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The Triton™ Sacroiliac Joint Fixation system is intended for fixation of sacroiliac joint distruptions, and intended for sacroiliac joint fusion for conditions including;
-sacroiliac joint disruptions,
-degenerative sacroiliitis
-to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
-Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint

The Triton™ Sacroiliac Joint Fixation System is a multiple component system consisting of non-sterile instruments and sterile, cannulated Ø8mm, Ø12mm and Ø14mm Screws offered in multiple lengths. The Triton SI Screws are manufactured from medical-grade titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, Class C. The implants feature 3 fluted channels for bone collection and a tapered proximal tip. The Ø12mm and Ø14mm Screws feature multiple open and porous-filled windows for packing and disbursement of autograft and allograft materials.

This FDA 510(k) summary is for a medical device called the Triton™ Sacroiliac Joint Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically understood in the context of AI/ML device performance or clinical outcomes.

The provided document primarily focuses on non-clinical testing for mechanical properties (e.g., static pull-out, torsion, cantilever) to demonstrate the safety and effectiveness of the physical implant by comparing its mechanical characteristics to existing predicate devices.

Therefore, many of the requested categories related to AI/ML device performance, human expert involvement, ground truth, and training data cannot be extracted from this document, as they are not applicable to the type of 510(k) submission described.

Here's a breakdown based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists non-clinical mechanical tests, but doesn't explicitly state acceptance criteria as pass/fail thresholds against specific numerical values. Instead, it implies that the device's performance in these tests was comparable to that of predicate devices, leading to a conclusion of substantial equivalence.

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

Not applicable. The "test set" here refers to physical components of the device undergoing mechanical testing, not a dataset for AI/ML. The provenance would be the materials used in manufacturing the device components for these tests.

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

Not applicable. This is not AI/ML performance testing requiring expert ground truth for classification or prediction. The "ground truth" for mechanical testing is established by standard engineering principles and test methods, often performed by engineers or technicians.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication in the context of mechanical testing as described here. Results are objectively measured according to the ASTM standards.

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. This is not an AI/ML device that assists human readers.

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

No. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing is based on established engineering standards and measurements of mechanical properties (e.g., force, torque, displacement) as defined by ASTM standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device.

Summary of the Study Proving Device Acceptance Criteria (based on the provided document):

The Triton™ Sacroiliac Joint Fixation System underwent a series of non-clinical mechanical tests to demonstrate its performance and substantial equivalence to legally marketed predicate devices. These tests were conducted according to established ASTM standards:

• Static Pull Out (ASTM F543)
• Static Torsion (ASTM F543)
• Static Cantilever (ASTM F2193)
• Dynamic Cantilever (ASTM F2193)

The document concludes that the "differences in geometry are not significant and would not adversely affect the use of the product. The Triton™ System is substantially equivalent in material, size offerings, classification, anatomical location, manufacturing and sterilization methods, surgical approach, principle of operation, indications for use, and mechanical testing plan." This statement implies that the device successfully met the performance expectations by demonstrating comparable mechanical characteristics to the predicate devices, thereby establishing its safety and effectiveness for its intended use. The "ground truth" for these tests was the objective measurements obtained through adherence to the specified ASTM testing protocols.

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Triton is used for debridement, removing the smear layer, and cleansing the root canal system.

Triton is a two-part, dual-action root canal cleanser. Triton Part A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. Triton Part B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed solution cleanses and debrides the root canal system by removing the organic debris during and after endodontic instrumentation.

This document is an FDA 510(k) clearance letter for a dental device called Triton. It primarily addresses the substantial equivalence of Triton to a previously cleared predicate device, V-Mix. It is not a study report detailing clinical performance or acceptance criteria for a new AI/medical imaging device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, especially in the context of an AI-powered or medical imaging device. The device in question, Triton, is a root canal cleanser, and the clearance is based on its chemical composition being identical to a predicate device, with only changes in packaging and shelf-life, which were supported by non-clinical testing.

There is no information in this document to populate the requested table or answer the specific questions about AI/imaging device study methodologies.

To answer your request, I would need a different type of document, such as a clinical study report for an AI/imaging device submission.

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The Triton Cage is indicated for use with bone graft (autograft bone graft composed of cancellous and or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Patients with previous non-fusion spinal surgery at the treated. These patients should be sketally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

The Medyssey, Triton Cage is an interbody fusion device utilized to achieve fusion in the lumbar spine. The cage is manufactured from PEEK (ASTM F2026) and additively manufactured titanium alloy (ASTM F136) available in three variants (LLIF, ALIF, OLIF) and a range of sizes to accommodate different surgical approaches and anatomies.

The provided text describes the 510(k) premarket notification for the Triton Cage, an intervertebral body fusion device. While it details the device's indications for use, materials, and substantial equivalence to predicate devices, it does not contain any information about a study proving the device meets specific acceptance criteria based on its performance in a clinical or imaging-based assessment where AI or human performance is evaluated.

The "Performance Testing Summary" section only mentions mechanical testing (Static Compression, Dynamic Compression, etc.) performed on the device to demonstrate substantially equivalent performance to predicate devices in a benchtop setting, not a clinical study involving human or AI perceptual performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this device based on the given document. The document focuses on regulatory clearance based on substantial equivalence of the physical device's characteristics and mechanical properties to previously cleared devices.

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The Triton Sponge System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges. The Triton Sponge System is intended to be used with surgical sponges, software, hardware and accessory devices which have been validated for use with the Triton Sponge System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The Triton Sponge System is also intended to calculate an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user-entered patient serum Hb value. The validated surgical sponges, hardware, software, accessory devices and Hb mass ranges are listed in the Instructions for Use. The Triton Sponge System is also indicated for use to aid in counting surgical sponges and may be used to record and display case-specific blood components infused over time. The Triton Sponge System is additionally indicated for use to aid in managing surgical sponges, including providing a visual record of sponge images, and to record the user-entered weight of used surgical sponges in order to calculate an estimate of fluid volume on the sponges.

The Triton Sponge System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges. The Triton Sponge System is intended to be used with surgical sponges, software, hardware and accessory devices which have been validated for use with Triton Sponge System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. This version of the Triton Sponge System includes 4 updates from the predicate Triton System (K160338): Qualified new hardware accessory: Apple's iPad Pro to be used with Triton Sponge System. Qualified new accessory for imaging sponges: Users will use a commercially available 3D IR laser depth sensor (referred to as the Natural User Interface or NUI Sensor in the submission) that allows for automatic detection of sponges as well as a touch-free interface with the device to facilitate imaging of the sponge on Apple's iPad Pro device. To allow the use of the NUI Sensor with the Triton Sponge System, a new algorithm called the Sponge Recognition Algorithm (SRA) was added to the System. The SRA analyzes the depth maps provided by the NUI Sensor to determine whether or not a User is presenting a sponge for imaging. To allow the NUI Sensor to securely connect to the iPad Pro, NUI mounting brackets are provided to connect the NUI Sensor to the iPad Pro. Addition of a step to include imaging a calibration placard with Triton Sponge App to normalize ambient light settings. The calibration card is provided to standardize the image of each sponge. Updates to the Hemoglobin Algorithm to improve hemoglobin mass estimates by performing scene normalization as well as utilizing new data provided by the calibration palette and NUI Sensor.

The provided text describes the Triton Sponge System, a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges. It explains the acceptance criteria for this device and the studies conducted to prove it meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls Required for 21 CFR §880.2750" (Table 6-1 on page 14). The device performance is summarized from the "Special Control Met" column and the "PERFORMANCE DATA" section (pages 10-14).

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

• Sample Size for performance testing (bench-top and system validation): The document states "Testing involved running the software app/system test protocol with sample specimens" for bench testing and for system validation, it used "mock surgical case simulated by reconstituting whole blood samples of known Hb concentration from units of human packed red blood cells and plasma to create various pre-specified blood volumes. Serial dilution with sterile saline yielded sponge blood samples reconstituted to ranges of fluid volume, dilution, and Hb mass representative of a surgical operation."
  • The exact number of "sample specimens" or "blood volumes" / "dilution levels" is not explicitly stated in the provided text.
• Data Provenance: The data used for performance testing (bench-top and system validation) appears to be prospective and simulated in a laboratory/mock surgical setting. The blood samples were "reconstituted" and "serial dilution with sterile saline" was performed. There is no indication of patient data or data from a specific country of origin, suggesting it's synthetic or laboratory-generated.

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

The ground truth for the performance tests (bench and system validation) was established using "pre-measured Hb mass (Assay sHbL)" of the samples. This indicates a direct quantitative measurement rather than expert interpretation.

• Therefore, no experts were used to establish the ground truth in the traditional sense of clinical assessment (e.g., radiologists, pathologists). The ground truth was based on laboratory assay measurements.
• The qualifications of individuals performing these assays are not specified, but it's implied to be standard laboratory practice for measuring hemoglobin mass.

4. Adjudication Method for the Test Set

Since the ground truth for performance testing was based on pre-measured laboratory assays, there was no adjudication method involving multiple human readers or experts. The comparison was directly between the device's output and the established objective measurement.

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 conducted involving human readers with and without AI assistance to measure effect size. The studies described are primarily technical performance validation (accuracy of Hb estimation) and human factors usability of the device itself.

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

Yes, standalone performance testing was done for the algorithm's core function. The bench-top and system validation tests evaluated the algorithm's ability to estimate hemoglobin mass (sHbL) from imaged sponges by comparing "Triton sHbL" (algorithm output) to "Assay sHbL" (pre-measured ground truth).

• The process involved the App capturing images, transferring them to a server-based hemoglobin algorithm software, which then calculated the Triton sHbL. This calculated value was then compared to the Assay sHbL. This effectively represents the algorithm's standalone performance in estimating Hb mass from image input.

7. The Type of Ground Truth Used

The type of ground truth used for the quantitative performance studies (bench-top and system validation) was objective laboratory measurement of hemoglobin mass, referred to as "pre-measured Hb mass (Assay sHbL)". This involved depositing known quantities of blood with known Hb mass on surgical sponges.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set used to develop or refine the Hemoglobin Algorithm, nor does it specify if a separate training set was used for the Sponge Recognition Algorithm (SRA). The text focuses on the testing and validation of the device.

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

The document does not provide information on how the ground truth for any training set was established. It primarily details the methods for creating test data and establishing ground truth for validation purposes.

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The Triton System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges.

The Triton System is intended to be used with surgical sponges, software and accessory devices which have been validated for use with the Triton System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The Triton System is also intended to calculate an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user-entered patient serum Hb value. The validated surgical sponges, hardware, accessory devices and Hb mass ranges are listed in the Instructions for Use.

The Triton System is also indicated for use to aid in counting surgical sponges and may be used to record and display case-specific blood components infused over time. The Triton System is additionally indicated for use to aid in managing surgical sponges, including providing a visual record of sponge images, and to record the user-entered weight of used surgical sponges in order to calculate an estimate of fluid volume on the sponges.

The Triton System is a software program (mobile medical application) used on an Apple iPad® tablet to capture images of used surgical sponges to assist surgical personnel in the management of surgical sponges after surgical use and to aid in the estimation of blood loss.

Here's a breakdown of the acceptance criteria and the study information for the Triton System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the sample size used for the test set. It mentions "previous non clinical testing" for the performance criteria and verification testing for the current submission, but lacks details on the number of cases or samples.

The data provenance is not explicitly stated (e.g., country of origin). However, given that Gauss Surgical Inc. is located in Los Altos, California, USA, and this is an FDA submission, it's highly probable that the studies were conducted in the United States. The document does not specify if the data was retrospective or prospective.

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

The document does not provide information regarding the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

The document does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study. The submission focuses on comparing the Triton System to a predicate device (Pixel 3 System) based on technological characteristics and indications for use, rather than human reader performance with and without AI assistance.

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

The document describes the Triton System as a "software application intended to be used as an adjunct in the estimation of blood loss." This implies that it's designed to assist human users, rather than being a fully standalone diagnostic tool replacing human expertise. The performance data mentioned largely relates to the device's ability to measure hemoglobin mass and blood volume, which is a standalone function of the algorithm itself, to then be used by clinicians. However, no specific "standalone" study separate from its "adjunct" role is detailed. The focus is on the algorithm's accuracy in its intended use.

7. The Type of Ground Truth Used

The document mentions that the non-clinical performance data involved "comparison to a scientifically valid alternative method for measuring deposited hemoglobin mass." This indicates that the ground truth for blood loss estimation (specifically hemoglobin mass) was established using a scientifically valid, presumably quantitative, laboratory or reference method rather than expert consensus, pathology, or outcomes data in this context. While not explicitly named, it would likely be a gold standard measurement for hemoglobin.

8. The Sample Size for the Training Set

The document does not provide the sample size for the training set.

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

The document does not explicitly detail how the ground truth for the training set was established. It implicitly suggests that the ground truth for hemoglobin mass would be established through a "scientifically valid alternative method" as mentioned for the performance testing.

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The Triton Canister System is a software application intended to be used as an adjunct in the estimation of blood loss.

The Triton Canister System is intended to be used with blood bearing canisters, software, hardware, and accessory items which have been validated for use with the Triton Canister System to estimate the hemoglobin (Hb) mass contained within canisters with the input of the total volume in each canister. The Triton Canister System is also intended to calculate an estimate of blood volume in blood bearing canisters from the estimated Hb mass and a user-entered patient serum Hb value. The validated canister types, hardware, software, accessory devices, and Hb mass ranges are listed in the Instructions for Use.

The Gauss Surgical Triton Canister System is an image processing system to estimate the external blood lost from patients into a suction canister used to collect fluid during surgical procedures. The system is comprised of the software which runs on a mobile platform (Apple® iPad®) and two accessories provided by Gauss Surgical, a Canister Type Specific Insert and a Canister Scanning Label. The Insert and Label ensure variables associated with imaging are standardized.

Here's a breakdown of the acceptance criteria and study information for the Triton Canister System:

Acceptance Criteria and Device Performance

The general acceptance criteria for "Non-clinical performance data" is that the device performs as intended under anticipated conditions of use, with a comparison to a scientifically valid alternative method for measuring deposited hemoglobin mass. Specific conditions tested include:

• Lighting conditions
• Range of expected hemoglobin concentrations (and hemolysis levels)
• Range of expected blood volume absorption in canisters
• Presence of other non-sanguineous fluids (e.g., saline irrigation fluid)

The study employed Bland-Altman analysis to establish the bias and limits of agreement between the device's estimated hemoglobin mass (Triton cHbL) and the pre-measured hemoglobin mass (Assay cHbL).

Study Details for Performance Testing Bench

1. Sample Size used for the test set and the data provenance:

   • The document states, "Whole blood samples of known Hb concentration and various pre-specified volumes were reconstituted from units of human packed red blood cells and plasma." It also mentions, "Serial dilution yielded canister samples reconstituted to ranges of fluid volume, dilution, hemolysis levels and Hb mass."
   • The exact numerical sample size for the test set (number of canisters/samples) is not explicitly stated in the provided text.
   • Data Provenance: The blood samples were reconstituted from units of human packed red blood cells and plasma. The testing was retrospective in nature, as it involved preparing samples with known characteristics in a lab setting ("bench testing") rather than collecting data from live surgical procedures. The country of origin for the data is not specified, but given it's an FDA submission, it's highly likely to be within the United States.

2. 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):

   • The ground truth for the test set was established by "pre-measured Hb mass (Assay cHbL)" of the reconstituted samples. This implies a laboratory assay was used, which would typically be performed by trained lab technicians or scientists.
   • The document does not specify the number or qualifications of individuals who established this ground truth, beyond referencing the "scientifically valid alternative method" of laboratory assay.

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

   • The ground truth was established by direct measurement (Assay cHbL) rather than expert consensus on interpretive data. Therefore, an adjudication method for human readers is not applicable in this context.

4. 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 comparative effectiveness study was not done. This study focuses on the standalone performance of the device in estimating hemoglobin mass in canisters, not on human reader performance with or without AI assistance. The device is described as "an adjunct in the estimation of blood loss," implying it provides data to clinicians, rather than directly assisting in the interpretation of images by human readers in a diagnostic setting.

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

   • Yes, a standalone performance study was done for the algorithm. The "Performance Testing Bench" described the "ability of the Triton Canister System (including algorithm, app, server and accessories – Insert and Scanning Label) to estimate canister hemoglobin mass loss and canister blood volume loss in comparison to a scientifically valid method of estimating hemoglobin mass and blood volume contained in canisters." The algorithm calculated the "Triton cHbL" which was then compared to the "Assay cHbL." While a user-entered volume is an input, the core estimation of Hb mass from the image is an algorithmic, standalone function.

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

   • The ground truth used was laboratory assay / direct measurement of hemoglobin mass ("Assay cHbL") in the prepared samples. This is a highly objective, quantitative form of ground truth.

7. The sample size for the training set:

   • The document does not explicitly state the sample size used for the training set for the Triton Canister System's algorithm. It describes the testing of the performance of the algorithm.

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

   • The document does not explicitly describe how the ground truth for the training set was established. However, given the nature of the device and the performance testing, it is highly probable that the training data would also utilize laboratory-measured hemoglobin mass in similar prepared samples, just like the test set.

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The IPC System with the TRITON Electric High-Torque Handpiece is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The purpose of this submission is to add a new handpiece and an accompanying software module as a line extension to the current Integrated Power Console IPC® System. The handpiece is powered by the previously cleared integrated Powered Console. In order to operate the TRITON Electric Handpiece, the IPC will be equipped with the appropriate software module to drive the handpiece. The handpiece is used for sawing, drilling, driving and placing screws, wires and pins when used in conjunction with various attachments previously cleared for use during spinal surgery.

The provided text describes a 510(k) premarket notification for the TRITON Electric High Torque Handpiece and Software Module, a device used in various surgical procedures. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices based on laboratory bench testing.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical data or patient samples. The testing described is laboratory bench testing. Therefore, the concept of sample size for clinical test data or data provenance (country of origin, retrospective/prospective) is not applicable here as the study is not a clinical trial involving human subjects or patient data.

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

Not applicable. As the study is based on laboratory bench testing, there is no "ground truth" derived from expert consensus on clinical cases. The performance metrics are objectively measured physical properties of the device.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for laboratory bench testing of device performance characteristics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document makes no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers or AI assistance. This submission pertains to a surgical handpiece, not an imaging or diagnostic device typically evaluated with MRMC studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical surgical tool with an accompanying software module to control its operation. It is not an AI algorithm or a standalone diagnostic tool that would operate without human intervention. The "standalone" performance here refers to the device's functional characteristics as measured in a lab.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on objective physical measurements obtained during laboratory bench testing. These measurements are compared against the performance characteristics of predicate devices, which serve as the reference for establishing substantial equivalence.

8. Sample Size for the Training Set

Not applicable. The document describes a physical medical device (surgical handpiece) and its controlling software. There is no "training set" in the context of machine learning. The software module is designed to drive the handpiece and recognize its control parameters, not to learn from a data set.

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

Not applicable. As there is no machine learning "training set," there is no ground truth established for it. The software's functionality is pre-programmed based on engineering design and specifications.

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The ASI Triton Mobile Dental System (Models 2025 and 2025M) is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.

The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.

The ASI Triton Mobile Dental System (Models 2025 and 2025M) is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any such criteria.

The document is a 510(k) premarket notification letter from the FDA regarding the "Triton Self Contained Dental System." It states that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

The document does not contain:

1. A table of acceptance criteria or reported device performance.
2. Information about sample sizes for a test set, data provenance, or training set.
3. Details on the number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. A standalone algorithm performance study.
7. The type of ground truth used.
8. How ground truth for a training set was established.

This type of FDA letter primarily confirms the substantial equivalence of a new device to existing ones, rather than detailing specific performance studies against acceptance criteria in the format requested.

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The Triton Medical TMed IV-Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a ven. The device is for prescription use only.

Depending on configuration, the device may include the following; protective cap(s), drip chamber, tubing, back check valve(s), anti-siphon valve, needle free Y-site, roller clamp, 0.22 micron filter or 1.2 micron filter, male Luer lock, spike, and medi-hook.

This 510(k) summary (K073444) for the Triton Medical TMed IV-Set indicates that the device is considered substantially equivalent to a predicate device (Dragon Heart Intravascular Administration Set, K043235) based on a comparison of technical characteristics and manufacturing processes. It does not describe a study that establishes acceptance criteria through performance testing with a specific test set.

Instead, the submission argues for substantial equivalence because:

• The device is manufactured by the same manufacturer (Dragon Heart Medical Device Co., Ltd) as the predicate.
• It is made from the same materials.
• It is built to the same specifications as the predicate.
• Therefore, any testing performed on the predicate would be identical for this device, and no new tests or clinical studies were deemed necessary.

Given this, the requested information elements related to performance criteria, test sets, ground truth establishment, expert review, MRMC studies, or standalone algorithm performance are not applicable to this specific 510(k) submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and reported device performance:
   • Acceptance Criteria: Not explicitly stated as performance metrics in this document. The implicit acceptance criterion is "substantial equivalence" to the predicate device, meaning it performs as safely and effectively as the predicate without raising new questions of safety or efficacy.
   • Reported Device Performance: No quantitative performance metrics are reported. The document states, "The device is the same device as the predicate. It is manufactured by the same manufacturer, from the same materials, and to the same specifications as the predicate. Any testing is identical." This implies its performance is considered the same as the predicate.

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

   • Not applicable. No new test set data was generated or used for this submission to demonstrate performance against acceptance criteria. The equivalence argument relies on the identity to the predicate.

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 ground truth establishment was performed for a new test set.

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

   • Not applicable. No test set adjudication method was used.

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 an IV-set, not an AI-enabled diagnostic tool, and therefore no MRMC study was performed.

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

   • Not applicable. This device is an IV-set, not an algorithm, and therefore standalone performance was not assessed in this context.

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

   • Not applicable. No ground truth was established for the purpose of a new performance study.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no training set.

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

   • Not applicable.

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The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide traction and mobilization of skeletal structures and skeletal muscles.

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide a treatment in static, intermittent, progressive and cycling distraction forces to relieve pressures on micentifies that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions.

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices with the optional EMG (a.k.a. sEMG) biofeedback feature may be used to relieve peripheral radiation/sciatica and nain associated with:
➤ Protruding discs
➤ Bulging discs
➤ Herniated discs
➤ Degenerative disc disease
➤ Posterior facet syndrome
➤ Acute facet problems
➤ Radicular pain
➤ Prolapsed discs
➤ Spinal root impingement
➤ Hypomobility
➤ Degenerative joint disease
➤ Facet syndrome
➤ Compressions fractures
➤ Joint pain
➤ Discogenic pain

EMG (a.k.a. sEMG)
Determination of the activation magnitude and timing of muscles for:
a) retraining of muscle activation
b) coordination of muscle activation
Determination of the force produced by muscle for control and maintenance of muscle contractions
Relaxation muscle training
Muscle re-education

The Chattanooga Group powered traction device consists of an electric traction treatment unit, and may be sold with the following: EMG (a.k.a. sEMG) biofeedback feature, Pull-Pattern intermittent traction preset feature, patient traction treatment table device, positioning bolster accessories, patient traction belt accessories, high volt pulsed electrotherapy device and miscellaneous traction devices and/ or accessories. The device is intended to be used in hospitals, physical therapy clinics and chiropractic clinics for treatment in static, intermittent, progressive, regressive and cyclic, distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). The device is restricted to sale by or on the order of a licensed physician or licensed practitioner.

The primary features of the Triton/ Tru-Trac/ TX/ Triton DTS Traction hardware are the traction unit (a.k.a. traction head), display screen, traction rope, mounting assembly and patient stop treatment switch.

The EMG biofeedback feature is used to detect muscle activation and relaxation for Frie ENC oferous traction therapy. The treating clinician determines the minimum muscle activation or minimum muscle relaxation threshold set point. This is done by utilizing the visual display. The intermittent traction reacts to these threshold settings and administers prescribed traction treatment. The Pull Pattern feature is a preset of intermittent traction settings, less the setting of traction force, less setting of traction time. Force and time parameters are determined by the treating clinician.

The provided information does not describe a study that proves the device meets specific acceptance criteria in terms of performance metrics or clinical outcomes. Instead, it details the submission for 510(k) premarket notification for the Triton/ Tru-Trac/ TX/ Triton DTS Traction device, which primarily relies on demonstrating substantial equivalence to legally marketed predicate devices.

The acceptance criteria mentioned are related to compliance with recognized consensus standards for medical equipment safety and electromagnetic compatibility, rather than clinical efficacy or specific performance benchmarks.

Here's a breakdown of the requested information based on the provided text, with notes where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify performance acceptance criteria related to clinical effectiveness (e.g., specific pain reduction percentages, range of motion improvements, or target success rates). The primary "performance" reported is compliance with safety and EMC standards and technical similarity to predicate devices.

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

• Sample Size of Test Set: Not applicable. The submission is for a medical device seeking market clearance through substantial equivalence, not a clinical study with a test set of patient data for performance evaluation against ground truth. The "test set" here refers to the device itself being tested for compliance with technical standards.
• Data Provenance: Not applicable for a clinical test set. The data provenance described is the device's technical specifications and comparisons to predicate devices for substantial equivalence.

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

• Number of Experts: Not applicable. This document does not describe a study where experts established ground truth for a clinical test set. The "ground truth" for this submission revolves around established safety and EMC standards, and the technical characteristics of predicate devices.
• Qualifications of Experts: Not applicable for a clinical test set. The compliance with standards would be assessed by testing laboratories and regulatory bodies.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no mention of an adjudication process for a clinical test set in this 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The document does not describe an MRMC comparative effectiveness study.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no MRMC study was conducted, and the device is a powered traction unit, not an AI-assisted diagnostic or interpretative system. The optional EMG biofeedback feature provides data for the clinician but isn't described as an AI-driven interpretive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? No. The device is a physical therapy traction unit, and its function involves direct human application and interaction (clinician administering treatment, patient interacting with the device). There is no "algorithm only" performance that would be evaluated in a standalone study without human involvement.

7. Type of Ground Truth Used

• Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is established by:
  • Regulatory Standards: Compliance with recognized safety and electromagnetic compatibility standards (UL 60601-1: 2003, IEC 60601-1-2: 2001).
  • Predicate Device Characteristics: The technical specifications and indications for use of the listed predicate devices (e.g., Triton/Tru-Trac/TX Traction, Eskotek EST Trac 401 Traction, etc.) serve as the benchmark for demonstrating substantial equivalence. The argument for substantial equivalence is based on comparing the new device's features, intended use, and technological characteristics to those of legally marketed predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI-driven device that requires a training set of data for an algorithm. The device is a physical medical device.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

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