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KYPHON® 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 kyphoplasty or vertebroplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.

KYPHON® HV-R® Bone Cement is provided as a two component system. The powder component consists of a PMMA copolymer (polymethylmethacrylate/ 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.

This document is a 510(k) premarket notification for the KYPHON® HV-R® Bone Cement. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own performance against specific acceptance criteria. Therefore, most of the requested information regarding a device performance study is not present in this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance:

This document does not establish new acceptance criteria or report specific device performance metrics from a new study. Instead, it claims substantial equivalence to previously cleared devices (KYPHON® HV-R® Bone Cement (K093828) and KYPHON® Xpede™ Bone Cement (K102397)). The "performance" being demonstrated here is that the new device shares fundamental scientific technology, equivalent implant materials, and sterilization methods with 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):

Not applicable. This document does not describe a new clinical or performance study with a test set. The claim is based on equivalence to existing 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):

Not applicable. No new test set or ground truth establishment by experts is described for this submission.

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

Not applicable. No new test set or adjudication method is described.

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-assisted diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This device is bone cement, not an algorithm.

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

Not applicable. No new ground truth data is generated or used for this submission. The "ground truth" for the substantial equivalence claim resides in the prior clearance of the predicate devices based on their established performance and safety profiles.

8. The sample size for the training set:

Not applicable. This document pertains to a medical device (bone cement), not a machine learning model, so there is no concept of a training set.

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

Not applicable. As above, there is no training set for this device submission.

In summary: The provided document is a 510(k) submission where the primary argument for clearance is substantial equivalence to already legally marketed predicate devices. It does not contain information about a new performance study with acceptance criteria, test sets, expert adjudication, or AI performance metrics. The information focuses on the technical characteristics and intended use being similar to the predicates, thereby concluding that the device does not raise new questions of safety or effectiveness.

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The CD HORIZON® Spinal System without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to following indications: degeneralive discase (defined as back pain of discogenic origin with degencration of the disc confirmed by history and radios); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis (i.e., scoliosis, kyphosis and/or lordosis); turnor, pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative discase, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforcementioned indications in skeletally mature patients as an adjunct to fusion. The 3,5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle serew lixation in pediatic patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scollosis, Additionally, the CD HORIZON® Spinal System is intended to treat patients diagnosed with the following conditions: spondylolistlesss / spondylolysis and fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or all. Pediatric pedicle screw lixation is limited to a posterior approach.

The CD HORIZON® SPIREIM Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T)-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disease (as previously defined); spondylolisthesis; trauma; and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates, and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD HORIZON® Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, SPIRE™ Plates and DYNALOK® bolts. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromiummolybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System in non-pediatric cases. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples, washers, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so that the correct components are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, medical grade cobalt-chromiummolybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.

The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium alloy, and cobaltchromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.

PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium, or cobalt-chromiummolybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates or in pediatric patients.

The purpose of this 510(k) is to add additional sterile rods to the CD HORIZON® Spinal System.

The subject rods, along with other components such as metal screws, hooks and other connecting components, are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of thoracic, lumbar, and/or sacral spine. The subject rods are manufactured out of Commercially Pure (CP) Titanium.

This document is a 510(k) summary for the CD HORIZON® Spinal System, specifically addressing the addition of sterile rods. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a premarket notification for substantial equivalence, not a performance study report.

Therefore, I cannot provide the requested information from the given text.

The document primarily focuses on:

• Device Description: What the CD HORIZON® Spinal System is composed of.
• Indications for Use: The medical conditions for which the device is intended.
• Technological Characteristics: How the device is similar to its predicate.
• Substantial Equivalence: The argument that the new sterile rods are substantially equivalent to previously cleared versions and predicates.
• Non-Clinical Testing: A mention of a sterilization assessment and shelf-life rationale, which are part of establishing substantial equivalence rather than proving specific performance acceptance criteria for a novel device function.

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The ANATOMIC PEEK CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC® PEEK™ device is to be used with supplemental fixation. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach.

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is designed for use as a cervical interbody fusion device. The device is manufactured from PEEK™ OPTIMA™ and is to be used with autogenous bone graft. The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM consists hemicylindrical of cages of various widths, heights and depths. The hollow geometry of the implants allows them to be inserted between two cervical vertebral bodies packed with autogenous bone graft in cervical fusion procedures. The ANATOMIC PEEK™ device is to be used with cleared cervical supplemental fixation.

The provided text describes a 510(k) premarket notification for the "ANATOMIC PEEK™ CERVICAL FUSION SYSTEM" and does not contain information about a study proving the device meets acceptance criteria in the context of a software or AI-based medical device. Instead, it details non-clinical testing performed on the physical device to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested categories in your prompt are not applicable to the provided document. I will fill in the information that is present and indicate where information is not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria were based on established ASTM standards: ASTM F2077-03, ASTM F2267-04, and ASTM F-04.25.02.02 (Draft Static Push-out Test Method). The specific numerical thresholds for acceptance are not detailed in this document but are implied to be part of these standards.

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

This information is not applicable as the document describes non-clinical physical device testing (mechanical characteristics) rather than testing related to AI/software performance or human subject data.

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

This information is not applicable. The "ground truth" for the physical device performance was established by the technical specifications outlined in the ASTM standards for mechanical testing.

4. Adjudication Method for the Test Set

This information is not applicable. The mechanical tests would have objective pass/fail criteria based on measured physical properties, rather than expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable. No MRMC study was conducted or is relevant for this type of physical device submission.

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

This information is not applicable. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth was based on pre-defined mechanical performance specifications as outlined by the standards ASTM F2077-03, ASTM F2267-04, and ASTM F-04.25.02.02. This is a form of engineering or objective performance metrics, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, and there is no "training set" in the context of machine learning.

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

This information is not applicable. As there is no training set for a physical device, no ground truth was established for it.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using allograft and/or autograft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System Implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TSRH® Pediatric Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The TSRH® Spinal System is intended to help provide immobilization and stabilization of solnal segments as an adjunct to fusion of the thoracic. Iumbar. and/or sacral spine.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tallor-made for the individual case.

A subset of TSRH® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, and connecting components as well as CD HORIZON® Spinal System components cleared for pediatric use. Similarly to the TSRH® implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy and medical grade cobalt -chromium-molybdenum alloy.

TSRH® Spinal System staples are specifically excluded for use in pediatric patients.

Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking screws; DYNALOK® PLUS bolts, and Vantage™ Anterior Fixation System screws.

The hooks are intended for posterior use only. The staples are for anterior use only. The TSRH-3D® and TSRH® 3Dx™ connectors, and TSRH-3D® and TSRH® 3Dx™ screws are intended for posterior use only. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.

The TSRH® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium or titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The purpose of this 510(k) submission is to expand the indications of use to allow for use of pedicle screw based constructs to treat pediatric patients.

The provided document describes the Medtronic TSRH® Spinal System, a medical device for spinal fixation, and its 510(k) submission for an expanded indication for use in pediatric patients.

Here's an analysis of the acceptance criteria and study information contained within the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the traditional sense (e.g., specific thresholds for success, failure rates, or statistical significance levels). Instead, the performance is demonstrated through the concept of "substantial equivalence" to a predicate device and positive clinical data.

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

• Sample Size:
  • 40 pediatric patients treated with TSRH® pedicle screws only.
  • 105 pediatric patients treated with a hybrid of TSRH® hooks and pedicle screws.
  • Total patients in the reported clinical data = 145 patients.
• Data Provenance:
  • Country of origin: Not explicitly stated.
  • Retrospective or Prospective: "Published retrospective clinical data" indicates it was a retrospective study.

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

The document does not mention the use of experts to establish a "ground truth" for the clinical data in the context of a specific reader study or algorithm evaluation. Instead, the "truth" is based on the clinical outcome of the patients as documented in the retrospective data. It is implied that the diagnoses (adolescent idiopathic scoliosis) and treatment outcomes were established by the treating physicians and documented in patient medical records.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe a process for adjudicating interpretations or measurements in the clinical data. The clinical data appears to be a record of patient treatments and outcomes.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document discusses a spinal system (an implantable device), not an imaging or diagnostic AI algorithm that would typically involve human readers. Therefore, there is no mention of human readers improving with or without AI assistance.

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

No, a standalone performance study in the context of an algorithm or AI without human intervention was not conducted. This document describes a physical medical device (spinal system), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the clinical data used to support the expanded indication is based on clinical outcomes data and patient diagnoses. Specifically:

• Diagnosis of "adolescent idiopathic scoliosis."
• Treatment with TSRH® Spinal System (pedicle screws or hybrid).
• Presumably, the success or failure of the fusion and correction of scoliosis as observed in the clinical follow-up of these patients.

8. Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm that requires a training set. The clinical data mentioned is for validating the device's expanded indication, not for training a model.

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

Not applicable, as there is no training set for an AI/ML algorithm in this context.

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