(116 days)
The Elekta Beam Modulator is an X-ray collimator, designed to be used in a linear accelerators and intended to assist a licensed practitioner in the delivery of radiation to defined treatment volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fraction delivery of radiation in all areas of the body where such treatment is indicated.
The provided document is a Summary of Safety & Effectiveness for the Elekta Beam Modulator™ and an FDA 510(k) clearance letter. It does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the format typically expected for AI/software device performance.
Instead, the document focuses on regulatory compliance, substantial equivalence to predicate devices, and general safety assurances in the context of a physical medical device (a multileaf collimator for radiation therapy).
Therefore, I cannot extract the requested information as it is not present in the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance (in terms of specific metrics like accuracy, sensitivity, specificity, etc., which would be relevant for software/AI).
- Sample sizes for test sets, data provenance, or expert qualifications.
- Adjudication methods.
- Multi-reader multi-case comparative effectiveness studies.
- Standalone performance studies.
- Types of ground truth.
- Training set sample size or how its ground truth was established.
Summary of what the document does state regarding safety and effectiveness:
- Device Type: The Beam Modulator™ is an enhancement to previously reported MLCs (Multileaf Collimators) and is a physical component of a radiation therapy system.
- Predicate Devices: K904124 (MLCi), K990085 (Varian Millennium MLC), and K030609 (Tarritom Moduleaf). The document states these have an "established and proven track record for safety."
- Purpose: To provide more precise conformance to desired treatment volume by offering a leaf pitch of 4 millimetres.
- Safety & Effectiveness Rationale:
- Does not raise additional types of safety or effectiveness considerations compared to predicate devices.
- Considered an "enhancement" to previously cleared Elekta devices.
- User documents provide comprehensive information for safe and effective use.
- Compliance testing to IEC 60601-1 and IEC 60601-2-1.
- Designed to bear the CE mark (European compliance).
- Developed under an ISO 9001, ISO 13485, and MDD 93/42/EEC Annex II compliant Quality Management System (QMS).
- Hazard analysis concluded no new safety/effectiveness hazards.
- Level of concern for the device is "Major" as per FDA guidance for devices containing software (though the document doesn't detail what "software" is involved or its function).
- Intended Use (from FDA letter): Used in linear accelerators to assist licensed practitioners in delivering radiation to defined treatment volumes (e.g., tumors) while sparing normal tissue. Intended for single fraction or multi-fraction delivery in all body areas.
In conclusion, this document is a regulatory submission for a physical medical device enhancement based on substantial equivalence and compliance with established safety standards, not a performance study for an AI or software-driven diagnostic or prognostic device.
§ 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.