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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 Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilum). posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatic patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5 mm/6.0mm parallel connectors. the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Syn-thes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5 mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.

Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.

When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5 mm tapered rods, the Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Synthes USS 5.5 mm rod systems.

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum allov rods, which can only be used with USS Monoaxial Dual Core (Single-Opening) Screws. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.

The Synthes USS is a comprehensive system of spinal implants and instruments for non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1- S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Currently cleared components of the system include monoaxial and polyaxial pedicle screws, rods, hooks, locking caps, transconnectors, transverse bars, parallel connectors, and extension connectors.

The provided text is a 510(k) summary from the FDA for a medical device called the "USS System," which is a thoracolumbosacral pedicle screw system. This document is a regulatory approval, not a description of a study proving a device meets acceptance criteria for an AI/ML algorithm.

Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, expert ground truth establishment, or MRMC studies because the document describes a mechanical medical device, not a software-based AI system that would typically undergo such validation.

The "Performance Data" section in the document refers to mechanical testing (dynamic compression bending) of the screw and rod, not performance metrics of an AI algorithm.

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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 DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware: fracture fixation (open and closed) pseudoarthrosis of long bones limb lengthening (epiphyseal or metaphyseal distraction) joint arthrodesis infected fractures or nonunions correction of bony or soft tissue deformities correction of segmental defects.

The DePuy Synthes MAXFRAME™ Multi-Axial Correction System, with adult and pediatric indications, is an external ring fixation system that is combined with web-based software in treatment of soft tissue and bone deformities. In the MAXFRAME system, implanted transfixion wires, Schanz screws and pins are attached to the rings and plates surrounding the deformity using bolts, nuts and connecting plates. Upper and lower rings are then connected to one another using six telescoping struts, creating a "Stewart Platform" type device. Adjusting the strut length allows for correction of length, rotation, and angular deformity at the same time. The modular nature of a ring fixation frame allows multiple frame options. A ring fixation frame is assembled individually by the surgeon to address the different characteristics of each case. The materials of construction for this system include aluminum, elgiloy, stainless steel and various polymeric materials. This system has been validated as MR Conditional.

The provided text describes the DePuy Synthes MAXFRAME™ Multi-Axial Correction System, a medical device, and its FDA 510(k) summary. However, it does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The device itself is a physical external ring fixation system combined with web-based software for treatment planning, not an AI diagnostic or predictive tool in the context of typical AI performance studies.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to AI, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI component.

The document discusses performance in terms of:

• Construct testing: ASTM 1541-02 (2011)
• Component testing: Static & Dynamic Compression testing, Static Torsion, Static Cantilever, Static and Dynamic Fatigue, Wire Slip and Ring to Wire Interface Testing
• System Validation
• Software Verification: In accordance with Special Controls & EN IEC 62304:2006-05 Medical device Software life cycle processes
• MR Conditional Technical Data: In accordance with FDA Guidance and ASTM F2503-13
• Reprocessing of SUD in accordance with Special Controls

The conclusion states that "The objective evidence presented demonstrates that the mechanical performance of the proposed device is comparable to that of the predicate device(s) and supports substantial equivalence for safety and effectiveness."

No clinical evaluation was deemed necessary for the determination of substantial equivalence for this device.

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The T-PAL Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with supplemental internal fixation systems.

The T-PAL Titanium Spacer System is indicated for use as an intervertebral body firsion device in skeletally mature patients with degenerative disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Titanium Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six mon-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with supplemental internal fixation systems.

The SYNFIX Evolution Spacer System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SYNFIX Evolution Spacer can be used in patients diagnosed with spinal deformities as an adjunct to fusion with DePuy Synthes Spine supplemental internal fixation products (e.g. pedicle screw system) for use in the lumbar spine in addition to integrated screws. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

T-PAL and T-PAL Titanium Spacer System: The T-PAL Spacer is a radiopaque intervertebral body fusion device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals. The T-PAL Spacer is available in various heights and geometries to best accommodate individual patient pathology and anatomical conditions. The components of this device are manufactured from a radiolucent polymer and titanium alloy.

SYNFIX Evolution System: The SYNFIX Evolution is a combination radiolucent and radiopaque stand-alone anterior lumbar interbody device designed to be inserted within the intervertebral disc space in order to provide structural stability in skeletally mature individuals. The SYNFIX Evolution is available as assembled components in various heights and geometries to suit individual patient pathology and anatomical conditions. The components of this device are manufactured from a radiolucent polymer, titanium alloy, and tantalum.

This document is a 510(k) premarket notification for the T-PAL Spacer System, T-PAL Titanium Spacer System, and SYNFIX Evolution System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria and a study proving device performance against those criteria.

Therefore, I cannot provide the requested information based on the provided text. The document states:

"No additional testing was required as there were no changes to the technological characteristics of the subject devices."

This indicates that the submission relies on the established safety and effectiveness of the predicate devices and existing literature, rather than new performance studies with specific acceptance criteria.

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The DePuy Synthes T-PAL Ti Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacers should be packed with autogenous bone graft (i.e. autograft).

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

The T-PAL Spacers are intended to be used with DePuy Synthes supplemental fixation.

The DePuy Synthes T-PAL Ti Spacer is an interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. Previously, only T-PAL Spacers manufactured from PEEK (With TAN marker pins) material were available. The subject T-PAL Ti spacers will be manufactured entirely of TAN per ASTM F1295. The T-PAL Ti Spacer is available in two footprints and a range of heights and is angulated 5° to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle). Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. These teeth are oriented along a contour that follows the curve of the implant to assist in implantation. A bullet-nose design also facilitates self-distraction and ease of insertion. The open architecture of the devices allows them to be packed with autogenous bone graft material, i.e. autograft.

This document is a 510(k) premarket notification decision letter from the FDA regarding the DePuy Synthes T-PAL Ti Spacer. It is not a study demonstrating acceptance criteria or device performance in the context of an AI/algorithm-driven medical device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and the reported device performance: This document does not contain performance metrics that would be applicable to an AI device. The "performance data" mentioned (Section H) refers to a Finite Element Analysis of the physical implant, not an AI algorithm's performance.
• Sample size for the test set and data provenance: No such data is presented.
• Number of experts and qualifications for ground truth: Not applicable to this type of device submission.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not conducted as this is a physical implant, not an AI device.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: No training data for an algorithm is mentioned.
• How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

The document concerns the regulatory clearance (510(k)) of a new version of an existing intervertebral body fusion device, the DePuy Synthes T-PAL Ti Spacer. The key aspects are:

• Device: DePuy Synthes T-PAL Ti Spacer (an intervertebral body fusion device).
• Changes from predicate: The main changes are a material change (from PEEK to Ti-6Al-7Nb (TAN) ASTM F-1295 titanium alloy), a sterilization modality change, and a minor design modification.
• Intended Use: For patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, requiring interbody fusion with supplemental fixation. The spacers must be packed with autogenous bone graft. DDD is defined by back pain of discogenic origin, confirmed by history and radiographic studies, in skeletally mature patients who have had six months of non-operative treatment.
• Predicate Device: Synthes T-PAL Spacer (K100089) and Patriot Signature® Ti Spacer (K122097).
• Demonstration of Equivalence: The submission asserts that the new device is substantially equivalent to the predicate devices because the intended use, performance, and technology remain "identical" despite the material and minor design changes.
• Performance Data (for the physical implant): A Finite Element Analysis (FEA) simulating static/dynamic axial compression and compression shear was performed to demonstrate that the proposed modifications do not introduce a "new worst case" regarding the physical implant's mechanical performance. This is not performance data for an AI algorithm.
• Conclusion: The FDA determined substantial equivalence based on the unchanged intended use and similar technological characteristics, with FEA and post-market data supporting that the changes do not raise new questions of safety and effectiveness.

In essence, this document is a regulatory approval letter for a medical implant, not a study of an AI device's performance against acceptance criteria.

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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 DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:

• Open reduction and internal fixation of fractures, mal-unions, and non-unions
• Following excision of benign bone tumors
• Replantations and reconstructions
• Arthrodeses of joints involving small bones
• Osteotomies, including deformity correction such as rotation, lengthening, shortening
• Pathological fractures, including impending pathologic fractures

The DePuy Synthes Variable Angle Locking Hand System consists of metallic plates and screws that offer screw-to-plate locking designed for various fracture modes of the hand. Generally, the system consists of plates, screws, and instruments which feature variable angle locking technology. The plates contained in the DePuy Synthes Variable Angle Locking Hand System are offered in a range of configurations to accommodate patient anatomy and surgical need. The plates are designed to accept existing 1.5mm cortex screws (K090047), previously cleared 1.5mm Locking Screws at the nominal angle only (K090047), and new 1.5mm VA Locking Screws. The new 1.5mm VA Locking Screws feature existing variable angle locking technology (K100776, K120689, K110354), and are designed to fit in the 1.5mm holes of the subject plates.

The provided text is a 510(k) premarket notification for a medical device (DePuy Synthes Variable Angle Locking Hand System). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance as would be seen in a PMA or De Novo submission.

Therefore, the document does not contain information typically found in acceptance criteria and study reports for software/AI devices (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details).

However, it does describe the non-clinical testing performed to demonstrate the substantial equivalence of the mechanical aspects of the device.

Here's an analysis of what information is available in the provided text, structured to address your request as much as possible given the limitations of the document:

Acceptance Criteria and Study to Prove Device Performance

This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing rather than clinical performance metrics with specific acceptance criteria typically associated with software or AI devices. The information below reflects the mechanical performance testing mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the non-clinical tests in the format of a table, nor does it provide the quantitative results of these tests. Instead, it lists the types of tests performed to support the device's performance and substantial equivalence to predicates.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not specified for the mechanical tests. For non-clinical mechanical testing, sample sizes are typically determined by relevant ASTM standards or internal validation protocols, often involving a small number of representative samples.
• Data Provenance: The tests are non-clinical (laboratory-based) and conducted by the manufacturer (DePuy Synthes). Country of origin is implied to be within the manufacturer's operational locations (e.g., USA, as the submitting entity is Synthes USA). The data is by nature "prospective" in the sense that the tests were designed and executed to evaluate this specific device configuration.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a mechanical implant, not an AI/software device requiring expert interpretation for ground truth establishment. The "ground truth" for mechanical testing is established by the physical properties of the materials and designs under standardized test conditions.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for clinical image interpretation or diagnostic decisions, not for mechanical testing of orthopedic implants.

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

Not applicable. This is a mechanical orthopedic implant, not an imaging device or AI diagnostic tool that would typically involve human readers.

6. Standalone Performance

The "standalone performance" in this context refers to the device's mechanical performance in laboratory settings, independent of human interaction during the test itself. The non-clinical tests (Dynamic Fatigue, Torsional, Pullout, Insertion Torque, FEA) evaluate the device in this standalone capacity.

7. Type of Ground Truth Used

For the mechanical tests, the "ground truth" is defined by:

• Standard ASTM methodologies: (e.g., ASTM F543 for screw properties).
• Engineering principles and material properties: Used in Finite Element Analysis.
• Physical measurements under controlled laboratory conditions.

This differs significantly from a "ground truth" for a diagnostic medical device which would involve expert consensus, pathology, or outcomes data.

8. Sample Size for Training Set

Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm involved in the primary function or evaluation of this mechanical device.

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