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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 MEDINAUT Kyphoplasty System is intended to be used 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. This 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 spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body it facilitate the insertion of bone cement through the use of the cement dispensing plunger. The benefits of MEDINAUT Kyphoplasty System are the reduction in back pain and increase of patient's functional abilities, allowing a return to the previous level of activity.

It consists of Balloon Catheter, Bone Expander Syringe, Needle Pipe, Needle Pin, Wire Pin (Troca Type, Round Type), Cannula, Expander, Spacer, Cement Pusher, Cement Filler, and Guide Wire. It is supplied sterile and for single disposable use.

The MEDINAUT Kyphoplasty System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The system is substantially equivalent in design, function and intended use to the predicate devices.

This device is a medical device, not an AI/ML device, so many of the requested fields are not applicable.

Here's an analysis of the provided 510(k) summary for the MEDINAUT Kyphoplasty System, focusing on acceptance criteria and performance data:

The MEDINAUT Kyphoplasty System is a physical medical device (an inflatable bone tamp system) used in kyphoplasty procedures. The "acceptance criteria" and "study" described are primarily bench tests comparing the device's physical properties and performance against a predicate device, rather than clinical studies or evaluations of an AI model's diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in the format of pass/fail thresholds for each test. Instead, it presents "Test Criteria" which are more akin to the methodology or conditions of the test, and then provides "Test Result" for both the MEDINAUT Kyphoplasty System and the predicate device (Kyphon Inflatable Bone Tamp). The implicit acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device. This means the new device's performance should be comparable to or better than the predicate's, and not raise new questions of safety or effectiveness.

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

The document does not explicitly state the exact sample size (e.g., number of devices tested for each parameter) for the bench tests. It refers to "IBE-10," "IBE-15," "IBE-20" for the applicant's device and "K13A," "K09A," "K08A" for the predicate, which likely correspond to different sizes or models of the devices tested. Without further detail, we cannot determine the n for each specific test.

The data provenance is from bench testing conducted by IMEDICOM Co., Ltd. (Republic of Korea) and compared against the Kyphon Inflatable Bone Tamp. This is laboratory data, not patient-derived data, and therefore the concepts of "country of origin of the data," "retrospective or prospective" (in a clinical sense) are not directly applicable.

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

This question is not applicable to this type of device and study. The "ground truth" for these bench tests is established by physical measurement and engineering standards, not by expert interpretation of medical images or patient outcomes. The physical properties (e.g., tensile strength, burst pressure) are objectively measurable.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used for establishing ground truth in human-reviewed data sets, especially when there's variability in expert interpretations. Bench tests rely on standardized measurement protocols.

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 relevant for AI/ML diagnostic devices where the output of the AI is compared to human readers' performance, with or without AI assistance, on a set of clinical cases. The MEDINAUT Kyphoplasty System is a physical surgical tool, not a diagnostic AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable. The device is a physical, non-AI medical tool. The concept of "standalone performance" without human intervention doesn't apply to a surgical instrument that is used by a surgeon.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests is based on engineering measurements and specifications of the physical properties (e.g., strength, pressure resistance, dimensions, forces). The comparison is made against the performance of a legally marketed predicate device to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design of the device is based on engineering principles and iterative development, not data-driven machine learning training.

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

This question is not applicable for the same reasons as #8.

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