(42 days)
The Abbott Spine Spinnaker System is intended for use as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.
When used as a cement dispenser, the Spinnaker System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
The Abbott Spine, Inc. Spinnaker System is intended for use as a vertebral body biopsy and cement dispenser device. The system is comprised of aspiration/injection taps, handles, a targeting needle, a bone awl, ports and dilators, a Luer cap, and k-wire. The system provides the surgeon with a convenient method of performing vertebral body bone biopsy, as well as dispensing cement cleared for use in the spine into a vertebral body using a single system.
The Abbott Spine, Inc. Spinnaker System is a medical device intended for use as a vertebral body biopsy and cement dispenser. The provided documentation does not contain detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics in the way that an AI/ML device study would. Instead, the summary focuses on substantial equivalence to predicate devices through mechanical testing.
Here's an analysis based on the provided text, using the requested categories where applicable:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional requirements for performing vertebral body bone biopsy. | Mechanical testing demonstrated that the Spinnaker System exhibits the functional requirements to support its use for performing vertebral body bone biopsy. |
| Functional requirements for dispensing cement into a vertebral body for vertebral body augmentation. | Mechanical testing demonstrated that the Spinnaker System exhibits the functional requirements to support its use for dispensing cement into a vertebral body for vertebral body augmentation. |
| Substantial Equivalence to predicate devices (Stryker Capture Vertebral Body and Bone Biopsy Kit and Parallax Medical Core-Assure Bone and Vertebral Body Biopsy Kit). | The Abbott Spine Spinnaker System was determined to be substantially equivalent to the predicate devices. This determination implies meeting similar safety and effectiveness profiles as the legally marketed predicate devices. |
Note: The provided document is a 510(k) summary for a medical device that predates the common rigorous performance criteria and study formats seen for AI/ML devices. Therefore, the "acceptance criteria" are implied functional requirements and substantial equivalence rather than quantitative statistical metrics (e.g., sensitivity, specificity, AUC).
Study Details (Based on available information)
- Sample Size used for the test set and the data provenance: Not applicable. This 510(k) summary refers to mechanical testing, not a clinical study involving a "test set" of patient data or clinical outcomes. The "test set" for mechanical testing would refer to the number of devices or components subjected to specific engineering tests. This information is not provided in the summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" in this context refers to engineering specifications and performance against those specifications, not clinical diagnostic accuracy or reader performance.
- Adjudication method for the test set: Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or uncertain diagnoses. Mechanical testing relies on objective measurements against engineering standards.
- 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. This is a traditional medical device (biopsy tool and cement dispenser), not an AI/ML diagnostic or assistive device. Therefore, MRMC studies and AI-driven performance improvements are not relevant here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device; there is no "algorithm" in the sense of AI/ML.
- The type of ground truth used: For mechanical testing, the ground truth would be established engineering standards, material properties, and functional specifications defined by validated test methods.
- The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of device submission.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study:
The study described is mechanical testing. This testing evidenced that the Spinnaker System "exhibits the functional requirements" for its intended uses: vertebral body bone biopsy and cement dispensing. The specific parameters tested, the methodology, and the quantitative results of these mechanical tests are not detailed in this 510(k) summary, which is typical for such submissions where the focus is on the conclusion of meeting functional requirements for substantial equivalence. The overall determination of marketability was based on substantial equivalence to two predicate devices: the Stryker Capture Vertebral Body and Bone Biopsy Kit and the Parallax Medical Core-Assure Bone and Vertebral Body Biopsy Kit.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.