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When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with KYPHON® HV-R Fenestrated Screw Cement, the CD HORIZON® Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON® Fenestrated Screws augmented with KYPHON HV-R® Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. KYPHON HV-R® Fenestrated Screw Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. KYPHON HV-R® Fenestrated Screw Cement will be provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.

2. The CD HORIZON® Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON® LEGACY™ and CD HORIZON® SOLERA™ implants contained in the CD HORIZON® Spinal System. The CD HORIZON® Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON® Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These screws are provided non-sterile.

The provided document is a 510(k) premarket notification for the KYPHON HV-R® Fenestrated Screw Cement and CD HORIZON® Fenestrated Screw Set. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study with specific metrics like sensitivity, specificity, or reader performance.

Therefore, many of the requested details about acceptance criteria, study design for performance measurement, ground truth, and expert involvement are not available in this type of regulatory document.

However, I can extract information regarding performance data and the overall conclusion.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Applicable. The document explicitly states "Clinical data and Non-Clinical testing were provided in support of substantial equivalence of the subject device." This indicates that the performance data was used to demonstrate that the new device is as safe and effective as the predicate devices, rather than meeting predefined acceptance criteria for diagnostic performance metrics (like sensitivity/specificity) for a specific task (e.g., detecting a condition). The performance data cited would likely be mechanical properties, biocompatibility, or other engineering parameters relevant to medical devices, not diagnostic accuracy.

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

• Not Available. The document does not specify test set sample sizes or data provenance. The "clinical data" mentioned would typically be focused on patient outcomes and safety profiles compared to predicate devices, not on a "test set" for an AI algorithm's performance.

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 device is a medical implant and bone cement system, not an AI diagnostic tool. Therefore, there is no "ground truth for a test set" in the context of expert review for diagnostic accuracy as there would be for an AI algorithm. Ground truth, if applicable in a clinical study for an implant, would relate to patient outcomes, imaging results post-procedure, or pathology reports after explantation, which are typically assessed by treating physicians or pathologists, not necessarily a panel of experts specifically for "ground truth establishment" in the way it's described for AI.

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

• Not Applicable. As explained above, this is not an AI diagnostic device and therefore, adjudication methods for a test set based on expert review are not relevant to this document.

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 is a medical device (cement and screws), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described in this document.

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

• Not Applicable. This is not an algorithm or AI system.

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

• Outcomes Data/Substantial Equivalence to Predicates: While not framed as "ground truth" for an AI, the "Performance Data" and "Clinical Data and Non-Clinical testing" would have relied on various forms of data to demonstrate safety and effectiveness. For implants, this typically includes:
  • Mechanical Testing Data: Demonstrating the physical properties (strength, fatigue, etc.) of the cement and screws.
  • Biocompatibility Testing: Ensuring the materials are safe for implantation.
  • Clinical Outcomes Data: Potentially from studies comparing the device to existing treatments, or from safety monitoring, though detailed clinical trial results are not provided in a 510(k) summary. The primary "ground truth" here is often the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. This is a medical device, not an AI model requiring a training set.

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

• Not Applicable. This is a medical device, not an AI model.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical "AI performance study" framework, it does describe its substantial equivalence to predicate devices based on presented data.

Device(s) being reviewed:

• KYPHON HV-R® Fenestrated Screw Cement
• CD HORIZON® Fenestrated Screw Set

Predicate Devices:

• KYPHON® HV-R® Bone Cement (K150460)
• CD HORIZON® Spinal System (K042025 and K113174)

Basis of Substantial Equivalence (implied "performance criteria" for a 510(k) device):
The substantial equivalence is based on demonstrating that the new device has the same intended use, similar technological characteristics, and comparable performance to the legally marketed predicate devices. The document explicitly states:

• KYPHON HV-R® Fenestrated Screw Cement: "identical in composition, method of manufacture and sterilization to the primary predicate Kyphon® H-VR® Bone Cement... The only differences between the subject and predicate cement are the method in which the cement is delivered and that the subject cement is limited to patients with advanced stage tumors..."
• CD HORIZON® Fenestrated Screw Set: "have the same or similar indications, intended use, fundamental scientific technology, and are manufactured from similar materials as the pedicle screws found in the following FDA cleared CD HORIZON® Spinal System applications... The primary difference is the subject screws contain fenestrations which allow PMMA cement to flow in a controlled manner through the screw and into the targeted pedicle."

Conclusion:
"Based on the provided performance data, the subject KYPHON® HV-R Fenestrated Screw Cement is substantially equivalent to the KYPHON® HV-R® Bone Cement (K150460, SE 04/28/15) and the CD HORIZON® Fenestrated Screw Set is substantially equivalent to the CD HORIZON® Spinal System (K042025 (SE 08/25/2004) and K113174 (SE 11/21/2011))."

Performance Data Mentioned:
"Clinical data and Non-Clinical testing were provided in support of substantial equivalence of the subject device." (Details of this data are not provided in this summary.)

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The CD HORIZON® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency including early-onset scoliosis. The CD HORIZON® Growth Rod Conversion Set may be used with any cleared traditional CD HORIZON® Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK Rods, SPIRE™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.

The CD HORIZON® Growth Rod Conversion Set consists of a variety of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct which can be surgically lengthened on a periodic basis as the patient grows. The CD HORIZON® Growth Rod Conversion Set components are manufactured from stainless steel or titanium alloy and are designed to interact with rod-based pedicle screw/hook constructs in which the rods range in diameter from 3.5mm to 5.5mm. The CD HORIZON® Growth Rod Conversion Set is specifically to be used with any traditional CD HORIZON® Spinal System (3.5mm) fusion construct cleared for pediatric usage. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK Rods, SPIRE® Spinous Process Plates and/or Shape Memory Alloy (SMA) Staples. The CD HORIZON® Growth Rod Conversion Set is limited to a posterior approach. The CD HORIZON® Growth Rod Conversion Set connectors are provided in both sterile and non-sterile form. The sterile implants are sterilized via gamma irradiation.

This device is a CD HORIZON® Growth Rod Conversion Set and the 510(k) summary (K150200) describes a submission to add sterile connectors and set screws to the existing device, utilizing gamma irradiation and sterile packaging. This submission is about a modification to an existing medical device, specifically regarding its packaging and sterilization process, rather than a new device with performance metrics related to diagnostic accuracy or clinical outcomes. Therefore, the standard elements for performance criteria and a study proving those criteria (as might be expected for an AI/ML device or a device with clinical efficacy claims) are not applicable in the usual sense.

However, I can extract the relevant information regarding the "acceptance criteria" and the "study" that proves the device meets them, reinterpreting these terms in the context of this specific 510(k) submission.

Acceptance Criteria and Device Performance (in the context of sterilization and packaging):

Study Information (reinterpreted for sterilization and packaging validation):

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

   • Test Set Sample Size: The document does not specify a "sample size" for a clinical or performance test set in the traditional sense, as this submission is focused on sterilization and packaging validation. Instead, the "testing" involved adherence to established standards and protocols for manufacturing, sterilization, and packaging. These standards (e.g., ISO, ASTM) would have their own sample size requirements for their validation methods, but these are not enumerated here.
   • Data Provenance: The data is based on adherence to international and US standards for medical device manufacturing, materials, sterilization, and packaging. This is generally laboratory-based testing conducted by the manufacturer or contracted labs, rather than data from specific countries or retrospective/prospective studies on patient populations.

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

   • Not applicable in the context of this specific submission. The "ground truth" here is adherence to established engineering, materials science, and sterilization standards, validated by standard test methods rather than expert consensus on clinical data. The FDA reviewers are experts in regulatory compliance and relevant scientific fields.

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

   • Not applicable. This is not a study requiring adjudication of expert interpretations.

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 is a spinal implant component, not an AI/ML device.

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

   • Not applicable. This is not an algorithm.

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

   • The "ground truth" is adherence to validated engineering standards and material specifications (ASTM F136, ASTM F138, ISO 11137, ASTM D4169, ASTM F88, ASTM F1929) for material composition, sterilization efficacy, and packaging integrity. The primary "ground truth" for the overall submission is demonstrating substantial equivalence to a previously cleared predicate device (K133904) based on these technical considerations.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device and does not involve a training set.

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

   • Not applicable.

Summary of the study/evidence presented:

The "study" in this context refers to the engineering and validation documentation provided by Medtronic Sofamor Danek USA, Incorporated to demonstrate that the changes (sterile connectors with pre-loaded set screws and gamma irradiation sterilization) to the CD HORIZON® Growth Rod Conversion Set do not alter its fundamental scientific technology or safety and effectiveness compared to the predicate device.

The evidence relies on:

• Material Equivalence: Stating that the materials (stainless steel per ASTM F138 or titanium alloy per ASTM F136) are identical to those in the predicate device and have a long history of safe clinical use.
• Design Equivalence: Confirming that no design changes were made to the implants themselves.
• Sterilization Validation: Referring to compliance with ISO 11137-1 and ISO 11137-2 for gamma irradiation.
• Packaging Validation: Referring to compliance with ASTM F88/F88M, ASTM D4169, and ASTM F1929 for seal strength, shipping, and leak detection.
• Risk Analysis: Performed to support the claim that the modified device does not represent a new worst case.

The conclusion is that, based on this documentation and adherence to standards, the modified device is substantially equivalent to the predicate device due to identical design, materials, method of implantation, and intended use, with only the sterilization and packaging method being updated.

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