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The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine; hand, tibia; radius and calcaneus. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cernents that are legally marketed for use in vertebroplasty or kyphoplasty procedures.

The SKy System consists of the following components:

• Expandable tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.
• Delivery system used for the insertion, expansion, and retrieval of the expandable tube.
• Instrumentation Set - a set of accessories to assist in insertion and location of the device.

I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for the SKy Bone Expander System, outlining its intended use, description, and substantial equivalence to previously cleared devices. It does not include details about performance testing, sample sizes, ground truth establishment, or clinical studies.

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The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

The SKy System consists of the following components:

• Expandable Tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced diameter configuration and expanded within the bone.
• Delivery System used for the insertion, expansion, and retrieval of the expandable tube.
• Instrumentation Set a set of accessories to assist in insertion and location of the device.

The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Disc-O-Tech Medical Technologies Ltd. SKy Bone Expander System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against specific acceptance criteria.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and the study proving the device meets them, as that information is not present in the given input.

The document discusses:

• Company and Product Information: Name, contact, date prepared, trade/proprietary name, classification.
• Predicate Devices: Lists similar devices.
• Intended Use: Specifies the medical application of the device.
• System Description: Describes the components of the SKy System.
• Substantial Equivalence: Highlights similarities between the modified SKy System and its previously cleared version, and other predicate devices, focusing on operating principles, design, materials, packaging, and sterilization.
• FDA Correspondence: Official letter from the FDA confirming the substantial equivalence determination and allowing the device to be marketed.
• Indications for Use Form: A standard form reiterating the intended use.

None of these sections include data from performance studies, acceptance criteria, or details regarding ground truth, sample sizes, expert qualifications, or adjudication methods typically found in effectiveness or validation studies.

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The SKy System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

The SKy System consists of the following components:

• √ Expandable Tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.

• Delivery System used for the insertion, expansion, and retrieval of the expandable tube.

• V Instrumentation Set a set of accessories to assist in insertion and location of the device.

This 510(k) summary (K034037) for the SKy Bone Expander System primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information regarding acceptance criteria, performance studies, or quantitative results often found in submissions for novel or higher-risk devices.

Therefore, many of the requested sections cannot be fully populated from the provided text.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria or a reported device performance table. The submission is a 510(k) seeking substantial equivalence, which implies that the device's performance is expected to be "as safe and effective as, and performs as well as or better than" the predicate devices. Performance is likely demonstrated through substantial equivalence arguments and engineering testing rather than a clinical study with stated acceptance criteria.

Study Information

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

• Acceptance Criteria: Not explicitly stated in the provided text. For a 510(k) based on substantial equivalence, acceptance criteria would typically relate to mechanical performance, biocompatibility, sterilization, and sometimes clinical equivalence to predicate devices.
• Reported Device Performance: Not explicitly reported in a quantitative table within the provided text. The document states similarities to the predicate device in terms of intended use, operating principles, design principles, materials, packaging, and sterilization methods.

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

• The provided text does not describe a clinical "test set" with a specific sample size. The substantial equivalence argument relies on comparing the new device to previously cleared predicate devices.
• Data Provenance: Not applicable in the context of a clinical test set in this document. The manufacturer is Disc-O-Tech Medical Technologies Ltd., based in Herzliya, Israel.

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. The document does not describe a clinical study requiring ground truth establishment by experts.

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

• Not applicable. The document does not describe a clinical study requiring 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

• Not applicable. The device (SKy Bone Expander System) is a physical surgical implant/instrument, not an AI-assisted diagnostic or therapeutic tool.

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

• Not applicable. The device is a physical surgical implant/instrument, not an algorithm.

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

• Not applicable. The document does not describe a study involving ground truth in a clinical context. Substantial equivalence for this type of device is typically demonstrated through engineering testing (e.g., mechanical strength, fatigue), biocompatibility testing, and comparison of design features and materials to predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

Summary of available information regarding the device and its clearance:

• Device Name: SKy Bone Expander System (SKy System)
• Applicant: Disc-O-Tech Medical Technologies, Ltd. (Israel)
• Date Prepared: December 2003
• Classification: Class II
• Predicate Devices:
  • B-Twin Bone Expander System (K032358), by Disc-O-Tech Medical Technologies Ltd.
  • KyphX Inflatable Bone Tamp (K981251, K010246, K032212), by Kyphon Inc.
• Intended Use: As a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.
• System Description: Consists of an Expandable Tube, Delivery System, and Instrumentation Set.
• Substantial Equivalence Argument: Based on having the same intended use, operating principles, design principles, similar/same materials, same packaging, and same/equivalent sterilization method as the B-Twin BE System predicate.
• FDA Determination: FDA found the device substantially equivalent (K034037) to legally marketed predicate devices, allowing it to proceed to market under general controls.

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