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Source Production & Equipment Co., Inc. (SPEC) Model M-19 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized turnors. 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, bronchus, 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 external beam radiation therapy.

SPEC Model M-19 is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 199 ridium pellet. The pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.

The provided document does not contain acceptance criteria for device performance or the results of a study to prove the device meets such criteria.

The document is a 510(k) summary and the FDA's clearance letter for the SPEC Model M-19 192Iridium Brachytherapy Source. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting performance data against defined acceptance criteria.

Therefore, I cannot populate the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily covers:

• Device Identification: Submitter, device name (SPEC Model M-19 192Iridium Brachytherapy Source), classification, common name, and proprietary name.
• Predicate Devices: Lists three legally marketed predicate devices.
• Device Description: Describes the Model M-19 as a singly-encapsulated 192Iridium Brachytherapy Source consisting of a stainless steel capsule with a solid radioactive pellet.
• Intended Use/Indications for Use: For the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative, or surface irradiation for various anatomical sites.
• Technological Characteristics: States it's similar to predicate high-dose-rate brachytherapy sources using 192Iridium photons.
• FDA Clearance: The letter confirms substantial equivalence and allows marketing.

To obtain the information requested, a different type of document, such as a full clinical study report or a detailed device performance evaluation, would be necessary.

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