The Momentum Posterior Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum™ Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.

In order to achieve additional levels of fixation, the Momentum Posterior Spinal Fixation System can also be connected to the Cortium® Universal OCT Spinal Fixation System or neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the Cortium or neon3 Instructions for Use for a list of indications for use.

The Momentum® Posterior Spinal Fixation System is a standard pedicle screw and rod systems designed for fixation and correction in the thoracolumbar and sacroiliac spine. This 510(k) submission adds hooks, various connectors, and monoaxial screws to the previously cleared system from K231809 and K191932.

The subject hooks are intended to provide deformity correction according to patient anatomical needs. The subject connectors are intended to provide additional options to improve stability. The subject monoaxial fenestrated screws are identical below the tulip to the previously cleared fenestrated screws with the addition of the option to use G21 V-Steady bone cement. The Momentum® Posterior Spinal Fixation System is manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3 and cobalt chromium Co-Cr-28Mo per ASTM F1537 and ISO 5832-12.

This document is a 510(k) premarket notification decision letter for a medical device called the "Momentum® Posterior Spinal Fixation System." It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The letter simply states that the FDA has reviewed the submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison of the device's indications for use, technological characteristics, and performance data (mechanical strength testing results) to existing predicate devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study data for an AI/ML powered device based solely on the provided text. The document concerns a traditional implantable medical device, not an AI/ML product.

To reiterate, the provided text does not contain any of the following information:

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is not an AI/ML device with performance metrics like sensitivity, specificity, etc.
2. Sample sizes used for the test set and the data provenance: Not applicable for an AI/ML model. The "test set" here refers to mechanical testing of physical components, not a data-driven model.
3. Number of experts used to establish the ground truth...: Not applicable, as ground truth is not established in the context of an AI/ML model for this device.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The performance data mentioned (ASTM F1717 Dynamic Compression Bending) refers to mechanical testing of the spinal fixation system components to ensure their structural integrity and durability, not the performance of an AI/ML algorithm.

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The VCFix Spinal System is indicated for use in the reduction of vertebral compression fractures that may result from osteoporosis or trauma (fracture types A according to Magerl/AO Spine classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). The VCFix Spinal System is intended to be used in combination with Teknimed F20 bone cement, and to be placed, using a transpedicular approach, in a fractured vertebra from level T9 to L5.

The VCFix Spinal System is a cannulated screw-shaped implant with an expandable plate structure and is available in multiple sizes to accommodate varying patient anatomy. A pair of implants are inserted into the pedicles and manipulated with the toolset, resulting in the expansion of the device to restore the vertebral height. The implant is made of titanium alloy (Ti6Al4V ELI). During the procedure, the surgeon inserts the implants bilaterally through each pedicle of the fractured vertebra and adjusts the height and angle of the device (to correct local kyphosis) based on the unique vertebral fracture of the patient.
The VCFix Spinal System includes sterile, single-use implantation kits and a preparation kit. The kits include a pair of implants and all tools necessary for preparing the implant site and vertebral body expansion. The positioning and expansion of the implant must imperatively be followed by the injection of Teknimed F20 bone cement (K103433) to fixate the restored vertebral body. The bone cement and its delivery system are sold separately.

The provided text is a 510(k) clearance letter and summary for a medical device (VCFix Spinal System). It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance testing.

Crucially, this document describes performance testing for a medical implant (a physical device), not an AI/ML medical device. The questions you've asked are specific to AI/ML device studies, particularly concerning acceptance criteria based on metrics like sensitivity, specificity, or F1 score, and elements like ground truth establishment and expert adjudication.

Because the VCFix Spinal System is a physical implant and not an AI/ML device, the detailed information requested about AI/ML specific study design (e.g., sample size for test set/training set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) is not applicable and therefore not present in this document.

The "Performance Testing Summary" section describes the mechanical and functional testing conducted for the implant. These tests are designed to ensure the physical device meets its engineering specifications and safety requirements, not to evaluate the diagnostic or predictive performance of an AI algorithm.

Here's a breakdown of the relevant information provided and an explanation of why other requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical implant, "acceptance criteria" here refers to engineering specifications and mechanical performance standards, not statistical performance metrics for an AI algorithm. The document states that "All necessary testing has been performed for the worst-case configuration of the VCFix Spinal System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended."

Information Not Applicable / Not Available for this Type of Device (Physical Implant):

The following points are specific to AI/ML device studies and are not found in this document because the VCFix Spinal System is a physical implant, not an AI/ML software device.

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing for implants involves physical specimens or in-vitro/in-vivo models, not image or clinical text data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML typically refers to expert labels on data. For an implant, "ground truth" relates to objective measurements from mechanical tests or clinical outcomes from trials (which are not detailed here beyond safety and equivalence).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to how expert disagreements are resolved for data labeling in AI/ML studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. MRMC studies are for evaluating AI's impact on human diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to the performance of an AI algorithm on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be the objective results of the specified mechanical and biological tests, demonstrating it meets engineering specifications and safety requirements.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that undergoes "training."
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) pertains to a physical medical device (spinal implant) and its clearances are based on comprehensive engineering, mechanical, and biological testing, demonstrating substantial equivalence to existing predicate devices. Therefore, the specific details and study design elements common to AI/ML medical device evaluations are not present in this documentation.

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The XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is intended for delivery of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement, which is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is divided into two parts, bone cement and a delivery system.

Bone cement is provided as a two-component system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.

The delivery system consists of a bone cement mixing device and a hydraulic pump. The Bone Cement Mixing Device can mix and stir the powder and liquid and transfer it to the injection barrel. Then, the bone cement is extruded and injected into the vertebral body by the hydraulic pump.

This FDA clearance letter pertains to a bone cement system and its delivery system, not an AI/ML powered device. As such, the typical acceptance criteria and study descriptions relevant to AI/ML devices (e.g., sensitivity, specificity, MRMC studies, expert adjudication) are not present in this document.

The provided text focuses on the substantial equivalence of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement System to a predicate device, primarily based on its materials, indications for use, and pre-clinical testing for the delivery system.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The information presented is for a traditional medical device (bone cement and its delivery system).

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SPECTRUM® GV Bone Cement is indicated for the fixation of the REMEDY® & REMEDY SPECTRUM® GV Spacers, and for the fixation of prostheses to living bone in the second stage of a two-stage revision of a total joint arthroplasty after the initial infection has been cleared.

SPECTRUM® GV Bone Cement is a radiopaque, PMMA bone cement with gentamicin and vancomycin. The bone cement is single-use and provided sterile. SPECTRUM® GV Bone Cement is a traditional bone cement in that the liquid is contained in a vial and the powder in a sachet. The two components are mixed manually immediately before use. The device is protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

This FDA 510(k) clearance letter is for a bone cement, not a medical device that utilizes AI or requires complex studies to demonstrate performance through acceptance criteria in the way you've described.

The document indicates that SPECTRUM® GV Bone Cement is substantially equivalent to a previously cleared predicate device (K231556), and therefore, extensive new studies to prove acceptance criteria in the context of device performance metrics (like sensitivity, specificity, or reader improvement with AI) were not required.

Here's why and what information is provided:

• Device Type: This is a Polymethylmethacrylate (PMMA) bone cement, a physical material used for fixation. It's not a diagnostic imaging device, a software as a medical device (SaMD), or an AI algorithm.
• Substantial Equivalence: The clearance is based on the device being "substantially equivalent" to a legally marketed predicate device. This means the FDA has determined it is as safe and effective as the predicate, often due to identical or very similar technological characteristics and intended use.
• No New Performance Data (for the requested criteria): The document explicitly states: "Non-clinical testing was not required as the subject device is identical to that of the predicate." This confirms that specific performance metrics, sample sizes for test sets, expert adjudication, or AI-related studies were not performed for this specific submission because the device itself hasn't changed.

Therefore, I cannot provide the detailed information requested in your prompt because the provided 510(k) letter does not contain the type of acceptance criteria and study analysis that would be relevant for an AI-powered diagnostic device. The questions about sensitivity, specificity, MRMC studies, ground truth establishment, and training/test set sizes are pertinent to AI/software device clearances, not to the material science and manufacturing consistency demonstrated for a bone cement via substantial equivalence.

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The VADER® Pedicle System:

The VADER® Pedicle System is 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis) and spinal instability due to infection, surgical debridement, or decompression.

The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

VADER®one Pedicle System:

The VADER ®one Pedicle System is 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.

The VADER®one Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System and VADER®one Pedicle System with additional connector components. The VADER® Pedicle System and VADER®one Pedicle System are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of:

• Polyaxial cannulated, fenestrated pedicle screws,
• Polyaxial, cannulated, pedicle screws, ●
• Curved. straight. S-rods. J-rods. ●
• Connectors .

The VADER® Pedicle System and VADER®one Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

Based on the provided text describing the VADER® Pedicle System and VADER®one Pedicle System, it's clear this document is an FDA 510(k) clearance letter for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness of a new technology.

Therefore, the document does not contain the kind of information requested regarding acceptance criteria, performance studies involving AI, human readers, ground truth establishment, or sample sizes related to AI/algorithm development. The performance testing mentioned is confined to "Bench testing consisting of static axial gripping capacity testing and static torque gripping capacity per ASTM 1798 and dynamic compression bending per ASTM F1717 was successfully completed," which are mechanical performance tests, not clinical or AI-related studies.

In summary:

• There is no mention of acceptance criteria and reported device performance related to an AI/software component. The "acceptance criteria" discussed implicitly by the FDA in a 510(k) context are those for establishing substantial equivalence to a predicate, primarily through material, design, and mechanical performance comparisons.
• There is no data regarding a "test set" for an AI or imaging algorithm. The "study" described is bench testing of the pedicle system's mechanical properties.
• No experts, ground truth, or adjudication methods are discussed in the context of clinical AI performance.
• No MRMC comparative effectiveness study or standalone algorithm performance is described.
• The type of ground truth used is not applicable as this is not an AI/imaging device. The "ground truth" for this device would be its physical properties meeting standards and its successful mechanical performance.
• No training set for an AI algorithm is mentioned.
• Ground truth for a training set is not applicable.

This document pertains to the market clearance of a pedicle screw system, primarily based on its mechanical performance and substantial equivalence to existing devices, not on the performance of an AI or imaging diagnostic algorithm.

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NEO Pedicle Screw System™

The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (scoliosis, kyphosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use with 5 mm to 8 mm screw diameters at spinal levels (thoracic and lumbar T1 to L5) where the structural integrity of the spine is not severely compromised.

BonOs® Inject

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. BonOs® Iniect

BonOs® Iniect is a radiopaque, iniectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a twocomponent system consisting of a powder and a liguid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

2. NEO Pedicle Screw System™

The NEO Pedicle Screw System™ has been optimized and consists of 27 pedicle and 8 iliac screws, rods and connectors which are available in different sizes. The system includes a reduced optimized trav of instruments providing options for open and MIS surgical techniques. The implants are all delivered sterile and ready to use. The relevant instruments are mainly delivered as single use, disposable and delivered sterile, just a few optional instruments are reusable and delivered non-sterile.

All the system components are made of materials compliant with ASTM and/or ISO standards. Screws and rods are made of titanium-alloy (Ti-6AI-4VELI) and comply with ISO 5832-3 or ASTM-F136. The screws are made out of a titanium alloy and delivered pre-mounted to a screw extender including a tissue dilator and sterile. The rods are made out of a titanium alloy or cobalt chrome alloy CoCrMo (ISO 5832-12, ASTM F1537) and delivered sterile, Connectors are made out of titanium alloy and delivered sterile.

The pedicle screws are offered in diameters of 4.5 – 8.0 mm and lengths of 25 - 55 mm. Illiac screws are offered in diameters of 8.0 mm and 10.0 mm and lengths of 70 – 100 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 35 – 100 mm, straight rods in lengths from 30 - 500 mm and the special-bent rod in either 30 or 40 mm length.

The NEO Pedicle Screw System™ provides immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system can be used via an open or minimally invasive posterior approach. lliac screws shall be placed via Sacral Alar Iliac (SAI) and/or Posterior Superior Illiac Spine (PSIS) approach. The size and form of the device is adjusted to the morphology of the body and the surgical technique.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called the "NEO Pedicle Screw System™" and "BonOs® Inject Bone Cement." This document details the administrative information, device description, indications for use, and a summary of performance data to support substantial equivalence to a predicate device.

However, the document specifies that "No clinical studies were conducted." This means that the information requested regarding acceptance criteria for a study proving device performance (especially for AI/algorithm-based devices), sample size for test and training sets, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment cannot be provided from this document.

The performance data mentioned in the document are limited to non-clinical testing, primarily focusing on mechanical performance, biological evaluation, and MRI compatibility. These types of tests are used to demonstrate that changes to the device (like new components or size extensions) do not negatively impact its existing, cleared performance characteristics, and that it is substantially equivalent to the predicate device.

Therefore, I cannot populate the requested table or answer the specific questions related to the acceptance criteria and study that proves the device meets the acceptance criteria in the context of an AI/algorithm-driven device's performance study, as this submission is for a physical orthopedic implant system, not a software or AI product requiring such a study.

Here's what can be inferred from the document regarding "acceptance criteria" and "proof" in the context of this device:

The "acceptance criteria" for the modifications introduced in this 510(k) submission are implicitly met if the device demonstrates substantial equivalence to its predicate device. This is primarily demonstrated through:

• Mechanical Performance: Meeting the requirements for pedicle screw spinal systems according to relevant ASTM and ISO standards (e.g., ASTM F1717 for dynamic compression bending). The document states: "Non-clinical performance testing demonstrate that the NEO Pedicle Screw System™ meets the requirements for Pedicle screw spinal systems according to Spinal System 510(k)s Guidance for Industry and FDA Staff Document issued on: May 3, 2004 and is substantially equivalent to its predicate devices."
• Biological Evaluation: Compliance with ISO 10993-1 series for the new components.
• MRI Compatibility: Meeting standards like ASTM F2052-15, ASTM F2182-11a, and ASTM F2119-07 (R2013).
• Functionality: Internal validation confirming new components function as intended.

Table of Acceptance Criteria (Implicit for a Mechanical Device) and Reported Performance:

Regarding the specific questions about an AI/algorithm performance study:

1. Sample size for the test set and data provenance: Not applicable. No clinical or external algorithm performance test set was used.
2. Number of experts used to establish the ground truth and qualifications: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. MRMC comparative effectiveness study: Not applicable.
5. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
6. Type of ground truth used: Not applicable. Ground truth for a physical device is often demonstrated by meeting design specifications and performance under defined test conditions (e.g., material strength and fatigue testing).
7. Sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional mechanical medical device, not an AI/ML powered one. Therefore, the specific criteria and study details requested, which are pertinent to AI/ML device evaluations, are not present in this submission. The "proof" for this device's acceptance rests on its demonstration of substantial equivalence to a predicate device through non-clinical laboratory testing.

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GENTAFIX is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.

Teknimed's GENTAFIX® cements with gentamicin are a family of surgical cements of various viscosities, each containing the antibiotic gentamicin. GENTAFIX® bone cements are intended for fixation of prosthetic components into bone medullar cavity in cemented arthroplasty procedures. GENTAFIX® can be used with the Teknimed's own Class I 510(k) exempt accessories: bowl and spatula, and a Vacuukit® vacuum mixing and injection system. Following are the GENTAFIX models identified based on their viscosities:

• o GENTAFIX® 1 is a high viscosity bone cement intended for digital use.
• . GENTAFIX® 3 is a low viscosity bone cement intended for syringe application.
• GENTAFIX® 3 MV is a medium viscosity bone cement intended for syringe application.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called Gentafix, a bone cement. It focuses on demonstrating substantial equivalence to a predicate device, primarily through material composition, technological characteristics, and performance testing.

However, this document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-based medical device. The product is a physical bone cement, and the testing described (physical, chemical, mechanical, sterilization, biocompatibility) are standard tests for such a material, not for an AI/ML diagnostic or prognostic tool.

Therefore, I cannot fulfill your request based on the provided text, as it does not describe:

• Acceptance criteria for an AI/ML device.
• The reported device performance for an AI/ML device.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The document is entirely about the regulatory clearance for a bone cement, not an AI/ML system.

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The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine; degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injection of bone cements, the fenestrated Reform pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Reform Pedicle Screw System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, dominoes, and lateral offsets. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium alloy described by such standards as ASTM F158, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The products are supplied clean and "non-sterile". The Fenestrated Screws allow the augmentation of PMMA bone cement to the insertion site. These modular Fenestrated Screws are assembled during surgery with the Reform Standard Modular Tulips or the Reform Reduction Modular Tulips which were cleared under K150856 and their compatible rods and set screws. The Fenestrated Screws are to be used with the G21 V-Fast Bone Cement or V-Steady Bone Cement cleared under K150408. Bone Cement is delivered into the pedicle screw and bone through the delivery instrumentation.

The provided text is a 510(k) summary for the Reform Pedicle Screw System. This document focuses on the mechanical testing and equivalence of a medical device, specifically a pedicle screw system, rather than a diagnostic AI/ML device that would have acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC).

Therefore, the typical acceptance criteria and study design elements you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) for an AI/ML device are not applicable to this submission.

Instead, the performance data provided is entirely about mechanical and material testing to demonstrate the physical characteristics and safety of the implanted device.

Here's a breakdown of the relevant information from the provided text, framed within the context of a traditional medical device submission, recognizing that it doesn't fit the AI/ML paradigm:

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

The document describes performance testing rather than specific acceptance criteria in a tabular format with quantitative metrics for a pass/fail. However, it states the following tests were conducted:

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

• Sample Size: Not specified in the summary. For mechanical testing, this would typically involve a specific number of test articles (e.g., screws, constructs) for each test.
• Data Provenance: The "study" is non-clinical mechanical bench testing performed according to ASTM standards. It's not human-centric data, so concepts like "country of origin" or "retrospective/prospective" studies are not applicable.

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

• Not applicable. Ground truth in this context is established by engineering specifications, standard ASTM testing methodologies, and objective mechanical measurements. It does not involve expert readers reviewing images or clinical data.

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

• Not applicable. Adjudication is relevant for subjective expert reviews, not for objective mechanical testing.

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

• Not applicable. This device is a physical implant, not an AI-powered diagnostic tool. MRMC studies are used to evaluate the diagnostic performance of AI or imaging modalities.

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

• Not applicable. There is no algorithm or AI component in this device. The testing is entirely for the physical device's characteristics.

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

• The "ground truth" for this type of device is established by engineering standards and physical test methodologies (e.g., ASTM F1717 for spinal implant constructs). The performance is measured against these established standards and compared to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning; therefore, there is no training set.

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

• Not applicable. There is no training set for this type of device.

In summary, the provided document details the substantial equivalence of a physical medical implant through mechanical testing, not the performance claims or evaluation of an AI-powered diagnostic device.

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OSTEOPAL® V bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

OSTEOPAL® V is a PMMA bone cement for use in vertebroplasty. It is formed from powder and liquid by exothermic polymerization.

This document is a 510(k) premarket notification for a medical device called OSTEOPAL® V, which is a polymethylmethacrylate (PMMA) bone cement. The purpose of the submission is to gain clearance for modifications to an existing device (K050085). Based on the provided text, the device itself is a material (bone cement), and thus the acceptance criteria and study described are for the performance of the material, not for an AI/software device. Therefore, many of the requested fields are not applicable.

Here's the information derived from the provided document regarding the acceptance criteria and the study that proves the device meets them:

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

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

The document primarily discusses non-clinical testing for material properties and risk assessments. There is no mention of a "test set" in the context of patient data or clinical imaging. The studies performed are mechanical testing, stability testing, and risk assessments. For these non-clinical tests, specific sample sizes are not provided in this summary. The data provenance is implied to be from Heraeus Medical GmbH in Germany, where the device is manufactured and where the tests would typically be performed. The tests are prospective in nature (i.e., new tests performed on the modified device).

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 as there is no "test set" or "ground truth" related to expert opinions on medical images or diagnoses for this device. The evaluation is based on engineering standards, material science, and risk assessment.

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

This is not applicable as there is no "test set" requiring adjudication by experts.

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. OSTEOPAL® V is a bone cement, not an AI/software device, and no MRMC study with human readers assisting with AI was performed or is relevant.

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

This is not applicable. OSTEOPAL® V is a bone cement, not an algorithm.

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

For the non-clinical tests (mechanical, stability, material characterization), the "ground truth" is established by adherence to recognized international standards (e.g., ISO 5833, ASTM F451, DIN EN ISO 14971) and validated laboratory testing methodologies. For the MR safety assessment, the "ground truth" is based on the material properties and scientific rationale. For the labeling and risk assessments, the "ground truth" is derived from clinical evaluations of the device's performance in the field (implicitly from the predicate device's history and relevant medical literature), coupled with the risk assessment process. There is no specific "expert consensus" or "pathology" ground truth mentioned as would be relevant for a diagnostic device.

8. The sample size for the training set

This is not applicable as there is no "training set" for an AI/software model. The device is a physical product (bone cement).

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

This is not applicable as there is no "training set."

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Hip Spacer Molds with stainless-steel reinforcement stems, centralizers and Hip Head Inserts are indicated for use to mold a temporary hemi-hip spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-hip spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The temporary hemi-hip spacer made from Hip Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the temporary hemi-hip spacer material (Cemex Genta LV) the temporary hemi-hip spacers is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.

Femoral Knee Spacer Molds and Tibial Knee Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Cemex Genta LV and inserted into the joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The temporary total knee spacer made from the Femoral Knee Spacer Molds and Tibial Knee Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty fusion, etc.). Due to the inherent mechanical limitations of the temporary total knee spacer material (Cemex Genta LV), the temporary total knee spacer is only indicated for patients who will consistently use traditional mobility devices (e.q., crutches, walkers) throughout the implant period.

Shoulder Spacer Molds with stainless-steel reinforcement stems, centralizers and Shoulder Head Inserts are indicated for use to mold a temporary hemi-shoulder spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-shoulder spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The temporary hemi-shoulder spacer made from Shoulder Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of hemi-shoulder prothesis material (Cemex Genta LV) the temporary hemi-shoulder prothesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

The Hip Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemi-hip spacers in a two-stage septic hip joint endoprosthesis. The Hip Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

The Femoral and Tibial Knee Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary knee spacers in a two-stage septic knee joint endoprosthesis. The Knee Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

The Shoulder Spacer Molds are sterile, sinqle use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemishoulder spacers in a two-stage septic glenohumeral joint endoprosthesis. The Shoulder Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

This FDA 510(k) clearance letter pertains to medical device molds (Hip, Knee, Shoulder Spacer Molds) used to create temporary orthopedic spacers. The submission does not describe an AI/ML powered device and therefore, the information requested about acceptance criteria and studies proving the device meets the criteria in the context of AI/ML is not available in the provided text.

The document discusses performance data related to the physical characteristics of the molds and the resulting spacers, but not in the context of an AI/ML algorithm's performance. Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size and data provenance for an AI/ML test set.
• Number and qualifications of experts for AI/ML ground truth.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML.
• Sample size and ground truth establishment for an AI/ML training set.

The performance data mentioned in the document relates to:

• Sterilization and Shelf Life: Validation according to ISO 11135, shelf life of 2 years.
• Biocompatibility: Categorized per ISO 10993-1, with tests performed including Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous reactivity (ISO 10993-23), Pyrogenicity (ISO 10993-11), and Acute systemic toxicity (ISO 10993-11).
• Mechanical Performance Testing:
  • Endurance properties of stemmed femoral hip components according to ISO 7206-4 and ISO 7206-6.
  • Wear of total knee-joint prosthesis according to ISO 14243-1.
  • Endurance properties of tibial trays according to ASTM F1800.
  • Endurance properties of shoulder spacer stem and neck region based on ISO 7206-4 and ISO 7206-6.
  • Antibiotic (gentamicin) elution testing.

These tests are designed to demonstrate the physical and biological safety and effectiveness of the medical device molds and the spacers they produce, showing substantial equivalence to predicate devices, rather than evaluating the performance of an AI/ML algorithm.

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