(434 days)
The Notebook Imager™ is a gamma camera system which is intended for use in the generation of clinical images in Nuclear Medicine applications. Specifically, the Notebook Imager™ is intended to image the distribution of radionuclides in the body. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.
For Nuclear Medicine Imaging Device
A. Planar imaging Yes Energy Range (KeV) 30-300
F. Other indication(s) in the device label, but not included in above list To image the distribution of radionuclide in the human body.
The Notebook Imager™ system is a gamma camera which consists of an Imaging Head, an Arm and Cart assembly, and SITCO Nuclear Medicine software. The computer consists of a PC, Video Display Terminal, Keyboard, optional Printer and processing Software. The Imaging Head consists of a two-dimensional array of room-temperature, solid-state gamma-ray detectors with readout circuitry for constructing planar images of the emission from radiopharmaceuticals. This array consists of from 1 to 64 identical one-inchby-one-inch imaging modules, each containing 64 (8x8) cadmium-zinctelluride (CZT) semi-conductor detector elements mounted on a multichip submodule. The multichip submodule provides amplification of the input signals and identifies the address of the detector element in which each incoming photon is absorbed.
The provided document does not contain information regarding detailed acceptance criteria, device performance, or a study specifically designed to prove the device meets such criteria. It explicitly states that "No clinical testing was necessary."
However, based on the information provided, I can infer what would typically be considered as the "acceptance criteria" and "performance" in the context of a 510(k) submission for a gamma camera, and how the document addresses the "study" (or lack thereof) to meet those criteria.
Here's an interpretation based on the provided text, recognizing the inherent limitations of the data for the requested level of detail:
1. Table of Acceptance Criteria and Reported Device Performance
Since no specific numerical acceptance criteria or detailed performance metrics are provided, I will construct this table based on the statement of "substantial equivalence" and the performance characteristics mentioned in comparison to predicate devices. The "performance" here refers to the claimed improvements over predicate devices.
| Acceptance Criteria Category (Inferred) | Specific Criteria (Inferred) | Reported Device Performance (Inferred from "Substantial Equivalence" and Device Description) |
|---|---|---|
| Intended Use | The device should be intended for use in the generation of clinical images in Nuclear Medicine applications, specifically to image the distribution of radionuclides in the body for interpretation by authorized medical personnel. | The Notebook Imager™ has the same intended use as the predicate devices: "to image the distribution of radionuclides in the body" and "produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel." It is intended for planar imaging within 30-300 KeV range. |
| Principle of Operation | The device should use a radiation detection principle similar to predicate gamma cameras. | The Notebook Imager™ "uses the same principle of radiation detection" as the predicate devices (gamma camera operation). |
| Performance Characteristics | Performance characteristics should be similar to or better than predicate devices, particularly regarding aspects like spatial resolution, which is a key imaging quality metric for gamma cameras. | The Notebook Imager™ has "very similar performance characteristics" to predicate devices. Crucially, it "improves substantially the spatial resolution" compared to conventional cameras by using CdZnTe semiconductor detector elements. |
| Safety | The device should not introduce new safety risks or should decrease existing risks compared to predicate devices. | The changes (CdZnTe elements, eliminating NaI crystal/PMTs) "will have either no effect on the patient's safety, or rather decrease the risk to the patients, because of the reduced weight of the detector." |
| Energy Range | Capable of detecting isotopes within typical nuclear medicine energy ranges. | Indicated for Planar imaging with an energy range of 30-300 KeV. |
Summary of the "Study" that Proves the Device Meets Acceptance Criteria:
The core "proof" of meeting the acceptance criteria for this 510(k) submission is based on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study with detailed performance metrics. The document explicitly states: "No clinical testing was necessary."
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. No clinical or performance test set data is provided or referenced, as "No clinical testing was necessary." The submission relies on comparative claims to predicate devices and inherent design advantages.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable. No test set was used requiring expert ground truth establishment.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring adjudication was used.
5. 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
- MRMC Study: No. This device is a gamma camera (hardware), not an AI-assisted diagnostic software.
- Effect Size of AI Improvement: Not applicable.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a hardware device.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable for a direct performance study. The "ground truth" for the substantial equivalence claim rests on the established performance and safety profiles of the predicate devices. The claim is that the Notebook Imager™ performs at least as well as, and in some aspects better than (e.g., spatial resolution), the predicate devices for its intended use.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a hardware device submission, not a software algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable.
In summary, for K961104, the "study" demonstrating meeting acceptance criteria was primarily a regulatory comparison to predicate devices, asserting substantial equivalence based on engineering design and principle of operation, rather than new clinical trials or performance testing. The key argument was that the new technology (CdZnTe detectors) offered benefits (improved spatial resolution, reduced weight) without compromising safety or intended use, thereby making clinical trials unnecessary for this 510(k) submission.
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).