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510(k) Data Aggregation
(78 days)
SPEC Model M16
Source Production & Equipment Co., Inc. (SPEC) Model M16 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Best Medical High Dose Rate Remote Afterloader. The Model M16 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 M16 is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a solid radioactive 192Iridium 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 text is a 510(k) premarket notification for a medical device (SPEC Model M16 ¹⁹²Iridium Brachytherapy Source) and does not contain information about acceptance criteria and a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or a clinical outcome.
Instead, this document focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (SPEC Model M15) through non-clinical testing. The "acceptance criteria" discussed are related to physical and mechanical properties and dosimetry, not diagnostic performance or clinical effectiveness studies in the context of AI/software as a medical device.
Therefore, I cannot extract the requested information (points 1-9) in the format you provided because the document describes a different type of device and regulatory submission.
Specifically:
- There's no mention of a "device performance" that would typically be reported for an AI/diagnostic device (e.g., sensitivity, specificity).
- There's no test set, data provenance, ground truth, experts, adjudication methods, MRMC studies, or standalone performance evaluation in the context of an AI/diagnostic device.
- The "training set" and "ground truth for the training set" are not applicable to this type of physical brachytherapy source.
The document describes the following non-clinical tests and their "acceptance criteria" in a general sense:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Physical Device):
| Acceptance Criterion (Standard) | Reported Device Performance (SPEC Model M16) |
|---|---|
| Physical Testing (ANSI N43.6, ISO 2919) | Equaled or exceeded requirements for classification C53211 (same as predicate device). |
| Tensile Testing | Withstood 294 N (66 lb) without failure (more than 17x max force of afterloader). |
| Withstood tensile fatigue tests (107 N > 6x max force; 10 sequential applications of >53 N > 3x max load; then 294 N without failure). Concluded sufficient for intended application (equivalent to or better than predicate). | |
| Operational Testing | Successfully negotiated "S" and "U" curves in a Best Medical Afterloader, simulating various applicator pathways. No damage to source assembly (equivalent to predicate). |
| Dosimetry (AAPM TG-43, ESTRO) | Dose distribution calculated by Monte Carlo simulation in accordance with recommendations. |
| Dose Rate Constant ($\lambda$): 1.11 cGy h⁻¹ U⁻¹ | |
| Anisotropy ($\phi$ av): 0.97 | |
| (Equivalent to predicate device). | |
| Biocompatibility | Not applicable as source never directly contacts patient; outside is stainless steel (biocompatible material). |
| Sterility | Not required as source never directly contacts patient. |
| Chemical Safety | Not applicable as source never directly contacts patient; outside is stainless steel, will not chemically react with body tissue. |
| Radiation Safety | Adherence to appropriate precautions during handling to minimize radiation exposure to personnel, personnel monitoring required, use within properly shielded enclosure within regulatory limits, emergency operations precautions (equivalent to predicate). |
| Compatibility with Environment & Other Devices | Source is radioactive material, strictly controlled, used with specified conditions and limitations by licensing authority, stored in shielded container, loss reported to agency, stored at normal room temperature, disposed of by authorized recipient (equivalent to predicate). |
Points 2-9 (Not Applicable as per document content):
- Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical engineering and physics tests on prototype devices, not a test set for diagnostic accuracy with patient data.
- Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth in this context refers to physical material properties and engineering standards, not expert medical opinion on patient data.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic device involving human readers.
- If a standalone performance was done: Not applicable in the context of AI/diagnostic software. The performance mentioned is the physical and dosimetric performance of the source itself.
- The type of ground truth used: For physical/mechanical tests, the "ground truth" is adherence to established engineering standards (ANSI N43.6, ISO 2919) and physical principles. For dosimetry, it's compliance with established calculation methodologies (AAPM TG-43, ESTRO).
- The sample size for the training set: Not applicable. This is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
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