(109 days)
RAPID Strand ™ Rx is indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable turnors) or for treatment of residual disease after excision of the primary tumor.
RAPID Strand TM Rx may be indicated for use concurrent with or at the completion of other treatment modalities, such as external bear or adiation therapy or chemotherapy.
This Special 510(k) is for the addition of a loading services provider, addition of bone wax needle plugging material and removal of a seed design.
The provided text describes a 510(k) submission for a medical device called RAPID Strand Rx. The submission is not for a new device requiring extensive performance studies but for modifications to an already cleared device. Specifically, this Special 510(k) is for:
- Addition of a loading services provider.
- Addition of bone wax needle plugging material.
- Removal of a seed design.
The central claim is that the modified device is "substantially equivalent" to its predicate device (RAPID Strand Rx, K063177). Therefore, the study described focuses on demonstrating this substantial equivalence rather than proving new performance criteria in a clinical setting.
Given this context, many of the requested categories for acceptance criteria and study details (like sample size for test set, number of experts, MRMC studies, standalone performance with AI, training set details) are not applicable to this type of submission. This 510(k) is not about evaluating a diagnostic algorithm or a device with measurable performance metrics in the way those questions imply.
Here's an attempt to answer based on the available information:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Substantial Equivalence to Predicate Device (K063177) Medi-Physics Inc. concluded that the device is substantially equivalent to the predicate device. Safety and Effectiveness Medi-Physics Inc. concluded that the device is safe and effective for its intended use. Technological Characteristics of Bone Wax Formulation Subject to design controls and risk management. All identified hazards have been sufficiently mitigated. All results are acceptable. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable (N/A). This 510(k) is for modifications to an existing device and relies on engineering assessments and substantial equivalence, not a clinical test set with patient data. -
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 (N/A). Ground truth as typically defined for a diagnostic study is not established here. The assessment is based on design controls and risk management for the modifications. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable (N/A). No test set requiring expert adjudication is described. -
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 (N/A). This device is a radionuclide brachytherapy source, not an AI-powered diagnostic tool, and no MRMC study is mentioned or relevant to this submission type. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable (N/A). This is not a standalone algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is the established safety and performance of the predicate device, against which the modified device's technological characteristics (specifically the bone wax formulation) were assessed through design controls and risk management. It's not a clinical ground truth but rather an engineering and regulatory "ground truth" of substantial equivalence. -
The sample size for the training set
Not applicable (N/A). There is no training set for an algorithm mentioned. -
How the ground truth for the training set was established
Not applicable (N/A). There is no training set for an algorithm mentioned.
§ 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.