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DenTack PYRAMIDION Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only.

DenTack has developed a range of expandable dental implants made of titanium (the most common material for dental implants) to serve the need of patients that require partial or complete tooth restoration.

The implant is placed so its end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone.

The system also includes various accessories that are attached to the implant. The PYRAMIDION has an external hex connection with 0.7mm height and 2.7mm hex with a distinct projection externally to the implant body. The connection between the prosthetic part to the upper platform of the implant interacts with a recessed plain of 15-degrees into the upper platform of the implant body while it is projected from the prosthetic part.

All DenTack's implants are made of biocompatible Titanium. Prostheses and Surgical components are made of same Titanium alloy, stainless-steel and polymers.

DenTack's PYRAMIDION Implants with are the subject of this submission are available in outer diameter (OD) of 4.1 mm and in length of 5 and 6 mm.

DenTack's Prostheses and dimension ranges are identified as follows:
Metal Housing: 3.3 mm Height
Plastic Cup: 2.7 mm Height
Straight Multi-Unit Sleeve: 11 mm Height
Straight Multi-Unit Screw: 2.3 mm Diameter
Angled Abutments 15° And 22.5°: Length: 7 mm – 9 mm
Angled Abutments 15° Large: Total Length: 9 mm – 12 mm
Ball Attachments: 2, 3 and 4 mm Height
Direct Screw Platform
Straight Abutments 2, 3, 8.5 mm Length
Straight Multi-Unit Abutments 2, 3 and 4 mm Length
Angled Multi Unit Abutments 17° and 1.5 and 3 mm Length
Healing Caps 3, 4, 5 and 6 mm
Cover Screw

The Direct Screw Platform is to be used with a burn-out plastic sleeve for ensuring a minimum post height of 4 mm (with no angular correction).

Like the QUAD implants cleared under K152188, the subject PYRAMIDION implants expansion is performed using a reusable Expansion Tool and Ratchet Torque).

The provided text is a 510(k) summary for the DenTack PYRAMIDION Dental Implants and Prostheses. It describes the device, its intended use, and comparative testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance metrics.

The document primarily focuses on mechanical, physical, and biocompatibility testing of dental implants and prostheses, comparing them to legally marketed predicate devices. It covers aspects like:

• Fatigue testing (ISO 14801): To assess durability.
• Surface analysis (SEM): To characterize the implant surface.
• Implant removal after expansion: To evaluate interaction with artificial bone.
• Minimal rotation torque after placement and expansion: To assess stability.
• Partially expanded implant reciprocating effect test: To evaluate effects of rotation.
• Biocompatibility (ISO 10993): To ensure biological safety.
• Sterilization validation (Gamma and Steam): To ensure sterility.
• Cleaning validation: For reusable tools.
• Shelf life validation: To confirm sterility maintenance over time.
• Comparative pull-out test (ASTM F543): To assess mechanical strength.
• Comparative bone to implant contact surface area analysis: To compare integration potential.
• Implant surface area analysis: For physical characteristics comparison.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria and performance, as the document does not contain any details about an AI/ML component or study.

The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance) are highly specific to AI/Machine Learning model validation in a medical context, which is not described in this 510(k) summary for dental implants.

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The Medtronic Sofamor Danek PYRAMID® +4 ANTERIOR LUMBAR PLATE System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral lev :l below the bifurcation of the vascular structures or as an or anteriorly lateral placed supplemental fixation device for the 1.1 -L5 region.

When properly used, this system will ielp provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neo )lastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scolio is, lordosis, and/or kyphosis) associated with deficient posterior elements such as t at resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.

The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation of the vascular structures or laterally above the bifurcation of the vascular structures.

When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelcmenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic or liquity.

The subject device represents an expansion of the PYRAMID® ANTERIOR PLATE System. The prodicate system will be renamed the PYRAMID® +4 ANTERIOR LUMBAR PLATE System. Like its predicate counterpart, the subject device is intended for use as an ant rior fixation device to supplement an anterior lumbar interbody fusion. The variety of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System provides surgeons wit 1 options in the placement of the device to avoid interference with the vasculature, whil : still allowing for fixation. The PYRAMID® +4 ANTERIOR LUMBAR PLATE components are made of titanium alloy.

The information provided describes the Medtronic Sofamor Danek PYRAMID® +4 Anterior Lumbar Plate System. This is a medical device, specifically an anterior lumbar plate system, and the provided document is a 510(k) summary for its premarket notification to the FDA.

Based on the provided text, the device's acceptance criteria are demonstrated through substantial equivalence to previously cleared devices rather than a performance study with specific metrics and thresholds. Therefore, a table of acceptance criteria and reported device performance in the traditional sense of diagnostic accuracy metrics cannot be fully generated.

However, I can extract the information to address the other points about the "study" that proves the device meets the acceptance criteria, which in this case is a comparative analysis for substantial equivalence.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not describe a clinical "test set" in terms of patient data. The "study" here is based on mechanical testing and a comparison to predicate devices. The sample size for these mechanical tests is not specified in the provided text.
• Data Provenance: The data provenance is primarily from in-vitro mechanical testing performed by the manufacturer, Medtronic Sofamor Danek. It is not patient data from a specific country or retrospective/prospective study.

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

This point is not applicable to this type of device submission. There was no "ground truth" established by human experts on a test set of data (e.g., medical images or patient outcomes). The assessment of substantial equivalence relies on the FDA's review team evaluating the provided documentation, including design specifications and mechanical test results, against predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring an adjudication method. The FDA's review process itself can be considered a form of adjudication but is not structured like a consensus-based ground truth establishment for a diagnostic device.

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

No, an MRMC comparative effectiveness study was not done or described for this medical device submission. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to evaluate human performance with and without AI. The PYRAMID® +4 Anterior Lumbar Plate System is a physical implant, not an imaging or diagnostic tool.

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

This question is not applicable. The device is a physical implant (anterior lumbar plate), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on the established safety and effectiveness of the identified predicate devices (PYRAMID® Anterior Plate Fixation System and XANTUS® Anterior Lateral Supplemental Fixation System), as well as engineering principles and mechanical testing to demonstrate that the new device performs similarly and is safe for its intended use. There is no biological or clinical "ground truth" in the typical sense of a diagnostic study (e.g., pathology, outcomes data).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this physical device. The device's design is based on engineering principles, existing medical knowledge, and the established designs of predicate devices, not on data used for machine learning.

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

Not applicable, as there is no training set. The "truth" for the design derives from engineering validation and comparison to established, legally marketed predicate devices.

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The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.

When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.

The PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental fixation construct consisting of a variety of shapes and sizes of plates, and screws, as well as ancillary products and instrument sets. The PYRAMID™ ANTERIOR PLATE Fixation System implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made of titanium alloy (Ti-6A 1- 4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct.

This document is a 510(k) summary for a medical device called the Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information, specifically addressing the acceptance criteria and study aspects you've requested.

It's important to note that this document is a 510(k) summary, which is a premarket notification for devices demonstrating substantial equivalence to a predicate device. It typically does not contain detailed clinical trial data or performance metrics in the same way a PMA (Premarket Approval) application would for novel, high-risk devices. The "study" here refers to mechanical testing for equivalence, not a clinical study on human subjects.

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)

• Sample Size for Test Set: Not explicitly stated in terms of number of physical components tested, but implies sufficient samples were used for mechanical testing to establish equivalence. This is not a clinical "test set" in the traditional sense of patient data.
• Data Provenance: The origin of the mechanical testing data (e.g., specific lab, country) is not specified. Given Medtronic's location in Memphis, TN, it's likely U.S.-based or from a reputable international testing facility. This would be considered "prospective" testing as it was conducted specifically for this submission.

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 section is not applicable to this type of submission. Ground truth established by medical experts (e.g., radiologists) is relevant for diagnostic devices or AI algorithms interpreting medical images. For a spinal fixation system, "ground truth" for mechanical performance is established by engineering standards and comparative testing to predicate devices, typically assessed by engineers and regulatory bodies.

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

This is not applicable. Adjudication methods like 2+1 (two readers agree, third resolves discrepancy) are used for clinical studies involving human interpretation (e.g., image reading). Mechanical testing relies on objective measurements against defined criteria.

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 is not applicable. This device is a passive implantable medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be performed for this product.

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

This is not applicable. This device does not involve an algorithm.

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

For the mechanical testing performed, the "ground truth" would be the established performance characteristics and safety profiles of the predicate devices based on their own clearances and recognized engineering standards (e.g., ASTM/ISO). The new device's performance is compared to these benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

This is not applicable. This device is a physical implant, not a machine learning algorithm requiring a training set.

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

This is not applicable as it applies to machine learning algorithms.

Summary of the "Study" mentioned:

The study referred to in this 510(k) summary is mechanical testing.

• Objective: To demonstrate that the PYRAMID™ ANTERIOR PLATE Fixation System is "substantially equivalent" in terms of functionality and safety to the predicate devices (ZPLATE-ATL™ Anterior Fixation System and BUTTERFLY™ PLATE Fixation System).
• Methodology: Mechanical tests were performed. While specifics of the tests (e.g., fatigue testing, static testing, torsional testing) are not detailed in this summary, they would typically involve applying forces and stresses to the device and comparing its performance (e.g., strength, durability, screw pull-out resistance, plate bending strength) against those of the predicate devices.
• Proof of Meeting Acceptance Criteria: The statement "Mechanical testing was performed... which determined it to be substantially equivalent..." serves as the proof that the device meets the (implied) acceptance criteria of performance comparable to the cleared predicate devices. This equivalence demonstrates that it is as safe and effective as the devices already on the market.

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1. Posterior restorative material for Class I, II and V, and composite core build-up.

PYRAMID is a condensable, highly filled (79% w/w), light-cured radiopague composite. Its physical properties are similar to the predicate device and uses are identical. Like the predicate device, PYRAMID is glass frit filled dimethacrylate composite. It hardens by light cure polymerization mechanism employing light initiators. Both devices are designed to be used with high quality dentin / enamel adhesive systems.

The provided text describes the predicate device "BISFIL™P" and the applicant device "PYRAMID™", both composite restorative materials. The submission focuses on demonstrating substantial equivalence, primarily through material properties tests rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set) are not applicable or cannot be extracted from the given text.

Here's an analysis of the available information:

Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily states that PYRAMID's physical properties are "similar to the predicate device" and are designed to be "more wear resistance as well as higher tensile and compressive strength" (in a general sense of desirable properties for posterior composites). The only specific numerical acceptance criterion implied by direct comparison is the DTS value being close enough to the predicate to establish substantial equivalence.

Study Details

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

   • Sample Size: Not specified for the DTS test.
   • Data Provenance: The document refers to "non-clinical tests" and standards like ISO 4049 and American Dental Association #27. Cytotoxicity testing was performed by a "commercial testing laboratory (NAMSA)". No country of origin for the data is explicitly mentioned beyond the US location of the applicant. The data is retrospective in the sense that the tests were performed on the materials after their development to demonstrate equivalence.

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

   • Not applicable. This was a materials property study, not a clinical study requiring expert ground truth for diagnostic accuracy.

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

   • Not applicable. Not a diagnostic study requiring adjudication.

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

   • Not applicable. This is not an AI-assisted diagnostic device.

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

   • Not applicable. This is not an AI algorithm. The performance described is for the material itself in laboratory settings.

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

   • Ground Truth: For the physical properties, the "ground truth" is the measured value from standardized non-clinical tests (e.g., DTS per ISO standards). For biocompatibility, it's the official report from the commercial testing laboratory based on ISO 10993-5.

7. The sample size for the training set:

   • Not applicable. This is a material, not a machine learning model.

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

   • Not applicable. This is a material, not a machine learning model.

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The pyramidal trocars with spring-return protective sleeve are designed for establishing access by piercing a vessel or chamber to facilitate insertion of the trocar sleeve (cannula) to carry out diagnostic and therapeutic measures.

Trocars are made of medical grade stainless steel and brass (satin chromeplated).

The provided text describes a 510(k) Summary of Safety and Effectiveness for a medical device: "Pyramidal Trocar with spring-return protective sleeve" manufactured by Richard Wolf Medical Instruments Corporation.

Based on the provided information, the following answers can be given:

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

The document does not explicitly state specific acceptance criteria (e.g., numerical thresholds for performance metrics). Instead, it makes a general statement about 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 states under "9.0 Clinical Tests: No clinical tests performed." This implies that there was no test set of patient data, and therefore no information on sample size or data provenance in that context. The "testing" mentioned under "8.0 Performance Data" likely refers to in-house engineering and bench testing, not clinical studies.

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, as no clinical tests were performed, and thus no expert-established ground truth for a clinical test set.

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

Not applicable, as no clinical tests were performed.

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 surgical instrument (trocar), not an AI-powered diagnostic or assistive tool. No MRMC study was mentioned or would be relevant.

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

Not applicable. This device is a physical surgical instrument, not an algorithm.

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

Not applicable, as no clinical tests were performed. The "ground truth" for the device's safety and performance would have been established through engineering design specifications, material testing, and functional bench testing against internal standards for surgical instruments.

8. The sample size for the training set

Not applicable, as this device does not involve a machine learning model requiring a training set.

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

Not applicable, as this device does not involve a machine learning model requiring a training set.

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