(30 days)
The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs
The Xpress.cardiac & Xpress3.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the devices, which utilize parallel and non - parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible. The devices have been modified by including Attenuation and Scattering Corrections (ACSC).
Here's an analysis of the provided text regarding the acceptance criteria and the study conducted for the K091073 submission:
Acceptance Criteria and Study Details for Xpress.cardiac & Xpress3.cardiac
Based on the provided 510(k) summary, the device is a modified version of previously cleared devices, with the addition of Attenuation and Scattering Corrections (ACSC). The core of the acceptance criteria and the study is demonstrating equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance (Conclusion) |
|---|---|
| Reconstructed and ACSC corrected images are equivalent to images reconstructed and ACSC corrected by predicate Xeleris device. | Bench and clinical data demonstrate that reconstructed and ACSC corrected images are equivalent in comparison to images that are reconstructed and ACSC corrected by predicate Xeleris device. |
Important Note: The provided text does not specify quantitative acceptance thresholds (e.g., "sensitivity must be >90%"). Instead, the fundamental acceptance criterion is a qualitative assessment of "equivalence" to a specific predicate device (Xeleris).
Detailed Study Information:
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "bench and clinical data" but does not quantify the number of cases or images used in the clinical study.
- Data Provenance: Not explicitly stated. The document does not specify the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not explicitly stated. The document does not provide details about experts or how ground truth was established for the clinical data.
4. Adjudication Method for the Test Set:
- Not explicitly stated. The document does not mention any adjudication method (e.g., 2+1, 3+1).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:
- Not explicitly stated that an MRMC comparative effectiveness study was done. The summary mentions "clinical data" demonstrating equivalence, but it does not describe a study design where human readers evaluated both AI-assisted and non-AI-assisted cases to measure improvement. The focus appears to be on the device's output being equivalent to the predicate, rather than human performance with and without the device.
- Effect Size: Not applicable, as an MRMC study with this objective is not described.
6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:
- Yes, implicitly. The statement "Bench and clinical data demonstrate that reconstructed and ACSC corrected images are equivalent in comparison to images that are reconstructed and ACSC corrected by predicate Xeleris device" implies a standalone assessment of the algorithmic output. The comparison is between the device's output and the predicate's output, suggesting the algorithm's performance without direct human intervention as the primary point of comparison.
7. The type of Ground Truth used:
- Implicitly, the predicate device output. The ground truth for this equivalence study appears to be the images reconstructed and ACSC corrected by the predicate Xeleris device. The goal was for the new device's output to match or be equivalent to this established standard. There is no mention of pathology, long-term outcomes, or detailed expert consensus as the ground truth.
8. The Sample Size for the Training Set:
- Not explicitly stated. The document focuses on validation/testing data ("bench and clinical data") but does not provide information about the training data used to develop the algorithms for Attenuation & Scattering Corrections.
9. How the Ground Truth for the Training Set was Established:
- Not explicitly stated. As the training set size is not mentioned, neither is the method for establishing its ground truth.
Summary of Limitations in Provided Detail:
The provided 510(k) summary is a high-level overview and lacks granular detail typically found in a full study report (e.g., number of subjects, specific metrics used for equivalence, reader qualifications, detailed study protocol). Its primary assertion is that the modified device's output (images) is equivalent to a legally marketed predicate, which is a common strategy for 510(k) clearances. The "acceptance criteria" here are qualitative in nature, focusing on the concept of "equivalence" rather than quantitative performance benchmarks against a gold standard.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.