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AOS Interstitial Templates, Needles, and Accessories are indicated for use in adults where Brachytherapy of the cervix or prostate is an accepted clinical practice.

AOS Interstitial Templates, Needles, and Accessories are designed for interstitial Brachytherapy treatments of the cervix and prostate. The Templates are designed to be sutured to the perineal area in order to fix the geometry of the Template Need into the cervix or prostate. AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (Center-to center). AOS Templates are supplied in two configurations to accommodate a prostate or GYN treatment. The Template is sutured in place and Template Needles are inserted into the Template. The number and type of Template Needles is dependent on the model of Afterloader. Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole with a quide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide groove. The Vaginal Guide is pushed to the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS Collar is then used to push the Vaginal Guide until it can be slipped over and on to the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaqinal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required. Where an Afterloader is used, the Template Needles are connected to the Afterloader via an appropriate connector. If the Template Needle has a female Luer Adaptor on the proximal end, connection to the AOS Universal Connecting Guide Tube, P/N SGJ0007, provides an unobstructed pathway for the source wire or cable from the Afterloader to the appropriate distance as determined by the Afterloader. Some Afterloaders provide a transfer tube, which is connected to the other end slips over the plain end of the Template Needle and is tightened down to hold and connect the Template Needle.

The provided text is a 510(k) summary for the AOS Interstitial Templates, Needles, and Accessories. This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, not a study report detailing specific acceptance criteria and performance data for the device itself.

Therefore, the information you've requested (acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present in the provided text.

The document explicitly states:

• "Nonclinical testing were not performed as device is identical to the predicate device." This indicates that no new performance studies (clinical or non-clinical) were conducted for this specific submission because the device is considered identical to a previously cleared predicate and relies on the predicate's established safety and effectiveness.

In summary, I cannot generate the requested table and study details based on the provided text, as the document focuses on regulatory equivalence rather than presenting an independent performance study with specific acceptance criteria and results for the new device.

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AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site in adults.

AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site.

This document is a 510(k) premarket notification for the AOS Marker Seeds (SMG0242-025), which are 24k gold, 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site.

Based on the provided text, the device is considered substantially equivalent to a legally marketed predicate device (K062825, AOS Marker Seeds). The core of this submission is the claim of identity to the predicate device, rather than new performance data.

Therefore, most of the requested information regarding acceptance criteria and study proving device performance (like accuracy metrics, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable to this specific 510(k) submission.

Here's how the provided information addresses your questions:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of performance metrics for a new device. The "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to the predicate device. This means the new device must have the same technological characteristics and indications for use as the predicate, or any differences must not raise new questions of safety and effectiveness.
• Reported Device Performance: No new performance data is reported as the device is deemed "identical to the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. No new testing was performed; the device is asserting substantial equivalence based on its identity to a previously cleared predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No new testing was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No new testing was performed.

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:

• Not Applicable. This device is a physical marker seed, not an AI or imaging diagnostic tool. It does not involve human readers or AI assistance in the context of diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. No new performance study was conducted. The "ground truth" for this submission relies on the established safety and effectiveness of the identical predicate device.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning/AI device, so there is no training set in that context.

9. How the ground truth for the training set was established:

• Not Applicable. As per point 8.

Summary from the document that supports the above responses:

• "Nonclinical testing was not performed as device is identical to the predicate device." (Page 4)
• "Clinical testing was not performed as device is identical to the predicate device." (Page 4)
• "Nonclinical and clinical testing were not performed as device is identical to the predicate device." (Page 5)
• "Indications for use have been rephrased for clarity but are the same as the predicate device." (Page 4)
• "All other technological characteristics are the same as the predicated device." (Page 4 - referring to the only differences being the discontinued silver version and the change from sterile factory shipment to end-user sterilization).

In conclusion, this 510(k) submission is based on the concept of substantial equivalence, where the new device is considered "identical" to a previously cleared predicate. Therefore, no new performance data or studies (clinical or non-clinical in terms of performance metrics) were required or presented.

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The AOS Orion Ir-192 Source Cable is a sealed radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. This device is the replaceable Ir-192 source for the Nucletron Corp. MicroSelectron HDR V2 and V3 Afterloaders.

The AOS Orion Ir-192 Source Cable (Model No. CSO0012-192) is a nominal 12 Curie Iridium-192 source cable for use in the Nucletron microSelectron HDR Version 2 (Model No. 105.99) and the Nucletron microSelectron V3 (Model No. 106.990) Remote Afterloaders.

Here’s an analysis of the provided text, focusing on the acceptance criteria and the study (performance test) that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Range of Motion: While the predicate requires a radius of ≥ 15mm, the new device reports ≥ 12mm. The document states that the new cable design "provides the same strength and flexibility as the 2 piece predicate cable," implying that the different radius is considered an acceptable, equivalent performance characteristic due to the design change.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of individual units. The performance tests refer to "series of tests" and "the Orion Cable" (singular), suggesting that a sufficient number of cables were tested to demonstrate compliance with the specified criteria. Specific numbers for units tested are not provided.
• Data Provenance: The document does not specify the country of origin for the test data nor explicitly state whether the study was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these would typically be internal, prospective performance tests conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The "ground truth" for a physical medical device like an Ir-192 source cable is established by objective, measurable engineering and performance standards (e.g., ISO, tensile strength tests, cycle tests), not by expert consensus on clinical data or images.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of data (e.g., medical images) where there can be inter-reader variability. For objective performance tests of a physical device, the results are typically directly measured against a predetermined standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable. An MRMC study is designed to evaluate the performance of human readers, often with and without AI assistance, in interpreting medical images or data. The AOS Orion Ir-192 Source Cable is a physical brachytherapy source, and its performance is assessed through engineering and physical property tests, not through human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. Standalone performance (algorithm-only) applies to software algorithms (like AI) that perform a task without immediate human intervention. The device in question is a physical medical device, not a software algorithm. Its "standalone" performance is simply its inherent physical and mechanical properties.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on objective engineering and material standards, specifically:

• ISO 2919 and ISO 9978: International standards for sealed radioactive sources.
• Predicate device performance: The performance characteristics of the legally marketed predicate devices (MicroSelectron HDR Version 2 and MicroSelectron V3) serve as a benchmark for equivalence. This includes specific numerical values for dimensions, strength, and cycle testing.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning or AI models. This device is a physical product, and its development and testing do not involve a training set in the AI sense. Its design is based on engineering principles and materials science.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as in point 8.

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The purpose of the AOS Universal Connecting Guide Tube is to provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply radionuclide source into the body or to the surface of the body for radiation therapy.

Alpha-Omega Services (AOS) Universal Connecting Guide Tube is used to connect any Alpha-Omega applicator accessory with Luer Lock fittings to a High Dose Rate (HDR) Afterloader. The Alpha-Omega universal Connecting Guide Tube is supplied in the nominal length of 100cm. The distal end is a female luer lock, which is used to connect to the male end of the Luer Lock applicator/accessory or to the Extension Adaptor and Needle combination, providing an un obstructed pathway for the source wire or cable from the Afterloader to the tip of the applicator/accessory.

This 510(k) summary describes a device-to-device comparison, not a study involving human-AI interaction or diagnostic performance. Therefore, many of the requested categories related to clinical studies, expert review, and AI performance metrics are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here refers to the characteristics of the predicate device that the new device must meet or be equivalent to. The "reported device performance" indicates how the new device compares to these characteristics. The key difference noted is sterilization.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This was not a study involving a "test set" in the context of clinical data or AI performance. This was a direct comparison of device characteristics for substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, in the context of medical image analysis or AI, is not relevant here as this is a comparison of physical device characteristics. The assessment of substantial equivalence was performed by the FDA.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring adjudication in the context of clinical or AI performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes a submission for substantial equivalence of a medical device, not a comparative effectiveness study involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical medical instrument (guide tube), not an algorithm or AI software. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this submission is the established characteristics and safe/effective use of the predicate device (AOS Universal Connecting Guide Tube, K964910). The new device is deemed substantially equivalent if it shares these fundamental characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no training set involved.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

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The purpose of AOS Interstitial Templates, Needles and Accessories is to provide and enclosed pathway for application of radioactive source(s) into the body or surface of the body for radiation therapy (brachytherapy).

Alpha-Omega Services (AOS) Templates, Template Needles and Accessories provide a fixed array of needles, via the template. AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (center-to center). AOS templates are supplies in various sizes to accommodate treatment sites as prostate, rectum, or vagina.

The Template is sutured in place and Template Needles are inserted into the holes of the Template. The number and type of Template needles is dependant on the model of Afterloader or if the manual LDR method is used, which consists of strands or ribbons of discrete sources.

Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole, with a guide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide strip with the guide grove. The Vaginal Guide is pushed do the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS collar is then used to push the O-Ring along the Vaginal Guide until it can be slipped over and on to the grooved ring on the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaginal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required.

Template Needles may have a plain end or some sort of attachment device, such as a female luer adaptor if an Afterloader is to be used. If the Manual LDR method is used, typically a Template Needles with or without a collar is chosen. Where an Afterloader is used, the Template Needles are connected to the HDR Afterloader via an appropriate connector. If the Template Needle has a female Luer Adaptor on the proximal end, connection to the AOS Universal Connecting Guide Tube (K964910) provides an unobstructed pathway for the source wire or cable from the Afterloader to the appropriate distance as determined by the Afterloader. Some Afterloaders provide a transfer tube, which is connected, to the Afterloader while the other end slips over the plain end of the Template Needles and is tightened down to hold and connect the Template Needle.

The provided text, K062823, is a 510(k) Summary for medical devices and does not contain information about a study that measures the device's performance against specific acceptance criteria. This document is a regulatory submission demonstrating substantial equivalence to previously marketed devices, rather than a performance study.

Here's why the requested information cannot be extracted from this document:

• Nature of the Document: A 510(k)
  Summary for substantial equivalence primarily focuses on comparing the new device's design, materials, intended use, and other characteristics to those of predicate devices that are already legally marketed. Its goal is to demonstrate that the new device is "as safe and effective" as the predicate, not to prove performance against specific quantitative criteria through a new study.
• Absence of Performance Data: The document explicitly states under "PERFORMANCE STANDARDS": "No performance Standards for Brachytherapy Applicators are in effect at this date." This indicates that there are no pre-defined quantitative benchmarks that the device needed to meet through a new performance study.
• Substantial Equivalence Section: The "SUBSTANTIAL EQUIVALENCE" section directly compares the "NEW DEVICE" to "PREDICATE" devices, listing qualitative similarities (e.g., "share the same design," "constructed of the same materials," "Single Use Only"). The only difference noted is that the new devices are sterile, while the predicates were non-sterile. This comparison does not involve quantitative performance metrics.
• Conclusion: The conclusion states: "The Conclusion drawn from the above is that the AOS Interstitial Templates, Needles & Accessories are equivalent in safety and efficacy to their predicate devices." This reinforces that the submission aims to establish equivalence, not to report on new performance study results.

Therefore, since no performance study demonstrating meeting acceptance criteria is described in the provided text, I cannot fill in the table or answer the other questions about such a study.

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AOS Marker Seeds are used to provide reference positions around a proposed treatment site in order to re-apply a radionuclide source into the body or to the surface of the body for multiple sessions of radiation therapy.

AOS Marker Seeds are small, cylindrical pieces of 24k gold or silver, which are easily visible with radiography imaging systems.

Here's an analysis of the provided information regarding the acceptance criteria and supporting study for the AOS Marker Seeds:

Analysis:

This 510(k) submission for the "AOS Marker Seeds" does not contain a traditional performance study comparing the device against specific acceptance criteria for a new, independent claim. Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed predicate device (also "AOS Marker Seeds," but preamendment and non-sterile).

Therefore, many of the requested fields below will be marked as "Not Applicable" or "Not Provided" because the nature of this 510(k) is a comparison to a predicate, not a de novo performance evaluation with objective acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not Applicable / Not Provided. This submission does not include a performance study with a test set of data. The equivalence is based on design and material comparison.
• Data Provenance: Not Applicable / Not Provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Not Provided. No ground truth establishment was conducted as part of a performance study in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided. No adjudication of a test set was performed.

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

• No, an MRMC study was not done. This device is a passive marker seed, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No, a standalone algorithm performance study was not done. This device is a physical marker, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided. No ground truth was established for a performance study. The "ground truth" for this submission is the established safety and efficacy of the predicate device based on its preamendment history and previous FDA clearance.

8. The sample size for the training set

• Not Applicable / Not Provided. This submission does not involve machine learning or a training set.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided. No training set was used.

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A high specific activity radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. Device is the active source for a Nucletron Microselection Device.

The source is made of a stainless steel capsule with an outer diameter of approximately 1.1mm. A hole is drilled through the center of the capsule to a depth of the ir 192 seed. The closed end of the capsule is welded to a 1.1 mm diameter 7 X 7 stranded stainless steel cable. On the opposite end, a solid connector is welded in the same manner to the free end of the cable A Ir 192 seed is inserted into the open end of the capsule. The Ir 192 seed is secured by welding the open end of the capsule. The post-weld length of capsule is approximately 4.5 mm in length and overall length of the finished source cable assembly is approximately 2000 mm. These physical specifications are the source for the Nucletron Microselection HDR device.

The provided text is a 510(k) summary for the "Alpha-Omega Services, Inc., 10 Curie Iridium 192 Source, Model CSN0010-192". This document does not describe a study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Nucletron Microselection Source, K864210) based on comparisons of:

• Indications for Use: Both devices are high specific activity radionuclide brachytherapy sources for placement onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy, and are active sources for a Nucletron Microselection Device.
• Physical Size and Materials: The subject device has identical dimensions (1.1 mm diameter, 2000 mm ± 5% length) and uses the same materials (Stainless steel 316LVM, 7X7 Stranded cable type, IR-192 Seed 3.5 mm) as the predicate device. The only difference noted is the "Seal Method" (Laser/Tig Welding for the subject device vs. Laser Welding for the predicate device).
• Radioisotope and Activity: Both use IR-192 with a radioactive half-life of 75 days and apparent activity levels of 9-13 Ci at the time of shipping.
• Tested Transfer Cycles: The subject device was tested for 50,000 transfer cycles, exceeding the predicate device's 20,000 tested cycles and both devices' recommended 5,000 cycles.

Given that this is a 510(k) submission based on substantial equivalence to a predicate device, and not a de novo clearance or PMA submission, a standalone clinical study with detailed acceptance criteria and performance metrics for the new device (as would be typical for an AI/software device) is not presented or required in this document. The "acceptance criteria" here are essentially the demonstration of equivalence to the predicate.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone study, ground truth types for test/training sets, training set size) are not applicable or cannot be extracted from this specific document, as they pertain to clinical or performance studies of a different nature than what is presented.

Here's the information that can be extracted, adhering to the spirit of the request where possible:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable. This document describes a medical device (a brachytherapy source) and a 510(k) submission based on substantial equivalence, not a performance study of an AI/software device with test sets and data provenance in the typical sense. Equivalence is primarily based on design specifications and performance characteristics derived from physical testing (like transfer cycles) and material properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. See point 2. Ground truth establishment by experts for a test set is not part of this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 2.

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

Not applicable. See point 2. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. See point 2. This device is a physical brachytherapy source, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this type of physical medical device, "ground truth" (in the context of clinical or diagnostic performance) is not applicable. The equivalence is established against the known and accepted characteristics and performance of the predicate device. For "tested transfer cycles," the ground truth is the physical measurement of cycles completed before failure or degradation.

8. The sample size for the training set

Not applicable. See point 2. No training set is involved.

9. How the ground truth for the training set was established

Not applicable. See point 2. No training set is involved.

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To provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply a radionuclide source into the body or to the surface of the body for radiation therapy. Single Use Device. Do not re-clean, re-sterilize device. Any reprocessing may result in changes in the physical characteristics of the device. Do not counter accepted clinical practice or institution guidelines.

The AOS Universal Connecting Guide Tube coupling catheters are substantial equivalence to Varian Coupling catheter (K952913), and Omnitron International Coupling catheter (K881665). Construction and materials are the same for all referenced devices. All devices are listed as single use, provided as non sterile.

This document is a "Summary & Certification" for a medical device called the "AOS Universal Connecting Guide Tube." It appears to be a submission to a regulatory body (likely the FDA in the US, given the "K" numbers for predicate devices). It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel diagnostic or AI-powered device.

Therefore, many of the requested points cannot be directly addressed from the provided text. I will answer what is available and indicate where information is not present.

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a study with a test set of data. It is a declaration of substantial equivalence based on comparison to existing predicate devices, primarily in terms of construction, materials, indications for use, and manufacturing. No sample size, data provenance, or study type (retrospective/prospective) for a performance test is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set requiring expert-established ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication is described.

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

Not applicable. This is not a study of an AI or diagnostic device; it is a regulatory submission for a physical medical device (coupling tube) demonstrating substantial equivalence.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" here is the established safety and efficacy of the predicate devices. The document asserts that the new device shares the same "construction and materials" and "indications" as these devices, leading to the conclusion of "equivalent in safety and efficacy." There is no other empirical ground truth established by a study within this document.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable. No training set and thus no ground truth for a training set is mentioned.

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