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510(k) Data Aggregation
(87 days)
The intended use of the Dyna Camera 2 series collimator is to detect and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body. Same as predicate.
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This document describes the 510(k) summary for Park Medical Systems' 511 KeV collimator for their ISOCAM I and ISOCAM II nuclear imaging systems. The submission aims to demonstrate substantial equivalence to a predicate device, the Dyna camera 2 series high energy collimators, rather than proving the device meets specific acceptance criteria through a dedicated study with statistical endpoints.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial or performance study with defined thresholds for sensitivity, specificity, etc. Instead, it presents a comparison table of technological characteristics and performance metrics against a predicate device to demonstrate substantial equivalence.
| Feature/Spec. | Predicate (Dyna Camera 2 Series High Energy Collimator) | Park 511 KeV Collimator (ISOCAM I/II) | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) |
|---|---|---|---|
| Intended Use | Detect and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body. | Same as predicate. | Be suitable for the same intended use. |
| Physical Description: | |||
| 1) Name | High Energy Collimator | Ultra High Energy Collimator | Be a collimator for high energy imaging. |
| 2) No. of holes | 1,100 (round) | 7,500 (hex) | Number and shape of holes is a design choice, not a direct performance criterion for equivalence. |
| 3) Energy Range | 44 - 525 KeV | 50 - 562 KeV | Operate within a similar high-energy range. |
| 4) Thickness | 2.5 inches = 63.5 mm | 76 mm | Have a physical thickness suitable for high-energy attenuation. |
| 5) Hole Size | 0.20 inches = 5.08 mm | 4 mm | Hole size is a design choice affecting resolution and sensitivity trade-offs. |
| 6) Septa thickness | 0.156 inches = 3.94 mm | 2 mm | Septa thickness is a design choice affecting resolution and septal penetration. |
| 7) Field Size | 11.8 inches = 300 mm (diameter) | 419 mm × 566 mm (rectangular) | Have a field size suitable for nuclear imaging. |
| Performance | Resolution | Resolution | Resolution performance comparable to the predicate. |
| FWHM 99mTc (surface) | 5.59 mm | N/A | < 5.59 mm (implied, or at least not significantly worse) |
| FWHM 18F (surface) | 5.70 mm | 5.74 mm | Comparable to 5.70 mm (within acceptable limits for equivalence) |
| FWHM 99mTc (3" from surface) | 11.76 mm | N/A (measured at 10 cm, which is ~3.94 inches) | Comparable to 11.76 mm (adjusted for distance difference) |
| FWHM 18F (3" from surface) | 13.20 mm | N/A (measured at 10 cm, which is ~3.94 inches) | Comparable to 13.20 mm (adjusted for distance difference) |
| FWHM 99mTc (10 cm from surface) | N/A (measured at 3") | 10.1 mm | Comparable to 11.76 mm (at 3") when considering different distances. (e.g., 10.1mm at 10cm is better than 11.76mm at 7.62cm given resolution degrades with distance). |
| FWHM 18F (10 cm from surface) | N/A (measured at 3") | 11.8 mm | Comparable to 13.20 mm (at 3") when considering different distances. (e.g., 11.8mm at 10cm is better than 13.20mm at 7.62cm). |
Note on Acceptance Criteria: The "acceptance criteria" here are implied by the substantial equivalence framework. The device is "accepted" if its performance and characteristics are comparable to a legally marketed predicate device, especially considering the NEMA NU 1-1994 standard for performance measurements. The specific numerical values for resolution are directly compared, and the new device generally performs within or better than the predicate's reported values, especially when adjusting for measurement distances.
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 describe a "test set" in the context of human data or a clinical study. The performance data (e.g., resolution) appears to be derived from device characterization measurements according to NEMA standards, not from a clinical test set involving patients or data sets. Therefore, there is no information on sample size for a test set or data provenance (country of origin, retrospective/prospective).
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. No "test set" with ground truth established by experts is described as this is a device performance characterization against a predicate, not a clinical diagnostic study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" requiring adjudication is described.
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 submission is for a physical medical device (collimator for a gamma camera) and does not involve AI or human reader performance studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical component of an imaging system. The performance data presented (e.g., resolution) represents the standalone performance characteristics of the collimator itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance metrics like resolution (FWHM) would be based on physical phantom measurements according to the NEMA NU 1-1994 standard for performance measurements of scintillation cameras. This involves standardized radioactive sources and measurement setups to objectively quantify resolution.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device. The document describes a physical medical device and its characteristics.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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