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The Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are intended to be used for the reduction and fixation of fractures and or creation of a void in cancellous bone in the spine. This includes use during percutancous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.

Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon catheters are designed for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty in association with cleared spinal polymethylmethacrylate (PMMA) bone cements.

The inflation of the balloon serves to create a cavity in the vertebral body, compressing the cancellous bone and/or move cortical bone, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. Winch Kyphoplasty (15 and 20 mm) 11 Gauge balloon catheters fit through a 10 Gauge cannula allowing a minimally invasive kyphoplasty procedure.

The low preinflation profile (low wrapping profile of folded balloon) enables their insertion into these small working cannulas. The stiff distal end of the balloon catheter provides rigidity for smooth insertion while flexible proximal catheter allows for easy maneuverability.

I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for the "Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters."

This document focuses on:

• FDA's substantial equivalence determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Device description and indications for use: Explaining what the device is and what it's intended to do.
• Comparison to predicate devices: Highlighting similarities in technological characteristics.
• Biocompatibility testing: Listing the types of tests performed to ensure the device is biocompatible.
• Performance data (general statement): A general statement that the device "met specifications and performance characteristics" and that "The testing included functional testing" (e.g., dimensional characterization, inflation/deflation time, burst characteristics) and "mechanical testing according to ISO 10555-1:2013".

However, the document does NOT provide:

• A specific table of acceptance criteria.
• Reported device performance against those criteria.
• Details about a formal study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance details, training set information) that would typically prove a medical device meets specific performance acceptance criteria. The performance data mentioned are general functional and mechanical tests to demonstrate equivalence, not a clinical or performance study with detailed statistical outcomes.

Therefore, I cannot fulfill your request based on the provided text.

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The Osseoflex® SB is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® needle to fill the previously created void(s).

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or software device that undergoes training.

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

Not applicable, as there is no training set for a physical medical device.

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