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510(k) Data Aggregation
(73 days)
IVAS 8 GAUGE BONE BIOPSY KIT
The Stryker IVAS Bone Biopsy Kit can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.
The Stryker® Inflatable Vertebral Augmentation System (iVAS®) 8 Gauge Bone Biopsy Kit may be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.
The Stryker® iVAS® 8 gauge bone biopsy kit is a disposable device, intended for single-use, individually packaged and provided sterile. The biopsy device will be sold in a kit consisting of a coaxial biopsy needle, obturator and syringe. The biopsy kit is used with access cannula and stylet accessories of compatible size. The access cannula and stylet are sold separately and are Class I exempt under 21 CFR 888.4200, product code OAR (Injector, vertebroplasty (does not contain cement).
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Non-Clinical Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Impact testing | Biopsy needle to withstand impact loads of at least 25 cycles at 2-in-lb. | Not explicitly stated, but implied to have met criteria. The document states, "Stryker has determined that the device modification to the predicate device(s) raises no new questions of safety or effectiveness." |
| Tensile force testing | Biopsy needle and obturator to withstand a force measuring less than 15-lbs. | Not explicitly stated, but implied to have met criteria. |
| Non-axial torque testing | Biopsy needle handle to withstand a force measuring less than 25-in-lb. | Not explicitly stated, but implied to have met criteria. |
| Axial torque testing | Biopsy needle handle to withstand a force measuring less than 3.25-in-lb. | Not explicitly stated, but implied to have met criteria. |
| Functional testing | Non-swaged biopsy needle must retain an equivalent or greater average subjective size measurement than the swaged biopsy needle. | Not explicitly stated, but implied to have met criteria. The document states, "Verification and validation testing have been conducted to ensure there are no new concerns of safety and effectiveness." |
| Sterilization testing | Sterilization method is VDmax25, in compliance with the ISO 11137-1 and ISO11137-2 standards, acceptance criteria includes: | |
| Bioburden less than 1000 CFU | ||
| Less than 2 positive tests of sterility in product verification dose experiment | ||
| SAL 10-6 | Not explicitly stated, but implied to have met criteria. |
Important Note: The document consistently states that testing was performed to mitigate risk and ensure no new safety or effectiveness concerns, indicating that all acceptance criteria were met, even if the specific numerical results are not listed.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for each non-clinical test. It generally refers to "verification and validation testing" without detailing the number of units tested for each criterion.
- Test Set Sample Size: Not specified.
- Data Provenance: The testing was non-clinical (laboratory/bench testing) performed by Stryker Instruments. The country of origin for the data is implicitly the USA (Kalamazoo, Michigan), where Stryker Instruments is located. The tests were prospective as they were performed to evaluate the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that this is a 510(k) submission for a physical medical device (bone biopsy kit) and involves non-clinical bench testing, the concept of "experts establishing ground truth for a test set" in the context of image analysis or diagnostic performance is not directly applicable.
The "ground truth" for the non-clinical tests is established by the engineering specifications and regulatory standards (e.g., ISO 14971, ISO 11137-1/2) that define the performance metrics and their acceptance limits. The experts involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists within Stryker who designed the tests, conducted them, and interpreted the results against these established standards. Their qualifications would be in engineering, materials science, and medical device regulations. The document does not specify the exact number of such individuals involved.
4. Adjudication Method for the Test Set
Again, for non-clinical bench testing of a physical device, an "adjudication method" as typically understood in studies involving human interpretation (e.g., 2+1 consensus) is not directly relevant.
The "adjudication" in this context would involve:
- Verification and validation testing protocols: These define how each test is to be performed and how results are to be interpreted.
- Quality control procedures: Internal company procedures ensure that testing is conducted correctly and documented accurately.
- Review and approval processes: Engineering and quality management teams would review the test results against the acceptance criteria. Any discrepancies or failures would lead to further investigation or device redesign.
The document states that a "Risk Management File (RMF), in compliance with EN ISO 14971:2012" was completed, indicating a structured process for risk assessment and verification activities.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance, as AI is not part of this device or its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical bone biopsy kit, not an algorithm or AI-powered system.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is based on:
- Engineering specifications: Design requirements for physical strength, torque resistance, impact resistance, and functional performance (e.g., sample size retention).
- Regulatory standards: Compliance with international standards for sterilization (ISO 11137-1 and ISO 11137-2 for VDmax25, SAL 10-6) and risk management (EN ISO 14971:2012).
- Predicate device characteristics: The modified device's performance is compared to the established performance and safety profile of the predicate device (Stryker Bone and Vertebral Body Biopsy Kit K032943) to ensure substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this physical device.
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