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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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Summary from K123771)
Technological Characteristics	The fundamental scientific technology, design characteristics, materials of construction, packaging, and sterilization process should be identical or equivalent to the predicate device.	"The fundamental scientific technology of the subject Kyphon® Express™ II Inflatable Bone Tamps is identical to the predicate KYPHON Xpander™ II Inflatable Bone Tamps."
"The Kyphon® Express™ II Inflatable Bone Tamps have the same design characteristics, packaging, use the same sterilization process, and are made of equivalent materials as the predicate KYPHON Xpander™ II Inflatable Bone Tamps."
"The subject and predicate Inflatable Bone Tamps are identical in terms of indications for use, intended use, performance specifications, and fundamental technological characteristics."
Indications for Use (IFU)	The IFU must be the same as the predicate device.	The IFU for the Kyphon® Express™ II Inflatable Bone Tamps explicitly states: "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," indicating alignment with the predicate.
Performance Specifications/Safety & Effectiveness	The device must function as intended and not raise new issues of safety or effectiveness. This is typically assessed through mechanical testing and other verification/validation activities.	"Mechanical testing and other verification/validation activities, including tolerance analyses were conducted to confirm that the modified device functions as intended and does not raise any new issues of safety or effectiveness."
"A risk analysis and associated verification/validation testing was completed for the device modifications."
Substantial Equivalence Conclusion	Based on the above, a conclusion of substantial equivalence to a legally marketed predicate device must be drawn.	"Medtronic believes the subject Kyphon® Express™ II Inflatable Bone Tamps to be substantially equivalent to the legally marketed predicate KYPHON Xpander™ II Inflatable Bone Tamps." The FDA concurred with this assessment in their letter.

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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