(273 days)
The Accu-Source™ remote control high dose rate afterloading brachytherapy system is intended for the treatment of cancer and other lesions by intracavitary, interstitial, intralumenal, intraoperative, endobronchial and surface applicator irradiation treatments.
The Accu-Source™ is a remote afterloading system for High Dose Rate Brachytherapy. The system is designed to deliver a predetermined dose of radiation to organs and tissue via a radioactive source. The ACCU-SOURCE™ system includes an operator console and a remote afterloading device. The ACCU-SOURCE™ system has a tungsten shielded storage safe which houses a radioactive source when the system is not in use. There are encoders and motors used in conjunction with electronic circuitry that drive the source and keep track of its position. A battery is used for back-up power and an uninterruptible power supply is also integrated into the ACCU-SOURCE™ system to charge the battery backup subsystem.
The provided document is a 510(k) summary for a medical device called Accu-Source™, a Remote Control High Dose Rate Afterloading Brachytherapy Device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a formal clinical study with performance metrics as one might see in a de novo or PMA submission.
Therefore, the document does not contain the acceptance criteria and study details as requested in the input prompt (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic device).
Instead, it focuses on demonstrating that the Accu-Source™ device is substantially equivalent to a legally marketed predicate device (Nucletron MicroSelectron HDR Version 2). This is done through a comparison of technical specifications, intended use, and general features.
Here's a breakdown of what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as "acceptance criteria" in the context of a performance study. However, the implicit acceptance criteria for a 510(k) submission are that the new device is as safe and effective as a predicate device and does not raise new questions of safety or effectiveness. This is demonstrated by showing similar specifications and performance characteristics to the predicate.
- Reported Device Performance: The document provides a comparison table of technical specifications between the Accu-Source™ and its predicate, the Nucletron MicroSelectron HDR Version 2. This table highlights features, intended use, and various physical and operational parameters. The "performance" here is described by these specifications, rather than quantitative metrics from a clinical study.
| FEATURE | Nucletron Micro-Selectron (Predicate) | Oncology Systems, Inc. ACCU-SOURCE™ (New Device) | Comparison |
|---|---|---|---|
| Intended Use | Remote Afterloading Brachytherapy for various treatments | Remote control high dose rate brachytherapy for various treatments of cancer and other lesions | Equivalent |
| Height | Variable | 101cm | Similar |
| Weight | 150 lbs | 180 lbs | Similar |
| Transportable | V2 only | Yes | Similar |
| Power Supply | 110 VAC | 110 VAC/220 VAC | Similar |
| Mobile | Yes | Yes | Equivalent |
| HDR | Yes | Yes | Equivalent |
| Number of Channels | 18 | 24 | Different |
| Shielding | Tungsten | Tungsten | Equivalent |
| Maximum Activity of Shielding | 10 Ci | 12 Ci | Different |
| Maximum Treatment Activity | 10 Ci | 12 Ci | Different |
| Maximum exposure rate at XX distance containing the maximum activity | At 10cm = >2mR/h | Inner vault: > 100mR/h at 20cm; Outer vault: >2mR/h at 10cm | Different |
| Dwell positions per channel | 48 | Up to 100 dwell points per channel not to exceed 1200 total | Different |
| Total Channels | 18 | 24 | Different |
| Contains radiation monitor | Optional | Yes, Included | Different |
| Device Control OS Software | Windows | Windows XP | Similar |
| Treatment Data maintained during power failure | Yes | Yes | Equivalent |
| Simulator (Dummy) Source | Yes | Yes | Equivalent |
| Verification of Channel Length by direct measurement | By direct measurements | Yes, By direct measurements | Equivalent |
| Source Positioning | Distal to proximal | Distal to proximal | Equivalent |
| Maximum Source Position error over treatment length (+/- .5mm) | 1mm | .5 mm | Different (Better) |
| Emergency container for the source included | Optional | Yes, Included | Different |
| Response to Emergency signal | Automatic Retraction of Source | Automatic Retraction of Source | Equivalent |
| Emergency manual | Yes | Yes | Equivalent |
| Source Isotope | Ir192 | Ir192 | Equivalent |
| Source Maximum Activity | 10 Ci | 12 Ci for Ir192 | Different |
| Source Maximum Treatment Activity | 10 Ci | 12 Ci for Ir192 | Different |
| Source Capsule Dimensions | 4.5mm length by .9mm width | 4.5mm length by .9mm width for Ir192 and 6.9 mm length by 1.17 mm width for Yb169 | Different |
| Source Active dimensions | 3.6mm length by .65mm width | 3.6mm length by .65mm width for Ir192 and 5.4mm length by .8mm width for Yb169 | Different |
| Source extension length | 150cm | 160cm | Different |
| Operator Console with personal computer | Yes | Yes | Equivalent |
| Keyswitch Control | Yes | Yes | Equivalent |
| Operating Voltage | 110/220 VAC | 110/220 VAC | Equivalent |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable: The document does not describe a clinical performance study with a test set of data. It is a comparison of technical specifications against a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: No clinical performance study or ground truth establishment is described for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No clinical performance study or 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 device is a remote afterloading brachytherapy system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is a physical brachytherapy system, not solely an algorithm. Its performance is demonstrated through its physical and operational specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable: The concept of "ground truth" for a performance study is not relevant in this 510(k) submission, which focuses on substantial equivalence based on technical specifications and safety features.
8. The sample size for the training set:
- Not Applicable: No machine learning or algorithm development with a training set is described.
9. How the ground truth for the training set was established:
- Not Applicable: No machine learning or algorithm development with a training set is described.
In summary: The provided 510(k) summary for the Accu-Source™ device establishes substantial equivalence by comparing its technical specifications and intended use to a predicate device, rather than through a detailed clinical or diagnostic performance study that would typically involve acceptance criteria, test/training sets, expert ground truth, or MRMC studies.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.