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The Kyphon Discyphor Direct™ Catheter System for the Functional Anaesthetic Discography™ Procedure, and its components, are intended for use in delivering either a single dose or continuous administration of radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space.

The Kyphon Discyphor Direct™ Outer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Direct™ Inner Needle and Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct ""Outer Needle is intended to be used only with the Discyphor Direct™ Catheter System.

The Kyphon Discyphor Direct™ Inner Needle is intended to access the nucleus of an intervertebral disc for the purpose of performing provocative discography and facilitating placement of the Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct " Inner Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Discyphor Direct" voner Needle is intended to be used only with the Discyphor Direct " Catheter System.

The Discyphor Direct™ Catheter System is comprised of a Discyphor Direct™ Catheter, a Balloon Inflation Assembly, a Stopcock Assembly, an Injection Assembly, an EPI-Guard Catheter Anchoring Device, Adhesive Clips, a Sheet of Labels, 1-cc Syringes and a Discyphor Direct™ Outer Needle (with stylet) and a Discyphor Direct™ Inner Needle (with stylet). The Discyphor Direct™ Catheter is a micro-catheter with a double lumen shaft and an inflatable balloon at its distal end.

The Balloon Inflation Assembly, a Stopcock Assembly, an Injection Assembly are intended to be connected to the lumens of the catheter and to provide access to the lumens. The Balloon Inflation Assembly consists of an a 3-cc Syringe and a pressure relief valve. The Stopcock Assembly consists of a Stopcock, a Touhy Borst adapter and a Wing Nut. The Injection Assembly consists of a Touhy Borst adapter, a One-way valve and a Wing Nut. The EPI-Guard Catheter Anchoring Devices secures the catheter close to the needle puncture site. The Adhesive Clips are used to secure the catheter to the patient.

The 1-cc Syringes can be used for injection of contrast, antibiotic, and/or saline into the disc space.

The labels provided on the Label Sheet are used to identify the solutions used during the procedure or to denote the level at which the Discyphor Catheter has been placed.

The Discyphor Direct " Outer Needle is manufactured from stainless steel and has a stainless steel stylet with a beveled tip and a polycarbonate wing.

The Discyphor Direct™ Inner Needle is manufactured from stainless steel and has a stainless steel stylet.

The provided text describes the Kyphon Discyphor Direct™ Catheter System and its components (Outer Needle, Inner Needle). It states that the device was submitted for a 510(k) premarket notification, indicating a claim of substantial equivalence to previously cleared predicate devices. The study performed is not a clinical study in the traditional sense, but rather a series of engineering and performance tests to demonstrate that the device meets specifications and is substantially equivalent to predicates.

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

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

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

The text does not specify the sample sizes used for each of the tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. These are engineering and performance tests, not clinical studies involving human subjects in a traditional sense.

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 section is not applicable to this type of device and study. "Ground truth" in the context of expert consensus is typically relevant for studies evaluating diagnostic accuracy, where human expert interpretation is compared to an AI's output. The Kyphon Discyphor Direct™ system is a medical device for delivery of substances, and its performance is evaluated through engineering and functional tests against predefined specifications, not by expert interpretation of images or clinical outcomes in the same way an AI diagnostic tool would be.

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

This section is not applicable for the same reasons as in point 3. Adjudication methods are used in clinical trials or diagnostic accuracy studies to resolve discrepancies among expert readers. The tests performed for this device are objective engineering and performance tests.

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

There was no MRMC comparative effectiveness study done. This device is not an AI diagnostic tool; it is a catheter system for delivering substances. Therefore, a study comparing human readers with and without AI assistance is not relevant or applicable.

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

This section is not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" for the engineering and performance tests was based on predefined design specifications and industry standards for medical device performance, safety, and biocompatibility. For instance, dimensions must fall within specified tolerances, materials must meet certain tensile strength, and sterilization must achieve a specified sterility assurance level.

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical medical device. Manufacturing processes and design iterations might involve internal testing, but this is not analogous to an AI training set.

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

This section is not applicable for the same reasons as in point 8.

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The Kyphon Discyphor Catheter System for the Functional Anaesthetic Discography™ Procedure, and its components, are intended for use in delivering either a single dose or continuous administration of radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space.

The Kyphon Discyphor Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Spinal Needle, Discyphor Catheter and Discyphor Guidewire into the intradiscal space. The Kyphon Discyphor Introducer Needle is intended to be used only with the Kyphon Discyphor Catheter System.

The Kyphon Discyphor Spinal Needle is intended to access the nucleus of an intervertebral disc for the purpose of nerforming provocative discography and facilitating placement of the Discyphor Catheter and Guidewire into the intradiscal space. The Discyphor Spinal Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Kyphon Discyphor Spinal Needle is intended to be used only with the Kyphon Discyphor Catheter System.

The Discyphor" Catheter System is comprised of a Discyphor" Catheter with guidewire funnel, a Discyphor" Guidewire, a Discyphor" Introducer Needle, a Discyphor" Spinal Needle, a stopcock, syringes, catheter connectors and labels. The Discyphor Catheter is a micro-catheter with a flexible shaft and a balloon located near the distal tip. The metallic Discyphor Guidewire is .009" in diameter and is radiopaque when viewed using fluoroscopy. The stopcock retains pressure within the balloon when used in conjunction with the syringes. The catheter connectors are connected to the lumens of the Discyphor Catheter and provide access to the lumens. Labels are used to identify the solutions used during the procedure or to denote the level at which the Discyphor Catheter has been placed.

The Discyphor Introducer Needle is designed specifically for use with the Discyphor Catheter System. The Discyphor Introducer Needle is stainless steel with a removable stainless steel stylet. The Discyphor Catheter is delivered through the Discyphor Introducer Needle and is tracked over the Discyphor Guidewire.

The Discyphor" Spinal Needle is a standard stainless steel needle with a removable stainless steel stylet. The hubs of the needle and stylet are comprised of polymer.

Here's an analysis of the provided text regarding the Discyphor™ Catheter System, focusing on acceptance criteria and supporting studies:

It is important to note that this 510(k) submission describes a material change to one component (the guidewire) of an existing device system, rather than an entirely new device. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that the new guidewire material is equivalent to the previous one and that the overall system remains safe and effective for its stated intended use. This is a common approach in 510(k) submissions for modifications to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated for any of the individual tests. The document refers to "in vitro testing" and "laboratory physician preference testing" without providing specific numbers of samples or participants.
• Data Provenance: The studies were in vitro (laboratory-based) and "laboratory physician preference testing." There is no mention of human clinical data or animal studies in this submission for the material change. The data provenance is likely research and development labs (Kyphon Inc. or contract labs).

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

• Number of Experts: For the "laboratory physician preference testing," the number of physicians involved is not specified.
• Qualifications of Experts: The document refers to "physician preference testing," implying that the experts were medical doctors. However, their specific qualifications (e.g., years of experience, specialization) are not detailed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable or not specified. This type of engineering and preference testing typically doesn't involve formal adjudication methods like "2+1" or "3+1" that are common in clinical image-reading studies. Physician preference is often a direct assessment.

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 evaluating the impact of AI algorithms on human reader performance, typically in diagnostic imaging. The Discyphor Catheter System is a medical device (catheter, needles, guidewire), not an AI-powered diagnostic tool. The submission is for a material change to a guidewire, which focuses on physical and biological properties.

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

• Not applicable. The Discyphor Catheter System is a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply. The tests described (in vitro, biocompatibility, physician preference) evaluate the device components themselves.

7. The Type of Ground Truth Used:

• Ground Truth: For the material properties (bending stiffness, axial strength, fracture, kink resistance), the "ground truth" would be established by engineering and material science standards and measurements.
• For "physician preference testing," the "ground truth" is subjective expert opinion/preference from the participating physicians.
• For biocompatibility, the "ground truth" is compliance with established biocompatibility standards and guidelines (e.g., ISO 10993).

8. The Sample Size for the Training Set:

• Not applicable/Not mentioned. This submission is for a physical medical device and a material change, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI.

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

• Not applicable. As there is no AI training set, there is no ground truth established for one.

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The Functional Anaesthetic Discography (F.A.D.) Catheter System is intended for use in delivering either a single dose or continuous administration of a radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space. The Functional Anaesthetic Discography (F.A.D.) Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating placement of the F.A.D. Catheter and Guidewire into the intradiscal space.

The F.A.D. Catheter is a micro-catheter with a flexible shaft. The F.A.D. Catheter has a polymer balloon located near the distal tip. Once the F.A.D. Catheter is properly positioned, the balloon is inflated with a radiopaque contrast medium and assists in maintaining proper catheter placement during the procedure. The balloon is then deflated prior to removal of the F.A.D. Catheter. Two stainless steel tubes are contained inside the polymer shaft of the F.A.D. Catheter and serve as lumena. The inflation lumen is used for inflating and deflating the balloon and the guidewire / injection lumen is used for insertion of a guidewire and injection of radiopaque contrast, local anaesthetics, and/or saline solution. The proximal portion of both lumena are connected to the Portex® Epidural Catheter Connector Adapters during the procedure. There are two radiopaque markers on the F.A.D. catheter shaft, located proximally and distally within the balloon, allowing for radiographic positioning of the balloon. There are eight markers on the proximal end of the catheter which can be utilized to monitor stable catheter placement during the course of the procedure. The F.A.D. Introducer Needle is designed specifically for use with the F.A.D. Catheter System. The F.A.D. Introducer Needle is manufactured from stainless steel and has a stainless steel stylet. The F.A.D. Introducer Needle has a square cut distal tip with rounded edges. The stylet has a bevel tip. The F.A.D. Introducer Needle provides access to the area adjacent to the intradiscal space. The F.A.D. Catheter is delivered through the F.A.D. Introducer Needle and is tracked over the guidewire. The F.A.D. Catheter System is comprised of the following: One F.A.D. Catheter, One F.A.D. Introducer Needle, One Spinal Needle, One Guidewire, One Stopcock, One 3cc syringe, Two 1cc syringes, Two Catheter Connectors (toughy-borst adapters), One package of sterile labels. The F.A.D. Introducer Needle is also offered a la carte.

This document is a 510(k) Premarket Notification for the Kyphon Functional Anaesthetic Discography (F.A.D.) Catheter System and Introducer Needle. It primarily focuses on an addition of labeling information and asserts substantial equivalence to a previously cleared device (K043500), rather than presenting a study to prove a device meets specific performance acceptance criteria through clinical or analytical testing.

Therefore, many of the requested elements (e.g., acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not explicitly present in the provided text.

Based on the provided information, here's what can be extracted:

• No new study was conducted to prove the device meets acceptance criteria. The submission is focused on labeling changes for an already-cleared device. The "study" mentioned is implicitly the original submission (K043500) that established substantial equivalence for the device itself.

1. Table of Acceptance Criteria and Reported Device Performance:

• This information is not provided in the current document because it's a labeling update submission, not an initial clearance for a new device requiring performance studies. The original predicate device (K043500) would have contained such data.

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

• Not applicable to this submission, as no new test set or performance study is described.

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

• Not applicable to this submission.

4. Adjudication method for the test set:

• Not applicable to this submission.

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 MRMC study was done. This device is a mechanical catheter system, not an AI-driven diagnostic or assistive tool, so MRMC studies and AI effect sizes are not relevant.

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

• No standalone algorithm performance study was done. This is a medical device, not a software algorithm.

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

• Not applicable to this submission. The "ground truth" for this 510(k) is the assertion that the updated labeling does not change the fundamental safety or effectiveness demonstrated by the predicate device.

8. The sample size for the training set:

• Not applicable to this submission.

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

• Not applicable to this submission.

Summary based on the document:

This 510(k) submission (K061210) for the Kyphon Functional Anaesthetic Discography (F.A.D.) Catheter System and Introducer Needle is a labeling update only. It explicitly states: "This 510(k) is being filed for the addition of labeling information in the Instructions for Use... The additional contraindication, warnings, and adverse events noted in this submission do not represent a change to either device's intended use or indications for use. There are also no changes to the primary design elements for either device that are the subject of this submission. Therefore, devices and the device labeling are substantially equivalent to the devices already cleared under K043500."

Because this is a labeling update and not a submission for a new device or a significant modification, the typical performance data and study details requested are not part of this specific document. The evidence of the device meeting acceptance criteria would have been established during the clearance of the predicate device, K043500.

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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® HV-R™ bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemagioma and giant cell tumor.

Like the predicate devices, KyphX® HV-RTM Bone Cement is provided as a two-component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/methyl-methacrylate-styrene-copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N.N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

The provided text is a 510(k) Premarket Notification Summary for a medical device (KyphX® HV-R™ Bone Cement) seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way one might expect for an AI/ML medical device.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

• Chemical Composition: Comparing the ingredients and their percentages.
• Mechanical Tests: Verifying equivalence as defined by ISO 5833:2002 ("Implants for Surgery - Acrylic resin cements").
• Biocompatibility: Meeting requirements for "Implant, Tissue/Dentin/Bone, Permanent Contact" as described in FDA Blue Book Memorandum #G95-1 and verified as substantially equivalent to the predicate device per ISO-10993.
• Sterilization: Describing sterilization methods and Sterility Assurance Levels (SAL).
• Intended Use: Showing that the intended use is substantially equivalent to predicate devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or not explicitly detailed in this type of submission, as it's not a study validating AI performance. The "acceptance criteria" here are implicitly the FDA's requirements for demonstrating substantial equivalence for this specific type of device.

Here's a breakdown of the available information:

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

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 provided in the document. The document refers to "mechanical tests" and "biocompatibility tests" but does not detail the sample sizes or data provenance for these tests. It indicates the tests were done "in direct comparison" to a predicate device.

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 is not applicable to this type of device submission. The "ground truth" here is defined by objective engineering and biocompatibility standards (ISO 5833:2002, ISO 10993, FDA G95-1 Memorandum) rather than expert consensus on medical images or diagnoses.

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

This is not applicable. The assessment for substantial equivalence for this device is based on laboratory-derived physical and chemical properties and biocompatibility, not on human interpretation or adjudication processes typical for diagnostic AI devices.

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. This is a bone cement device, not an AI/ML diagnostic tool, so no MRMC study would be performed for its clearance.

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

This is not applicable. This is a material-based medical device, not an algorithm.

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

The "ground truth" for this device's performance is established by international standards and regulatory guidelines for bone cements and medical device biocompatibility, specifically:

• ISO 5833:2002 ("Implants for Surgery - Acrylic resin cements") for mechanical properties.
• ISO-10993 ("Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") for biocompatibility.
• FDA Blue Book Memorandum #G95-1 for biocompatibility requirements for permanent contact implants.

8. The sample size for the training set

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

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

This is not applicable. As it's not an AI/ML device, there is no training set or associated ground truth establishment process in the context of machine learning.

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The KyphX® HV-R bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure.

Like the predicate device, KyphX® HV-R bonc coment is provided as a two-component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/methyl-methacrylate-styrene-copolymer) with barium sulfate as a radiopacifier and benzoyl pcroxide as an initiator. The liquid component consists ી methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

The provided text is a 510(k) Premarket Notification for a medical device, the KyphX® HV-R bone cement. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria and a detailed performance study as would be seen for new or high-risk devices.

Therefore, much of the requested information regarding acceptance criteria, specific device performance against those criteria, detailed study design for proving performance, and ground truth establishment is not available in this document.

Here's a breakdown of what can be extracted and what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Information Not Provided in the Document:

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

• This document does not detail specific "test sets" for a clinical study in the way an AI/software device would. The comparisons are primarily based on material properties, biocompatibility, and intended use equivalence to a predicate device. If mechanical or biocompatibility tests involved samples, those sample sizes are not specified.

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 in this context. Ground truth establishment for a diagnostic AI is not part of a bone cement's 510(k) submission.

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

• Not applicable.

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 bone cement, not an AI or software product.

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

• Not applicable.

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

• The "ground truth" here is the established performance and safety profile of the predicate device (Surgical Simplex®P) and adherence to recognized standards (ISO 5833:2002, ISO-10993, FDA Blue Book Memorandum #G95-1). It's not about a diagnostic outcome for a patient.

8. The sample size for the training set:

• Not applicable. There is no AI model or training set involved.

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

• Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the KyphX® HV-R bone cement meets its (implicit) acceptance criteria is a direct comparison study against a legally marketed predicate device, Surgical Simplex® P. This comparison focused on:

• Chemical Composition: Comparing the exact percentages of components (PMMA copolymer, barium sulfate, benzoyl peroxide in the powder; methyl methacrylate, N,N-dimethyl-p-toluidine, hydroquinone in the liquid). The provided table (Table 5-1) serves as the evidence for this.
• Mechanical Properties: Testing performed in accordance with ISO 5833:2002, demonstrating "substantial equivalence" to the predicate. (Specific test results are not detailed in this summary).
• Biocompatibility: Evaluation against FDA Blue Book Memorandum #G95-1 and comparison to the predicate as defined by ISO-10993, demonstrating "substantial equivalence."
• Sterilization: Verification of sterility and non-pyrogenicity, with specific details on methods and SALs.
• Intended Use: Clinical information was reviewed to confirm that the new device's intended use is substantially equivalent to the predicate's and does not negatively impact safety or effectiveness.

The conclusion is that the KyphX® HV-R bone cement is substantially equivalent to the predicate device based on these comparisons, allowing it to be cleared for market without requiring a full PMA (Premarket Approval) application.

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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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