(94 days)
Oncology Systems Model ACU-007S Source Assembly, with an individual activity up to 12Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy.
This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, or chemotherapy.
Oncology Systems, Inc. Model ACU-007S is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a single solid radioactive 192 Iridium pellet sealed in a stainless steel capsule that is attached to a cable. Its purpose is to permit manipulation by the Oncology Systems, Inc AccuSource 1000 remote afterloader system for the treatment of cancer and other lesions.
The provided text is a 510(k) summary for the Oncology Systems, Inc. Model ACU-007S 192 Iridium Brachytherapy Source. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or image quality, which are common for diagnostic or AI-powered devices.
As this is a brachytherapy source, the "acceptance criteria" and "study" described in the prompt are not applicable in the way they would be for a diagnostic or AI device. The submission focuses on physical and technical characteristics, intended use, and equivalence to a legally marketed predicate device.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This type of performance data (e.g., sensitivity, specificity, accuracy) is not included in the document for a brachytherapy source. The "performance" here relates to its functional characteristics and safety, which are implicitly accepted by demonstrating substantial equivalence.
- Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of diagnostic performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth determination study is described.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide:
The document primarily focuses on establishing substantial equivalence to a predicate device (Source Production and Equipment Company Model M-19, K052947). This is the key "acceptance criterion" for a 510(k) submission of this type.
Key information provided related to "acceptance" for this type of device:
- Intended Use: The device is intended for the treatment of cancer and other lesions by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation. This is a critical aspect for regulatory acceptance.
- Technological Characteristics: The device is described as a singly-encapsulated 192Iridium Brachytherapy Source consisting of a single solid radioactive 192Iridium pellet sealed in a stainless steel capsule attached to a cable. Its similarity to the predicate device (Source Production and Equipment Company Model M-19) in utilizing photons from 192Iridium is highlighted as the basis for substantial equivalence.
- Predicate Device Comparison: Section 12.1 (mentioned but not included in this extract) would detail the comparison of similarities and differences with the predicate device. This comparison forms the "study" demonstrating that the new device is as safe and effective as the predicate.
- Regulatory Classification: The device is classified under 21 CFR 892.5730 as a Radionuclide brachytherapy source, Regulatory Class II, Product Code KXK. This classification dictates the regulatory pathway for acceptance.
In summary, for K092522, the "acceptance criteria" are met by demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of its design, materials, and intended use, rather than through a clinical performance study with statistical metrics.
§ 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.