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510(k) Data Aggregation
(50 days)
SOURCE PRODUCTION AND EQUIPMENT CO., INC.
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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(90 days)
Source Production and Equipment Co.,Inc.
Source Production & Equipment Co., Inc. (SPEC) Model M23 Source Assembly, with individual activity up to 27 Ci, is indicated for temporary interstitial, 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.
SPEC Model M23 is a singly-encapsulated 168 ftterbium Brachytherapy Source. It consists of a stainless steel capsule containing solid radioactive 160Ytterbium Oxide pellets. The pellets are sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
This document describes the premarket notification (510(k)) for the SPEC Model M23 169Ytterbium Brachytherapy Source, a device used for high-dose-rate brachytherapy. The submission demonstrates substantial equivalence to a predicate device (Implant Sciences Corp. Model HDR-4140) through nonclinical testing.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SPEC Model M23 Brachytherapy Source are primarily defined by adherence to established industry standards and mechanical performance requirements. The reported device performance is compared against these criteria.
| Feature / Test Category | Acceptance Criteria (Standard / Threshold) | Reported Device Performance (SPEC Model M23) |
|---|---|---|
| Physical Testing (ANSI N43.6 & ISO 2919) | Equal to or exceeding requirements for classification C53211 (brachytherapy sources). | Prototype sources subjected to ANSI N43.6-2007 and ISO 2919-2012, and equaled or exceeded the requirements corresponding to a classification of C53211. This is stated to be equivalent to the physical testing of the predicate device. |
| Tensile Testing (Minimum Failure Load) | Minimum failure load of the source assembly welds greater than 5 times the maximum force applicable by the Varian GammaMed Plus Afterloader (16 N). This implies a minimum failure load > 80 N. | Minimum failure load of 85 N (19 lb), which is more than 5 times the maximum force (16 N, 3.6 lb) applied by the Varian GammaMed Plus Afterloader. This is stated to be equivalent to or better than the predicate device. |
| Tensile Fatigue Testing (Load A) | Withstand a tensile load in excess of 40 N (2.5 times the maximum force of the afterloader). | Prototype sources successfully withstood a tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum force that can be applied by the Varian GammaMed Plus Afterloader. |
| Tensile Fatigue Testing (Load B) | Withstand ten sequential applications of a tensile load in excess of 16 N (the maximum load) of the afterloader. | Prototype sources successfully withstood ten sequential applications of a tensile load in excess of 16 N (3.6 lbs), which is more than the maximum load that can be applied by the Varian GammaMed Plus Afterloader. |
| Tensile Fatigue Testing (Load C) | Withstand a final tensile load in excess of 40 N (2.5 times the maximum force of the afterloader) to failure of each weld. The minimum failure load should be greater than 5 times the maximum afterloader force. | Following the sequential applications, prototype sources withstood a final tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum force. The minimum failure load was 84 N (19 lb), which is more than 5 times the maximum force. |
| Operational Testing (Curved Pathway Performance) | Successfully negotiate various "S" and "U" curves simulating applicator pathways, without damage to the M13 source assembly. | A prototype source assembly successfully negotiated all of these pathways (series of "S" and "U" curves with various radii, simulating GammaMed Plus Afterloader applicators). No damage to the M13 source assembly was observed. |
| Dosimetry (TG43) | Dose Rate Constant (λ) and Anisotropy (φav) deemed acceptable if similar to the predicate device's established values. | For Configuration H: λ = 1.17 cGy h-1 U-1, φav = 0.94. For Configuration P: λ = 1.18 cGy h-1 U-1, φav = 0.94. These values are very close to the predicate device's reported values (λ = 1.18 cGy h-1 U-1, φav = 0.94). |
| Sterility | Not required due to no direct patient contact. | "This source assembly never directly contacts the patient; sterility is not required." |
| Biocompatibility | Not applicable due to no direct patient contact; outer material (stainless steel) is biocompatible. | "This source assembly never directly contacts the patient; biocompatibility assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which is a biocompatible material." |
| Chemical Safety | Not applicable due to no direct patient contact; outer material (stainless steel) will not chemically react with body tissue. | "This source assembly never directly contacts the patient; chemical safety assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which will not chemically react with body tissue." |
| Mechanical Safety Standard | Conformance to ANSI N43.6 Class C64212. | "ANSI N43.6 Class C64212 Applied for Louisiana Registration." (Implies conformance, as it's directly compared to the predicate device meeting this standard). |
| Radiation Safety | Appropriate precautions for handling, personnel monitoring, and use within shielded enclosures. | "[...] appropriate precautions must be taken during handling to minimize radiation exposure to personnel. Personnel monitoring is required. [...] should only be used within a properly shielded enclosure designed to maintain radiation dose rates outside the enclosure within regulatory limits." (These are operational considerations, not direct test results on the device itself, but are part of demonstrating safe use.) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document mentions "Prototype sources" for physical, tensile, and operational testing. It does not specify the exact number of prototype sources used for each test. For example, "Prototype sources were subjected to the tests specified..." and "A prototype source assembly was subjected to a curved pathway performance test...".
- Data Provenance: The data is generated from nonclinical, bench-top testing conducted by the manufacturer, Source Production & Equipment Co., Inc. There is no mention of human clinical data, animal data, or country of origin for such data. This testing appears to be conducted in-house or by a facility contracted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable as the evaluation involves nonclinical, physical, and mechanical performance testing, not diagnostic or interpretive tasks requiring expert ground truth establishment in the traditional sense (e.g., radiologists interpreting images). The "ground truth" here is objective physical measurement against defined standards and engineering principles.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. There is no subjective interpretation or diagnostic outcome that requires an adjudication method. The tests are objective measurements (e.g., tensile strength, adherence to dimensional requirements, successful navigation of pathways).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device is a physical brachytherapy source, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical device, not an algorithm or AI system. Its performance is inherent in its design and manufacturing, evaluated through physical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is primarily based on:
- Industry Standards: Compliance with recognized international and national standards such as ANSI N43.6 (American National Standard for Radioactive Materials-Industrial and Medical), ISO 2919 (Radiological protection – Sealed radioactive sources – Classification), and AAPM TG-43 (American Association of Physicists in Medicine Task Group No. 43).
- Engineering Specifications: Specific mechanical thresholds (e.g., tensile strength exceeding a certain multiple of operational force) derived from engineering analysis of the device's operational environment and safety requirements.
- Predicate Device Equivalence: Demonstrating that the new device's characteristics and performance are comparable to a legally marketed predicate device (Implant Sciences Corp. Model HDR-4140).
8. The sample size for the training set
This section is not applicable. This is a nonclinical submission for a physical device. There is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
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(48 days)
Source Production and Equipment Co.,Inc.
Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source, with individual activity up to 12 Ci, is indicated for temporary interstital, intraluminal, 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.
Source Production & Equipment Co., Inc. Model M13 192 ridium Brachytherapy Source is a sinqly-encapsulated 1921ridium 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 provided document is a 510(k) premarket notification for a medical device: the Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source. This device is a radionuclide brachytherapy source used for targeted cancer treatment.
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to recognized standards and performance metrics compared to a legally marketed predicate device (Source Production & Equipment Co., Inc. Model M15).
| Test/Characteristic | Acceptance Criteria (Standard / Predicate Equivalence) | Reported Device Performance (Model M13) |
|---|---|---|
| Physical Testing | - ANSI N43.6 Class C53211 | - Equaled or exceeded Class C53211 requirements after testing. |
| - ISO 2919 | - Equaled or exceeded requirements of ISO 2919 after testing. | |
| - Equivalent to predicate device (SPEC Model M15) | - Equivalent to the physical testing of the predicate device. | |
| Tensile Testing | - Minimum failure load > 5 times maximum force of afterloader (16 N) | - Minimum failure load of 85 N (19 lb), which is > 5 times 16 N. |
| - Tensile fatigue: withstands loads > 2.5 times max afterloader force (40 N) | - Withstood tensile load > 40 N after multiple cycles. | |
| - Tensile fatigue: withstands loads > max afterloader force (16 N) | - Withstood ten sequential applications of tensile load > 16 N. | |
| - Final weld failure load > 5 times max afterloader force (16 N) | - Minimum failure load of 84 N (19 lb) for welds, which is > 5 times 16 N. | |
| - Equivalent to or better than predicate device (SPEC Model M15) | - Equivalent to or better than the tensile testing of the predicate device. | |
| Operational Testing (Curved Pathway) | - Successfully negotiates "S" and "U" curves simulating applicators. | - Source capsule and cable successfully negotiated all pathways. |
| - No damage to source assembly. | - No damage to the M13 source assembly. | |
| - Equivalent to physical testing of predicate device. | - Equivalent to the physical testing of the predicate device. | |
| Operational Testing (Endurance) | - Performs a minimum number of exposure/retract cycles without failure. | - Performed > 35,000 exposure/retract cycles. |
| - No failure of source cable, capsule, or connection. | - No failure of source cable, capsule, or connection. | |
| - Equivalent to physical testing of predicate device. | - Equivalent to the physical testing of the predicate device. | |
| Dosimetry | - Calculated by Monte Carlo simulation. | - Calculated by Monte Carlo simulation. |
| - In accordance with AAPM and ESTRO recommendations. | - In accordance with AAPM and ESTRO recommendations. | |
| - Equivalent to predicate device (SPEC Model M15) | - Equivalent to the dosimetry of the predicate device. | |
| Materials (Radionuclide, Encapsulation, Cable) | - 192Iridium; Stainless Steel; Stainless Steel | - 192Iridium; Stainless Steel; Stainless Steel |
| Sterility | - Not required (device never directly contacts patient). | - Not required. |
| Biocompatibility | - Not applicable (device never directly contacts patient); external stainless steel is biocompatible. | - Not applicable; external stainless steel is a biocompatible material. |
| Chemical Safety | - Not applicable (device never directly contacts patient); external stainless steel is inert. | - Not applicable; external stainless steel will not chemically react with body tissue. |
| Energy Delivered | - 192Iridium decay with characteristic photons/electrons, betas/electrons absorbed by stainless steel. | - Identical description to predicate: 192Iridium decay, betas/electrons absorbed. Principal photon emissions (67, 201, 311, 467, 603 keV). |
| Compatibility with Environment & Other Devices | - Strict control of radioactive material; use per licensing authority; shielded storage; reporting loss; normal room temp storage; authorized disposal. | - Identical description to predicate for all points. |
| Where Used | - Within properly shielded enclosure to maintain regulatory limits. | - Identical description to predicate. |
| Standards Met | - Mechanical: ANSI N43.6; Dosimetry: AAPM TG-43 | - ANSI N43.6; AAPM TG-43 |
| Electrical/Thermal Safety | - Not Applicable | - Not Applicable |
| Radiation Safety | - Appropriate precautions, personnel monitoring, shielded enclosure, emergency operations. | - Identical description to predicate for all points. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document refers to "Prototype sources" and "A prototype source assembly" for the nonclinical tests. This implies a small sample size, likely one or a few units, manufactured specifically for these rigorous engineering tests. The exact number is not explicitly stated.
- Data Provenance: The tests are described as nonclinical tests conducted on prototype devices. The document does not specify the country of origin of the data, but given the company is US-based (Saint Rose, LA), it's highly probable the testing was conducted in the US or by a US-affiliated lab. These are prospective tests performed specifically to evaluate the new device model.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This category is not applicable in the context of this 510(k) submission.
- This device is a physical medical device (a brachytherapy source), not an AI/software device that requires human expert interpretation for "ground truth" establishment in a test set.
- The "ground truth" for this device's performance is established through physical measurements and engineering tests against industry standards (ANSI, ISO) and comparison to an established predicate device. For example, tensile strength is measured objectively with equipment, not adjudicated by an expert.
- Dosimetry involves Monte Carlo simulations, which are computational models, and adherence to physics guidelines (AAPM, ESTRO).
4. Adjudication Method for the Test Set
This is not applicable. As explained above, the tests are objective engineering and physics evaluations, not subjective clinical assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms which assess how AI impacts the performance of human readers. This device is a therapeutic source, and its evaluation focuses on its physical and dosimetric properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The entire submission details the standalone performance of the device itself and its components (source, cable, encapsulation) without human intervention in determining its core functional characteristics. The "performance" refers to its physical integrity (tensile strength, endurance, pathway negotiation) and its radiation dose distribution (dosimetry), which are intrinsic properties of the device, independent of a human operator's direct "performance interpretation" during testing. While a human initiates tests, the results themselves are objective measurements of the device's capabilities.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness is established through:
- Objective Engineering Standards: Adherence to established standards like ANSI N43.6 and ISO 2919 for physical integrity.
- Physics Principles: Use of Monte Carlo simulation and adherence to guidelines from organizations like AAPM and ESTRO for dosimetry.
- Predicate Device Equivalence: Direct comparison of technological characteristics and performance test results to a legally marketed predicate device (SPEC Model M15) to demonstrate substantial equivalence. This is the primary method of evaluation for 510(k) submissions.
8. The Sample Size for the Training Set
This is not applicable. This is a physical brachytherapy source, not an AI algorithm that requires a "training set" of data. The device itself is manufactured, and its performance characteristics are tested against established criteria.
9. How the Ground Truth for the Training Set was Established
This is not applicable. As mentioned, there is no training set for this device.
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(78 days)
Source Production and Equipment Co.,Inc.
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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(101 days)
SOURCE PRODUCTION & EQUIPMENT CO., INC.
The Source Production & Equipment Co., Inc. (SPEC) Model M15 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal, intraoperative or surface application to treat selected tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Nucletron microSelectron Classic High Dose Rate Remote Afterloader. The Model M15 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 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 M15 is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a stainless steel capsule containing 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 describes a 510(k) premarket notification for a medical device, the SPEC Model M15 192Iridium High Dose Rate Brachytherapy Source. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness. Therefore, the study described is primarily comparative, showing that the new device meets established safety and performance standards equivalent to the predicate.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Predicate Device (Alpha-Omega Services, Inc. Model CSN0010-192) Performance | SPEC Model M15 Performance | Acceptance Criteria / Equivalence Standard |
|---|---|---|---|
| Design | Solid 192Iridium pellet (0.6 mm dia x 3.5 mm long) singly encapsulated in stainless steel (1.1 mm dia x 4.5 mm long) and welded to a 7x7 stranded stainless steel cable (1.1 mm dia x 2000 mm long). | Solid 192Iridium pellet (0.6 mm dia x 3.5 mm long) singly encapsulated in stainless steel (1.1 mm dia x 4.8 mm long) and welded to a 7x7 stranded stainless steel cable (1.1 mm dia x 2000 mm long). | Essentially identical design. Minor length difference in encapsulation (4.5 mm vs 4.8 mm) is considered equivalent. |
| Materials | Radionuclide: 192Iridium, Encapsulation: Stainless Steel, Cable: Stainless Steel | Radionuclide: 192Iridium, Encapsulation: Stainless Steel, Cable: Stainless Steel | Identical materials. |
| Performance Dosimetry (TG43) | Dose Rate Const (λ): 1.13 cGy h⁻¹ U⁻¹, Anisotropy (Φav): 0.95 | Dose Rate Const (λ): 1.11 cGy h⁻¹ U⁻¹, Anisotropy (Φav): 0.97 | Equivalent dosimetry characteristics based on Monte Carlo simulation in accordance with AAPM and ESTRO recommendations. The slight numerical difference is within expected ranges for equivalence. |
| Sterility | "This source assembly never directly contacts the patient; sterility is not required." | "This source assembly never directly contacts the patient; sterility is not required." | Not required (same as predicate). |
| Biocompatibility | "This source assembly never directly contacts the patient; biocompatibility assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which is a biocompatible material." | "This source assembly never directly contacts the patient; biocompatibility assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which is a biocompatible material." | Not applicable, due to external contact only through biocompatible stainless steel (same as predicate). |
| Mechanical Safety | ANSI N43.6 Class C53211 | ANSI N43.6 Class C53211, Applied for Louisiana Registration | Meets ANSI N43.6 Class C53211 (same as predicate). Physical testing confirmed this. |
| Chemical Safety | "This source assembly never directly contacts the patient; chemical safety assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which will not chemically react with body tissue." | "This source assembly never directly contacts the patient; chemical safety assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which will not chemically react with body tissue." | Not applicable due to external contact only through stainless steel (same as predicate). |
| Energy Delivered | 192Iridium (half-life: 73.81 days) decays by beta emission and electron capture with characteristic photons (67 keV x-rays, 201, 311, 467, 603 keV gammas). Betas and electrons absorbed by stainless steel capsule. | 192Iridium (half-life: 73.81 days) decays by beta emission and electron capture with characteristic photons (67 keV x-rays, 201, 311, 467, 603 keV gammas). Betas and electrons absorbed by stainless steel capsule. | Identical radioactive properties and shielding (same as predicate). |
| Mechanical Performance (Tensile Strength) | Sufficient for intended application. | Minimum failure load > 10x max force of Nucletron microSelectron "Classic" afterloader. Cyclic test: after sequential loads > 10x max force, failure load > 10x max force. | Equivalent to or better than the predicate device. Demonstrated robust tensile strength exceeding operational requirements. |
| Operational Performance | Successfully negotiates pathways. | Successfully negotiated all "S" and "U" curves in Nucletron microSelectron "Classic" Afterloader without damage. | Equivalent to the physical testing of the predicate device; demonstrated compatibility with intended afterloader. |
| Standards Met | Mechanical: ANSI N43.6, Dosimetry: AAPM TG-43 | Mechanical: ANSI N43.6, Dosimetry: AAPM TG-43 | Device meets ANSI N43.6 for mechanical aspects and AAPM TG-43 for dosimetry, aligning with predicate device and regulatory guidance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document refers to "Prototype sources" being subjected to tests. It does not specify an exact number of prototype sources used for each test (physical, tensile, operational). For the tensile cyclic test, it mentions "each prototype" was subjected to sequential loads, implying multiple prototypes were used, but an exact 'n' is not given.
- Data Provenance: The tests were conducted by the manufacturer, Source Production & Equipment Co., Inc. (SPEC). The data is prospective as it involves new testing on the SPEC Model M15 prototypes specifically for establishing its performance. The country of origin for the data generation would be the United States, given SPEC's location in St. Rose, LA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission is a 510(k) for a physical medical device, not an AI/software device that requires human expert review for "ground truth" to evaluate diagnostic performance. Therefore, the concept of "experts" establishing ground truth in the context of diagnostic interpretations (e.g., radiologists reviewing images) is not applicable here.
The "ground truth" for this device's performance is based on established engineering and physics standards:
- ANSI N43.6 (American National Standard)
- ISO 2919 (International Organization for Standardization)
- AAPM TG-43 (American Association of Physicists in Medicine Task Group 43) and ESTRO (European Society for Therapeutic Radiation Oncology) recommendations for dosimetry.
The experts involved would be the engineers and physicists who performed and analyzed these standardized tests and calculations, ensuring adherence to the specified methodologies. Their qualifications would be expertise in mechanical engineering, radiation physics, and relevant national/international standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this device does not involve subjective human interpretation or diagnostic decision-making that would require an adjudication method like 2+1 or 3+1. The tests yield objective measurements or pass/fail outcomes against predefined performance standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or decision-support AI where human readers interact with the device. The SPEC Model M15 is a physical brachytherapy source, and its performance is assessed through physical, mechanical, and dosimetric testing against established standards and comparison to a predicate device's specifications.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a physical radionuclide brachytherapy source, not an algorithm or AI system. Its performance is inherent to its physical properties and how it functions as part of a treatment system (e.g., with a remote afterloader). The nonclinical tests (physical, tensile, operational, dosimetry) serve as the "standalone" performance evaluation of the device itself.
7. Type of Ground Truth Used
The ground truth for evaluating the SPEC Model M15 is based on:
- Established international and national standards (ANSI N43.6, ISO 2919, AAPM TG-43, ESTRO recommendations).
- Physical performance characteristics of the predicate device (as defined in its 510(k) clearance and specifications).
- Empirical measurements from laboratory testing (e.g., tensile strength, operational movement, Monte Carlo simulations for dosimetry).
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance is based on its physical design, manufacturing, and inherent properties of the radioactive material, all of which are validated through nonclinical testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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(68 days)
SOURCE PRODUCTION & EQUIPMENT CO., INC.
Source Production & Equipment Cc., Inc. (SPEC) Model M-31 198 Ytterbium Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial. intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors such as for lung cancer. Model M-31 Brachytherapy Source may be used concurrently with or following treatment with other interventions, such as external beam therapy, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.
SPEC Model M-31 is a singly-encapsulated 18° vtterbium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive 19° tterbium pellet. The capsu the pellet consists of a titanium tube which is closed on each end with titanium wires which are laser-welded to the tubing.
This document is a 510(k) summary for a medical device (Radionuclide Brachytherapy Source) and does not contain information about studies conducted to prove device performance against acceptance criteria. Instead, it describes the device, its intended use, and its technological characteristics, and declares substantial equivalence to predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria and study details.
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(181 days)
SOURCE PRODUCTION & EQUIPMENT CO., INC.
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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