(44 days)
The PoleStar system is a magnetic resonance diagnostic device intended for general diagnostic use to present images, which reflect the spatial distribution and/or magnetic resonance spectra, which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance.
The StarShield V3 is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar system.
The StarShieldV3 is an accessory of Odin's PoleStar Intraoperative Magnetic Resonance system. It is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent, required Elootromagnotion The RF Tent is a portable modular structure that consist of four principal components:
- The foldable frame .
- The cover .
- The control unit .
- The floor .
The RF Tent is not connected to the PoleStar gantry or the OR table.
The provided text is a 510(k) summary for the StarShield V3 device, which is an accessory to an Intraoperative Magnetic Resonance system. The submission aims to demonstrate substantial equivalence to a predicate device (Odin's RF Tent). The primary function of the StarShield V3 is to reduce Electromagnetic Interference (EMI) during MRI image acquisition.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for the StarShield V3 in the typical sense of performance metrics with thresholds. Instead, it provides a "Substantial Equivalence Comparison Table" that lists parameters of the StarShield V3 and compares them to its predicate device, the RF Tent (K022157). The implicit acceptance criterion is that the StarShield V3 performs equivalently to the predicate device in terms of EMI reduction.
| Parameter | Predicate Device (RF Tent - K022157) | StarShield V3 | Acceptance/Performance |
|---|---|---|---|
| Application | To create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar system | Same | Equivalent |
| Materials - Frame | Aluminum alloy AlMg Si 0.5 | Same | Equivalent |
| Materials - Cover | (Polyethylene Terephthalate) PET incorporating Cu+Ni, laminated with flame-retardant PVC. | Same | Equivalent |
| Dimensions - Length (Folded) | 950 mm | Same | Equivalent |
| Dimensions - Length (Extended) | 3500 mm | Same | Equivalent |
| Dimensions - Width/Base | 1250 mm | Same | Equivalent |
| Dimensions - Maximum height | 1650 mm | Same | Equivalent |
| Clearance between the RF tent and the operating table - Foot side (height) | 200 mm | Same | Equivalent |
| Clearance between the RF tent and the operating table - Width (each side) | 100 mm | Same | Equivalent |
| Clearance between the RF tent and the operating table - Head side (distance from scanner) | 70 mm | Same | Equivalent |
| Average Attenuation | >40dB at 100 MHz | Same | Equivalent |
| Floor | Matte aluminum alloy sheet measuring 3.8 x 1.5 m | Same | Equivalent |
| Energy used | Pneumatic | Electric | Different (Minor) |
| Where Used | Operating Room | Same | Equivalent |
| Biocompatibility | Does not contact patient | Same | Equivalent |
Note regarding "Acceptance/Performance": For most parameters, "Same" indicates the StarShield V3 meets the performance of the predicate by having identical specifications. For "Average Attenuation," the ">40dB at 100 MHz" is a specific performance metric that the StarShield V3 also claims as "Same," implying it meets or exceeds this level of attenuation. The only notable difference is "Energy used," which changed from pneumatic to electric, but the document implicitly suggests this change does not affect the substantial equivalence in terms of the primary function (EMI reduction).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide information on a test set, its sample size, or data provenance. This 510(k) submission is for a physical medical device (an EMI shielding tent), not a software or diagnostic algorithm that would typically require a dataset to evaluate its performance. The "study" here is primarily a comparison of specifications and physical attributes to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. As this is a physical device intended for EMI reduction, there is no "ground truth" derived from expert consensus on medical images or diagnoses. The performance is based on engineering specifications (e.g., attenuation levels).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no test set requiring expert adjudication.
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
Not applicable. This device is not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to its purpose.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The StarShield V3 is a physical accessory, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the StarShield V3's performance, as implied by the comparison table, is based on engineering specifications and measurements related to EMI attenuation. The predicate device (RF Tent) established a benchmark of ">40dB at 100 MHz" for average attenuation. The StarShield V3 is declared to have the "Same" attenuation, meaning it is expected to meet this engineering standard.
8. The sample size for the training set
Not applicable. This device is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.