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The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures, and traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation. They are intended to be used in combination with Stryker Vertaplex® and Vertaplex® HV bone cement.

Vertaplex® Radiopaque Bone Cement is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with the Spinelack Expansion Kit, Vertaplex® Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures.

Vertaplex® HV Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with ES2® Augmentable Spinal System, Vertaplex® High Viscosity (HV) Radiopaque Bone Cement 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. Vertaplex® High Viscosity (HV) Radiopaque Bone Cement and the ES2® Augmentable Spinal System are for use together at spinal levels where the structural integrity of the spine is not severely compromised. When used in conjunction with the Spinelack Expansion Kit, Vertaplex® High Viscosity (HV) Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures.

The SpineJack® Expansion Kit ("SpineJack") is an implanted reduction system intended to reduce vertebral compression fractures. The SpineJack is used with a Preparation Kit (sold separately) which prepares the vertebra for implant. The SpineJack is available in three sizes to accommodate different vertebral body sizes, specifically 4.2 mm. 5 mm. and 5.8 mm. After the implant is inserted, it is expanded to reduce the vertebral compression fracture and Vertaplex Radiopaque Bone Cement or Vertablex HV Radiopaque Bone Cement (sold separately) is injected at low pressure to fixate the restored vertebral body.

Vertaplex® Radiopaque Bone Cement and Vertaplex® High Viscosity (HV) Radiopaque Bone Cement are PMMA bone cements. Powder and liquid components are mixed together so that they polymerize and form a hardened acrylic polymer. The mixture is in a pourable and injectable state for a period of time, before it cures to form a hardened structure, capable of long-term load support, bone augmentation and implant encapsulation in the treatment of vertebral compression fractures.

The provided document describes a 510(k) premarket notification for the Stryker SpineJack® Expansion Kit, Vertaplex® Radiopaque Bone Cement, and Vertaplex® High Viscosity (HV) Radiopaque Bone Cement. The submission focuses on seeking an expanded indication for use for traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) in addition to the existing indication for osteoporotic vertebral compression fractures.

Crucially, the document states that "No bench or biocompatibility testing was required to support the proposed indications. Additionally, no prospective clinical data was generated for the purpose of supporting this submission." This means there isn't a traditional study with a test set, ground truth experts, or an MRMC study as would be seen for a new AI/software-based device.

Instead, the submission relies on Real World Evidence (RWE) consisting of outside-of-US clinical data published in the clinical literature and a post-market outside-of-US clinical study. The acceptance criteria are not in the form of specific performance metrics (e.g., sensitivity, specificity, F1-score) for an AI or diagnostic algorithm, but rather a demonstration that the expanded indication (traumatic VCFs) does not introduce new safety or effectiveness concerns compared to the existing indication (osteoporotic VCFs).

Therefore, a table of acceptance criteria and reported device performance in the typical sense for a diagnostic device (e.g., AI performance metrics) cannot be extracted from this document as the criteria are based on equivalence in safety and effectiveness for an expanded indication of a physical medical device.

However, I can describe the justification for the expanded indication based on the information provided:

1. Acceptance Criteria and Reported Device "Performance":

The acceptance criteria here are qualitative, focusing on the absence of new safety or effectiveness concerns for the expanded indication.

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

• Test Set (Implicit): Not a traditional "test set" for an algorithm. The evidence relies on:
  • Outside-of-US clinical data published in the clinical literature: Sample sizes would vary per publication, but specific numbers are not provided in this document.
  • A post-market outside-of-US clinical study: Specific sample size is not provided in this document.
• Data Provenance: Outside-of-US clinical data. The document states it is "Real World Evidence (RWE)." It does not specify whether the RWE was retrospective or prospective beyond calling the post-market study "clinical data," which could imply prospective elements.

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

• Not applicable in the context of this 510(k) submission. The "ground truth" for the RWE would be the clinical outcomes and safety profiles reported in the literature and the post-market study, as adjudicated by the treating physicians and researchers of those respective studies. The document does not detail individual expert qualifications for establishing this "ground truth" for the RWE, as it is leveraging existing clinical data.

4. Adjudication Method for the Test Set:

• Not applicable as it's not a diagnostic algorithm test set requiring expert adjudication. The RWE would have its own data collection and analysis methods from the original studies.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI or imaging interpretation devices to assess human reader performance with and without AI assistance. This submission pertains to a physical medical device (vertebral augment), not an AI diagnostic tool.

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

• No, this is not an algorithm, so a standalone performance study is not applicable.

7. The Type of Ground Truth Used:

• The implicit "ground truth" for demonstrating equivalence is based on clinical outcomes and safety profiles observed in published outside-of-US clinical literature and a post-market outside-of-US clinical study. This is an outcomes data approach, focusing on observed adverse events and clinical effectiveness (reduction/fixation of fractures).

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set. The "evidence" is based on existing clinical data (RWE) to support an expanded indication for a physical device.

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

• Not applicable as there is no training set for an AI/ML model. The RWE utilized for the submission would have its "ground truth" established through standard clinical and research methodologies for patient diagnosis, treatment, and follow-up in the original studies where the data was collected.

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VertaPlex® HV High Viscosity Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacroplasty or sacroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

When used in conjunction with ES2® Augmentable Spinal System, Vertaplex® HV High Viscosity Radiopaque Bone Cement 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. Vertaplex® HV High Viscosity Radiopaque Bone Cement and the ES2® Augmentable Spinal System are for use together at spinal levels where the structural integrity of the spine is not severely compromised.

When used without cement, the ES2® Augmentable Spinal System is intended for posterior, non-cervical fixation as an adjunct to fusion 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, tumor and/or trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with the Vertaplex® HV High Viscosity Radiopaque Bone Cement, the ES2® Augmentable Spinal 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. ES2® Augmentable Spinal System augmented with the Vertaplex® HV High Viscosity Radiopaque Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

VertaPlex® HV High Viscosity Radiopaque Bone Cement is bone cement comprised of a liquid component and powder component which when mixed together polymerize to form a hardened acrylic polymer. The mixture is in an injectable state for a period of time before it cures to form a hardened structure, capable of long-term load support and bone augmentation in the treatment of symptomatic osteoporotic vertebral compression fractures.

The powder component of VertaPlex® HV High Viscosity Radiopaque Bone Cement is Ethylene Oxide (EO) sterilized and is packaged in a polyethylene/foil pouch while the liquid monomer is aseptically filled into an amber glass ampoule which is EO sterilized. The device contains the following components: Polymer powder, Monomer liquid and Barium Sulfate. Accessories to the subject cement device are compatible Stryker cement mixers such the Stryker Autoplex System and the Stryker PCD System.

ES2® Augmentable Spinal System is a gamma sterilized, titanium implantable screw with fenestrations and blocker designed as a stabilization solution for the aging spine. The subject system (screw and blocker) has been developed to provide improved anchorage of pedicle screws with and without Vertaplex® HV High Viscosity Radiopaque Bone Cement during pedicle screw augmentation in vertebrae with reduced bone quality as compared to pedicle screw augmentation in healthy bone.

The provided text is a 510(k) summary for the Stryker Vertaplex® HV High Viscosity Radiopaque Bone Cement and ES2® Augmentable Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technological characteristics, rather than presenting a study proving a device meets specific acceptance criteria based on its performance in a clinical or analytical setting.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is largely not present in this type of FDA submission.

Here's what can be extracted and inferred based on the provided document:

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

The document states: "The subject devices were tested and met all respective acceptance criteria as specified per the individual test report." and "The acceptance criteria for the subject device were similar to the acceptance criteria for the Stryker predicate device." However, the specific acceptance criteria and detailed performance metrics are not provided in this summary.

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 refers to "Bench" testing and "cadaver validation."

• Sample Size: Not specified for any particular test.
• Data Provenance: Implied to be in-house testing by Stryker Instruments, likely in the USA given the company's address. The testing is non-clinical.

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

Not applicable. The "tests" mentioned are physical/mechanical bench tests and cadaver validation, not diagnostic or clinical assessments requiring expert ground truth for interpretation.

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

Not applicable, as no expert-based ground truth establishment or adjudication is described.

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, an MRMC study was not done. This device is a bone cement and a spinal system, not an AI-powered diagnostic tool. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." It does mention a "clinical literature review" to support safety and effectiveness of PMMA bone cement with augmentable pedicle screws, but this is a review of existing literature, not a new comparative effectiveness study.

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

Not applicable. This device is not an algorithm.

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

For the non-clinical bench testing, the "ground truth" would be the established engineering and materials science standards (e.g., ASTM F1798-12, ASTM F1717-12, ANSI/AAMI ST72:2011(R2016), ISO 11137-2:2013, ASTM F1980, ISO 11607) that define acceptable performance for device characteristics like static strength, pullout force, sterility assurance, endotoxin limits, and shelf life.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device.

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G1 40 Radiopaque Bone Cement is intended for use in arthroplasty procedures of the hip, knee, ankle, shoulder and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

G1 40 Radiopaque Bone Cement is a polymethylmethacrylate (PMMA) bone cement that provides two separate, premeasured sterilized components which, when mixed, form a radiopaque rapidly setting bone cement. The packaging configuration (powder pouches, amber glass ampoule) for the subject device is identical to the predicate device.

The provided text describes the G1 40 Radiopaque Bone Cement, a medical device intended for use in arthroplasty procedures. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore,
No information is available regarding acceptance criteria and a study proving a device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

Instead, the document details performance testing conducted to show that the G1 40 Radiopaque Bone Cement has comparable characteristics and performs similarly to its predicate devices. This type of testing is common for demonstrating substantial equivalence for Class II devices.

Here's a breakdown of the available information regarding the performance comparison, addressing the relevant parts of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative "acceptance criteria" for clinical performance (e.g., a certain percentage of successful fixation). Instead, the "acceptance criteria" are implied by compliance with established international and ASTM standards for bone cement properties. The "reported device performance" is framed as "comparable" to predicate devices and "in compliance" with these standards.

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

• Test Set Sample Size: Not explicitly stated as a number of samples or patients. The testing involved material samples for mechanical and material characterization, and biological samples for biocompatibility. The standards listed (e.g., ASTM F451-08, ISO 5833:2002) would dictate appropriate sample sizes for each specific test, but these are not enumerated in the document.
• Data Provenance: Not specified. Given the nature of material and biological testing, it would be laboratory-generated data, likely from the manufacturer or a contracted testing facility. No information on country of origin or whether it's retrospective/prospective is provided, as these terms are more relevant to clinical studies.

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

• Not Applicable. This document describes laboratory and material testing, not human-read clinical data where expert ground truth would be established. The "ground truth" for these tests is based on objective measurements against established international and industry standards.

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

• Not Applicable. See point 3.

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 bone cement, not an AI-powered diagnostic or assistive technology.

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

• Not Applicable. This is not an algorithm or AI device. The "standalone" performance refers to the device's material properties and biological effects, which were indeed tested directly.

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

• The "ground truth" for these material and biological performance tests is objective physical and chemical measurement against established international and industry standards. For example, compressive strength is objectively measured and compared to the acceptable range defined in ASTM F451. Biocompatibility is assessed through standardized in-vitro and in-vivo tests according to ISO 10993.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. See point 8.

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G3 40 Radiopaque Bone Cement is intended for use in arthroplasty procedures of the hip, knee, ankle, shoulder and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

G3 40 Radiopaque Bone Cement is a polymethylmethacrylate (PMMA) bone cement that provides two separate, premeasured sterilized components which, when mixed, form a radiopaque rapidly setting bone cement. The packaging configuration (powder pouches, amber glass ampoule) for the subject device is identical to the predicate device.

The provided text describes the 510(k) summary for the G3 40 Radiopaque Bone Cement, which is a polymethylmethacrylate (PMMA) bone cement. It details the substantial equivalence to predicate devices rather than providing a study proving the device meets specific performance acceptance criteria for an AI/ML device.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, sample size for training set, and how training set ground truth was established) are not applicable as this document pertains to a traditional medical device (bone cement) and not an AI/ML powered device.

However, I can extract the information relevant to the performance of the bone cement for the applicable categories.

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)

• Not Applicable. This is a physical medical device (bone cement), and the testing described is primarily in-vitro and mechanical characterization, not a clinical study with patients or data requiring test sets in the context of AI/ML.

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

• Not Applicable. Ground truth for an AI/ML algorithm is not relevant for this traditional medical device.

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

• Not Applicable. Adjudication methods are not relevant for the performance testing of this physical medical device.

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 is not an AI/ML device, so an MRMC study is not relevant.

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

• Not Applicable. This is a physical bone cement, not an algorithm.

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

• Physical Properties/Standardized Tests: The "ground truth" for this device's performance is established by adherence to recognized international and ASTM standards (e.g., ISO 10993 for biocompatibility, ISO/ASTM standards for mechanical properties like compressive strength, bending modulus, cyclic fatigue, tensile properties, creep, fracture toughness, and shrinkage). The results of these tests define its performance against established benchmarks for PMMA bone cements.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

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FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™) is indicated for the fixation of pathological fractures of the vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

When used in conjunction with CREO® or REVLOK® Fenestrated Screw Systems for posterior fixation, FORTRESS™ Radiopaque Bone Cement 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. FORTRESS™ Radiopaque Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

CREO® Fenestrated 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 in the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the CREO® Fenestrated Screw System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the CREO® Fenestrated Screw System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

When used for posterior fixation in conjunction with FORTRESS-Plus™ bone cement, the CREO® Fenestrated 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. CREO® Fenestrated with FORTRESS™ or FORTRESS-Plus™ bone cement are intended for use at spinal levels where the structural integrity of the spine is not severely compromised.

REVLOK® Fenestrated 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 in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the REVLOK® Fenestrated Screw System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the REVLOK® Fenestrated Screw System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

When used for posterior fixation in conjunction with FORTRESS™ or FORTRESS-Plus™ bone cement, the REVLOK® Fenestrated 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. REVLOK® Fenestrated with FORTRESS™ or FORTRESS-Plus™ bone cement are intended for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. FORTRESS™ Radiopaque Bone Cement: FORTRESS™ Radiopaque Bone Cements (FORTRESS™, FORTRESS-Plus™) are radiopaque, self-curing PMMA bone cements. FORTRESS™ is provided as two sterile components, a liquid component and a powder component, which are mixed together prior to use to form the cement. The bone cement is intended for single use only.

2. CREO® Fenestrated Screw System: CREO® Fenestrated Screw System consists of fenestrated monoaxial screws, uniplanar screws, polyaxial screws, dual outer diameter screws, reduction screws, rods and locking caps. Screws are available in a variety of sizes to accommodate individual patient anatomy. CREO® Fenestrated Screws mate with 4.75mm, 5.5mm, and 6.35mm diameter rods and connecting components from the CREO® Stabilization System. In addition, CREO Threaded screws and locking caps mate with 6.0mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws are intended for posterior use only. Staples are intended for anterior use only. Monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws to the rod. CREO® Fenestrated Screws are composed of titanium alloy, cobalt chromium molybdenum alloy, or stainless steel as specified in ASTM F136, F1537, F1295, F67 and F138. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium molybdenum alloy implants. CREO® Fenestrated Screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

REVLOK® Fenestrated Screw System: The REVLOK® Fenestrated Screw System consists of monoaxial screws, uniplanar screws, polyaxial screws, dual outer diameter screws, reduction screws, rods and locking caps. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVLOK® implants mate with 5.5mm diameter rods and REVLOK® 6.35 implants mate with 6.35mm diameter rods, and connecting components from the REVERE® Stabilization System. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Locking caps are used to connect the screws to the rod. The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F67, F1537 and F138. All other REVLOK® implants are manufactured from titanium alloy or stainless steel, as specified in ASTM F136, F1295, F138, and F67. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium or titanium alloy implants. The REVLOK® Fenestrated Screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

I am sorry, but the provided text is a 510(k) summary from the FDA for a medical device (bone cement and screw systems) and does not contain information about a study that assesses the device's performance against specific acceptance criteria in the context of an AI/ML algorithm.

The document discusses:

• Indications for Use: What the device is intended for.
• Device Description: Details about the bone cement and screw systems.
• Performance Data: States that "Clinical literature data and cadaveric testing was provided to support the substantial equivalence of the subject device. Mechanical testing (axial pull-out and torque removal testing of augmented screws) was conducted in accordance with ASTM F543 and the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s,' May 3, 2004. Performance data demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011."
• Technological Characteristics: Compares the subject device to predicate devices.
• Basis of Substantial Equivalence: Concludes substantial equivalence.

However, it does not include any of the AI/ML specific information requested in your bullet points, such as:

1. A table of acceptance criteria and reported device performance (in the context of AI/ML).
2. Sample size used for an AI/ML test set or data provenance.
3. Number of experts or their qualifications for AI/ML ground truth.
4. Adjudication method for an AI/ML test set.
5. MRMC comparative effectiveness study results (AI vs. human performance).
6. Standalone AI performance details.
7. Type of ground truth used for AI/ML.
8. Sample size for the AI/ML training set.
9. How ground truth for the AI/ML training set was established.

This document is for a physical medical device (bone cement and screw systems) and its substantial equivalence to other legally marketed devices, not for an AI/ML powered diagnostic or therapeutic device.

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CONCORD Plus™ Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The CONCORD Plus™ Radiopaque Bone Cement is a high-viscosity, radiopaque, self-curing, PMMA bone cement. It is provided sterile, as a two component system, a liquid component and a powder component which are mixed together prior to use to form the cement. The bone cement is intended for single use only.

I am sorry, but based on the provided text, there is no information available regarding an AI device, its acceptance criteria, or a study proving it meets those criteria.

The document is a 510(k) premarket notification for a medical device called "CONCORD Plus™ Radiopaque Bone Cement." This is a physical bone cement, not an AI or software-as-a-medical-device.

Therefore, I cannot provide the requested information in the table format or answer the questions related to AI device performance, sample sizes, ground truth establishment, or expert reviews. The text discusses the bone cement's physical and chemical properties, sterilization methods, and comparison to predicate devices, all of which are irrelevant to AI device evaluation.

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VertaPlex HV Radiopaque Bone Cement is indicated for the fixation of patholoqical fractures of the vertebral body usinq vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

VertaPlex® HV Radiopaque Bone Cement is comprised of a liquid component and powder component which when mixed together polymerize to form a hardened acrylic polymer. The mixture is in a pourable and injectable state for a period of time, before it cures to form a hardened structure, capable of long-term load support and bone augmentation in the treatment of symptomatic osteoporotic vertebral compression fractures.

The powder component of VertaPlex® HV Radiopaque Bone Cement is EO(Ethylene Oxide) sterilized and is packaged in a polyethylene/foil pouch while the liquid monomer is aseptically filled into an amber glass ampoule which is EO sterilized. The device contains the following components: Polymer powder (14g), Monomer liquid (9.5ml), and Barium Sulfate (6g

The provided document describes a 510(k) premarket notification for the Stryker® VertaPlex® High Viscosity (HV) Radiopaque Bone Cement. The submission seeks to expand the indications for use of the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: This submission is for an expanded indication for a previously cleared device. The focus of the "study" is to demonstrate safe use in the expanded anatomical area (sacrum) and procedure (sacroplasty), primarily concerning the risk of cement extravasation, rather than proving the overall effectiveness of the bone cement for fracture fixation. The primary comparator is the predicate device, and the demonstration of substantial equivalence relies heavily on the fact that the underlying technology and composition remain unchanged.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of quantitative acceptance criteria for device performance. Instead, the "acceptance criteria" are implied by demonstrating that the expanded indications for use, particularly for the sacrum and sacroplasty, do not introduce new safety or effectiveness concerns, specifically regarding extravasation. The general acceptance criterion is demonstrating substantial equivalence to the predicate device, meaning the new indication is as safe and effective as the predicate.

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

• Sample Size: The document refers to "the cadavers included in this study" but does not specify the exact number of cadavers used in the cadaveric study.
• Data Provenance: The study was a non-clinical cadaveric study. The country of origin is not specified, but it's a Stryker Instruments submission, likely conducted or overseen in the US.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth within the cadaveric study itself. However, it does state that the study aimed to demonstrate safety when the procedure "is performed with meticulous imaging guidance by a physician who is trained and experienced in vertebral augmentation and acetabuloplasty." This implies that the study was conducted or observed by such qualified personnel, but they are not explicitly called "experts for ground truth." The "ground truth" here is the direct observation of extravasation or lack thereof in the cadavers.

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

The document does not mention any adjudication method for the cadaveric study. The assessment of extravasation appears to be direct observation or imaging during the study.

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, an MRMC comparative effectiveness study was not done. This submission is for bone cement, not an AI-powered diagnostic or assistive device.

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

No, a standalone algorithm-only performance study was not done. This is not an AI device. The cadaveric study investigated the physical performance (extravasation) of the bone cement when applied by human operators following specific surgical techniques.

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

For the cadaveric study, the ground truth for "no instances of cement extravasation" was likely established through direct observation and/or post-procedure imaging (e.g., CT evaluation) of the cadaveric specimens, possibly with expert interpretation of these observations/images. This is a direct physical assessment rather than an expert consensus on interpreting indirect data.

8. The sample size for the training set

Not applicable. This submission describes a non-AI medical device (bone cement) and does not involve machine learning models with training sets.

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

Not applicable. As above, there is no training set for this device.

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Vertaplex Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty of kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Vertaplex is Polymethyl Methacrylate cement used for the treatment of painful vertebral fractures based on the predicate device Spineplex. Vertaplex can be injected directly into the fractured vertebral body by either Vertebroplasty or Kyphoplasty procedures to relieve pain.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, or a study proving the device meets acceptance criteria in the way you've outlined.

The document is a 510(k) summary for a medical device (Stryker Vertaplex Radiopaque Bone Cement). It focuses on demonstrating substantial equivalence to a predicate device (Stryker Spineplex Radiopaque Bone Cement).

Here's what the document does state, which is relevant to your request, but doesn't fully answer it:

• Performance Standards: "Stryker Vertaplex has been developed in accordance with the FDA Guidance document entitled "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement."" This implies that certain performance characteristics relevant to PMMA bone cement are expected to be met, as per the guidance document. However, the specific acceptance criteria from that guidance are not detailed in this 510(k) summary.
• Safety and Effectiveness: "In vitro testing shows that the device meets similar performance specifications as those for the predicate device." This indicates that some form of testing was done to compare its performance to the predicate, but again, the specific results, acceptance criteria, or a detailed study description are not provided.
• Biocompatibility: "All appropriate biocompatibility tests have been performed on Vertaplex and have met the standard requirements." This confirms biocompatibility testing was performed and met standards, but doesn't specify the tests or criteria.

The 510(k) process primarily relies on demonstrating equivalence rather than exhaustive clinical trials for de novo authorization. Therefore, the detailed study design (like sample sizes, ground truth establishment, MRMC studies, etc.) you're asking about is not typically part of what's presented in a 510(k) summary for this type of device.

Therefore, I cannot populate your table or answer most of your detailed questions because the provided text does not contain that information.

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The Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects resulting from compression fracture, in order to provide stabilization of the collapsed vertebral body and pain relief. The following modifications are being made: Change to the formulation of the bone cement liquid component.

The provided text is a 510(k) premarket notification for a medical device: Vertebroplastic™ Radiopaque Bone Cement. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and testing results as would be typical for software or AI/ML-based devices.

Therefore, much of the requested information cannot be extracted directly from this document. The device is a physical bone cement, not a software or AI/ML device, so concepts like "test set," "training set," "ground truth experts," "adjudication method," and "MRMC study" are not applicable in the way they would be for digital health technologies.

However, I can extract information related to the device description and the basis of substantial equivalence.

Here's an attempt to answer the questions based on the provided text, noting where the information is not applicable or available:

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

The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device based on "technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization)" and "intended use and indications for use."

Therefore, a table of acceptance criteria and reported device performance as commonly understood for digital health devices cannot be created directly from this text. The "performance" assessment is qualitative, comparing the modified device to its predicate.

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

Not applicable. This is a physical bone cement, not a software or AI/ML device that would undergo testing with a "test set" of data. The "study" mentioned is a comparison of characteristics to a predicate 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)

Not applicable. The concept of "ground truth for a test set" is not relevant to the substantial equivalence review of this physical device.

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

Not applicable. This is not a study involving human readers or a test set requiring adjudication in this context.

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 is not an AI-assisted device, and no MRMC study is mentioned.

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

Not applicable. This is a physical bone cement, not an algorithm.

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

Not applicable. The review focuses on material properties and chemical composition compared to a predicate, not on clinical outcomes or diagnostic accuracy requiring "ground truth" as typically defined for AI/ML devices.

8. The sample size for the training set

Not applicable. This is a physical bone cement, not an AI/ML device that requires a "training set."

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

Not applicable.

Summary of what can be extracted from the document regarding the "study" for this device:

The "study" or justification for this device meeting its criteria is a demonstration of substantial equivalence to previously cleared predicate devices.

• Predicate Devices:

  • Vertebroplastic™ Radiopaque Bone Cement (K043406) - This is the original version of the same device, with the current submission being a modification.
  • SmartSet GMV Endurance Gentamicin Bone Cement (K033382)

• Basis of Substantial Equivalence:

  • Technological Characteristics: Chemical composition, material properties, performance characteristics, manufacture, packaging, and sterilization. (The document mentions a "Change to the formulation of the bone cement liquid component" as the modification being made.)
  • Intended Use and Indications for Use: The intended use and indications for use are stated to be similar (identical) to the predicate Vertebroplastic™ Radiopaque Bone Cement (K043406).

In essence, the "acceptance criteria" here implicitly are that the modified device's characteristics and intended use are sufficiently similar to the predicate devices such that it raises no new questions of safety or effectiveness. The "study" involves comparing the modified formulation against the established properties of the cleared predicate devices. Specific quantitative performance data from a clinical trial or bench test proving performance against strict numerical acceptance criteria are not presented in this summary, as is typical for 510(k)s seeking substantial equivalence for material modifications.

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Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects, in order to provide stabilization of the vertebral body and pain relief. Vertebroplastic™ Radiopaque Bone Cement has a low viscosity and long working and setting time

I am sorry, but the provided text is for a medical device called "Vertebroplastic™ Radiopaque Bone Cement," which is a polymethylmethacrylate (PMMA) cement used for filling spinal vertebral body defects. This is a physical product and not an AI/ML powered device. As such, the concepts of "acceptance criteria for an AI model," "sample size for test set," "ground truth," "MRMC study," or "training set" are not applicable to this document.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailed performance studies and acceptance criteria as would be found for an AI/ML device.

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