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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 Topcon DRI OCT Triton is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.

The DRI OCT Triton is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.

It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the human retina to a database of known normal subjects. The DRI OCT Triton is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

The DRI OCT Triton ("Triton") and the DRI OCT Triton (plus)") are non-contact, highresolution, tomographic and bio-microscopic imaging systems that merge optical coherence tomography (OCT) and fundus camera into a single device. Triton and Triton (plus) employ the swept source OCT (SS-OCT) technology. Both can take anterior OCT images in addition to fundus OCT images. The fundus camera, in both Triton and Triton (plus), includes color imaging, red-free imaging, and infrared light imaging (hereinafter, IR imaging) capabilities for fundus observation. The Triton (plus) has fluorescein angiography (FA), and fundus autofluorescence angiography (FAF) imaging function in addition to all fundus functions for Triton.

The fundus photographs and OCT images are captured by different system components of this device, which enables Triton to capture an OCT image and a fundus image sequentially. It allows in vivo viewing, axial cross sectional, and three dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures. It also has a reference database for posterior ocular measurements of normal subjects, which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head and the macula.

Captured images are transferred from the device to an off-the-shelf personal computer (PC) via LAN cable, where the dedicated software for this device is installed. The transferred data is then automatically processed with analysis functions such as the automatic retinal layers segmentation, the automatic thickness calculation with several grids, the optic disc analysis and comparison with a reference database of eyes free of ocular pathology, and is finally automatically saved to the PC. It allows the user to manually adjust the automated retinal layer segmentation results and optic disc analysis results.

Accessories include the power cord, chin-rest paper sheet, monitor cleaner, LAN cable; chin-rest paper pins, external fixation target, dust cover accessory case, user manual, unpacking and analysis software DVD.

The Topcon DRI OCT Triton is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying, and storing data of the retina and surrounding parts of the eye. It is indicated for in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of posterior ocular structures (retinal nerve fiber layer, macula, and optic disc) and anterior ocular structures. It includes a Reference Database for posterior ocular measurements to quantitatively compare these structures to a database of known normal subjects. The device is intended as a diagnostic aid in the diagnosis, documentation, and management of adult ocular health and diseases.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Topcon DRI OCT Triton were based on demonstrating substantial equivalence to its predicate devices, the Topcon 3D OCT-1 Maestro and the Topcon TRC-50DX Retinal Camera. This was evaluated through agreement and precision studies, as well as image quality evaluations. The specific acceptance criteria are implicit in the reported performance metrics shown below.

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

For the Agreement and Precision Study (comparing Triton to Maestro):

• Sample Size: 76 participants, including:
  • 25 Normal eyes
  • 26 Retinal eyes
  • 25 Glaucoma eyes
• Data Provenance: Prospective comparative clinical study conducted at a single U.S. clinical site. (Page 6)

For the Fundus Autofluorescence and Fluorescein Angiography Image Quality Evaluation Study (comparing Triton (plus) to TRC-50DX):

• Specific sample size (number of participants/eyes) is not explicitly stated, but the submission mentions "Majority of the FAF and FA images were graded by both graders" and "response rates (i.e., percentage of subjects whose Triton grades were equal to or better than the corresponding TRC-50DX grades)".
• Data Provenance: Prospective clinical study conducted at one clinical site, located in the United States. (Page 55-56)

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

• Agreement and Precision Study (Fundus Photographs, Anterior B Scan, Posterior B Scan evaluations): The image quality of the fundus photographs, and the image quality of anterior and posterior OCT B scans were graded by two masked independent experts. (Page 7). Their specific qualifications (e.g., years of experience, specialty) were not detailed in the provided text.
• Fundus Autofluorescence and Fluorescein Angiography Image Quality Evaluation Study: The FAF and FA images were graded by two masked independent graders in a blinded and randomized fashion. Their specific qualifications were not detailed. (Page 56).

4. Adjudication Method for the Test Set

• Agreement and Precision Study: The text describes that two masked independent experts graded the images. For fundus photographs, the company performed a further analysis on image quality grades that differed by 1 point, stating this difference is not considered significantly different when both graders' scores are certain values. For posterior B scans, it states that 34% of images differed by one grade, but all these images were considered clinically useful by both graders. This suggests a form of implicit agreement or tolerance for minor discrepancies, rather than a formal adjudication process like 2+1 or 3+1 where a third expert decides.
• Fundus Autofluorescence and Fluorescein Angiography Image Quality Evaluation Study: The text indicates images were graded by "two masked independent graders" who performed the grading in a "blinded and randomized fashion." No explicit adjudication method (e.g., tie-breaking by a third reader) is mentioned for instances of disagreement.

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

• A MRMC comparative effectiveness study was not explicitly described for evaluating human reader improvement with AI assistance. The clinical studies focused on comparing the performance and agreement of the Triton device (algorithm included) with predicate devices directly, and on establishing a reference database. Human readers were involved in grading image quality for agreement studies, but the studies were not designed to measure the effect of AI assistance on human reader performance.

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

• The study primarily focuses on the standalone performance of the DRI OCT Triton device compared to predicate devices for quantitative measurements and image quality. The device itself performs the image acquisition, segmentation, and thickness calculations. The evaluation of image quality by experts is a pragmatic assessment of the output generated by the device, essentially evaluating its standalone output for clinical utility. The quantitative metrics (e.g., retinal thickness measurements, optic disc parameters) are direct outputs of the device's algorithms.

7. The Type of Ground Truth Used

• For the Agreement and Precision Study: The ground truth for quantitative measurements was established by comparison against the measurements obtained from the predicate device (Maestro). For image quality evaluations, the ground truth was established by expert grading/consensus from two masked independent experts.
• For the Fundus Autofluorescence and Fluorescein Angiography Image Quality Evaluation Study: The ground truth for image quality was established by expert grading/consensus from two masked independent graders comparing Triton (plus) images to TRC-50DX images.

8. The Sample Size for the Training Set

The provided text describes clinical studies for performance evaluation and for establishing a reference database. It does not explicitly mention a training set sample size for the device's algorithms. The clinical studies appear to be validation studies rather than studies for training the underlying algorithms. The "Reference Database" was established with 410 evaluable eyes. While this database is used for quantitative comparison within the device, it's not explicitly stated to be the training set for the segmentation or measurement algorithms.

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

Since a "training set" is not explicitly detailed or a method for establishing its ground truth described, this information cannot be provided from the given text. The reference database for quantitative comparisons was established from measurements of 410 normal eyes (age ≥18, no glaucomatous optic nerve damage) collected across six U.S. clinical sites. For these eyes, various scan parameters (full retinal thickness, RNFL thickness, GCL+IPL thickness, GCC thickness, optic disc measurements, TSNIT circle profile measurements) were collected, and percentiles were estimated using quantile regression with age and/or disc area as covariates. This database serves as a "ground truth" for comparison for normal subjects within the device's functionality, but not explicitly as a ground truth for training the segmentation or measurement algorithms themselves.

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The CamX Triton HD Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.

The CamX Triton HD "Proxi" aids in the detection and diagnosis of proximal caries. It consists of a toothbrush-sized handpiece and a "Proxi" head. A USB cable connects the handpiece to a personal computer with PACS software such as DBSWIN to enable communication between a PC computer and the handpiece. After a camera cover (single patient disposable sheath, K132953) is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the teeth to be examined. The camera functions by transilluminating sound tooth enamel with infrared light. Areas that spread and reflect the light (e.g. caries lesions) show up clearly delimited bright areas. A digital camera converts the object situation into an electrical signal, sent it over USB to a computer, converted into an image (by imaging software) and presented on a monitor in monochrome colors to illustrate suspected areas of decay.

This document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through a clinical study. Therefore, comprehensive information regarding acceptance criteria and a detailed study proving the device meets them, as typically found in a clinical trial report, is not present.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not explicitly state acceptance criteria in a quantitative table format with corresponding performance results. Instead, it relies on a comparison to the predicate device and validation of key performance attributes.

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

The document explicitly states: "11. Clinical Data: Not required for a finding of substantial equivalence." This means a clinical test set of patient data, as would be used in a typical clinical study, was not required or performed for this submission. The performance assessment was based on non-clinical data.

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)

Given that clinical data was not required, there is no mention of experts establishing ground truth for a clinical test set. The "ground truth" concept in a clinical context (e.g., confirmed caries presence) is not applicable here as no clinical study was performed.

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

Not applicable, as no clinical test set requiring adjudication 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 is a device for detecting caries, not an AI-assisted diagnostic tool for human readers in the context of an MRMC study.

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

The device is described as "a diagnostic aid," implying human-in-the-loop use. The primary mode of operation described is a digital camera converting the object situation into an electrical signal, sent to a computer, converted into an image, and "presented on a monitor in monochrome colors to illustrate suspected areas of decay." This suggests the image is then interpreted by a dentist. A standalone algorithm performance was not reported.

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

For the non-clinical testing of "illumination and image quality," the ground truth implicitly would be objective measurements and comparisons against the predicate device's characteristics and output. For biocompatibility and sterilization, the ground truth is adherence to established international standards and successful completion of specified tests.

8. The sample size for the training set

Not applicable. This device does not appear to be an AI/machine learning product that would require a "training set" in the conventional sense. Its function is based on transillumination and image capture.

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

Not applicable, as there is no mention of a training set for an AI/machine learning model.

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The Electric Drill System is a electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Additionally, the Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

• Lumbar Microdiscectomy
• Lumbar Stenosis Decompression
• Posterior Lumbar Interbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Anterior Lumbar Interbody Fusion (ALIF)
• Direct Lateral Interbody Fusion (DLIF)

The Electric Drill System consists of an electric Integrated Power Console, Electric Foot Control unit with Y-Splitter, Connection Cables, Irrigation/Cooling Sets including a remote Irrigation Control Unit, and various Electric Handpieces and/or electric motors and Attachments to drive various Surgical Dissecting Tools. The Integrated Power Console device of the Electric Drill System can also function as an endoscope lens cleaning system.

Thank you for providing the detailed documentation for the Medtronic Powered Surgical Solutions. However, after careful review, I must inform you that the provided information does not contain the specific details required to complete your request for acceptance criteria and a study proving a device meets those criteria.

The document is a 510(k) premarket notification for an Electric Drill System. While it discusses the device's indications for use and compares it to predicate devices, it primarily focuses on demonstrating substantial equivalence to previously cleared devices.

Here's why the requested information is not available in the provided text:

• Acceptance Criteria for Device Performance: The document does not explicitly state quantitative or qualitative "acceptance criteria" for the device's performance that would typically be associated with a new or significantly modified device needing to demonstrate its capabilities against specific benchmarks. The focus is on demonstrating that the device performs similarly to previously cleared devices for its expanded indications.
• Study Proving Device Meets Acceptance Criteria: Consequently, there is no detailed study described that proves the device meets such acceptance criteria. The performance testing sections (9.12) describe a "Clinical Literature Review" and "Cadaveric Testing."
  • The Clinical Literature Review supports the use of the system for expanded indications, but doesn't quantify device performance against specific targets.
  • The Cadaveric Testing states that "The Medtronic Electric Drill System is acceptable for its intended use in various surgical procedures," which is a qualitative conclusion rather than a demonstration against defined acceptance metrics. There are no details about what was measured, how it was measured, or what values would be considered acceptable.

Therefore, I cannot provide the requested table or detailed information regarding sample sizes, data provenance, ground truth establishment, or specific performance metrics from the provided document.

The document's purpose is to establish substantial equivalence based on comparable performance and indications for use, rather than to present a de novo study with explicit acceptance criteria for a new device's performance.

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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 Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Additionally, the Pneumatic Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

• Lumbar Microdiscectomy
• Lumbar Stenosis Decompression
• Posterior Lumbar Interbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Anterior Lumbar Interbody Fusion (ALIF)
• Direct Lateral Interbody Fusion (DLIF)

The Pneumatic Drill System is a pneumatically powered high-speed drill system consisting of a choice of various Pneumatic Handpieces (comprising of a High Pressure and Exhaust Hose, and Handpiece) equipped with a foot or finger controller, Pneumatic Foot Control Unit, Surgical Dissecting Tools, System Accessories, and where applicable, Attachments to support various Surgical Dissecting Tools, and System Accessories.

The provided text describes a 510(k) premarket notification for a surgical drill system. This type of submission is for establishing substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a study with quantifiable performance metrics. Therefore, many of the requested categories are not applicable or cannot be extracted directly from this document.

However, I can provide information based on the typical content of a 510(k) summary regarding performance claims and testing.

Here's an analysis of the provided information relative to your request:

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

This document does not provide a table of acceptance criteria with corresponding performance metrics in the way one might expect for an AI/CAD diagnostic device. The "performance" described is largely functional and safety-based, focused on equivalence to predicate devices and suitability for expanded indications.

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

• Test Set (Cadaveric Testing): The document mentions "Users evaluated the acceptability of the subject drill system to its intended use on a variety of procedures using cadavers." However, the specific sample size of cadavers used is not provided.
• Data Provenance: Not specified, but likely from a laboratory or clinical setting where cadaveric studies are conducted. It would be considered prospective for the purposes of evaluating the device for expanded indications.

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)

• The document states "Users evaluated the acceptability...". The number and specific qualifications of these "users" (likely surgeons or medical professionals) are not provided. Their role was to evaluate the acceptability of the drill system, which serves as the "ground truth" for its functional performance in a surgical simulation.

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

• The document does not describe a formal adjudication method (like 2+1 or 3+1) for the cadaveric testing. The phrase "Users evaluated the acceptability" suggests a direct evaluation by the involved parties, but no specific adjudication process is detailed.

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 comparative effectiveness study was not done. This type of study is relevant for AI/CAD systems that assist human readers in tasks like image interpretation. This submission is for a surgical drill system, which does not involve "human readers" in the context of image interpretation.

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

• No, a standalone AI algorithm performance study was not done. This device is a physical surgical instrument, not an AI algorithm. Its performance is intrinsically linked to human-in-the-loop operation by a surgeon.

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

• For the cadaveric testing: The "ground truth" was established by the evaluation and assessment of the surgical performance and acceptability by the "users" (presumably surgeons) during simulated surgical procedures on cadavers. This would fall under a form of expert assessment/consensus regarding functional performance and safety.
• For the clinical literature review: The "ground truth" was based on existing published clinical evidence regarding the safe and effective use of drill systems.

8. The sample size for the training set

• Not applicable. This document describes a physical surgical device, not an AI model that requires a training set.

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

• Not applicable. As above, no training set for an AI model is involved.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence for a physical surgical device and its suitability for expanded indications through functional testing and literature review, rather than quantifiable performance metrics typical of AI or diagnostic devices. Therefore, many of the specific questions about AI study design and ground truth establishment for AI models are not relevant to this document.

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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).

• Deposited known quantities of blood volume and Hb mass into canisters.
• Canister fluid samples represented clinically-expected ranges and distributions of fluid volume, dilution (by saline), Hb mass, hemolysis levels, ambient light illuminance, and serum patient Hb.
• Triton Canister App used to capture scans under three different ambient lighting conditions.
• User-entered volumes were recorded.
• Images and volumes transferred to server-based software to calculate Triton cHbL.
• cHbL compared to pre-measured Hb mass (Assay cHbL).
• Result: Strong positive linear correlation between Triton cHbL and Assay cHbL across tested conditions.
• Result: Bias and outer 95% CIs of the Bland-Altman Limits of Agreement fell within pre-determined acceptance criteria.
• This testing informed look-up tables and "error estimate" values displayed on the user interface. |
  | Software display of cumulative error | Software display must include an estimate of the cumulative error associated with estimated blood loss values. | Met: An estimate of the cumulative error associated with blood loss values is displayed to the user with each estimated hemoglobin mass and blood loss value. The results of verification testing and Bland-Altman methods inform these displayed values. |
  | Human factors testing and analysis | Validate that the device design and labeling are sufficient for appropriate use by intended users of the device. | Met: A usability study was conducted in a simulated setting with personnel who track blood loss during surgical procedures. Both quantitative and qualitative survey data were collected. All users successfully completed tasks per protocol pass/fail criteria. |
  | Electromagnetic Compatibility (EMC) and wireless performance | Appropriate analysis and non-clinical testing must validate the EMC and wireless performance of the device. | Met: EMC and wireless coexistence testing completed for the predicate device (Pixel 3 System) using the same iPad 2 was reviewed. The iPad 2 was found to be EMC compatible with the operating room environment (Class B requirements of IEC 60601-1-2:2007) and maintained essential wireless functionality under noisy conditions. |
  | Software verification, validation, and hazard analysis | Appropriate software verification, validation and hazard analysis must be performed. | Met: Software is considered a moderate level of concern. All elements of software information for moderate LOC devices (per FDA Guidance May 11, 2005) were provided, including development program, hazard analysis (patient's and user's standpoint), validation process, system-level test protocols, pass/fail criteria, results, and cybersecurity risk mitigation. Testing demonstrated software performs as intended and risks are mitigated. |
  | Labeling | Labeling must include:
  A. Warnings, cautions, and limitations for safe use;
  B. Detailed summary of performance testing pertinent to use, including bias and variance;
  C. Validated surgical materials, range of hemoglobin mass, software, hardware, and accessories;
  D. EMC and wireless technology instructions and information. | Met: Labeling includes all required details from the special controls. |

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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