(40 days)
The Point of Care Stranding System provides a method for the physician to custom configure and assemble sterile TheraSeed® strands in the operating room at the time of the implant procedure.
The Point of Care System may also be used to custom load sterile I-Seed in non-stranded configurations.
The Point of Care Stranding System is designed to facilitate intra-operative treatment planning by providing a means of joining sterile TheraSeed® sources with sterile spacers of varying lengths to form the desired strand configuration. The device also facilitates transfer of the sterile strand either directly into a CP Medical brachytherapy needle, or via a transfer tube into a MICK style applicator needle. The device system consists of the following components: Assembly Device, Seed Magazine, Spacer Cartridges, Stylet, and Transfer Tube (optional).
Here's an analysis of the acceptance criteria and the study information for the Point of Care Stranding System based on the provided text:
The document does not provide specific numerical acceptance criteria for device performance (e.g., minimum tensile strength, maximum displacement). Instead, it states that the device's functional performance was verified in accordance with the design specifications. This suggests that internal, proprietary design specifications were used as the acceptance criteria, but their details are not disclosed in this document.
The document describes a Design Verification study which encompassed bench testing and user validation.
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative acceptance criteria are not provided, a table cannot be fully completed. However, based on the text, we can infer the general categories of acceptance and the reported successful performance.
| Category of Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Functional Performance (Design Specifications) | Met: "The testing demonstrated the functional performance of the device in accordance with the design specifications." This indicates the device successfully performed its intended functions of custom configuring and assembling sterile TheraSeed® strands and loading I-Seed in non-stranded configurations, and facilitating transfer. This includes the "press-fit concept" of linking seeds and spacers. |
| Manufacturing Processes Validation | Validated: This implies that the manufacturing processes consistently produce devices that meet specifications. |
| Device and Component Performance Verification | Verified: Individual components and the integrated device performed as intended. |
| Sterilization Validation | Validated: The device successfully undergoes sterilization and maintains sterility for its intended use. |
| Package Validation | Validated: The packaging successfully protects the device and maintains its sterility and integrity until use. |
| Strand Assembly, Transfer, and Integrity (User Validation) | Successful: "User Validation was conducted to verify that the device could be successfully used to assemble, transfer, and implant the strand while maintaining strand integrity." This confirms the device's ability to produce stable and usable strands in a simulated or actual clinical-like setting. |
| Safety and Effectiveness | Demonstrated: "The cumulative test results demonstrated the functionality, safety and effectiveness of the Point of Care Stranding System and its components, as well as its substantial equivalence to the predicate device and methodology." This is a global conclusion based on all verification activities. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "bench testing" and "User Validation" but does not quantify the number of devices, strands, or users involved in these tests.
- Data Provenance: Not specified, but given the manufacturer is based in Buford, GA, USA, and the 510(k) is submitted to the FDA, it is highly probable the testing was conducted in the USA or under US regulatory oversight. The study is prospective in nature, as it is a design verification conducted to demonstrate the device meets its design specifications before widespread commercialization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: The "User Validation" involved users who could "successfully use" the device. While not explicitly stated to be "experts," it can be inferred that these users would be healthcare professionals (e.g., physicians, nurses, technicians) who are familiar with brachytherapy procedures, as they are assembling, transferring, and implanting strands. The document does not specify their exact qualifications or experience level.
4. Adjudication Method for the Test Set
Not applicable. The described verification is a technical and functional performance test, not one involving subjective interpretations or disagreements requiring an adjudication method (like reading medical images). The "User Validation" would likely have involved clear pass/fail criteria for successful assembly, transfer, and integrity, rather than a consensus-based adjudication process.
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 mechanical stranding system for brachytherapy, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As noted above, this is a mechanical device, not an algorithm, so the concept of standalone performance for an algorithm does not apply. The device's "standalone" functional performance was tested via bench testing, ensuring it performed as designed without direct human intervention after initiation (e.g., the press-fit mechanism functions).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is its design specifications and intended functional outcome.
- For bench testing: The ground truth was whether the device's mechanical actions (e.g., pressing solid spacers into seed endcups to link alternating seed-spacer pairs) occurred as geometrically and mechanically specified, and whether the resulting strand met physical integrity requirements (e.g., acceptable bond strength, correct spacing).
- For User Validation: The ground truth was the successful assembly, transfer, and intact implantation of the strand as evaluated by the users. This is essentially an objective functional outcome.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.