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The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions, osteotomies, nonunions, and malunions of the bones of the forefoot, midfoot, and hand in patients 2 years of age and older in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 2.0 mm Quick Insertion Screws (Ql Screws) are twist-off style screws comprised of a screw and post which are intended to separate at a predefined location (the breakpoint) as the screw is implanted into bone. The screws are offered with an external thread diameter of 2.0 mm and in lengths ranging from 11 mm to accommodate varying patient anatomy and fracture patterns in the foot and hand. The screws are made of a titanium alloy (Ti-6Al-7Nb) in accordance with ASTM F1295.

The provided text is a 510(k) summary for a medical device (DePuy Synthes 2.0 mm Quick Insertion Screws) and does not contain information about an AI/ML-based device or a study involving human readers and AI assistance.

Therefore, I cannot extract the requested information to describe acceptance criteria and a study proving a device meets acceptance criteria using AI/ML-related performance metrics. The document focuses on establishing substantial equivalence to predicate devices based on material properties, mechanical performance, and intended use for bone fixation screws.

Specifically, the document states:

• "No clinical performance data is provided in this submission." (Section 8)
• The non-clinical performance data provided relates to mechanical testing of the screws (insertion torque, axial pullout, bending strength), not AI/ML performance.

Therefore, I cannot fill out the requested table or answer the questions related to AI/ML study design, ground truth establishment, sample sizes for AI training/testing, or expert involvement in AI model evaluation.

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The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.

The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.

Cranium

• . The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.

DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, and infants. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs as detailed in the table below.

Acceptance Criteria and Study for Craniomaxillofacial Distraction System (CMFD)

The provided document describes the Craniomaxillofacial Distraction System (CMFD) and its demonstration of substantial equivalence to predicate devices. The "acceptance criteria" here refers to the performance benchmarks demonstrated through non-clinical testing to ensure the device is safe and effective and comparable to existing devices, especially given some technological differences.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for the individual non-clinical tests (e.g., how many constructs were tested for bending strength, how many devices for reversing prevention). The tests are described generally, without providing specific numbers of units or repetitions.

The provenance of the data for these non-clinical tests would be the device manufacturer's (DePuy Synthes) internal testing laboratories or contracted labs, likely in the US (where the company is based). These are prospective tests performed specifically to support this regulatory submission.

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

This section is not applicable to the type of study presented. The studies described are non-clinical (mechanical, materials, sterilization, endotoxin) which rely on objective measurements and engineering standards, not expert interpretation of results to establish ground truth in the way a clinical study with image interpretation would.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments, where disagreements among experts need a resolution process. The tests performed here are objective engineering and laboratory tests.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicate devices, along with a literature review of the previous device. There is no mention of human readers or AI assistance.

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

This is not applicable as the device is a mechanical surgical implant (Craniomaxillofacial Distraction System), not an algorithm or AI software, so there is no standalone algorithm performance to evaluate.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is established by:

• Engineering Standards and Specifications: For mechanical tests like bending strength, torsional strength, and tensile strength, the ground truth is defined by established engineering principles, material properties, and predetermined performance thresholds derived from predicate devices or clinical requirements.
• Biocompatibility Standards: ISO 10993-1 provides the framework for biocompatibility assessment.
• Sterilization Standards: ANSI/AAMI/ISO 17665-1 defines the "overkill" method for sterilization validation, setting the SAL of 10^-6 as the ground truth for sterility.
• Endotoxin Limits: Established limits (e.g., 2.15 EU/device) are the ground truth for endotoxin testing.
• Predicate Device Performance: Performance of the predicate devices implicitly sets a benchmark for acceptable "ground truth" performance for comparison.

8. The Sample Size for the Training Set

This section is not applicable. This is a submission for a mechanical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set" in the context of device development or testing mentioned here.

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

This section is not applicable for the same reasons as #8.

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The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.

The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the mandibular body and mandibular ramus where gradual bone distraction is required in adults and pediatric patients. DePuy Synthes CMF Distraction System is intended for single use only.

Mandible

• The 1.0 mm plates and screws are intended for neonates and infants under the age of 12 months
• The 1.3 mm plates and screws are intended for neonates, infants, and children 4 years of age and younger
• The 1.5 mm and 2.0 mm plates and screws are intended for infants, children, adolescents, and adults 1 year of age and older

DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the mandibular body and mandibular ramus in adults, adolescents, children, infants, and neonates. The distractor implant consists of several components; the distractor body, footplates, extension arms, and bone screws, many of which are available in a variety of configurations to meet patient and surgeon needs as detailed the table below.

The distractor body is first secured to bone using footplates and screws, and then activation of the distractor is accomplished through the rotation of an advancement/lead screw with an activation instrument either percutaneously or intra-orally.

I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text.

The provided document is a 510(k) premarket notification for a medical device called the "Craniomaxillofacial Distraction System (CMFD)". This type of submission to the FDA focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than on proving the device meets specific performance acceptance criteria through the rigorous study design you've outlined in your request.

Here's why the text doesn't contain the information you're asking for:

• Focus on Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by demonstrating similar technological characteristics, indications for use, and by performing non-clinical testing that shows comparable performance.
• Lack of Clinical Performance Data: Section 5.8 explicitly states: "No clinical performance data is included in this submission." This means there isn't a human clinical study with a test set, ground truth experts, adjudication methods, or MRMC studies.
• Non-Clinical Data: The "Non-clinical performance data" section (5.7) describes engineering and in-vitro tests (e.g., bending strength, torque input/force output, tensile strength, biocompatibility, sterilization) to address the recall issue and support equivalence. These are not the type of studies that would establish the specific acceptance criteria for a "device performance" metric in the way you've described (e.g., accuracy, sensitivity, specificity, etc., typically associated with AI/diagnostic devices).
• No "Acceptance Criteria" Table: The document doesn't present a formalized table of acceptance criteria for diagnostic or performance metrics because it's not a performance study for a novel device, but rather a submission for a modification to an existing one to address a recall.

Therefore, I cannot extract the information for your table (acceptance criteria, reported device performance), nor can I answer your specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to a clinical performance study. The document describes engineering tests and comparisons to a predicate, not the kind of clinical validation study you're asking about.

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The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula, and the bones of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non-unions, and malunions of various long bones, such as the humerus, femur and tibia; the pelvis, and the bones of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments; and the bones of the hand and foot, in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.

The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis.

The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intra-articular fractures, avulsions, non-unions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, non-unions, and malunions of small bones and small bone arthrodesis in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular fractures, non-unions, malunions, and osteotomies of small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of various bone fragments including bones of the foot, humerus, femur and tibia in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes Cortex, Cannulated, and Headless Compression Screws are metallic bone screws manufactured from Stainless Steel (ASTM F138), Commercially Pure Titanium (ASTM F67), and/or Titanium Alloy (ASTM F1295). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.

The DePuy Synthes Cannulated and Headless Compression screws are cannulated for use with guidewires for precise placement in bone with the exception of the 1.5 mm Headless Compression Screw, which is a solid screw and therefore does not allow for instrumentation with a guide wire. The Headless Compression Screws feature threaded heads that allow for purchase in the near cortex of bone during and after implantation, potentially reducing complications associated with countersinking of traditional cortex or cannulated screws.

This document is a 510(k) Pre-market Notification to the FDA for various bone fixation screws manufactured by DePuy Synthes. It aims to demonstrate substantial equivalence to previously cleared devices.

Based on the provided text, there is no acceptance criteria or study data related to an AI/ML powered medical device. This document pertains entirely to traditional medical devices (bone screws) and their mechanical properties, indications for use, and comparison to predicate devices. The "performance data" section explicitly states "There is no bench testing included in this submission," "There is no animal data included in this submission," and the "Clinical" section refers to "published clinical literature to support the safety and efficacy of the modifications to the Indications for Use" rather than a clinical study conducted by the manufacturer specifically for this submission.

Therefore, I cannot provide the requested information for an AI/ML powered medical device based on this document. The questions about test sets, data provenance, expert consensus, MRMC studies, standalone performance, and training sets are not applicable here.

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The Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

The Mandible External Fixator consists of the following components: Adjustable Parallel Pin Clamp; Adjustable Clamp; 2.5mm/4.0mm Schanz Screws; 2.0 mm K-wires; 2.5 mm K-wires;; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon Fiber Rods. The rods and Schanz screws are available in various lengths.

This document is a 510(k) premarket notification for a medical device called the "Mandible External Fixator - MR Conditional." It focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices, particularly regarding its MRI compatibility.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

The document doesn't present a formal table of acceptance criteria with specific numerical thresholds for general device performance. Instead, it describes the acceptance criteria implicitly through the non-clinical tests performed for MR Conditional labeling. The "reported device performance" is then stated as successfully meeting the requirements of these tests.

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

The document states, "Non-clinical testing to support MR Conditional labeling include assessments of magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts."

• Sample size: The document does not specify the sample size used for these non-clinical tests. It implies that the tests were performed on representative samples of the Mandible External Fixator components.
• Data provenance: The data is non-clinical performance data (laboratory testing) conducted to support the MR Conditional labeling. The country of origin of the data is not explicitly stated, but as the submitter is "Synthes USA Products, LLC" in "West Chester, PA, United States of America," it is likely that the testing was performed in the United States or at facilities supporting their US operations. The data is not retrospective or prospective clinical data as no clinical testing was performed 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 question is not applicable to this submission. The "ground truth" for non-clinical MR Conditional testing is based on established industry standards and regulatory guidance for evaluating the safety of devices in an MRI environment (e.g., ASTM standards for MR safety). It does not involve expert consensus on medical images or clinical outcomes. Therefore, no experts were used to establish ground truth in this context.

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

This question is not applicable as the evaluation of MR safety testing results does not involve human adjudication in the way clinical diagnostic studies might. The results are typically objectively measured and compared against predefined safety thresholds.

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 done. This submission is for a physical medical device (Mandible External Fixator) and focuses on its material properties and safety in an MRI environment, not on diagnostic image interpretation or AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical fixator, not an AI algorithm.

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

The "ground truth" for the non-clinical MR Conditional evaluation is based on established scientific principles, engineering standards (e.g., ASTM F2503 for MR Conditional labeling), and regulatory guidance concerning the interaction of materials with magnetic fields, radiofrequency energy, and their impact on image quality. It's an objective measurement against defined safety limits, not a subjective assessment by medical experts or clinical outcomes data.

8. The sample size for the training set

This question is not applicable. Since no AI algorithm is involved, there is no "training set." The testing performed was non-clinical and focused on the physical device's characteristics.

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

This question is not applicable as there was no training set since no AI algorithm was developed or evaluated.

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The Synapse OCT System, including Synapse, OC Fusion and Axon, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the instability. The Synapse OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Axon and Synapse Systems may be connected to the Synthes Universal Spinal System using parallel connectors and tapered rods. The Synapse OCT System can also be linked to the titanium DePuy EXPEDIUM Spine System using the 3.5mm/5.5mm titanium tapered rods.

The Synapse OCT System, including Synapse, OC Fusion and Axon consists of screws, hooks, rods, plates, transverse bars, parallel connectors, transconnectors, and locking screws. These implants are designed for fixation of the occiput, cervical, and/or upper thoracic spine (Occiput – T3). A complete OCT construct can be created by using components that have been previously cleared within the CerviFix, Axon, Synapse and OC Fusion Systems. The components of the Synapse OCT System are manufactured from Titanium Alloys, similar to the predicate device.

The provided document is a 510(k) premarket notification letter and summary for the Synapse Occipital-Cervical-Thoracic (OCT) System. This document describes a medical device, specifically a spinal fixation system, and its substantial equivalence to a predicate device. It does not contain information about the performance of an AI/ML device, nor does it present acceptance criteria or a study proving an AI/ML device meets such criteria.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) as it pertains to an AI/ML device from this document. The "Performance Data" section refers to bench testing of the mechanical properties of the spinal fixation system (implants), not an AI/ML diagnostic or prognostic tool.

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These Systems are intended for the following:

Hooks, Plate/Rods, Plates, Rods and Screws

When intended to provide stabilization as an adjunct to fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix, Axon, OC Fusion and Synapse Systems are indicated for skeletally mature patients using allograft for the following:
· Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
· Spondylolisthesis

• · Spinal Stenosis
• · Fracture/dislocation
• Atlantoaxial fracture with instability
• Occipitocervical dislocation
• · Revision of previous cervical spine surgery
• Tumor

When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars

The rods, clamps, screws, nuts, variable axis screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.

OC Fusion System

The Synthes OC Fusion System is intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, and Synthes Synapse System.

The OC Fusion System is indicated for skeletally mature patients using allograft and/or autograft for the following indications:

· Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

• · Spondylolisthesis
• · Spinal Stenosis
• · Fracture/dislocation
• Atlanto/axial fracture with instability
• · Occipital-cervical dislocation
• · Revision of previous cervical spine surgery
• · Tumors (primary and metastatic)

The use of screws is limited to placement in the occiput. Screws are not intended to be placed into the cervical spine.

The Synapse System is a hook, pedicle screw, and rod spinal system which is designed to provide spinal fixation to allow for stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Synapse System is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Axon System and CerviFix System also included in the indications for use statement are additional hook, pedicle screw, and rod spinal systems. These systems consist of anchors including bone screws, pedicle screws and hooks; interconnection mechanisms including locking screws, set screws, parallel rod connectors, clamps, transverse bars, rod collars and nuts; longitudinal members including rods and rod/plates; and transverse connectors including transconnectors.

The OC Fusion System consists of occipital plates, occipital screws, and rods intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. The OC Fusion System can be used with components from the Synthes CerviFix System including Axon and Synapse components to create a complete occipital-cervical-thoracic spinal construct.

Fixation of the rods included in the Synapse and OC Fusion Systems is achieved by using hooks from one of the aforementioned cleared systems. System components in the Synapse and OC Fusion Systems are implanted with Class I general use surgical instruments.

The provided text describes a 510(k) premarket notification for medical devices, specifically the Synapse System and OC Fusion System, which are spinal interlaminal fixation orthoses. The document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a study that defines and tests against acceptance criteria for a new device's performance characteristics.

Therefore, many of the requested details, such as a table of acceptance criteria with reported device performance, sample sizes for test and training sets, expert qualifications, and ground truth establishment, are not explicitly provided in this type of regulatory submission. This document confirms the material, intended use, and general performance testing (mechanical testing for a specific component) to demonstrate equivalence.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

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

This document does not provide a table of acceptance criteria for a newly developed performance characteristic nor detailed reported device performance against such criteria. The submission states that the device was evaluated using mechanical testing and found to be "substantially equivalent to or better than the predicate devices." This implies that the 'acceptance criteria' were likely an equivalence or superiority comparison to the predicate device's established performance, rather than specific numerical thresholds for novel 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 describes mechanical testing for the OC Fusion System components. It does not specify a sample size (e.g., number of test articles) for this mechanical testing. There is no information provided regarding data provenance (country of origin, retrospective/prospective) as the testing described is in vitro mechanical testing, not human-patient data.

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

This is not applicable. The study described is mechanical testing of physical device components, not an assessment requiring expert interpretation of medical images or patient data to establish ground truth.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of ambiguous cases, particularly in imaging, and are not relevant to mechanical performance 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

There is no MRMC study or AI component mentioned in this document. This submission is for physical spinal fixation devices, not a diagnostic or AI-powered medical device.

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

This is not applicable. There is no algorithm or software device described in this submission.

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

For the mechanical testing performed, the "ground truth" would be the direct physical measurements of device strength, fatigue, and other mechanical properties under controlled conditions, compared against the equivalent properties of the predicate devices according to ASTM F2706-08.

8. The sample size for the training set

This is not applicable. There is no training set mentioned as this is not a machine learning or AI-based device.

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

This is not applicable. There is no training set.

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For fracture fixation of small bones and small bone fragments including odontoid fractures.

DePuy Synthes Spine Dens Access System is comprised of screws and instruments. The screws are available in multiple lengths and will be offered non-sterile. The screws feature self-drilling, self-tapping tips, reverse cutting flutes and cancellous threads.

The K132910 submission describes the DePuy Synthes Spine Dens Access System, a bone fixation fastener intended for fracture fixation of small bones and small bone fragments, including odontoid fractures. The submission relies on mechanical testing to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative table. Instead, it mentions that "Mechanical testing was provided in order to provide data to support a substantial equivalence determination. These tests were performed to characterize the properties and functionality of the screw, as well as to allow comparison with established acceptance criteria." This implies that the device's performance in the mechanical tests met or exceeded the acceptance criteria, which were likely derived from the performance of the predicate devices or relevant industry standards.

The mechanical tests conducted were:

• Torque to failure test
• Cantilever bend test
• Pull-out strength test
• Insertion torque test

While the specific numerical results and acceptance thresholds are not detailed in this summary, the FDA's clearance (K132910) indicates that the device's performance was deemed acceptable for its intended use and substantially equivalent to the predicate devices.

Study Details

Detailed information regarding the specific studies (sample sizes, data provenance, ground truth establishment, etc.) directly related to this device's performance validation is not extensively provided in the summary. The provided submission is a 510(k) summary, which often provides a high-level overview rather than granular study details.

Based on the available text:

1. Sample size used for the test set and the data provenance: Not explicitly stated for each mechanical test. The data provenance is implied to be from internal lab testing conducted by Synthes Spine. No country of origin for the data is specified, but given the submitter is "Synthes Spine, West Chester, PA", it's reasonable to assume the testing occurred within the US or under their oversight. The studies were non-clinical.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this device's performance is established through objective mechanical testing against engineering specifications and predicate device performance, not expert consensus on medical images or clinical outcomes.
3. Adjudication method for the test set: Not applicable for mechanical testing.
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 a medical device (bone screw and instruments), not an AI-powered diagnostic or assistive tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
6. The type of ground truth used: The "ground truth" for the mechanical tests would be the established engineering specifications (e.g., maximum torque, bend strength, pull-out force) derived from industry standards (e.g., ASTM) and/or the performance characteristics of the predicate devices. The objective measurements from the tests are compared against these predetermined values.
7. The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance and Equivalence

The K132910 submission for the DePuy Synthes Spine Dens Access System demonstrates substantial equivalence to predicate devices (Synthes 4.0mm Cannulated Screw - K963192, HBS Headless Bone Screw - K020791, Headless Compression Screw - K112672) based on mechanical testing. The testing covered torque to failure, cantilever bend, pull-out strength, and insertion torque. While explicit numerical acceptance criteria and performance values are not detailed in this summary, the FDA's clearance indicates that the performed tests supported the claim of substantial equivalence in terms of design, materials, performance, intended use, and other relevant characteristics. No clinical studies were necessary for this determination.

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Synthes Hemostatic Bone Putty is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Synthes Hemostatic Bone Putty (HBP) stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during the surgical procedure. When applied as directed, HBP forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure and dissolves postoperatively, permitting normal tissue healing and bone regeneration. HBP is a blend of synthetic water soluble polymers that form a ready-to-use hemostatic agent that is substantially eliminated from the defect site in less than 48 hours. The constituents of Synthes Hemostatic Bone Putty and Ostene, the predicate, are similar. Ostene is comprised of a proprietary mixture of water soluble alkylene oxide copolymers. HBP is also comprised of water soluble alkylene oxide polymers. The remainder of HBP is a polysaccharide, carboxymethylcellulose (CMC), to improve handling. Ostene does not contain CMC.

The provided text describes a 510(k) submission for the Synthes Hemostatic Bone Putty (HBP) and mentions a variety of non-clinical tests performed for substantial equivalence comparison. However, it does not contain the detailed acceptance criteria or numerical performance data of the device in a structured table, nor does it present a study proving the device meets specific performance criteria.

The document primarily focuses on establishing "substantial equivalence" of HBP to a predicate device (Ostene CT Soluble Hemostasis Implant Material, K082491), rather than demonstrating direct performance against predefined acceptance criteria. Substantial equivalence in this context means the device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested sections regarding acceptance criteria, reported performance, sample sizes, ground truth, and expert involvement cannot be extracted directly from this document.

Here's what can be inferred or stated based on the provided text, while also explicitly noting what is not available:

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

This information is not provided in the document. The document lists several non-clinical tests that were performed, but it does not specify quantitative acceptance criteria for these tests or present the reported numerical performance of the device against such criteria. The studies listed are:

• Cytotoxicity Study Using the ISO Elution Method
• Mouse Peripheral Blood Micronucleus Study
• ISO Modified Intracutaneous Study, Solution with Measurement
• Genotoxicity: Bacterial Reverse Mutation Assay
• Genotoxicity: Mouse Lymphoma Assay
• ISO Guinea Pig Maximization Sensitization Test-Solution
• Systemic Toxicity Study
• An In Situ Study to Determine the HBP Resorption Rate in a Rat Craniotomy Model
• In Vivo Resorption Rate of a Hemostatic Bone Putty Subcutaneously Implanted in the Rabbit at 2, 4, 7, 14 Days.
• In Vivo evaluation of Hemostatic Bone Putty in a sheep vertebral body defect at 7 days
• Evaluation of Hemostatic Bone Putty in a Sheep Vertebral Body Defect
• An In Vivo Study to Determine Hemostatic Bone Putty Effect on Bone Healing In A Rat Craniotomy Model at 3, 6, and 12 Weeks

The document states that "Documentation is provided that demonstrates that Synthes Hemostatic Putty is substantially equivalent' to other legally" marketed devices. This implies that the results of these tests were considered satisfactory to demonstrate equivalence, but the specific performance outcomes or the acceptance thresholds are not detailed.

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 lists several in vivo and in vitro animal studies.

• Animal Models Used: Rat, Rabbit, Sheep.
• Sample sizes for these studies are not specified in the provided text.
• Data Provenance: Not explicitly stated, though the applicant is Synthes USA Products, LLC, with an address in West Chester, PA, USA. The studies likely originated from contract research organizations or internal labs, but the specific country of origin for the data is not mentioned.
• Retrospective or Prospective: These would be prospective animal studies, as they involve active experimentation to test the device.

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 as the evaluation is for a physical medical device (hemostatic bone putty) through non-clinical (animal and lab) studies, not a diagnostic AI device requiring expert consensus or ground truth derived from human interpretation. The "ground truth" would be the biological and physical measurements and observations from the animal models, analyzed by researchers/pathologists. The specific qualifications of those interpreting the animal study results are not provided.

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

This is not applicable to the non-clinical studies described, which are not based on human-in-the-loop diagnostic interpretations. The evaluation relies on laboratory and in vivo observation methods.

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. The device is a hemostatic bone putty, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

This is not applicable. The device is a hemostatic bone putty, not an algorithm.

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

For the in vivo studies, the "ground truth" would be established through direct observation, physiological measurements, histology, pathology, and possibly imaging (e.g., to assess bone healing), as performed by qualified personnel in the animal studies.

• For the resorption rate studies in rats and rabbits, the ground truth would be the measured presence/absence and degradation of the putty.
• For bone healing studies in rats and sheep, the ground truth would be pathological and histological assessment of bone regeneration and healing.
• For the hemostasis evaluation in sheep, the ground truth would be direct observation and measurement of bleeding control.
• For in vitro studies like cytotoxicity, genotoxicity, and sensitization, the ground truth would be laboratory assays according to ISO standards.

8. The sample size for the training set:

This is not applicable. The device is a physical medical product, not an AI model requiring a training set. The term "training set" is typically used in the context of machine learning.

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

This is not applicable, as there is no training set for a physical medical device.

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