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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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XeliteMed VertehighFix High Viscosity Spinal Bone Cement is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty 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 is provided as a twocomponent 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 provided text describes the 510(k) summary for a medical device, XeliteMed VertehighFix High Viscosity Spinal Bone Cement. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

The acceptance criteria and study that proves the device meets those criteria are focused on non-clinical performance testing rather than clinical study data involving AI or human readers, as the device is a bone cement, not an AI-powered diagnostic tool. Therefore, many of the requested points regarding AI and human reader studies (MRMC, standalone AI, training set details) are not applicable to this type of device and submission.

Here's an interpretation of the text for the applicable criteria:

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

The document states that "Test data indicate that the final properties of XeliteMed VertehighFix High Viscosity Spinal Bone Cement are in compliance with the standard reference for bone cement: ISO 5833 'implants for surgery - acrylic resin cements' and are substantially equivalent to the predicate device."

While a specific table of numerical acceptance criteria and reported device performance values is not explicitly provided in this public summary, the general acceptance criterion is compliance with ISO 5833 and substantial equivalence to the predicate device (Mendec Spine K042415) for the following non-clinical tests:

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

The document does not specify the sample sizes (e.g., number of test specimens) used for each non-clinical test. The data provenance is from Xelite Biomed Ltd. in New Taipei City, Taiwan (R.O.C.), and the tests are inherently prospective as they are conducted on the newly manufactured device to demonstrate its properties.

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

This question is not applicable as the "ground truth" for bone cement performance is established by objective, standardized laboratory measurements according to ISO standards, not by expert consensus or interpretation of images.

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

This question is not applicable as there is no human interpretation or subjective adjudication involved in the objective non-clinical performance testing of bone cement.

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 question is not applicable as the device is a bone cement, not an AI-powered diagnostic or assistive tool for human readers.

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

This question is not applicable as the device is a bone cement, not an AI algorithm.

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

The "ground truth" for this device's performance is based on established international standards (ISO 5833) and objective physical and chemical measurements of the bone cement's properties (e.g., mechanical strength, setting time, chemical composition, biocompatibility). For bacterial endotoxin testing, the ground truth is established by the USP Bacterial Endotoxins Test limits.

8. The sample size for the training set

This question is not applicable as the performance testing described is for a physical medical device (bone cement), not a machine learning model that requires a training set.

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

This question is not applicable for the same reason as point 8.

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The Balloon Inflation System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Balloon Inflation System is mainly used to treat vertebral compression fractures caused by osteoporosis. Puncture needles or dilators are used to establish working channels, then balloon catheters are placed along the working channels and inflation device connect to balloon catheter and control it expansion to lift the upper and lower endplates of the vertebral body, restore the height of the vertebral body, and form bone cement filling cavities.

This is a 510(k) Premarket Notification for a Balloon Inflation System, which is a medical device, and therefore the document does not contain information about acceptance criteria and study designs typically associated with AI/ML-driven software devices. The provided text is a summary of documentation for a physical medical device.

Specifically, the document addresses:

• Device Name: Balloon Inflation System
• Regulation Number/Name: 21 CFR 888.3027, Polymethylmethacrylate (PMMA) Bone Cement
• Regulatory Class: Class II
• Product Code: NDN
• Intended Use: For the reduction of fractures and/or creation of a void in cancellous bone in the spine (percutaneous vertebral augmentation, e.g., kyphoplasty), to be used with cleared spinal PMMA bone cements.

The acceptance criteria and supporting studies for this type of device focus on non-clinical bench testing to demonstrate performance, safety, and substantial equivalence to a predicate device, rather than AI/ML performance metrics.

Here's a breakdown of the information that is present, relevant to a physical medical device, contrasted with the AI/ML-specific questions you asked:

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

The document provides a summary of non-clinical tests that were performed and states that the "test results met the preset criteria." However, it does not provide a detailed table of specific acceptance criteria values (e.g., "burst pressure > X psi") or the exact reported performance values. It only generically states that results met criteria.

Here's what's described:

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

For the non-clinical tests mentioned, sample sizes are not specified. Data provenance is implied to be laboratory testing conducted by or for Ningbo HicRen Biotechnology Co., Ltd. There is no mention of human subject data (retrospective or prospective) as this is not an AI/ML device.

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

This is not applicable to a physical medical device submission. "Ground truth" in this context refers to engineering specifications and performance standards established through industry standards (like ISO) and regulatory requirements.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of human image interpretations, which is not relevant here.

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 an AI/ML device-specific question.

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

Not applicable. This is an AI/ML device-specific question.

7. The type of ground truth used

For this physical device, the "ground truth" is based on engineering specifications, established international standards (e.g., ISO 11138-2, ISO 10993 series), and pre-set internal criteria for performance and safety. There is no pathology or outcomes data used for "ground truth" in this context.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set or corresponding ground truth for an AI/ML model for this physical device.

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V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine. It is intended to be used in combination with Teknimed F20® bone cement.

V-STRUT© Vertebral Implant 4.5mm diameter is part of V-STRUT© Transpedicular Vertebral System.

V-STRUT© Transpedicular Vertebral System is composed of:

• V-STRUT© Vertebral Implant (K191709, Class II),
• V-STRUT© Guide Wire (Class I),
• V-STRUT© Instrumentation Set (Class I).

V-STRUT© Vertebral Implant 4.5mm diameter is a medical device to be placed in the vertebrae through a minimally invasive procedure.
Two devices are implanted in each vertebra to be treated. Each implant is introduced posteriorly through the pedicle up to the anterior
vertebral body wall.

The implant is made of radio transparent polymer, PEEK (Polyetheretherketone as per ASTM F2026) and includes two visualizing markers
made of tantalum (as per ASTM F560).

V-STRUT© Vertebral Implant 4.5mm diameter exists in different lengths to accommodate individual patient's anatomy of thoracic and/or
lumbar vertebrae. It is provided sterile. It is implanted using specific instrumentation provided with the implant (V-STRUT® Guide Wire
and V-STRUT© Instrumentation Set).

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called V-STRUT® Vertebral Implant.

This type of document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting detailed performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested table and information based on the given input.

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RENOVA SPINE BALLOON CATHETER is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).

The RENOVA SPINE BALLOON CATHETER is a single use disposable sterile device available in 3 different models depending on the dimensions of the balloon: 10 mm, 15 mm and 20 mm.
RENOVA SPINE BALLOON CATHETER is a single use catheter (double lumen tube) with a balloon at the distal end.
The balloon catheter is normally inserted through a needle / working cannula and inflated through an inflation device.
The catheter has two separate lumens connected to a Y connector at the proximal end of the catheter. The outer lumen of the catheter is used to inflate the balloon while the central lumen contains a removable stylet used to aid in the introduction of the balloon catheter.

The provided text does NOT describe a study involving an AI/ML powered medical device. Instead, it is a 510(k) premarket notification for a medical device called the "RENOVA SPINE BALLOON CATHETER." This device is used in balloon kyphoplasty and is a physical, non-software device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing of its physical properties.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, as the document does not contain any details related to AI/ML device performance, ground truth establishment, expert adjudication, or clinical studies involving AI assistance.

The content discusses:

• Device Name: Renova Spine Balloon Catheter
• Intended Use: Reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty.
• Predicate Device: InterV Kyphoplasty Catheter and InterV Kyphoplasty Catheter (Mini) (K150322)
• Performance Data: This section refers to mechanical tests conducted on the physical device, such as Balloon Deflation Time, Burst Pressure, Fatigue Strength, etc. These are standard engineering tests for physical medical devices, not AI/ML model performance metrics.
• Clinical Data: Stated as "N/A," indicating no human clinical trials were required for this submission, which is common for 510(k)s demonstrating substantial equivalence based on physical and functional similarity to an existing device.

Without information about an AI/ML component, it is impossible to answer the specific questions related to AI/ML device acceptance criteria and study methodology.

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The Injection Pin, is indicated for fractures caused by severe osteoporosis, trauma, and tumors of the thoracic/lumbar spine from T9-L5. Injection Pin is indicated for use in combination with PMMA bone cement (Teknimed F200) for the treatment of fractures caused by trauma, osteoporosis, or turnors in the thoracic/lumbar spine from T9-L5.

The Injection Pin is a single piece of Titanium alloy (Ti 6Al 4V) that complies with ISO 5832-3 and ASTM F136. It is a fenestrated screw that is cannulated along its entire length, with lateral holes along the body that do not interfere or affect the threads. The spherical head of the screw has an internal hexagon for firm coupling with the insertion screwdriver (REF IPST0007).

The Injection Pin implant is a medical device to be placed in the thoracolumbar region through a minimally invasive procedure. This device being cannulated and fenestrated permits the use, when applicable, for the introduction of approved PMMA (Teknimed F20®). It is available in both 5 and 6mm diameters and in lengths 31-61mm in 3mm increments.

The Injection Pin is easily seen Intra-Operatively as well as post-Op with good visualization.

The SLK Ortho LLC Injection Pin (K221697) is a fenestrated screw made of Titanium alloy (Ti 6Al 4V) intended for use in combination with PMMA bone cement (Teknimed F20®) to treat fractures in the thoracic/lumbar spine (T9-L5) caused by severe osteoporosis, trauma, or tumors. The device's substantial equivalence to the predicate device, Hyprevention SAS V-STRUT© (K191709), was established through various performance tests.

Here's an analysis of the acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list "acceptance criteria" in a numerical or pass/fail format for the Injection Pin device. However, the performance data presented is used to demonstrate substantial equivalence to the predicate device, V-STRUT©. The implicit acceptance criterion is that the Injection Pin exhibits substantially equivalent safety, effectiveness, and performance to the predicate device.

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

• Test Set (Biomechanical and Biocompatibility): The document does not specify a numerical sample size for the mechanical testing or in silico simulations beyond mentioning "worst-case loading scenario" and "4 different scenarios." For biocompatibility, it states "Injection Pin was tested" indicating that testing was performed on representative samples of the device.
• Data Provenance:
  • Biomechanical: Testing was conducted at the Polytechnic University of Milan, Dept. of Structural Engineering. In silico simulations were conducted in Labs of Politecnico di Milano.
  • Biocompatibility: Testing performed on the Injection Pin device, likely in a laboratory setting.
• Retrospective or Prospective: The testing described appears to be prospective, specifically designed to evaluate the performance of the Injection Pin device for this submission.

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

This type of information is generally not applicable to the non-clinical performance studies (biomechanical, biocompatibility, sterility, shelf-life) used for the Injection Pin. These studies evaluate the physical and biological characteristics of the device itself rather than interpretation of clinical images or patient data by human experts. The "ground truth" for these tests is based on established scientific principles, engineering standards (e.g., ISO, ASTM), and laboratory methodologies.

4. Adjudication Method for the Test Set

Not applicable, as this refers to adjudication by experts for clinical data interpretation, which is not described here. The evaluation involves laboratory testing against established specifications and comparison to a predicate device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance data (biomechanical, biocompatibility, sterility, shelf-life) in comparison to a predicate device, rather than a clinical trial involving human readers.

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

Yes, the studies conducted (biomechanical, biocompatibility, sterility, shelf-life) are essentially "standalone" in nature, as they evaluate the device itself and its intrinsic properties without human-in-the-loop performance in a clinical setting. The in silico simulations are also a form of standalone evaluation.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical studies is:

• Biomechanical: Defined by established engineering principles, material science properties, mechanical loads, and the performance characteristics of the legally marketed predicate device (V-STRUT©).
• Biocompatibility: Based on established international standards (ISO 10993-1 parts 5 and ETO/ECH residual limits) and comparisons to a marketed device (Miniars Screws K143596).
• Sterility: Defined by a Sterility Assurance Level (SAL) of 10-6 and adherence to ISO 11135-1.
• Shelf-life: Defined by compliance with packaging and aging standards (e.g., UNI EN ISO 11607, ASTM F 1980-07).

8. The Sample Size for the Training Set

Not applicable. There is no information about a "training set" as this device assessment relies on non-clinical performance testing and in silico simulation for substantial equivalence, not machine learning or AI algorithm development that would involve training data.

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

Not applicable, as there is no training set described in the provided document.

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

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 Vertaplex HV Radiopaque Bone Cement (sold separately) is injected at low pressure to fixate the restored vertebral body.

The provided FDA 510(k) clearance document for the Stryker SpineJack® Expansion Kit (K223294) describes the device's indications for use and compares it to a predicate device (K211238). It states that no new performance data was generated for the submission as the modification concern only the indications for use and associated labeling; no physical device modifications were made. Therefore, the information provided focuses on the safety and effectiveness of the device for expanded indications based on existing clinical literature and real-world evidence.

Here's an attempt to structure the information based on your request, though it's important to note that a traditional "acceptance criteria" table with specific device performance metrics in the format you requested is not provided in this regulatory document, as it relies on substantial equivalence to a predicate and real-world evidence for an expanded indication. The document focuses on demonstrating that the safety and effectiveness profile for the new indication (malignant lesions) is comparable to the existing indications.

Acceptance Criteria and Device Performance (Interpreted from Clinical Literature Review)

The document does not present explicit numerical "acceptance criteria" for the device's performance in the context of a new study designed to meet specific thresholds for this 510(k) submission. Instead, it leverages existing clinical literature and real-world evidence (RWE) to demonstrate that the safety and effectiveness profile of the SpineJack system for malignant vertebral compression fractures is comparable to its use in osteoporotic and traumatic fractures, which were previously cleared.

The implicit "acceptance criteria" are derived from the observed safety profile (e.g., adverse event rates, particularly cement leakage) and effectiveness outcomes (e.g., pain reduction, quality of life improvement) reported in the analyzed literature for both the newly sought indication and the existing cleared indications.

Study Details Proving Acceptance Criteria (Derived from Literature Review and RWE)

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

   • Test Set Sample Size: The submission relied on a literature review which included evidence on 304 patients who received the SpineJack System across various studies. Of these, 117 patients were treated specifically for malignant vertebral fractures, which is the focus of the expanded indication.
   • Data Provenance: The data was retrospective, collected from an analysis of existing clinical publications and Real-World Evidence (RWE). The studies took place in Spain, France, Switzerland, and in the United States.

2. 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 or qualifications of experts involved in establishing the ground truth for the test set within the context of this 510(k) submission. Since it's a literature review, the "ground truth" for the reported outcomes (e.g., pain, adverse events) would have been established by the clinicians and researchers involved in the original studies themselves. The submission's "experts" would be the regulatory and clinical review staff at Stryker who analyzed the literature.

3. Adjudication method for the test set:

   • The document does not describe an adjudication method for a test set in the traditional sense of a new clinical trial. The data was collected from existing publications, implying that the outcomes reported in those publications were accepted as presented.

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

   • No MRMC study was performed. This device is a physical implantable reduction system, not an AI or imaging-based diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable.

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

   • Not applicable. The SpineJack is a physical medical device, not a standalone algorithm.

6. The type of ground truth used:

   • The ground truth for the effectiveness outcomes (pain, quality of life) and safety outcomes (adverse events, including cement leakage) was established through clinical outcomes data reported in peer-reviewed literature and real-world evidence from clinical practice. This includes patient-reported outcomes (VAS, EQ-5D VAS, Oswestry Disability Index) and objective clinical observations of adverse events.

7. The sample size for the training set:

   • Not applicable in the context of this 510(k) submission. This submission relies on a literature review and RWE for expanded indications, not a machine learning model that would require a distinct training set. The "training" for the device's original clearance and subsequent clinical use would have come from the broader body of medical knowledge and clinical experience for comparable devices and procedures.

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

   • Not applicable. As explained above, there is no "training set" in the machine learning sense for this device submission.

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The KYPHON™ VuE™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesing a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

KYPHON™ VuE™ Bone Cement is a polymethylmethacrylate (PMMA) acrylic resin intended for use for vertebroplasty or kyphoplasty procedures, and sacroplasty procedures. KYPHON™ VuE™ Bone Cement is a modification of the KYPHON® Xpede™ Bone Cement. Like the predicate, KYPHON™ VuE™ Bone Cement contains approximately 30% barium sulfate. However, KYPHON™ VuE™ Bone Cement contains barium sulfate in two forms (powder and granules) whereas the predicate has only the powder form of barium sulfate. The larger radio-opaque granules of barium sulfate increase visualization of the acrylic resin during delivery using fluoroscopy. KYPHON™ VuE™ Bone Cement is provided sterile in two components: 20 grams of powder and 9 grams of liquid. The powder contains methylmethacrylate-styrene copolymer, barium sulfate and benzoyl peroxide. The liquid contains methylmethacrylate (monomer), hydroquinone and N,N-dimethyl-p-toluidine. The components are manually mixed immediately prior to use.

This document is a marketing clearance (510(k)) for a medical device, KYPHON™ VuE™ Bone Cement, and as such, it primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than providing detailed acceptance criteria and performance data in the format typically seen for an AI/ML medical device.

Key takeaway: This document describes a PMMA bone cement, not an AI/ML device. Therefore, the specific types of acceptance criteria and study designs (e.g., MRMC studies, ground truth establishment with experts, data provenance for test/training sets) that are applicable to AI/ML devices are not relevant to this 510(k) submission and are not present in the provided text.

The document discusses acceptance criteria and performance data related to the physical and chemical properties of the bone cement, its biocompatibility, sterility, and shelf life, comparing it to existing predicate devices.

However, to answer your request using the information available and adapting it to the framework you provided (even though it's designed for AI/ML), I will interpret "acceptance criteria" and "device performance" in the context of this traditional medical device.

Acceptance Criteria and Device Performance for KYPHON™ VuE™ Bone Cement

The acceptance criteria for KYPHON™ VuE™ Bone Cement, as described in this 510(k) submission, are primarily based on demonstrating substantial equivalence to legally marketed predicate devices, particularly KYPHON® Xpede™ Bone Cement and Spineplex™ Bone Cement. This equivalence is established through various performance tests that ensure the new device meets established standards for bone cements.

1. Table of Acceptance Criteria and the Reported Device Performance (Adapted for a Non-AI/ML Device):

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The TRACKER Plus Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, and calcaneus. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The TRACKER Plus Kyphoplasty System consists of the balloon catheter, cement dispenser kit, and cement mixing system. The cement dispenser kit and the cement mixing system are intended to be used with the balloon catheter, but are sold separately.

The provided text does not contain information about an AI/ML device or a study involving such a device. The document is a 510(k) premarket notification for a medical device called the "TRACKER Plus Kyphoplasty System," which is a system used for the reduction of fractures and/or creation of a void in cancellous bone.

Therefore, I cannot provide a response to your request, as it pertains to AI/ML device acceptance criteria and studies, and this document describes a traditional medical device (kyphoplasty system) that does not incorporate AI/ML capabilities.

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