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The KYPHON ELEMENT™ Inflatable Bone Tamp (IBT) is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during a balloon kyphoplasty procedure with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

The KYPHON ELEMENT™ Inflatable Bone Tamp is designed for the reduction of fractures. The main components are a single lumen shaft, Y-Adapter with a port to connect the inflation syringe for inflation/deflation, and the inflatable balloon located at the distal tip.

This document is a 510(k) summary for a medical device (KYPHON ELEMENT™ Inflatable Bone Tamp). It describes the device, its intended use, and its substantial equivalence to a previously cleared device. However, it does not contain any information about acceptance criteria, device performance metrics, or any clinical studies to prove these criteria are met.

The document primarily focuses on non-clinical testing to demonstrate substantial equivalence, stating:

• "Mechanical testing, biocompatibility testing and other verification activities were conducted to confirm that the modified device functions as intended and does not raise any new issues of safety or effectiveness."
• This refers to bench testing and material compatibility, not clinical performance studies with human subjects or expert evaluations against ground truth in a clinical setting.

Therefore, I cannot provide the requested information from the provided text as it is not present in the document.

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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 KYPHON Xpander™ II Inflatable Bone Tamps and Kyphon® Express™ II Inflatable Bone Tamps are intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

The Kyphon® Express™ II Inflatable Bone Tamps are designed for reduction of fractures. The main components are a coaxial dual lumen shaft. Y .- Adapter with a port to connect the inflation syringe for inflation/deflation, and the inflatable balloon located at the distal tip.

The Kyphon® Express™ II Inflatable Bone Tamp (K123771) received 510(k) clearance based on substantial equivalence to a predicate device, the KYPHON Xpander™ II Inflatable Bone Tamp (K101864). This type of submission does not typically involve the rigorous clinical trials or standalone performance studies often seen with novel devices or AI/software as a medical device (SaMD). Instead, the acceptance criteria are met by demonstrating that the new device is as safe and effective as a legally marketed predecessor through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The study that proves the device meets the acceptance criteria is detailed in the section "X. Brief Discussion of the Non-Clinical Tests Submitted":

• Nature of the Study: This was a non-clinical testing and verification/validation study. It focused on comparing the new device (Kyphon® Express™ II) to its predicate (KYPHON Xpander™ II) based on their design, materials, manufacturing processes, and functional performance. It specifically mentions "Mechanical testing and other verification/validation activities, including tolerance analyses."

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

• Sample Size: The document does not specify a "sample size" in the context of human subjects or clinical data for a test set, as this was a non-clinical comparison for substantial equivalence. The "sample size" would refer to the number of devices or components tested in the mechanical and verification/validation studies, which is not detailed in the summary.
• Data Provenance: Not applicable in the context of country of origin for clinical data, as this was a non-clinical submission relying on engineering and design control data.

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

• Not Applicable. This was a 510(k) submission based on substantial equivalence via non-clinical testing. It did not involve establishing ground truth from clinical experts for a test set in the way an AI/SaMD would. The "experts" involved would be Medtronic's internal engineering and regulatory personnel who performed and reviewed the design and testing.

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

• Not Applicable. There was no "test set" in the context of clinical data requiring expert adjudication.

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

• No. This type of study is entirely irrelevant to a 510(k) submission for an inflatable bone tamp based on substantial equivalence. This device is a manual surgical instrument, not an AI or imaging diagnostic tool.

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

• No. This is not an algorithm or software device. It is a physical medical instrument.

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

• Non-Clinical "Ground Truth": For this submission, the "ground truth" was established by comparing the Kyphon® Express™ II's engineering specifications, material properties, design characteristics, and mechanical performance against those of the predicate device (KYPHON Xpander™ II). The "truth" to be established was that the new device performs equivalently and safely, as confirmed by internal Medtronic testing and risk analysis, to its legally marketed predecessor.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of machine learning for this device. The development process involved engineering design, material selection, and mechanical testing, not algorithm training.

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

• Not Applicable. No training set, thus no ground truth for a training set to be established.

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The Osseoflex® SB 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 polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture 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. After the bone is disrupted, PMMA is injected through an Osseoflex® needle to fill the previously created void(s).

An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device to the pre-existing channel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

The Osseoflex® SB is an inflatable bone tamp designed for use in balloon kyphoplasty to create a cavity in the vertebral body for cement interdigitation, and to reduce fractures.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not mention a test set with a specific sample size. The studies conducted were non-clinical performance tests rather than tests involving patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in this context.

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

Not applicable. The reported studies are non-clinical performance tests (mechanical and material characteristic tests), not studies requiring expert review of data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring expert adjudication was described.

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

No. The document explicitly states: "N/A – No clinical test were conducted for this submission." Therefore, an MRMC comparative effectiveness study was not performed.

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

No. This device is a physical medical device (inflatable bone tamp), not an algorithm or AI software. Therefore, the concept of standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests was established by predefined engineering and material science requirements and standards for medical devices (e.g., minimum burst pressure, minimum burst volume, and material specifications). These are objective measurements rather than subjective expert interpretations.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or software device 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 KYPHON Xpander™ II Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures) hand, tibia, radius and calcaneus.

The KYPHON Xpander™ II Inflatable Bone Tamps are designed for reduction of fractures. The main components are the shaft, Y-Adapter and the inflatable balloon located at the distal tip.

Here's a breakdown of the acceptance criteria and study information for the KYPHON Xpander™ II Inflatable Bone Tamp, based on the provided text:

Important Note: This device is a physical medical instrument (inflatable bone tamp), not an AI/software device. Therefore, many of the questions related to AI performance metrics (like human reader improvement with AI, standalone AI performance, training/test set provenance, expert ground truth for imaging, MRMC studies) are not applicable to this type of submission. The provided text details engineering and biocompatibility testing, not clinical performance studies involving interpretation of data by humans or AI.

Acceptance Criteria and Reported Device Performance

Study Details (Applicable to this device type)

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

   • The document does not specify sample sizes for each individual test (e.g., how many tamps were subjected to fatigue testing, how many units were tested for balloon compliance).
   • The testing described is in vitro (bench testing) and in vivo (biocompatibility). Data provenance would be from laboratory experiments conducted by the manufacturer. No country of origin for data is specified for these tests, though the manufacturer is US-based.

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

   • Not applicable. For this type of physical device, "ground truth" is established by engineering specifications, material standards, and validated test methods, not by expert consensus on clinical data interpretation. The "experts" would be the engineers, material scientists, and testers involved in conducting and verifying the performance tests, whose qualifications are inherent in their roles within a medical device manufacturer.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for disagreements in human interpretation of data/images, often in clinical or diagnostic studies. This is a report of engineering and biocompatibility testing. The "adjudication" for these tests comes from the test protocols, acceptance criteria, and quality control processes of the manufacturer.

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:

   • Not applicable. This device is a manual surgical instrument, not an AI or imaging-related device that would involve human readers or AI assistance in interpretation.

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

   • Not applicable. This device is a manual surgical instrument and does not incorporate an algorithm or AI.

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

   • For the functional and mechanical testing: Engineering specifications and validated test methods/standards. The device's performance is measured against predefined physical parameters and tolerances.
   • For biocompatibility: International standard ISO-10993 (Part 1), which defines the biological evaluation of medical devices.

7. The sample size for the training set:

   • Not applicable. There is no "training set" for this type of physical medical device. Training sets are relevant for machine learning algorithms.

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

   • Not applicable. As above, no training set exists for this device.

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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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KyphX® Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus.

The KyphX® Inflatable Bone Tamps are the identified predicate devices. They are bone tamps with an inflatable component at the distal end. The products have the same technological characteristics and intended use as described for the predicates. Safety and effectiveness for use in kyphoplasty procedures is described in K033801.

The provided document is a 510(k) premarket notification summary for a medical device called the "KyphX® Inflatable Bone Tamps." This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process does not typically involve the elaborate clinical study designs and performance criteria associated with new drug applications or high-risk medical devices that require extensive clinical trials to establish efficacy and safety from scratch.

Therefore, the requested information regarding acceptance criteria, specific device performance against those criteria, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, or standalone algorithm performance cannot be fully extracted from this document because the 510(k) pathway primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical study data against a set of predefined acceptance criteria in the same way a new, unproven technology would.

Here's an analysis based on the information provided, while acknowledging the limitations:

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

This document does not present a table of acceptance criteria and reported device performance in the sense of a clinical trial or a study proving a new device's efficacy against specific benchmarks. The 510(k) process focuses on demonstrating substantial equivalence to predicate devices. This means that if the new device has the same intended use, technological characteristics, and safety/effectiveness profile as a legally marketed predicate device, it can be cleared for market. The "performance" here is implied to be similar to the predicates.

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

The document does not mention any specific test set sample sizes or data provenance because it's not a report of a new clinical study with a test set. The substantial equivalence is based on the device's design, materials, and intended use being similar to existing cleared devices.

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):

No information is available regarding experts or ground truth establishment because this document is a regulatory submission for substantial equivalence, not a clinical study report.

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

No information is available regarding adjudication methods.

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 device (KyphX® Inflatable Bone Tamps) is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned in the document.

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

This device is a physical medical instrument. The concept of "standalone algorithm performance" is not applicable.

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

The concept of "ground truth" as it applies to diagnostic or prognostic algorithms is not applicable to this device. The substantial equivalence argument relies on the device's design, materials, and intended function matching those of predicate devices that have already been cleared for safety and effectiveness.

8. The sample size for the training set:

There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable, as there is no training set.

Summary from the Document:

• Device Name: KyphX® Inflatable Bone Tamps
• Intended Use: "KyphX® Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus."
• Predicate Devices:
  • KyphX® Directional Inflatable Bone Tamp, K032212
  • KyphX® Inflatable Bone Tamp, K010246
  • Kyphon Inflatable Bone Tamp, K981251
• Basis for Equivalence: "The KyphX® Inflatable Bone Tamps are the identified predicate devices. They are bone tamps with an inflatable component at the distal end. The products have the same technological characteristics and intended use as described for the predicates. Safety and effectiveness for use in kyphoplasty procedures is described in K033801." (K033801 refers to Kyphon's cleared KyphX® HV-R™ Bone Cement, indicating that the overall procedure's safety and effectiveness were considered in a prior submission, and this device is equivalent to the tamp component of that system).

Conclusion:

This 510(k) submission demonstrates substantial equivalence by showing that the KyphX® Inflatable Bone Tamps have the "same technological characteristics and intended use" as already legally marketed predicate devices. It does not contain the detailed clinical study data, acceptance criteria tables, or AI-specific performance metrics that would be found in a Premarket Approval (PMA) application or a study for a novel diagnostic algorithm. The "study" proving the device meets criteria is essentially the FDA's review determining that it is substantially equivalent to previously cleared devices based on its design, materials, and intended use.

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KyphX® Directional Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneous.

The KyphX Directional Inflatable Bone Tamps (IBTs) are designed to compress cancellous bone and/or move cortical bone as they inflate. The inflatable component of the IBT is near the distal tip of the device. The catheter shaft contains an outer lumen for IBT inflation and a central lumen for a stylet to facilitate catheter introduction. At full inflation volume, the balloon design allows directionality of inflation with a maximum inflated diameter that is perpendicular to the catheter shaft. One design has a uniform balloon that is concentric to the catheter shaft. Another design has a non-uniform balloon that is tangential to the catheter shaft. Directionality of the balloon is indicated by external markers on the proximal Y-adapter component. Each design enables fluoroscopic visualization of the deflated balloon.

The document provided is a 510(k) premarket notification summary for the KyphX Directional Inflatable Bone Tamps. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics typically seen for novel devices.

As such, the information required to fully answer the request, particularly regarding specific numerical acceptance criteria and a detailed study proving the device meets those criteria, is not present in the provided document. The submission focuses on mechanical testing, biocompatibility, and intended use as justification for substantial equivalence.

However, I can extract the available information that relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a device like a bone tamp, “acceptance criteria” are primarily related to meeting performance specifications of predicate devices and demonstrating safety and effectiveness for its intended use through non-clinical means. Specific numerical clinical performance metrics (like sensitivity, specificity, accuracy) are not typically defined or reported for such a device in this type of submission.

2. Sample Size for Test Set and Data Provenance

The document describes mechanical testing and biocompatibility testing, not a clinical test set in the sense of patient data. Therefore, details like data provenance or a sample size for a clinical test set are not applicable or provided. The mechanical testing would involve a sample of devices, but the specific number is not disclosed in this summary.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission relies on engineering and biological testing, not expert interpretation of clinical data in the way an AI diagnostic device would.

4. Adjudication Method

Not applicable for this type of device and submission.

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

Not applicable. The device is a surgical instrument (bone tamp), not an AI-assisted diagnostic tool for interpretation of medical images.

6. Standalone (Algorithm Only) Performance Study

Not applicable. There is no algorithm for this device.

7. Type of Ground Truth Used

For the KyphX Directional Inflatable Bone Tamps, the "ground truth" for the tests performed would be:

• Mechanical Testing: Engineering specifications and performance metrics of the predicate devices.
• Sterilization: Compliance with the ANSI/AAMI/ISO11137 standard.
• Biocompatibility: Compliance with the FDA Blue Book Memorandum #G95-1 and ISO-10993 standards.

8. Sample Size for the Training Set

Not applicable. This device does not use an AI algorithm that requires a training set.

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

Not applicable.

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Kyphon Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction for fractures and/or creation of a void in cancellous bone.

The Kyphon Inflatable Bone Tamp is a bone tamp with an inflatable component at the distal end. It is designed to compress cancellous bone and/or move cortical bone as it inflates. The Inflatable Bone Tamp has a nominal length of 40 cm and consists of a double lumen catheter shaft constructed from two coaxially aligned tubings. The inflatable component is mounted near the distal tip of the catheter tubing. Two radiopaque marker bands are attached to the inner tubing and located at the proximal and distal ends of the inflatable component. A side arm adapter attached to the proximal end of the Inflatable Bone Tamp provides access to the catheter lumens. Inflation and deflation are accomplished by connecting the side arm port with an inflation syringe. The straight arm port is continuous with the inner lumen of the catheter to allow placement of a removable stiffening stylet, which attaches to the Luer fitting of the straight arm.

The Kyphon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative, pass/fail format. Instead, it describes a series of mechanical and preclinical tests performed to verify the device meets specifications and intended performance characteristics. The reported performance is generally stated as having met these specifications.

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

• Sample Size: The document indicates that preclinical testing was conducted in "isolated, fractured, cadaveric vertebral bodies" and "fractured tibial plateaus in cadaver knees and in unfractured vertebral bodies in cadaver spines." No specific numerical sample size is provided for the number of cadaveric specimens used.
• Data Provenance: The data is retrospective in the sense that cadaveric specimens are used, representing post-mortem human bone. The country of origin for the cadaveric specimens is not specified in the document.

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

The document does not mention the use of experts to establish a "ground truth" for the preclinical cadaveric testing. The evaluation appears to be based on physical measurements and observations of the device's performance in reducing fractures and creating voids, directly compared to predicate conventional bone tamps.

4. Adjudication Method for the Test Set

No adjudication method is described, as the evaluation seems to be based on direct physical and mechanical observations rather than subjective assessments requiring expert consensus.

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

An MRMC comparative effectiveness study was not performed. The study focuses on the standalone performance of the device and its equivalence to predicate devices, not on human reader improvement with or without AI assistance.

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

Yes, a standalone performance assessment was conducted. The mechanical and preclinical tests were performed on the device itself (and in cadaveric bone) to evaluate its physical properties and functional performance independent of human-in-the-loop interaction in a clinical setting. The conclusion states "the Kyphon Inflatable Bone Tamp meets design specifications and performs like conventional bone tamps, elevators and curettes," which refers to its standalone performance.

7. Type of Ground Truth Used

The ground truth for the preclinical testing was based on direct observation and measurement of the device's ability to:

• Reduce fractures
• Create voids in cancellous bone
• Conform to design specifications in bone
• Demonstrate mechanical properties (e.g., inflation parameters, bond strengths, fatigue)
• Exhibit biocompatibility

This can be categorized as direct physical and functional performance, objectively measured against defined engineering specifications and comparisons to predicate device performance.

8. Sample Size for the Training Set

No mention of a "training set" is made in the document. This project appears to be a 510(k) submission for a physical medical device, not an AI/machine learning algorithm, so the concept of a training set is not applicable.

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

As there is no training set mentioned or implied by the nature of the device and study, this question is not applicable.

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