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

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 Vertaplex HV Radiopaque Bone Cement (sold separately) is injected at low pressure to fixate the restored vertebral body.

The provided FDA 510(k) clearance document for the Stryker SpineJack® Expansion Kit (K223294) describes the device's indications for use and compares it to a predicate device (K211238). It states that no new performance data was generated for the submission as the modification concern only the indications for use and associated labeling; no physical device modifications were made. Therefore, the information provided focuses on the safety and effectiveness of the device for expanded indications based on existing clinical literature and real-world evidence.

Here's an attempt to structure the information based on your request, though it's important to note that a traditional "acceptance criteria" table with specific device performance metrics in the format you requested is not provided in this regulatory document, as it relies on substantial equivalence to a predicate and real-world evidence for an expanded indication. The document focuses on demonstrating that the safety and effectiveness profile for the new indication (malignant lesions) is comparable to the existing indications.

Acceptance Criteria and Device Performance (Interpreted from Clinical Literature Review)

The document does not present explicit numerical "acceptance criteria" for the device's performance in the context of a new study designed to meet specific thresholds for this 510(k) submission. Instead, it leverages existing clinical literature and real-world evidence (RWE) to demonstrate that the safety and effectiveness profile of the SpineJack system for malignant vertebral compression fractures is comparable to its use in osteoporotic and traumatic fractures, which were previously cleared.

The implicit "acceptance criteria" are derived from the observed safety profile (e.g., adverse event rates, particularly cement leakage) and effectiveness outcomes (e.g., pain reduction, quality of life improvement) reported in the analyzed literature for both the newly sought indication and the existing cleared indications.

Study Details Proving Acceptance Criteria (Derived from Literature Review and RWE)

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

   • Test Set Sample Size: The submission relied on a literature review which included evidence on 304 patients who received the SpineJack System across various studies. Of these, 117 patients were treated specifically for malignant vertebral fractures, which is the focus of the expanded indication.
   • Data Provenance: The data was retrospective, collected from an analysis of existing clinical publications and Real-World Evidence (RWE). The studies took place in Spain, France, Switzerland, and in the United States.

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

   • The document does not specify the number or qualifications of experts involved in establishing the ground truth for the test set within the context of this 510(k) submission. Since it's a literature review, the "ground truth" for the reported outcomes (e.g., pain, adverse events) would have been established by the clinicians and researchers involved in the original studies themselves. The submission's "experts" would be the regulatory and clinical review staff at Stryker who analyzed the literature.

3. Adjudication method for the test set:

   • The document does not describe an adjudication method for a test set in the traditional sense of a new clinical trial. The data was collected from existing publications, implying that the outcomes reported in those publications were accepted as presented.

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:

   • No MRMC study was performed. This device is a physical implantable reduction system, not an AI or imaging-based diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable.

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

   • Not applicable. The SpineJack is a physical medical device, not a standalone algorithm.

6. The type of ground truth used:

   • The ground truth for the effectiveness outcomes (pain, quality of life) and safety outcomes (adverse events, including cement leakage) was established through clinical outcomes data reported in peer-reviewed literature and real-world evidence from clinical practice. This includes patient-reported outcomes (VAS, EQ-5D VAS, Oswestry Disability Index) and objective clinical observations of adverse events.

7. The sample size for the training set:

   • Not applicable in the context of this 510(k) submission. This submission relies on a literature review and RWE for expanded indications, not a machine learning model that would require a distinct training set. The "training" for the device's original clearance and subsequent clinical use would have come from the broader body of medical knowledge and clinical experience for comparable devices and procedures.

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

   • Not applicable. As explained above, there is no "training set" in the machine learning sense for this device submission.

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