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The Spinelack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex HV bone cements.

The SpineJack Expansion Kit (herein referred to as "SpineJack") is an implanted fracture reduction system, intended to reduce vertebral compression fractures. The SpineJack Expansion Kit is used with the Preparation Kit. The Expansion Kit is available in three sizes, to accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and PMMA bone cement is injected at a low pressure to stabilize the restored vertebral body. The bone cement and its delivery system are intended to be used with the SpineJack, but are sold separately.

This document describes the premarket notification (510(k)) clearance for the SpineJack® Expansion Kit, a medical device used to treat painful osteoporotic vertebral compression fractures. The document outlines the device's indications for use, comparison to predicate devices, and the results of performance and clinical testing to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text, focusing on the clinical study (SAKOS study) as the primary proof of meeting acceptance criteria:

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

The primary acceptance criteria for the SpineJack device were demonstrated through a non-inferiority study compared to Balloon Kyphoplasty (BKP). The key criteria and results were:

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The MEDINAUT 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, radius, and calcaneus. 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.

The MEDINAUT Kyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine, tibia, radius, and calcaneus. Bone cement insertion using cement dispensing plunger is applied for spinal use only.

The MEDINAUT Kyphoplasty System consists of the MEDINAUT-X (Inflatable Bone Expander System) and MEDINAUT-I (Cement Dispenser System).

The MEDINAUT-X is comprised of a Balloon Catheter and a Bone Expander Syringe. The Balloon Catheter's main components are the shaft, Y-hub and the inflatable balloon located at the distal tip. The inflatable balloon is covered with a maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Catheter and Bone Expander Syringe are supplied sterile and are disposable.

The MEDINAUT-I is a cement dispenser system consisting of a Needle Pipe, Needle Pin, Wire Pin, Cannula, Expander, Spacer, Cannula Expander, Cement Pusher, Cement Filler, and Guide Wire. They are supplied sterile and are disposable.

This document is a 510(k) summary for the MEDINAUT Kyphoplasty System. It is an FDA submission seeking approval to market a medical device, asserting its substantial equivalence to previously cleared devices. It primarily details physical and functional attributes and does not contain detailed "acceptance criteria" or "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic AI device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. This means that the device is shown to be as safe and effective as a legally marketed device (the predicate device) that does not require premarket approval.

Here's an analysis based on the provided text, addressing your points where possible, and noting where the information is not applicable or unavailable in this type of submission:

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

This information is not present in the document as it would be for a diagnostic AI device. For a device like the MEDINAUT Kyphoplasty System, "acceptance criteria" are related to mechanical performance, biocompatibility, and sterilization standards, and "reported device performance" refers to the results of non-clinical bench tests comparing these attributes to pre-set criteria or predicate devices.

The closest equivalent is the "Non-Clinical Testing" section and the comparison table.

Non-Clinical Testing Summary:

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

This information is not applicable/provided in this context. This document describes a medical device (kyphoplasty system), not an AI/software device that processes data. The "test set" here refers to physical samples of the device undergoing mechanical, chemical, and biological testing, not a dataset of patient information. No patient data or provenance are mentioned because it's a non-clinical submission.

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

This information is not applicable/provided. The "ground truth" for this type of device is established through engineering and laboratory standards (e.g., ISO standards for sterilization, biocompatibility, and mechanical properties). There are no "experts" in the sense of clinicians establishing a diagnostic ground truth for patient data. The "experts" involved would be engineers and laboratory technicians performing standardized tests.

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

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies or evaluations of diagnostic performance where human interpretation of medical data (e.g., images) is involved. For non-clinical bench testing of a physical medical device, test results are typically validated against established quantitative standards and protocols, not through expert adjudication of uncertain cases.

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 information is not applicable/provided. MRMC studies are specific to evaluating diagnostic systems, especially AI in medical imaging, and its impact on human reader performance. This document concerns a physical surgical device for bone fracture reduction, not a diagnostic system. There is no AI component mentioned.

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

This information is not applicable/provided. As stated, this is a physical medical device (kyphoplasty system), not an algorithm or AI.

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

The "ground truth" for this device's safety and effectiveness is established through adherence to international standards (e.g., ISO 11137, ISO 11737, ISO 10993) and engineering specifications. For example:

• Sterilization: Demonstrated bacterial inactivation based on ISO standards.
• Biocompatibility: Demonstrated material safety based on ISO 10993.
• Mechanical Performance: Quantitative measurements (e.g., burst pressure, tensile strength) meeting design specifications and being comparable to predicate devices.

8. The sample size for the training set

This information is not applicable/provided. This device is not an AI model that requires a training set.

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

This information is not applicable/provided. As above, no training set for an AI model is involved.

Summary of Device and Equivalence Claim:

The document states that the MEDINAUT Kyphoplasty System (K153296) is substantially equivalent to its primary predicate device (MEDINAUT Kyphoplasty System, K133669) because it is identical in raw materials, design, and manufacturing processes. The purpose of the current 510(k) is to add more anatomical sites (tibia, radius, and calcaneus) to the indications for use. This expanded indication is supported by referencing an additional predicate device, the KyphX Inflatable Bone Tamp (K010246, K041454, K981251), which already has these broader claims and shares similar design, function, size, shape, materials, and physical specifications.

The "study that proves the device meets the acceptance criteria" (in this context, substantial equivalence to predicates for the expanded indications) is the non-clinical testing enumerated in section 8, which includes sterilization, shelf life, biocompatibility, and various bench tests. These tests confirmed that the device performs as intended and is safe when compared to established standards and the characteristics of the predicate devices.

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The NeuroTherm Parallax Balloon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The Parallax Balloon Inflatable Bone Tamp is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The NeuroTherm Parallax Balloon Inflatable Bone Tamp with an inflatable component at the distal end. The tamp is designed to compress cancellous bone and/or move cortical bone as it inflates. The catheter shaft contains an outer lumen for the tamp inflation and a central lumen for a stylet to facilitate catheter introduction. At full inflation volume, the balloon design allows for a uniform balloon that is concentric to the catheter shaft. The wire mandrel provides stiffness to the balloon catheter to facilitate insertion through the access cannula. The NeuroTherm Parallax Balloon Inflatable Bone Tamp may be used with FDA cleared balloon inflation syringes.

The NeuroTherm Parallax Balloon Inflatable Bone Tamp's acceptance criteria and performance study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are primarily demonstrated through substantial equivalence to predicate devices, supported by bench testing and compliance with relevant standards. No specific quantitative performance metrics or thresholds are explicitly stated as acceptance criteria beyond those inherent in establishing substantial equivalence.

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

The provided 510(k) summary does not specify a test set involving human data or a specific number of samples for the bench testing beyond the general statement "Bench testing supports that the NeuroTherm Parallax Balloon Inflatable Bone Tamp performs as expected." There is no indication of country of origin or whether any data was retrospective or prospective in detail. It appears the primary "test set" for substantial equivalence was the comparison to existing predicate devices and the internal bench testing.

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

This information is not provided in the given 510(k) summary. The summary focuses on engineering and regulatory comparisons rather than clinical performance studies requiring expert ground truth in the context of diagnostic or treatment efficacy.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary, as there is no mention of a formal adjudication process for a clinical test set.

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

No MRMC comparative effectiveness study was done. The device is a physical medical instrument (an inflatable bone tamp), not an AI-powered diagnostic or decision support system that would typically warrant such a study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is an instrument used directly by a surgeon; it's not an algorithm or software requiring a standalone performance evaluation in the context of AI.

7. Type of Ground Truth Used

The ground truth used for demonstrating substantial equivalence was primarily:

• Predicate Device Characteristics: The established design, intended use, and specifications of the legally marketed Kyphon Xpander II, KyphX Xpander, and KyphX Inflatable Bone Tamps.
• Bench Test Results: Internal engineering data demonstrating the device's functional performance against its design requirements (though specific metrics are not detailed).
• Compliance with Standards: Meeting the requirements of various recognized national and international standards related to medical devices.

8. Sample Size for the Training Set

There is no mention of a "training set" as this device is a physical instrument and not a machine learning or AI algorithm.

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

Not applicable, as there is no training set for this type of device.

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The Stryker® iVAS Inflatable Vertebral Augmentation System (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 use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

The Stryker® iVAS balloon catheter is a bone tamp with an inflatable component (balloon) at the distal end. The balloon is inflated to create a void within the vertebral body.

This document, K113477, is a 510(k) summary for the Stryker® iVAS Balloon Catheter, seeking clearance for a modification to a previously cleared device. As such, the study described is primarily focused on demonstrating substantial equivalence to predicate devices through functional and biocompatibility testing, rather than a clinical trial with acceptance criteria for disease detection or diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria for each test or detailed performance metrics in a table format as might be seen for a diagnostic device. Instead, it makes a general statement of compliance and equivalence.

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

The document does not specify the sample size for any of the tests (functional or biocompatibility). It also does not discuss data provenance in terms of country of origin or whether it was retrospective or prospective, as these are typically not relevant for benchtop and biocompatibility testing for medical device clearance of this nature.

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

This information is not applicable to the type of testing described. The document pertains to engineering performance and biocompatibility of a medical device, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations.

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 a medical device clearance for a physical catheter, not an AI or imaging diagnostic device.

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

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used

For functional testing, the "ground truth" would be established engineering specifications, safety standards, and performance benchmarks derived from the predicate devices. For biocompatibility, the ground truth is defined by the requirements of the FDA Blue Book Memorandum G95-1 and ISO-10993.

8. The sample size for the training set

Not applicable, as this is a physical medical device and not an AI/machine learning model that undergoes training.

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

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

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The Soteira Shield Kyphoplasty System (SKS) is intended to provide control of cement flow during injection of PMMA bone cement that has been cleared for use in vertebral augmentation for the treatment of acute, persistently painful (after a minimum of 6 weeks of conservative care), stable, anterior column osteoporotic compression fractures (wedge or concave) of the vertebrae at levels T4 - L5 in the adult spine.

The Soteira Shield Kyphoplasty System consists of a cement director (permanent implant), a delivery system (used to place the cement director within the vertebral body) and instruments that are used to achieve percutaneous access to the vertebral body and to create a cavity into which the cement director implant will be placed. The system is intended for use with commercially available PMMA bone cement.

The provided text describes a 510(k) premarket notification for the Soteira Shield Kyphoplasty System, a device for vertebral augmentation. The information focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria with specific acceptance thresholds for device performance.

Therefore, the concept of "acceptance criteria" as applied to a new AI/software device with quantitative performance metrics (e.g., accuracy, sensitivity, specificity) and a "reported device performance" against those criteria is not directly applicable here. The equivalence is demonstrated through comparative studies against established predicate devices.

However, based on the provided text, we can infer the "acceptance criteria" and "reported device performance" in terms of how the Soteira Shield Kyphoplasty System compares to its chosen predicate device (vertebroplasty) across various aspects.

Here's an interpretation of the request using the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" for a 510(k) submission are typically centered around demonstrating substantial equivalence to legally marketed predicate devices. This means showing that the new device is as safe and effective as the predicate. Quantifiable performance metrics against predefined thresholds, as seen in AI/software device evaluations, are not explicitly stated. Instead, the performance is assessed relative to the predicate.

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

The clinical study served as the primary "test set" for equivalence demonstration.

• Sample Size for Test Set:
  • Soteira Shield Kyphoplasty System: 69 subjects and 102 levels.
  • Control Device (Vertebroplasty): 28 subjects and 38 levels.
• Data Provenance: The study was a "prospective randomized study." The country of origin is not specified but implicitly within the US regulatory context (indicated by FDA 510(k) submission).

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

The text does not mention the use of experts to establish a "ground truth" in the diagnostic sense, as this is a medical device for treatment. The "ground truth" for the clinical study would be derived from clinical outcomes, patient-reported pain scores, functional assessments, and imaging assessments of cement leakage. The study's design (prospective, randomized) implies that standard clinical methodologies and assessments were used, likely carried out by treating physicians and study staff, but specific numbers and qualifications of "experts" for ground truth establishment are not provided.

4. Adjudication Method for the Test Set

The text does not explicitly describe an adjudication method for the test set data. In a prospective clinical trial like this, data collection and assessment would follow a pre-defined protocol, and outcomes (pain, function, adverse events, leakage) would be recorded. Any discrepancies in data recording or interpretation would typically be handled through standard clinical trial monitoring and data management processes, but a specific "adjudication method" beyond standard clinical practice is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This is not applicable. The study is for a physical medical device (Kyphoplasty System) for treating vertebral fractures, not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant to this submission.

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

This is not applicable. The device is a surgical system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was based on:

• Clinical Outcomes: Patient-reported pain levels, functional scores, and recorded adverse events.
• Imaging Data: Assessment of cement leakage.
• Medical Diagnosis: Diagnosis of osteoporotic compression fractures requiring intervention.

8. The Sample Size for the Training Set

This is not applicable. The Soteira Shield Kyphoplasty System is a physical medical device, not a machine learning algorithm that requires a "training set" in the computational sense. The "pilot study" mentioned could be considered an early phase of clinical data collection that might inform the design of the larger prospective study, but it doesn't function as a "training set" for an algorithm.

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

This is not applicable, as there is no "training set" in the context of an algorithmic device.

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The Stryker® iVAS Inflatable Vertebral Augmentation System (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 use during percutaneous vertebral augmentation. The system is to be used. with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

The Stryker® IVAS balloon catheter is a bone tamp with an inflatable component (balloon) at the distal end. The balloon is inflated to create a void within the vertebral body.

This 510(k) summary for the Stryker® IVAS Balloon Catheter (K093419) does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a submission for substantial equivalence to a predicate device (Kyphx Xpander Inflatable Bone Tamps, K041454). The core of the argument is that the Stryker® IVAS balloon catheter is "equivalent in intended use, technological characteristics, safety, and effectiveness" to the predicate, and does not "raise any new safety and efficacy concerns."

Therefore, I cannot populate the table or answer the questions based on the provided text. The document focuses on establishing equivalence rather than presenting an independent performance study with defined acceptance criteria.

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Intended for the reduction and fixation of fractures in cancellous bone in the spine for kyphoplasty (for use with Cardinal Health Radiopaque Bone Cement).

The Inflatable Bone Tamp (IBT) was designed for use in Balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. The wire stiffener provides stiffness to the balloon catheter to facilitate insertion through the access cannula

This document, K090211, describes an Inflatable Bone Tamp (IBT) submitted for 510(k) clearance by Cardinal Health. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove a specific level of performance for the device. Here's a breakdown of the requested information based on the provided text:

Key Takeaway: The provided document is a 510(k) summary, which aims to demonstrate "substantial equivalence" of a new device to existing predicate devices. It does not outline specific acceptance criteria for a new performance benchmark for the device, nor does it detail a study that proves the device meets such criteria as one might find for a novel device with new claims. Instead, it relies on demonstrating that the new device shares similar technological characteristics and performs comparably to already cleared devices.

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

Based on the provided text, specific acceptance criteria in the sense of quantitative performance thresholds (e.g., "Must achieve XYZ accuracy" or "Tensile strength of X MPa") are not explicitly stated. The "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating "substantial equivalence" to the predicate devices. The performance reported is that the device is substantially equivalent to its predicates.

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

The document mentions "Performance testing" and "biological qualification safety tests" but does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full 510(k) submission, not necessarily in the public summary.

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

This type of information is not applicable or not mentioned in this 510(k) summary. The context is not one of diagnostic accuracy or expert consensus on findings, but rather physical and biological performance of a medical device. "Ground truth" in this context would likely refer to established engineering and material science standards for device components, not expert interpretation of medical data.

4. Adjudication method for the test set

Not applicable or not mentioned. Adjudication methods are typically used in studies involving human interpretation or subjective assessments. The tests described (material safety, functional characteristics) are objective engineering and biological tests that wouldn't require an adjudication method in the clinical sense.

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 an Inflatable Bone Tamp, a physical medical device used in surgery, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is entirely outside the scope of this device.

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

Not applicable. As stated above, this is a physical medical device, not an algorithm.

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

For the non-clinical testing described:

• Material safety: The "ground truth" would be established by validated ISO 10993 standards and other industry-recognized test methods for biocompatibility and material properties.
• Functional characteristics: The "ground truth" would be the established performance characteristics of the predicate devices as measured against engineering specifications and validated test methods.

8. The sample size for the training set

Not applicable. This is not a study involving machine learning or algorithms that require a training set. The term "training set" is not relevant to the evaluation of this physical medical device.

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

Not applicable. As there is no training set for this type of device evaluation, there is no ground truth to establish for it.

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