Search Results

The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures, and traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation. They are intended to be used in combination with Stryker Vertaplex® and Vertaplex® HV bone cement.

Vertaplex® Radiopaque Bone Cement is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with the Spinelack Expansion Kit, Vertaplex® Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures.

Vertaplex® HV Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with ES2® Augmentable Spinal System, Vertaplex® High Viscosity (HV) Radiopaque Bone 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. Vertaplex® High Viscosity (HV) Radiopaque Bone Cement and the ES2® Augmentable Spinal System are for use together at spinal levels where the structural integrity of the spine is not severely compromised. When used in conjunction with the Spinelack Expansion Kit, Vertaplex® High Viscosity (HV) Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures.

The SpineJack® Expansion Kit ("SpineJack") is an implanted reduction system intended to reduce vertebral compression fractures. The SpineJack is used with a Preparation Kit (sold separately) which prepares the vertebra for implant. The SpineJack is available in three sizes to accommodate different vertebral body sizes, specifically 4.2 mm. 5 mm. and 5.8 mm. After the implant is inserted, it is expanded to reduce the vertebral compression fracture and Vertaplex Radiopaque Bone Cement or Vertablex HV Radiopaque Bone Cement (sold separately) is injected at low pressure to fixate the restored vertebral body.

Vertaplex® Radiopaque Bone Cement and Vertaplex® High Viscosity (HV) Radiopaque Bone Cement are PMMA bone cements. Powder and liquid components are mixed together so that they polymerize and form a hardened acrylic polymer. The mixture is in a pourable and injectable state for a period of time, before it cures to form a hardened structure, capable of long-term load support, bone augmentation and implant encapsulation in the treatment of vertebral compression fractures.

The provided document describes a 510(k) premarket notification for the Stryker SpineJack® Expansion Kit, Vertaplex® Radiopaque Bone Cement, and Vertaplex® High Viscosity (HV) Radiopaque Bone Cement. The submission focuses on seeking an expanded indication for use for traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) in addition to the existing indication for osteoporotic vertebral compression fractures.

Crucially, the document states that "No bench or biocompatibility testing was required to support the proposed indications. Additionally, no prospective clinical data was generated for the purpose of supporting this submission." This means there isn't a traditional study with a test set, ground truth experts, or an MRMC study as would be seen for a new AI/software-based device.

Instead, the submission relies on Real World Evidence (RWE) consisting of outside-of-US clinical data published in the clinical literature and a post-market outside-of-US clinical study. The acceptance criteria are not in the form of specific performance metrics (e.g., sensitivity, specificity, F1-score) for an AI or diagnostic algorithm, but rather a demonstration that the expanded indication (traumatic VCFs) does not introduce new safety or effectiveness concerns compared to the existing indication (osteoporotic VCFs).

Therefore, a table of acceptance criteria and reported device performance in the typical sense for a diagnostic device (e.g., AI performance metrics) cannot be extracted from this document as the criteria are based on equivalence in safety and effectiveness for an expanded indication of a physical medical device.

However, I can describe the justification for the expanded indication based on the information provided:

1. Acceptance Criteria and Reported Device "Performance":

The acceptance criteria here are qualitative, focusing on the absence of new safety or effectiveness concerns for the expanded indication.

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

• Test Set (Implicit): Not a traditional "test set" for an algorithm. The evidence relies on:
  • Outside-of-US clinical data published in the clinical literature: Sample sizes would vary per publication, but specific numbers are not provided in this document.
  • A post-market outside-of-US clinical study: Specific sample size is not provided in this document.
• Data Provenance: Outside-of-US clinical data. The document states it is "Real World Evidence (RWE)." It does not specify whether the RWE was retrospective or prospective beyond calling the post-market study "clinical data," which could imply prospective elements.

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

• Not applicable in the context of this 510(k) submission. The "ground truth" for the RWE would be the clinical outcomes and safety profiles reported in the literature and the post-market study, as adjudicated by the treating physicians and researchers of those respective studies. The document does not detail individual expert qualifications for establishing this "ground truth" for the RWE, as it is leveraging existing clinical data.

4. Adjudication Method for the Test Set:

• Not applicable as it's not a diagnostic algorithm test set requiring expert adjudication. The RWE would have its own data collection and analysis methods from the original studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI or imaging interpretation devices to assess human reader performance with and without AI assistance. This submission pertains to a physical medical device (vertebral augment), not an AI diagnostic tool.

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

• No, this is not an algorithm, so a standalone performance study is not applicable.

7. The Type of Ground Truth Used:

• The implicit "ground truth" for demonstrating equivalence is based on clinical outcomes and safety profiles observed in published outside-of-US clinical literature and a post-market outside-of-US clinical study. This is an outcomes data approach, focusing on observed adverse events and clinical effectiveness (reduction/fixation of fractures).

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set. The "evidence" is based on existing clinical data (RWE) to support an expanded indication for a physical device.

9. How the Ground Truth for the Training Set was Established:

• Not applicable as there is no training set for an AI/ML model. The RWE utilized for the submission would have its "ground truth" established through standard clinical and research methodologies for patient diagnosis, treatment, and follow-up in the original studies where the data was collected.

Ask a specific question about this device

The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex® HV bone cement.

The SpineJack Expansion Kit (herein referred to as “SpineJack”) is an implanted fracture reduction system, intended to reduce vertebral compression fractures. The SpineJack Expansion Kit is used with the Preparation Kit. The Expansion Kit is available in three sizes, to accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and a validated Stryker PMMA bone cement, such as Stryker VertaPlex® or VertaPlex® HV Bone Cement, is injected at a low pressure to stabilize the restored vertebral body. The bone cement and its delivery system are intended to be used with the SpineJack but are sold separately.

This document is a 510(k) premarket notification decision letter from the FDA regarding the SpineJack® Expansion Kit. It primarily addresses changes to the device's contraindications, specifically the removal of Type A trauma fractures, rather than providing detailed acceptance criteria and performance data for a new device or a device involving AI.

Therefore, the information required to answer your request about acceptance criteria and study proving device meets acceptance criteria (especially for an AI/software device) is NOT present in the provided text. The document explicitly states:

• Non-Clinical Testing: "Non-clinical testing was deemed not required for this 510(k). The SpineJack implant was previously tested to be non-pyrogenic."
• Clinical Testing: "Clinical testing was deemed not required for this 510(k)"
• Other Evidence: "Clinical literature, post-market surveillance data and a risk analysis per ISO 14971 were used in support of the subject modification."

This indicates that the submission is for a modification to an existing device (SpineJack Predicate Device, K181262), and the FDA determined that no new testing (clinical or non-clinical) was needed to establish substantial equivalence for the change (removal of Type A trauma fractures from contraindications). Instead, the decision was based on existing clinical literature, post-market data, and risk analysis.

Consequently, I cannot fill out the requested table or answer the specific questions about acceptance criteria, test set sample sizes, expert ground truth establishment, MRMC studies, or standalone performance, as this kind of data is not provided in the document. The document is a regulatory approval letter for a device modification, not a study report.

Ask a specific question about this device

The Spinelack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex HV bone cements.

The SpineJack Expansion Kit (herein referred to as "SpineJack") is an implanted fracture reduction system, intended to reduce vertebral compression fractures. The SpineJack Expansion Kit is used with the Preparation Kit. The Expansion Kit is available in three sizes, to accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and PMMA bone cement is injected at a low pressure to stabilize the restored vertebral body. The bone cement and its delivery system are intended to be used with the SpineJack, but are sold separately.

This document describes the premarket notification (510(k)) clearance for the SpineJack® Expansion Kit, a medical device used to treat painful osteoporotic vertebral compression fractures. The document outlines the device's indications for use, comparison to predicate devices, and the results of performance and clinical testing to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text, focusing on the clinical study (SAKOS study) as the primary proof of meeting acceptance criteria:

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

The primary acceptance criteria for the SpineJack device were demonstrated through a non-inferiority study compared to Balloon Kyphoplasty (BKP). The key criteria and results were:

Ask a specific question about this device