(118 days)
The LINAC Scapel Treatment Planning System is intended as a aid in quickly and precisely planning the radiation treatment of small lesions such as arteriovenous malformations, pituitary tumors. pincalomas, acoustic neuromas and malignant neoplasms.
The LINAC Scalpel Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer a digitizing graphics tablet, and radiation treatment planning application software.
This 510(k) submission (K962792) for the LINAC Scalpel Treatment Planning System is a pre-amendment device submission, and furthermore, it is from 1996. The regulatory requirements, particularly concerning clinical evidence and performance validation, were significantly different and less prescriptive than they are today.
Based solely on the provided text, the document does not contain any information regarding acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects requested in your prompt.
The document is a very brief 510(k) summary that focuses on:
- Company Information: Name and address.
- Product Name: LINAC Scalpel Treatment Planning System.
- Description: Hardware and software components.
- Intended Use and Indications: What it's designed to do (aid in planning radiation treatment for small lesions).
- Substantial Equivalence: Claims equivalence to other commercially available Radiation Treatment Planning Systems, but provides no details of the comparison or what data (if any) was used to support this claim.
Therefore, I cannot populate the table or answer the specific questions based on the provided input.
Here is an explanation of why the requested information is absent:
- Acceptance Criteria and Reported Performance: The document merely describes the product and its intended use. There are no performance metrics or criteria mentioned.
- Sample Size, Test Set Data Provenance, Ground Truth: These concepts related to clinical validation or rigorous performance testing are entirely absent. The submission predates modern expectations for such data for most software or planning systems.
- Experts, Adjudication, MRMC studies, Standalone Performance: These detailed aspects of clinical trials or performance assessments are not present.
- Ground Truth Type: Not mentioned.
- Training Set Sample Size and Ground Truth: The document does not describe any machine learning or AI components that would require a "training set" in the modern sense. It's a "treatment planning system," which in 1996 primarily involved algorithms for dose calculation and visualization based on physics and geometry, not data-driven learning from patient cases.
In summary: The provided 510(k) summary is extremely high-level and does not offer the kind of detailed performance validation information that would be standard in more recent submissions or for devices with a higher risk classification.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.