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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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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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