(139 days)
The Optistar Elite Injection System is a contrast delivery system and is designed to inject MR contrast media and flushing solutions into a patient's vascular system to obtain diagnostic images when used with Magnetic Resonance Imaging equipment.
The Optistar Elite is a delivery system designed to inject image enhancing MR contrast media and flushing solutions into the vascular system for the purpose of obtaining enhanced diagnostic images. The Optistar Elite consists of 4 main components and syringes, just like the predicate device: Power Head, Console, Power Control, and Power Supply. Syringes accommodated include Mallinokrodt Optimark pre-filled syringes (10 ml, 15 ml, 20 ml, 30 ml), Mallinckrodt pre-filled saline syringes (50ml and 125 ml), and empty disposable 60 ml Mallinckrodt syringes.
The provided document is a 510(k) Summary for the Optistar Elite Injection System, which is a premarket notification to the FDA for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone comprehensive study with detailed acceptance criteria and performance reports in the format requested.
Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test/training sets, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, or specific effect sizes from AI assistance is not present in this document. This is because the context is not a clinical trial or performance study designed to prove device efficacy against predetermined statistical thresholds for acceptance. Instead, it's about demonstrating that the new device is as safe and effective as a previously cleared device.
However, I can extract the available information to address as much of your request as possible.
Description of Acceptance Criteria and Study Findings for the Optistar Elite Injection System
The Optistar Elite Injection System's acceptance criteria and demonstrated performance are primarily evaluated through comparison to a predicate device (Optistar MR Injection System, K984088) to establish substantial equivalence. The performance testing largely focuses on verification steps against recognized standards and confirming that the new features are conveniences that do not negatively impact safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit, quantifiable "acceptance criteria" are not formally presented in the same way a clinical trial would define them, the table below reflects the comparison of features and capabilities between the Optistar Elite and its predicate device. "Reported Device Performance" here refers to the capabilities and specifications listed for the Optistar Elite. The "Acceptance Criteria" implicitly are that these features are equivalent or improved without compromising safety or fundamental function compared to the predicate, especially within the expanded MR environment.
| Feature | Acceptance Criteria (Implicitly, equivalent or improved w/o safety compromise vs. Predicate) | Reported Device Performance (Optistar Elite) |
|---|---|---|
| Intended Use | Same as predicate | Intended for injecting MR contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans. (Same as predicate) |
| MR Environment | ≥ 1.5 Tesla of predicate, safe and functional | Up to 3 Tesla. (Validated for use in magnetic field strengths up to 3.0 Tesla with various scanners.) |
| Multi-phasic Injections | Same as predicate | Yes - multiple phases per protocol (Same as predicate) |
| Protocol Storage | Same or improved vs. predicate | 40 protocols (Same as predicate) |
| Injection History | Same or improved vs. predicate | Stores last 48 injection results (Improved vs. predicate's 12 results) |
| Syringe Sizes | Support for relevant sizes, including pre-filled | Prefilled Contrast 10ml, 15ml, 20ml, 30ml syringes; Prefilled Saline 50ml & 125 ml syringes; 60 ml disposable syringes (Slight variation from predicate, e.g., 50ml & 125ml saline vs 25ml & 60ml disposable) |
| Single/Dual Syringe Modality | Same as predicate | Single syringe and Dual syringe capability (Same as predicate) |
| Syringe Drive System | Same as predicate | Piezoelectric (Same as predicate) |
| Syringe Heater | Same as predicate | No (Same as predicate) |
| Flow Rate (A side: MR contrast) | 0.1-8.0 ml/sec for 10-30ml; 0.1-10 ml/sec for 60ml (equivalent or improved) | 10, 15, 20, 30ml syringes: 0.1-8.0 ml/sec; 60 ml syringes: 0.1-10 ml/sec (Equivalent to predicate) |
| Flow Rate (B side: Saline) | 0.1-7.0 ml/sec for 60ml (equivalent or improved) | 60 ml syringes: 0.1-8.0 ml/sec; 50 & 125 ml syringes: 0.1-8.0 ml/sec (Improved for 60ml, new sizes supported) |
| Max Pressure Limit | Same as predicate | 200 psi (Same as predicate) |
| Pressure Limit Control | Same as predicate | User-settable, 10 psi increments (Same as predicate) |
| Flushing System | Same as predicate | Manual or via injector (Same as predicate) |
| Ability to check patency | Present, ideally more convenient | Yes - Manual or using Patency Check (Improved functionality compared to predicate's manual only) |
| Ability to run Test Injection | Present, ideally more convenient | Yes - Using Timing Bolus feature (Improved functionality compared to predicate's running 2 separate injections) |
| Remote Start | Same as predicate | Yes (Same as predicate) |
| Scan Delay | Same as predicate | 0 - 60 seconds (Same as predicate) |
| Phase Delays | Ideally present | Yes (New feature compared to predicate) |
| Inject Delay | Ideally present | Yes (New feature compared to predicate) |
| Console Controls | Same as predicate in type (touch screen color LCD) | Touch screen Color LCD (Same as predicate) |
| Power head Controls | Equivalent functionality (keypad/buttons) | Keypad (Slight difference in interface type from predicate's "Buttons" but functionally equivalent) |
| Post Injection Readout | Same as predicate | Yes (Same as predicate) |
| Enable Sequence | Same as predicate | Yes (Same as predicate) |
| Check for Air Button | Same as predicate | Yes (Same as predicate) |
| Volume Remaining Display | Same as predicate | Displayed on Console (Same as predicate) |
| Mode for keeping fluid path open | Same as predicate | Yes - Drip Mode (Same as predicate) |
| Ram Retraction | Same or improved vs. predicate | Manual or automatic (Improved vs. predicate's manual only) |
| Materials | Same as predicate | Plastic and non-ferrous (Same as predicate) |
| Sterility | Injectors not sterile, disposables sterile (same as predicate) | Injectors are not sterile products. Syringes and Disposables are provided sterile (Same as predicate) |
2. Sample size used for the test set and the data provenance
The document does not detail specific "test set" sample sizes in the context of clinical data for performance evaluation. The verification and validation activities mentioned are primarily engineering and software testing.
For the MR environment testing:
- Data Provenance: The Optistar LE injector (mechanically and electrically equivalent to Optistar Elite) was tested "with a variety of MR scanners from various manufacturers." The document does not specify the country of origin of this data or if it was retrospective or prospective, but the context implies prospective engineering and compatibility testing.
- Sample Size: The number of scanners or tests performed is not quantified beyond "a variety."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is technical verification and validation, not a clinical study requiring expert ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as it is not a clinical study based on expert interpretation of diagnostic images.
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
An MRMC study was not done, nor is there any mention of AI assistance in this medical device. The device is a power injector for contrast media, not an image analysis or diagnostic aid involving AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The Optistar Elite Injection System is a physical contrast delivery system that requires a human operator for programming and initiation. There is no "algorithm only" performance that stands alone in the way an AI diagnostic algorithm might.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the software verification, "Validation testing was performed by customers on production equivalent units in simulated clinical conditions." This suggests user feedback and internal performance metrics against "defined customer needs" and "intended use" serve as a form of "ground truth" for software functionality and usability, rather than clinical ground truth like pathology for diagnostic accuracy.
For hardware performance (e.g., in the MR environment), the "ground truth" was that "the injector performed as specified, delivering accurate volume, flow and pressures" and "did not interfere with the operation of the MR systems." This implies measurement against engineering specifications and non-interference as the ground truth.
8. The sample size for the training set
This information is not applicable and therefore not provided. The device does not employ machine learning or AI that would necessitate a "training set" in the conventional sense. Software verification involved unit, integration, exploratory, and system-level testing, which are standard software development practices, not AI model training.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided, as there is no training set for machine learning for this device.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.