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Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source, with individual activity up to 12 Ci, is indicated for temporary interstital, intraluminal, 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, 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.

The source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Elekta/Nucletron V2/V3 Afterloaders.

The intended use of the Source Production & Equipment Co., Inc. Model M14 194ridium Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

Source Production & Equipment Co., Inc. Model M14 194ridium Brachytherapy Source is a singly-encapsulated 192 ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1921ridium pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.

The source consists of a solid 192Iridium pellet (0.6 mm dia x 3.5 mm long) singly encapsulated in stainless steel (0.9 mm dia x 4.8 mm long) and welded to a 7x7 stranded stainless steel cable (0.9 mm dia x 2022 mm long).

The provided text is a 510(k) Premarket Notification for a medical device: the Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source. This type of FDA submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving stand-alone safety and effectiveness through extensive clinical trials as would be required for a novel, high-risk device.

Therefore, the document does not contain the information requested regarding acceptance criteria and study details for AI/ML-based medical devices (e.g., acceptance criteria tables, sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone algorithm performance, or training set details).

The information provided describes:

• The device description (a singly-encapsulated 192Iridium Brachytherapy Source).
• Its intended use (treatment of cancer via temporary interstitial, intracavitary, intraluminal, intraoperative, or surface irradiation).
• Its technological characteristics in comparison to a predicate device (SPEC Model M15).
• Nonclinical tests performed to demonstrate equivalence:
  • Physical Testing: Subjected to ANSI N43.6 and ISO 2019 standards, meeting Class C53211 requirements (equivalent to predicate).
  • Tensile Testing: Prototype sources subjected to tensile loads and fatigue tests exceeding maximum forces applicable by the afterloader (demonstrating sufficient strength, equivalent or better than predicate).
  • Operational Testing: Prototype successfully navigated curved pathways and endured over 50,000 exposure/retract cycles in an afterloader without failure (equivalent to predicate).
  • Dosimetry: Dose distribution calculated by Monte Carlo simulation in accordance with AAPM and ESTRO recommendations (equivalent to predicate).
• Clinical Tests: Stated as "Not Applicable," which is common for substantial equivalence claims where nonclinical data are deemed sufficient.

In summary, the document demonstrates that the new device is functionally identical to a previously cleared device for its intended use, based on nonclinical performance data that meets established industry standards. It does not present data related to acceptance criteria or studies as typically described for AI/ML-driven diagnostics where performance metrics like sensitivity, specificity, or reader improvement are key.

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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.

Ask a specific question about this device