bone grafting material, not an algorithm.

7. The type of ground truth used

Not applicable in the context of a performance study for a diagnostic algorithm. The "ground truth" for this 510(k) submission is the demonstrated equivalence to legally marketed predicate devices, which implies that the predicate devices themselves are considered safe and effective.

8. The sample size for the training set

Not applicable. PolyBone® Dental is a physical medical device (bone grafting material), not an AI algorithm that requires a training set.

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

Not applicable.

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PolyBone® Granule & Block is indicated for filling bone voids or defects that are not intrinsic to the stability of the bony structure. PolyBone® Granule & Block is to be packed into bony voids or gaps of the skeletal system (such as extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PolyBone® Granule & Block is a bone graft substitute that resorbs and it replaced with bone during the healing process.

PolyBone® Granule & Block is a synthetic resorbable calcium phosphate bone void filler consisted of 99.99% beta-tricalcium phosphate, and 0.01% polyphosphate. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The multidirectional interconnected porosity ranges from 7585% with a 200500 um pore size. Mechanism of PolyBone® Granule & Block's bone regeneration works by bone cells resorbing polyphosphate, which is a bone regenerating palpation material. Indication for use of PolyBone® Granule & Block is a filler of bone void regions. The device is available in a variety of shape and sizes.

The provided document is a 510(k) summary for a medical device called "PolyBone® Granule & Block," which is a resorbable calcium salt bone void filler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than clinical efficacy through studies with acceptance criteria for device performance.

Therefore, the document does not contain information related to acceptance criteria, specific device performance metrics, or a study of the device's clinical performance against such criteria. It relies on similarity to predicate devices and biocompatibility testing.

Here's an explanation based on the information provided and what is typically found in a 510(k) for this type of device:

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

• Not applicable / Not provided. The 510(k) submission for "PolyBone® Granule & Block" does not detail performance acceptance criteria for clinical outcomes (e.g., bone regeneration rate, fusion success rate) or specific device functions beyond its material properties and chemical composition. The "performance properties similarities" section refers to its intended use and material characteristics, not quantitative performance metrics.

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

• Not applicable / Not provided. No test set for clinical performance is described as this is a 510(k) submission based on substantial equivalence, not a clinical trial. The "test set" mentioned in typical AI/ML studies is not relevant here.

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

• Not applicable / Not provided. Ground truth determination by experts for a test set is specific to studies evaluating diagnostic or predictive algorithms, which is not the nature of this submission.

4. Adjudication method for the test set:

• Not applicable / Not provided. Adjudication methods are used in studies involving expert review of data, which is not described here.

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 provided. MRMC studies are conducted for diagnostic imaging devices or AI-assisted diagnostic tools. "PolyBone® Granule & Block" is a bone void filler, a therapeutic device, thus this type of study is not relevant.

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

• Not applicable / Not provided. This question pertains to AI/ML algorithms. "PolyBone® Granule & Block" is a physical medical device (bone void filler), not an algorithm.

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

• Not applicable / Not provided. As no clinical performance study against specific criteria is described, there's no mention of a "ground truth" for clinical outcomes. The "ground truth" for this device largely rests on its chemical composition being consistent, its biocompatibility, and its mechanical properties being suitable for its intended use as a bone void filler, and its similarity to established predicate devices.

8. The sample size for the training set:

• Not applicable / Not provided. This question is relevant for AI/ML models. No training set is mentioned as this is a physical medical device.

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

• Not applicable / Not provided. Similar to point 8, this is not relevant for this device.

Summary of the K082338 Submission:

The K082338 submission for PolyBone® Granule & Block primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (Kasios TCP, Vitoss Scaffold) by showing similarities in:

• Components: All devices are packed in a container.
• Indication for Use: All devices have the same indication for use: filling bone voids or defects that are not intrinsic to the stability of the bony structure.
• Chemical Similarities: All devices are made up of the ß-Tricalcium phosphate family. (PolyBone® is 99.99% beta-tricalcium phosphate, and 0.01% polyphosphate).
• Performance Properties Similarities: All devices are for filling bone voids or defects that are not intrinsic to the stability of the bony structure.
• Biocompatibility: The device underwent ISO10993-1:2003 testing (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, and implantation) and was found to be "biologically safe."

The FDA's review concluded that the device is "safe and effective and substantially equivalent to predicate device." This means it does not present new questions of safety or effectiveness compared to the predicate devices, and therefore does not require extensive new clinical studies to prove efficacy against defined acceptance criteria.

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PolyBone is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defiect as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

PolyBone consists of beta-tricalcium phosphate, monocalcium monobasic, calcium sulfate hemihydrate and polyphosphate. PolyBone is indicated for use as cranioplasty cement.

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)

The document does not mention a specific "test set" in the context of clinical studies for performance comparison or data provenance. The performance similarities are based on comparative material property testing.

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 information is not applicable as the submission details material property comparisons and biocompatibility testing, not a clinical study involving experts for ground truth establishment.

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

This information is not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as this device is an artificial bone substitute, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as this is a medical device (bone substitute), not an algorithm.

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

For the material properties (doughing time, setting time, working time, pH, compressive strength, dissolution rate), the "ground truth" or reference was derived from established standards (e.g., ISO 7490:2000 for compressive strength) and comparison to a legally marketed predicate device. For biocompatibility, the ground truth was based on compliance with ISO 10993-1:2003 guidelines.

8. The sample size for the training set

This information is not applicable as this is a medical device (bone substitute), not a machine learning model requiring a training set.

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

This information is not applicable.

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