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ZIPCLIP is indicated for use in surgical procedures to occlude blood vessels.

The GEM ZIPCLIP (ZIPCLIP) is a sterile, single-use automatic microclip applier. Each device contains 15 titanium microclips. When applied on a vessel, microclips remain with the patient as permanent implants. ZIPCLIP is for prescription use only and the use environment is the operating room. The ZIPCLIP device is a pre-loaded, disposable, single-patient use mechanical assembly comprised of plastic and metal components. The applier device has (2) scissor-like handles that, when driven medially, close the distal jaws forming a closed clip the device in the open configuration. When released, the handles return to their resting state and the closed clip disengages from the applier. Simultaneously, a new clip is automatically loaded into the distal jaws for consecutive firing. When ZIPCLIP is empty a lockout clip (anodized gold in color) deploys between the jaws, preventing them from closing. The ZIPCLIP is a mechanical assembly comprised of plastic and metal components. The clips are composed exclusively of titanium (Grade 1) and are supplied sterile in a preloaded channel that is incorporated into the number of clips per applier is fifteen (15). The clips are stacked and contained internal to the device. Clips cannot be reloaded once the stack is deployed and the applier is disposed of once emptied. Note, the ZIPCLIP preloaded microclips that can be used with the ZIPCLP device.

Here is an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your request.

Please note: The provided document is a 510(k) summary for a medical device (GEM ZIPCLIP, an implantable clip) and primarily focuses on demonstrating substantial equivalence to a predicate device. It describes performance testing but does not detail acceptance criteria in the format of specific thresholds for metrics like sensitivity, specificity, accuracy, or human reader improvement, which are typical for AI/ML-based medical devices or diagnostic tools. The document describes a traditional medical device (a surgical clip) and its mechanical performance rather than the performance of a software algorithm. Therefore, many of your requested points related to AI/ML device studies (e.g., ground truth establishment for training sets, MRMC studies, standalone algorithm performance, AI assistance effect size) are not applicable to this document's content.

Acceptance Criteria and Device Performance for GEM ZIPCLIP

As per the provided 510(k) Summary for the GEM ZIPCLIP, the device is a sterile, single-use automatic microclip applier containing titanium microclips for occluding blood vessels. The performance testing described is focused on the mechanical and functional aspects of the device, rather than the diagnostic capabilities typical of AI/ML software.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific, quantitative acceptance criteria (e.g., success rates, tensile strength thresholds) with corresponding numerical reported performance values. Instead, it states the purpose of the testing and implies successful meeting of implicit performance criteria necessary for safe and effective occlusion.

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

• Sample Size for Test Set: The document does not specify the exact number of test units (e.g., appliers, clips) or the number of vessels or simulations used in the bench testing. It broadly states that "bench performance testing" was performed.
• Data Provenance: The testing was "bench testing" conducted by Baxter (Synovis Micro Companies Alliance is part of Baxter, as indicated by the contact email). This implies a controlled laboratory environment.
  • Country of Origin: Not explicitly stated, but typically assumed to be the country of the manufacturer or its testing facilities (likely USA, given the FDA submission).
  • Retrospective or Prospective: Not applicable as this relates to clinical data. The bench testing would be considered prospective in its execution (i.e., tests were planned and executed to gather performance data).

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

This concept is not applicable to this type of device and study. The "ground truth" for a surgical clip is its physical performance (e.g., does it close properly, does it occlude a vessel, does it stay closed). This is assessed via engineering and mechanical testing, not by expert interpretation of images or clinical outcomes in the diagnostic sense.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts are involved in interpreting complex data (e.g., medical images) to establish a consensus "ground truth." For the mechanical testing of a surgical clip, direct measurements and observable outcomes determine performance.

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

No, a MRMC study was not done. This type of study is specifically designed for evaluating diagnostic devices, especially those involving AI, to measure the impact of AI assistance on human reader performance. As the GEM ZIPCLIP is a mechanical surgical device and not a diagnostic tool, an MRMC study is not applicable. Therefore, there is no effect size reported for human readers improving with AI assistance.

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

Not Applicable. The GEM ZIPCLIP is a physical medical device (surgical clip applier), not a software algorithm. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is:

• Physical Verification/Measurement: Successful deployment, proper closure of clips, and effective occlusion on "simulated vessels" using "benchtop models."
• Material Properties Testing: Verification of titanium material (Grade 1) and MR-Conditional properties.
• Functional Observation: Observing the mechanical actions of the applier (e.g., automatic loading, lockout mechanism).

Essentially, the "ground truth" is established by direct engineering and biomechanical testing demonstrating the functional capabilities and material characteristics of the device.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML algorithm, so there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the GEM ZIPCLIP device.

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The Gemini Cervical Fusion Cage System is indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one levels from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Gemini Cervical Fusion Cage System requires additional supplemental fixation cleared for the cervical spine. The Gemini Cervical Fusion Cage System is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment.

The Gemini Cervical Fusion Cage Systeme is an anterior cervical interbody device consisting of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is to be implanted via an open, anterior approach.

The Gemini Cervical Fusion Cage System is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The radiolucent PEEK-OPTIMA®material allows visualization of the defect site on radiography to assess bone growth and incorporates tantalum markers conforming to ISO13782 to permit verification of position. The Gemini Cervical Fusion Cage System is provided sterile via gamma irradiation for single use.Instruments are provided clean and non-sterile for steam sterilization at the user's facility.

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves a device meets acceptance criteria related to AI/ML or diagnostic performance.

The document is an FDA 510(k) clearance letter for a medical device called the "Gemini Cervical Fusion Cage System," which is an intervertebral body fusion device. The clearance is based on the substantial equivalence to a predicate device, focusing on:

• Mechanical performance: Verified through testing per ASTM F2077 and ASTM F2267, including static and dynamic axial compression, compression shear, torsional testing, and subsidence testing. The document states that "Test results meet the acceptance criteria described in ISO 23089-2 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices."
• Material: PEEK-OPTIMA® LT1 with tantalum markers, which is a common material for such implants.
• Design features: Graft windows, serrations, and comparable dimensions to the predicate.
• Sterilization: Gamma irradiation for single use.
• Intended Use and Indications for Use: Defined for anterior cervical interbody fusion procedures for cervical disc disease.

There is no mention of an AI/ML component, diagnostic performance, human readers, ground truth establishment, or any of the other criteria you listed that would be relevant to an AI/ML-driven device evaluation (e.g., MRMC studies, sample sizes for test/training sets, expert qualifications for ground truth).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the information provided.

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The Gemini Medical Cage System is indicated for use with autogenous 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 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.

Gemini Medical Cage System is manufactured from a biocompatible polymer (Polyetheretherketone (PEEK)) material embedded with radiopaque tantalum marker pins, which allow the surgeon to radiographically determine the position of the implant, both intraoperatively and postoperatively. The System consists of PEEK lumbar cages of various shape and size, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries.They are designed with angular teeth to allow the implant to grip the superior and inferior end plates. The top surface of the cages have anatomical design, parallel design and wedge-shaped design respectively to adapt various vertebrae anatomical scenarios. The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The cages are sterile provided and for single use. There are six models to accommodate different types of superior and inferior end plates depending on their technical design and shape, LF-I, LF-II, LF-III, LF-IV, LF-V and LF-VI. LF-I, LF-IV and LF-VI have curved top and bottom tooth surface, LF-II has flat top and bottom tooth surface, LF-III and LF-V have flat or wedge-shaped surface. LF-III, LF-IV and LF-V cages have a convex angle.

Here's an analysis of the provided text regarding the Gemini Medical Cage System, structured to answer your questions.

Important Note: The provided document is a 510(k) summary for a medical device. This type of submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than comprehensive clinical trials proving efficacy de novo. Therefore, many of your questions about AI study design (like ground truth, expert adjudication, MRMC studies, training/test sets) are not applicable to this type of traditional medical device clearance for an orthopedic implant.

This document focuses on demonstrating that the Gemini Medical Cage System performs equivalently to existing devices through non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative way for each test in a pass/fail format with specific thresholds. Instead, it lists the bench tests performed according to ASTM standards and implies that the device met the requirements of these standards to demonstrate substantial equivalence to predicate devices. The "reported device performance" is the successful completion of these tests, indicating compliance with the relevant ASTM standards for intervertebral body fusion devices.

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

• Sample Size: The document does not specify the exact number of devices tested for each bench test. For mechanical bench testing, the sample size is determined by the specific ASTM standard and statistical requirements for device qualification, but these details are not provided in this 510(k) summary.
• Data Provenance: The data is from non-clinical bench testing performed on the devices themselves. There is no patient data involved in this type of submission for this device. The tests were likely conducted by or for ZheJiang Decans Medical Devices Co., Ltd., which is based in China.

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

• Not Applicable. This is a mechanical orthopedic implant, not an AI/software device that requires expert-established ground truth from medical images or clinical data. The "ground truth" here is compliance with established engineering and biocompatibility standards (e.g., ASTM standards for mechanical properties).

4. Adjudication Method for the Test Set

• Not Applicable. As this is not a study involving human interpretation or subjective assessments, there is no adjudication method in the traditional sense. The "adjudication" is whether the device passed the objective criteria of the specified ASTM bench tests.

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 physical medical device (intervertebral body fusion device), not an AI software. Therefore, no MRMC studies or AI-assisted performance evaluations were conducted or are relevant.

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

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

7. The Type of Ground Truth Used

• Engineering Standards and Biocompatibility Testing: The "ground truth" for this device's performance demonstration lies in its compliance with recognized mechanical testing standards (ASTM F2077, ASTM F2267) and the biocompatibility of its materials (PEEK and tantalum markers). The goal is to show that the device is mechanically and biologically equivalent to predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI software requiring a training set.

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

• Not Applicable. This is a physical medical device, not an AI software requiring a training set.

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FLOW NOW is intended for monitoring blood flow in vessels.

FLOW NOW is indicated for monitoring blood flow in peripheral vessels during and following reconstructive microvascular procedures, re-implantation, and free flap transfers. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days postoperatively.

The GEM FLOW NOW (FLOW NOW) device is comprised of an implantable non-active silicone vessel sleeve (Figure 2), a 20 MHz ultrasonic Doppler transducer (probe) and probe wire, suture sleeve, probe connector, and an external lead that connects to a monitor. FLOW NOW has a soft, pliable silicone "vessel sleeve" that retains the Doppler probe via press-fit into a silicone bore. The device comes with vessel sleeve and probe already assembled.

The FLOW NOW Device is intended for monitoring blood flow in vessels. It is indicated for monitoring blood flow in peripheral vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively. The FLOW NOW device is intended for use with both currently cleared FLOW COUPLER Monitors (GEM1020M and GEM1020M-2).

The probe is removed from the patient 3 to 14 days after implantation, once monitoring is complete. The probe is separated from the vessel sleeve and removed from the patient's body. non-invasively, by the surgeon pulling on the probe wire outside the patient's body. The silicone vessel sleeve remains permanently implanted. The FLOW NOW device can be used to monitor blood flow through veins and arteries ranging from 2.0 to 4.0 mm in outside diameter.

The provided text is a 510(k) Summary for the GEM FLOW NOW (GEM2770-FN) device. It details the device's technical characteristics and claims of substantial equivalence to a predicate device but does not contain information about the acceptance criteria or a study proving device performance against those criteria in the context of human reader improvement with AI assistance (MRMC study) or standalone algorithm performance.

The document primarily focuses on non-clinical bench testing to demonstrate that the GEM FLOW NOW met defined specifications and comparable performance to its predicate device. It explicitly states that "Clinical performance testing was not required for the GEM FLOW NOW device."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance in those specific contexts, sample sizes for test sets, data provenance, expert details, adjudication methods, MRMC study effect sizes, or standalone algorithm performance.

Here's what I can extract based on the provided text, focusing on the available performance data:

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

The document mentions that "Pre-determined performance specifications were tested, and verification and validation activities were conducted to demonstrate that the GEM FLOW NOW met the defined criteria." However, the specific quantitative acceptance criteria and the detailed reported device performance are not provided in this document. It only states a general conclusion: "The GEM FLOW NOW met acceptance criteria and demonstrated comparable performance to the predicate device for the equivalent indications for use."

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

This information is not provided as the performance data described is non-clinical bench testing, not a clinical study with a test set of patient 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)

This information is not applicable/provided. The document discusses non-clinical bench testing, not studies requiring expert review of patient data for ground truth establishment.

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

This information is not applicable/provided. No clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing was not required for the GEM FLOW NOW device." This means no study involving human readers or AI assistance was conducted or reported here.

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

A standalone algorithm performance study was not done. The device is a physical diagnostic tool (ultrasonic pulsed doppler imaging system) and not an AI algorithm.

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

For the non-clinical bench testing, the ground truth would be based on engineering specifications and measurements from the physical device. Specific details are not provided.

8. The sample size for the training set

This information is not applicable/provided. The device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable/provided. The device is not an AI/ML algorithm that requires a training set.

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The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry (tHb, O2Hb, MetHb, HHb, sO2*) parameters from arterial, venous, or capillary lithium heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

*s02 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.

• · pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid- base disturbances.
• · Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
• Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insividus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
• Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment
• of disease conditions characterized by low or high blood potassium levels.
• Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.
• Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.
• · Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
• · Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism
• disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
• · Lactate (Lac) measurement is used:
• to evaluate the acid-base status of patients suspected of having lactic acidosis;
• to monitor tissue hypoxia and strenuous physical exertion;
• in the diagnosis of hyperlactatemia.
• · Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.

• CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin species.

– Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

• COHo: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

• MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.

• HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.

• O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status.

• sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

The GEM Premier 7000 with iQMs system provides health care professionals with quantitative measurements of lithium heparinized whole blood pH, pCO2, pO2, Na*, K*, Ch, Ca**, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO₂*) from arterial, venous or capillary samples at the point of health care delivery in a clinical setting and in a central laboratory.

*sO₂ = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.

Key Components:
Instrument: It employs a unique touch-sensitive color screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
PAK (Cartridge): All required components for sample analysis are contained in the GEM PAK, including sensors, optical cell for CO-Oximetry and total bilirubin, sampler, pump tubing, distribution valve, waste container and Process Control Solutions. The GEM PAK is an entirely closed analytical system. The operator cannot introduce changes to the analytical process before or during the GEM PAK's use-life on board the instrument. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests. The setup of the instrument consists of inserting the GEM PAK into the instrument. The instrument will perform an automated GEM PAK start-up during which the following is performed: warm-up (15 minutes), sensor conditioning (10 minutes), Process Control Solution (PCS) performance (15 minutes), all of which take about 40 minutes. After GEM PAK start-up, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte (PC Solution D and E), are run by the analyzer to validate the integrity of the PC Solutions and the overall performance of the analytical system. Note: GEM PAKs that include tBili analyte will require the successful performance of CVP 5 tBili. Includes all necessary components for hemolysis detection, such as an acoustofluidic flow cell, an LED light source and an optical detector, for appropriate flagging of potassium measurements in whole blood samples without additional sample volume or sample processing steps.
Intelligent Quality Management (iQM3): iQM3 is used as the quality control and assessment system for the GEM Premier 7000 system. iQM3 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external QC. iQM3 introduces hemolysis detection in whole blood samples, enhancing quality assessment in the pre-analytical phase of testing.

Based on the provided text, the device in question is the GEM Premier 7000 with iQM3, which is a portable critical care system for analyzing blood samples. The document describes its comparison to a predicate device, the GEM Premier 5000, and discusses its performance studies.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The document does not provide a direct table of specific numerical acceptance criteria for each analyte's performance (e.g., pH, pCO2, Na+, etc.) nor does it list the reported device performance in those exact terms. Instead, it states that "All verification activities were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met."

The "Performance Summary" section lists the types of studies conducted to demonstrate that the modifications (specifically the new iQM quality check/Hemolysis detection module) do not impact the performance data represented in the Operators Manual, aligning with recognized guidelines. This implies the acceptance criteria are tied to maintaining performance comparable to the predicate device and being within acceptable ranges as defined by the mentioned CLSI guidelines.

Therefore, a table of explicit numerical acceptance criteria and reported performance values for each analyte is NOT AVAILABLE in the provided text. The document broadly states that the device met its acceptance criteria.

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 mentions several types of performance studies:

• Verification (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Interference on Potassium, Hemolysis Verification)
• Shelf-life and Use-life studies

However, the specific sample sizes used for these test sets are NOT provided in the text. There is also no information about the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This information is NOT available in the provided text. The device is an in-vitro diagnostic (IVD) instrument that provides quantitative measurements of various blood parameters. The "ground truth" for such devices typically comes from reference methods, calibrated standards, or comparative analyses with established, highly accurate laboratory instruments, rather than human expert consensus on interpretations like with imaging.

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

Given that this is an IVD device for quantitative measurements of blood parameters, the concept of "adjudication" by multiple human readers (like in imaging studies) does not directly apply. Performance is assessed through analytical accuracy, precision, and interference studies against known standards or reference methods. Therefore, no adjudication method in the sense of expert consensus on interpretations is described or implied.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. This type of study is relevant for AI-assisted diagnostic tools where human interpretation is part of the workflow. The GEM Premier 7000 with iQM3 is described as an analytical instrument providing direct quantitative measurements, not an AI system assisting human readers with interpretation. The "iQM3" refers to Intelligent Quality Management, which is an automated quality control system for the instrument itself, not an AI for human diagnostic assistance.

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

The device itself is a standalone analytical instrument. The performance studies described (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Verification, etc.) essentially represent "standalone" performance, as they evaluate the accuracy and precision of the instrument's measurements directly. The iQM3 system is an internal quality control mechanism for the device's measurements. Therefore, yes, a standalone performance evaluation of the device's analytical capabilities was implicitly done.

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

For a device that provides quantitative measurements of blood parameters, the "ground truth" for the test set would typically be established using:

• Reference methods: Highly accurate and precise laboratory methods for measuring each analyte.
• Calibrated standards: Solutions with precisely known concentrations of the target analytes.
• Comparison to predicate device: As this is a 510(k) submission, a primary method of establishing "ground truth" performance for the new device is by comparing its measurements against those of a legally marketed predicate device (GEM Premier 5000), which itself would have been validated against reference methods and standards.

The text mentions "two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards" for "Auto PAK Validation (APV)". This strongly suggests that traceable standards and potentially CLSI-defined reference methods were used to establish the ground truth for performance evaluation.

8. The sample size for the training set

The document describes the GEM Premier 7000 with iQM3 as a medical device for quantitative measurements, not explicitly as a machine learning/AI model that requires a "training set" in the conventional sense (i.e., for supervised learning). The iQM3 is an "active quality process control program" with "Pattern Recognition (PR) software." While pattern recognition might involve some form of "training" or calibration, the document does not specify a separate "training set" in terms of data volume for such a process. It focuses on the validation of the device's analytical performance. Therefore, the concept of a "training set" sample size as applicable to AI/ML devices is not explicitly discussed or provided.

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

As noted above, the primary function of GEM Premier 7000 with iQM3 is quantitative measurement. If the "iQM3" component involved training for its "Pattern Recognition (PR) software," the document does not detail how a specific ground truth for such training was established. It primarily discusses the use of "Process Control Solutions (PCS)" and "Calibration Valuation Product (CVP 5)" for system checks and validation ("Auto PAK Validation (APV) process"). These solutions, traceable to NIST or CLSI standards, function as internal reference points for the device's operational checks and quality control, which could be considered an ongoing form of "ground truth" to maintain analytical performance, rather than a one-time "training set" for model development.

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The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of sodium (Na+), Potassium (K+), Ionized Calcium (Ca++), Chloride (Cl-), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance.

Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:

· Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

· Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

· Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. · Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

· Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

· Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.

· Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

· Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

· Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.

· Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3-) is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

· pH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

The GEM Premier ChemSTAT system provides fast, accurate, quantitative measurements of Sodium (Na"), Potassium (K*), Ionized Calcium (Ca*), Chloride (Cl·), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous lithium heparinized whole blood.

The provided text describes a Special 510(k) submission for an upgrade to the operating system of the GEM Premier ChemSTAT device. The device itself is an in vitro diagnostic (IVD) system for quantitative measurements of various blood parameters. The submission focuses on the software upgrade rather than a change in the device's fundamental function or performance.

Therefore, the "acceptance criteria" and "reported device performance" in this context refer to the successful verification and validation of the software upgrade and the continued adherence to the established performance of the unmodified device, as the indications for use and performance claims remain unchanged. The study proving this essentially consists of the software verification and validation activities.

Here's the information extracted from the document, tailored to the context of a software upgrade:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a software upgrade with no changes to the performance claims of the device, the general acceptance criteria are that the upgraded software performs as intended without adversely affecting the device's established performance specifications. The reported device performance is that these criteria were met.

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 does not specify a "test set sample size" or "data provenance" in the traditional sense for evaluating diagnostic performance. The focus is on software verification and validation. Therefore, the "sample" for testing the software functionality would be the various test cases and scenarios designed to validate the operating system upgrade and its interaction with the GEM Premier ChemSTAT application software.

The document states: "Performance data is limited to Software Verification and Validation as the scope of this Special 510(k) is specific to an operating system upgrade from Fedora 17 Linux to WindRiver LTS 18 Linux."

Further details on the specific number of test cases, the nature of the data (e.g., simulated, actual runs on the device), or its origin are not provided in this summary.

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)

This information is not applicable to a software operating system upgrade as described. "Ground truth" in the context of expert consensus is typically relevant for diagnostic performance studies where human interpretation or a gold standard reference is needed (e.g., pathology for an imaging device). Here, the "ground truth" is the proper functioning of the software and its integration with the hardware, which is evaluated through engineering and software testing.

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

This information is not applicable for a software operating system upgrade. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretation of diagnostic results. Software verification and validation typically rely on predefined test outcomes and engineering assessments.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. An MRMC comparative effectiveness study is used to evaluate the impact of an AI algorithm on human reader performance, usually for diagnostic tasks. This submission is for a software operating system upgrade for an existing IVD device, not for a new AI algorithm.

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

The concept of "standalone performance" in the context of an algorithm's diagnostic capability (like an AI algorithm) is not directly applicable here. The device itself (GEM Premier ChemSTAT) operates to provide quantitative measurements. The software upgrade ensures the continued, correct operation of the device. The verification and validation activities demonstrate that the upgraded software performs its functions correctly as part of the overall device system.

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

For this software upgrade, the "ground truth" is the expected behavior and functionality of the software and the device. This is established through:

• Functional specifications: The software is expected to perform according to its design specifications.
• Risk analysis: The software should not introduce new risks or fail to mitigate existing ones.
• Cybersecurity standards: The software should meet cybersecurity requirements.
• Established device performance: The software upgrade should not negatively impact the established analytical and clinical performance of the GEM Premier ChemSTAT device (which relies on the physical and chemical principles of its measurements).

The document explicitly states that the changes "do not introduce...changes to labeled performance claims." This implies that the performance of the device (e.g., accuracy, precision of Na+, K+, Glu measurements) remains the same as previously cleared, and the software upgrade was validated not to alter these.

8. The sample size for the training set

This information is not applicable. Training sets are used for machine learning models. This submission describes a conventional software operating system upgrade (Fedora 17 Linux to WindRiver LTS 18 Linux) for an existing IVD device, not the development or retraining of a machine learning algorithm.

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

This information is not applicable, as there is no training set for a machine learning model; it is a software operating system upgrade.

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The Cardioblate™ Gemini™ Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.

The Cardioblate Gemini surgical ablation device (Model 49351), figure 1 below, is a handheld, single-use, bipolar, radio-frequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. This device is intended for intermittent operation.

Model 49260 of the Cardioblate Gemini surgical ablation device is intended for use with Cardioblate 68000 Generator (figure 2), whereas Model 49351 is intended for use with the Valleylab™ FT10 Energy(figure 3), whereas model 49260 is intended for use with Cardioblate 68000 Generator(figure 3). The devices are provided sterile and nonpyrogenic, are disposable, and are for single use only. They are sterilized using ethylene oxide.

The Cardioblate Gemini-s is a bipolar electrode device that transmits radio frequency energy, generated by an external generator, between the two electrodes. The device has dual linear electrodes, 6.3 cm in length, with integral fluid delivery to the electrodes. The Gemini-s device is port accessible, intended for open or closed chest procedures to ablate tissue through resistive heating due to radiofrequency energy passing through tissue. The device is designed to reproduce the Cox-Maze lesion pattern by creating linear transmural lesions in both atria of the heart during cardiac procedures.

The Gemini-s surgical ablation device has a flexible neck design that provides the physician with the ability to access various anatomies utilizing a neck curve through the full range from 0 to 180-degree configuration.

Once the electrodes are correctly positioned, the parallel jaws lock by squeezing the handle. The electrodes have full contact with the tissue and the locking mechanism must be fully engaged to ensure accurate transmurality readings. Simultaneous with the actuation of the trigger and jaw closure is the opening of the (normally closed) fluid path to start the flow of saline. The device automatically shuts off the saline when the jaws are open and when the device is not in use.

The provided document is a 510(k) summary for the Medtronic Cardioblate Gemini-s 49260 and 49351 Surgical Ablation Devices. It states that the submission is a "Special 510(k) Notification" and that modifications were verified through "design verification testing." It also indicates that the "DFMECA file was updated along with the Risk Management File to reflect the current status and risk evaluations at the device and system level."

However, the document does not describe specific acceptance criteria and the study that proves the device meets those criteria, nor does it provide the detailed information requested in points 1-9 of your prompt.

The document focuses on demonstrating substantial equivalence to predicate devices (K121767 and K200514) based on having the same:

• intended use/indications for use
• contraindications
• operating principle
• energy type
• mechanism of action
• radiofrequency generator and delivery system
• patient contacting materials
• shelf life
• sterilization process
• dimensions
• performance
• irrigation
• electrical characteristics
• packaging configuration and materials

The only changes mentioned are "IFU updates (new warning and updated directions for use)." The document concludes that these changes "do not arise from different technological characteristics of the devices or raise different questions of safety and effectiveness."

Therefore, based solely on the provided text:

No information is available regarding specific acceptance criteria, reported device performance data, study design details (sample size, data provenance, expert involvement, adjudication), comparative effectiveness studies (MRMC), standalone performance, or training set details as requested. The document refers to "design verification testing" broadly, but does not provide any specifics about these tests, the criteria used, or the results obtained.

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GEM™ BIOVER disposable microvascular clamps are instruments which are used for all microsurgical procedures. They are used to occlude vessels during anastomosis, which is necessary as a result of vessel damage or thrombosis.

The GEM™ Biover Microvascular Clamps (Clamps) are arterial and venous clamps in both single and double clamp configurations, available in varying sizes. The clamps are sterile, disposable clamps for single use. The clamps are used in microsurgery, plastic surgery, and hand surgery for the temporary occlusion of blood vessels during an anastomosis.

The clamps are available for arteries and veins. The clamping force is higher for the arterial clamps than for the veinous clamps. The clamps are identified by a product reference code and by the color of the clamp. The clamps for veins are green, and the clamps for arteries are yellow.

The clamps are packaged individually in two Tyvek pouches (double pouched). The devices in the Tyvek pouches are gamma sterilized and are placed in cartons of 10. The clamps are used once and are disposed of after use.

This document is a 510(k) summary for the GEM™ Biover Microvascular Clamps, asserting their substantial equivalence to a previously cleared predicate device. This type of submission generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria in a robust statistical study.

Based on the provided text, the device is not an AI/ML powered device, nor is it a diagnostic device that requires high-level performance metrics, such as sensitivity, specificity, or AUC. The submission is for a physical medical device (microvascular clamps). Therefore, the information requested in the prompt regarding AI/ML performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment is not applicable to this document.

The document states:

• "The GEM Biover microvascular clamps remain unchanged from the predicate device."
• "There are no engineering or performance changes to the device or its packaging."

The "performance data" section mentions:

• "The label design change and the outer carton sales unit design change were assessed and validated in a Packaging Summative Human Factors/Usability Study."
• "Historical complaint data were reviewed and indicate no use-related concerns, thus, there are no use-related risks or complaints that trigger a need for further Human Factors validation."

This indicates that the "performance" considered for this submission relates to packaging and user interface (labeling/carton design), and the study conducted was a human factors/usability study, not a clinical performance study measuring accuracy or efficacy of a medical algorithm.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, AI/ML performance, and ground truth for a diagnostic or AI-powered device, as these details are not present and are not relevant to this type of device submission.

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Brasseler GEM is a USB-driven digital intraoral x-ray sensor which is intended to acquire dental radiographic images. Brasseler GEM must be operated by healthcare professionals who have been trained and are competent using various methods of acquiring radiographic images of dental anatomy. Brasseler GEM can be used with dental positioning devices and holders to assist with aligning an x-ray source beam with the sensor and anatomy. Brasseler GEM can also be aligned by hand with assistance of patient.

Brasseler GEM is a USB-driven digital sensor designed for health care professionals already acquainted with the standard procedures for acquiring dental intraoral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using appropriate additional diagnostic aides, professional judgement, and experience.

Brasseler GEM10 is for pediatric use and adult periapical use, GEM15 is for pediatric and adult bitewing and periapical use, and GEM20 is for adult use including bitewings. The Brasseler GEM design uses advanced ergonomic principles with four beveled corners, a moderate profile, and a rounded casing providing enhanced comfort for patients. Brasseler GEM is positioned in the patient's mouth in the same manner as intraoral film is positioned.

Brasseler GEM has a CMOS x-ray imager that creates a digital image from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to Brasseler GEM through the standard USB port. Image analysis software is not part of the submission. For Brasseler GEM to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer. Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings. Brasseler GEM capture x-ray images suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions. Inadequate images may result in misdiagnosis thereby subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient. Functions of the Brasseler GEM detector are controlled by software (firmware). The software of Brasseler GEM is of Moderate Level of Concern and is not based on the software of the predicate, Clio Prime.

Brasseler GEM shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs. Brasseler GEM can be used either in combination with positioners manufactured to facilitate the positioning and alignment with an x-ray beam, or it may also be positioned by hand with the assistance of the patient. Brasseler GEM can be used with patients of any age, providing the correct positioning of the sensor in the patient mouth can be realized. Using Brasseler GEM is a suitable diagnostic method and may offer reduced radiation exposure compared to analog procedures. Available software image enhancement tools may enhance sensitivity and consequently reduce errors introduced by subjective analysis. Brasseler GEM can perform and achieve the same type of two-dimensional images as conventional (traditional) film sizes 0, 1 and 2. Brasseler GEM cannot be used to, or as a substitution for extraoral or other types of dental x-ray. When using Brasseler GEM and software as a diagnostic aide, clinical experience and a combination of the diagnostic aides should be used to form a diagnosis and should not be solely relied upon for diagnosis.

The provided text describes Brasseler GEM, a digital intraoral x-ray sensor, and its equivalence to a predicate device, Clio Prime. The document primarily focuses on demonstrating substantial equivalence through comparison of technical specifications, rather than providing detailed acceptance criteria from a clinical study for diagnostic performance.

Therefore, the response below will focus on the information available in the provided text, and will explicitly state when information requested cannot be found.

Acceptance Criteria and Device Performance Study for Brasseler GEM

The provided document, a 510(k) summary, primarily relies on bench testing and comparison to a predicate device (SOTA Imaging's Clio Prime) to establish substantial equivalence. It does not detail specific diagnostic performance acceptance criteria in the manner one might find for an AI-based diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating that the Brasseler GEM is as safe and effective as the legally marketed predicate device.

The "study that proves the device meets the acceptance criteria" largely refers to the comparative analysis presented through the Comparison Table and the stated equivalence of technical performance metrics like MTF and DQE.

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

Based on the provided document, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, Clio Prime. The performance is assessed by comparing technical specifications and affirming identical/equivalent performance in areas relevant to image quality.

Note: The document emphasizes that "Brasseler GEM is not only similar in performance as Clio Prime but is also safe and effective based on performance testing." The performance testing mentioned is primarily bench testing and direct comparison of specifications.

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

The document refers to "extensive bench testing" and "clinical images" for performance testing.

• Test Set Sample Size: The specific sample sizes for bench testing are not explicitly quantified in terms of number of devices or number of test cases run beyond "extensive bench testing." For "clinical images," no specific number of images is provided, nor the number of patients/cases represented.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "RealCloud Imaging has provided clinical images."

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

Not applicable / Not specified. The study described focuses on technical equivalence and image acquisition capabilities, not on diagnostic accuracy requiring ground truth established by experts for clinical images. The text states: "Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using appropriate additional diagnostic aides, professional judgement, and experience." This implies the device provides images for human interpretation, rather than an AI producing a diagnosis that needs expert ground truth for validation.

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

Not applicable / Not specified. As the study is focused on technical equivalence rather than diagnostic accuracy determined by human readers, an adjudication method for a test set is not 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 performed as this is a device for image acquisition, not an AI assisting human readers with diagnosis. There is no AI component described that would augment human diagnostic performance.

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

Yes, in a sense. The "performance testing" described (bench tests, MTF, DQE comparison) reflects the standalone performance of the Brasseler GEM sensor and its ability to acquire images, independent of human interpretation or an AI algorithm. However, this is not an "algorithm only" performance meant for diagnostic output. The text states: "Image analysis software is not part of the submission... only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer." This implies the device itself is an image capture hardware without integrated diagnostic algorithms.

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

Not applicable / Not specified. The "performance testing" detailed focuses on technical specifications (MTF, DQE validation against a predicate device) and basic functionality via "clinical images" to show the system works as intended. There is no mention of "ground truth" for diagnostic accuracy established by expert consensus, pathology, or outcomes data, as the device's role is imaging, not diagnosis.

8. The sample size for the training set

Not applicable / Not specified. This device is an x-ray sensor (hardware), not an AI algorithm that requires a training set. The firmware of the device is mentioned as "software... of Moderate Level of Concern," but this refers to its operational control, not an AI model for image interpretation or diagnosis.

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

Not applicable / Not specified. As this device is a hardware sensor and not an AI algorithm requiring a training set, the concept of establishing ground truth for a training set does not apply here.

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