(170 days)
The PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat panel TV monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angels. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
PinPoint is not limited to any particular region of the body. It is equally viable for planning head and spine interventions as it is in the abdomen. It is expected that its major use will be in the planning biopsies of abdominal organs and drainage of fluid collections in the abdomen. However, more complicated procedures such as Brachy therapy and bone pinnings will be planned using the PinPoint.
The PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat panel video monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angels. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
The provided text does not contain specific acceptance criteria or an explicit study describing the device's performance against such criteria. The document is a 510(k) notice for the "PinPoint" CT accessory, primarily focusing on its substantial equivalence to legally marketed devices and its intended use.
Here's a breakdown of why the requested information cannot be fully provided:
- Acceptance Criteria and Reported Performance: The document states, "Effectiveness is established by Picker's evaluation throughout all phases of the PinPoint development. The product will perform in accordance with the development specifications." However, it does not list what those development specifications or acceptance criteria are, nor does it provide a table of reported device performance against them.
- Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document does not describe any specific study with details about sample size (test or training), data provenance, the number or qualifications of experts, the adjudication method, whether an MRMC study was performed, whether a standalone algorithm performance was evaluated, or how ground truth was established for any hypothetical study.
Missing Information Summary:
The following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or targets are given.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process is described.
- Adjudication method for the test set: No test set or adjudication process is described.
- 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 such study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No such evaluation is mentioned.
- The type of ground truth used: No ground truth definition is provided.
- The sample size for the training set: No training set is described.
- How the ground truth for the training set was established: No ground truth establishment process is described.
Conclusion based on the provided text:
The 510(k) notice for the PinPoint device emphasizes its substantial equivalence to predicate devices and describes its functionality for simulating and initiating interventional procedures using CT images. It asserts that "Effectiveness is established by Picker's evaluation throughout all phases of the PinPoint development," and that "The product will perform in accordance with the development specifications." However, it does not disclose the specific acceptance criteria or the detailed results of any study that proves the device meets these criteria. The document focuses on regulatory compliance and the intended use of the device rather than detailed performance metrics.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.