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The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti‐human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin‐coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen‐specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.

The provided FDA 510(k) clearance letter and summary for the NOVEOS Specific IgE (sIgE) Assay outlines the device's performance, but it does NOT describe "acceptance criteria" in an explicit, quantifiable manner that is typically found in a clinical study report. Instead, the document presents study results and compares them to a predicate device (ImmunoCAP Specific IgE) to demonstrate substantial equivalence, and also to clinical diagnosis of allergic status. The closest approximations to acceptance criteria are implicit in the performance metrics presented (e.g., target ranges for sensitivity, specificity, agreement, precision, linearity).

This device is an in vitro diagnostic (IVD) assay, not an AI/ML-based diagnostic imaging or analysis system. Therefore, the concepts of "human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "number of experts," "adjudication method," and "training set ground truth establishment" do not directly apply in the same way they would for AI-powered diagnostic imaging devices. The "ground truth" for this IVD device is established through reference methods (Skin Prick Test, Oral Food Challenge, ImmunoCAP predicate device) or established clinical diagnosis.

Here's a breakdown of the information that is provided and how it relates to the requested points, with interpretations where necessary for IVD context:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit acceptance criteria are not stated. However, the performance data presented effectively serves as the "reported device performance" that presumably met the FDA's requirements for substantial equivalence. I will present the key performance metrics from the document.

Key Performance Metrics (Implicit Acceptance Criteria)

• G010 (Johnson Grass): 72.9% (95% CI 62.7% to 81.2%)
• T007 (Oak): 71.7% (95% CI 58.4% to 82.0%)
• G002 (Bermuda Grass): 76.1% (95% CI 66.3% to 83.8%)
• W001 (Common Ragweed): 62.0% (95% CI 50.3% to 72.4%)
• E005 (Dog Dander): 71.9% (95% CI 54.6% to 84.4%)
• T003 (Common Silver Birch): 55.1% (95% CI 41.3% to 68.1%)
• F001 (Egg White): 52.8% (95% CI 37.0% to 68.0%)
• F002 (Cow's Milk): 50.0% (95% CI 34.1% to 65.9%)
  Literature citation provided for lower sensitivity values to support observed performance. |
  | Clinical Specificity | High, to minimize false positives | Varies by Allergen:
• G010 (Johnson Grass): 99.2% (95% CI 95.9% to 99.9%)
• T007 (Oak): 97.8% (95% CI 92.5% to 99.4%)
• G002 (Bermuda Grass): 97.1% (95% CI 92.9% to 98.9%)
• W001 (Common Ragweed): 93.6% (95% CI 86.8% to 97.0%)
• E005 (Dog Dander): 100.0% (95% CI 95.2% to 100.0%)
• T003 (Common Silver Birch): 100.0% (95% CI 93.2% to 100.0%)
• F001 (Egg White): 100.0% (95% CI 97.4% to 100.0%)
• F002 (Cow's Milk): 100.0% (95% CI 97.2% to 100.0%) |
  | Positive Agreement (vs. ImmunoCAP) | High, demonstrating comparability to predicate device | Varies by Allergen:
• G010 (Johnson Grass): 84.7%
• T007 (Oak): 83.8%
• G002 (Bermuda Grass): 89.4%
• W001 (Common Ragweed): 72.8%
• E005 (Dog Dander): 91.7%
• T003 (Common Silver Birch): 96.0%
• F001 (Egg White): 89.6%
• F002 (Cow's Milk): 64.5% |
  | Negative Agreement (vs. ImmunoCAP) | High, demonstrating comparability to predicate device | Varies by Allergen:
• G010 (Johnson Grass): 99.3%
• T007 (Oak): 94.6%
• G002 (Bermuda Grass): 96.8%
• W001 (Common Ragweed): 95.0%
• E005 (Dog Dander): 96.7%
• T003 (Common Silver Birch): 96.1%
• F001 (Egg White): 96.2%
• F002 (Cow's Milk): 98.9% |
  | Total Agreement (vs. ImmunoCAP) | High, demonstrating overall comparability | Varies by Allergen:
• G010 (Johnson Grass): 92.5%
• T007 (Oak): 88.5%
• G002 (Bermuda Grass): 93.8%
• W001 (Common Ragweed): 82.2%
• E005 (Dog Dander): 94.1%
• T003 (Common Silver Birch): 96.0%
• F001 (Egg White): 94.3%
• F002 (Cow's Milk): 86.9% |
  | Precision (Total %CV) | Typically low %CV for quantitative assays (e.g.,

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The indications for use for the RL-S20S-TWC include:
The Super Hair Removal (SHR) Mode are intended for temporary hair reduction.
The indications for use for the RL-S20S-755A include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick L-VI), including tanned skin.(HR. SHR Modes)
The indications for use for the RL-S20S-810B include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number of airs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

Not Found

The provided FDA 510(k) clearance letter and Indications for Use document for the Artemis Diode Laser System do not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The document primarily focuses on:

• Confirming the substantial equivalence of the device to legally marketed predicates.
• Listing the specific Indications for Use, which primarily involve temporary or permanent hair reduction across different skin types.
• Outlining regulatory compliance requirements (e.g., Quality System regulation, adverse event reporting).

Therefore, based solely on the provided text, it is not possible to answer your questions about the acceptance criteria, device performance study details, or ground truth establishment. This information would typically be found in the full 510(k) submission, which is not included here.

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Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management.

Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes.

Artemis Cryo Treatment Planning module is an add on to the existing Artemis software that allows physicians to prepare for cryo treatment planning based on positive pathology cores obtained during Artemis guided biopsies and registration results with other imaging modalities such as MRI, CT. The module allows accurate placement of cryo probes on targets, 3D tracking, real-time feedback on extend of cryo ice formation. The technology provided by Artemis generates ice models based on the specifications provided by the cryo device manufacturers and displays the models on the live ultrasound to provide guidance to the users during the procedure.

The module also allows outlining or segmenting other organs that surround the prostate. Organs include bladder and urethra.

Artemis is designed to display the 2-D live video received from commercially available ultrasound machines and use this 2-D video to reconstruct a 3-D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, probe, commercially available biopsy needle guide, needle gun combination, and cryoablation systems. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement, reporting and 3-D image registration.

Artemis is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position. The mechanical tracker is connected to a PC-based workstation containing a video digitizing card and running the image processing software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Artemis. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3-D image and 3-D rendered surface model of the prostate.

The reconstructed 3-D image can be further processed to perform various measurements including volume estimation, which can be examined for abnormalities by a physician. Patient information, notes, and images may be stored for future retrieval, and locations for biopsies may be selected by the physician. The system also allows previously acquired 3-D models to be recalled, aligned, or registered to the current 3-D model of the prostate, which is especially useful for patients under active surveillance.

The physician may attach a commercially available biopsy needle guide compatible to the ultrasound probe and use the probe and needle to perform tissue biopsy and or cryoablation. Whenever the ultrasound machine is turned on by the physician, the live 2-D ultrasound image is displayed on the screen of Artemis during the procedure. As the ultrasound probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe with respect to the organ is tracked. Artemis is able to add, display and edit loaded plans for the procedure as well as provide the probe position and needle trajectory relative to the 3-D image and 3-D rendered surface model of the prostate.

In addition to standard transrectal needle guidance procedures, Artemis also supports transperineal needle guidance by mounting a Needle Guide Attachment (NGA). A commercially available needle guide compatible with the NGA is used. This NGA will be used for both biopsy and cryo needles. The NGA provides additional data to track the needle direction angle. When using transperineal mode, the procedure planning, segmentation, registration and navigation are performed in the same way as the standard transrectal procedure. The only difference lies in how the needle guide needs to be moved to target the different planned locations. For the transrectal procedure, the needle guide is always attached to the probe. Therefore moving the probe moves the needle guide. In transperineal needle guidance procedures the needle is not attached to the probe. Therefore the NGA needs to be moved to move the needle guide. Artemis highlights the closed target to the current needle guide position.

Artemis offers the physician additional 3-D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous Ultrasound probe based procedures, and the physician always has access to the live 2-D ultrasound image during prostate assessment or biopsy procedure. The device also provides automated reports with information and pictures from the procedure.

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the Artemis medical imaging system.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance results. Instead, it broadly states that "Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met." It mentions that "Measurement validation using, phantoms, clinical CT, and MRI images were used to show that Artemis performs as well as or better than the predicate devices and furthermore shows that Artemis was safe and effective."

Below is a table summarizing the types of tests and the overall conclusion regarding acceptance, as the specific numerical criteria and results are not detailed in this public summary.

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

• Sample Size for Test Set: The document does not specify the exact sample size (number of phantoms or clinical images) used for the measurement validation or other performance tests. It states "Measurement validation using, phantoms, clinical CT, and MRI images were used."
• Data Provenance: The provenance (e.g., country of origin, retrospective or prospective) of the clinical CT and MRI images used for measurement validation is not specified in the provided text. The testing appears to be non-clinical and performed at the manufacturer's facility ("at the manufacturer's facility and has passed all in-house testing criteria").

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications. The testing described is "nonclinical and performance testing" and "measurement validation," suggesting a focus on technical accuracy rather than human interpretation studies.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for establishing ground truth, such as 2+1 or 3+1.

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

There is no mention of an MRMC comparative effectiveness study being performed, nor any effect size regarding how human readers might improve with AI vs. without AI assistance. The study described focuses on the device's technical performance and comparison to predicate devices, not on human-in-the-loop performance.

6. Standalone (Algorithm Only) Performance

The testing primarily focuses on the device's technical performance, including "measurement validation." This strongly implies that a standalone (algorithm only) performance evaluation was conducted to ensure the device's core functionalities, such as image reconstruction, segmentation, registration, and ice model generation, meet design specifications independently. The statement "Artemis has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications" supports this. Specific performance metrics (e.g., accuracy, precision) for these standalone functions are not provided, only a general statement of meeting acceptance criteria.

7. Type of Ground Truth Used

The type of ground truth used for performance validation included:

• Phantoms: For measurement validation.
• Clinical CT images: For measurement validation.
• Clinical MRI images: For measurement validation.

The basis for the "ground truth" on these phantoms and clinical images (e.g., known measurements for phantoms, expertly annotated features on clinical images) is implied but not explicitly detailed.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size used for any potential training set. The descriptions of "nonclinical and performance testing" and "measurement validation" focus on evaluation (test set) rather than model training. It's possible that a training set was used for specific software features involving image processing or reconstruction, but this is not mentioned.

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

As no information about a training set is provided, there is also no information on how its ground truth might have been established.

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The TITANEX™ MICROBEAM and TITANEX™ ARTEMIS Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

The TITANEX™MICROBEAMS and the TITANEX™ ARTEMIS screw systems contain fully threaded screws as a reconstruction solution providing various diameters of cannulated screws.

The TITANEX™ MICROBEAM's are provided in diameters of Ø2.0mm, Ø2.5mm, and the TITANEX™ ARTEMIS screws are Ø3.0mm, and Ø4.0mm. The Screws are a fully threaded design and come in variable lengths from 16mm - 70mm. The Ø2.0mm family: 16mm -50mm, for the Ø2.5mm family: 16mm - 50 mm, for the Ø3.0mm family: 12mm - 50mm, for the Ø4.0mm family: 16mm - 70mm. All screws are provided in 2mm increments.

All implants' components are manufactured from titanium (Ti-6AI-4V, ASTM F136).

Specific instrumentation including wires, drills, depth gages, and torx drivers are required for use with the system. The TITANEX™ Screws instruments are manufactured from stainless steel and aluminum.

This document describes the TITANEX™ MICROBEAM Screw System and TITANEX™ ARTEMIS Screw System, comparing them to a predicate device to establish substantial equivalence.

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

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

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to mechanical testing per a standard (ASTM F543-17) and computational analysis, implying that the performance met the requirements set forth by these methods and their associated thresholds. The discussion section states, "the testing supports that these differences do not raise any new questions of safety and effectiveness," indicating successful performance without providing specific numerical results.

However, based on the provided text, we can infer the tested performance aspects:

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 the sample size for any of the mechanical or computational tests, nor does it provide information on the data provenance (country of origin, retrospective/prospective).

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 is a medical device (screw system) that relies on mechanical and computational testing, not diagnostic performance tied to interpretations by experts. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications such as radiologists is not applicable here. The "ground truth" would be established by the engineering standards and validation protocols used in the mechanical and computational analyses.

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

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human interpretation studies (e.g., medical image reading). This document describes performance testing of a physical medical device (bone screws) and computational analyses. Therefore, an adjudication method in this context is not applicable.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI-powered ones) that involve human interpretation of cases. The TITANEX™ systems are bone fixation screws, and their acceptance is based on mechanical and computational performance, not diagnostic accuracy or human reader performance.

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

This question is not applicable to the TITANEX™ Screw System. The device is a physical implant, not an algorithm. The "standalone performance" here refers to its mechanical integrity and function as a standalone product. The performance data does describe standalone (algorithm-only) performance in the context of the computational analysis, which includes "Cross sectional Analysis" and "Axial Pullout per Chapman et al." These computational models would run independently without human-in-the-loop performance for their execution, although their validation and interpretation would involve human engineers.

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

For the mechanical testing, the "ground truth" would be the physical properties and behavior of the screws measured against established engineering standards and specifications (ASTM F543-17). For computational analysis, the "ground truth" would be the mathematical models and scientific principles (e.g., Chapman et al. for axial pullout) that govern the expected behavior of the device under simulated conditions. It's not expert consensus, pathology, or outcomes data in the traditional medical sense, but rather adherence to validated engineering and scientific principles.

8. The sample size for the training set

The concept of a "training set" is applicable to machine learning or AI models. Since the TITANEX™ Screw System is a physical medical device (bone screws) and not an AI/ML product, there is no "training set."

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

As there is no training set for this device, how its ground truth was established is not applicable.

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The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions.

Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures.

The provided text describes a 510(k) premarket notification for a medical device called the "Bladeless Trocar - Artemis Lap Cannula" (K231400) and references a previous clearance (K230058) as a primary predicate. This document is a regulatory submission, not a study report, and thus focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical or analytical performance study with acceptance criteria and detailed outcomes in the same way one might describe an AI/ML device study.

Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly aspects like sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable or available in this type of regulatory document for this specific device.

This device (Bladeless Trocar - Artemis Lap Cannula) is a physical surgical instrument, not an AI/ML diagnostic or prognostic system. The performance claims for such devices typically revolve around mechanical properties, biocompatibility, and sterility, which are verified through non-clinical testing and comparison to legally marketed predicate devices.

However, I can extract information regarding the non-clinical testing performed and the conclusion drawn from it, which serves as a form of "proof" of meeting the regulatory requirements for substantial equivalence.

Non-Clinical Testing and Performance for Bladeless Trocar - Artemis Lap Cannula (K231400)

1. Table of Acceptance Criteria and Reported Device Performance (Derived from Regulatory Review)

Explanation of "Acceptance Criteria" for this type of device:
For a physical surgical instrument like a trocar, "acceptance criteria" are typically defined by recognized consensus standards (e.g., ISO standards for medical devices, biomechanical testing standards) and comparison to predicate devices. The primary goal is to demonstrate that the new device is as safe and effective as a legally marketed device.

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

• Sample Size: Not specified in the provided text. Non-clinical testing typically involves a statistically relevant number of units for mechanical or material tests, but the exact count is not detailed here.
• Data Provenance: The testing was "Nonclinical Testing" conducted to support the 510(k) submission. This is laboratory-based testing, not human or patient data. The country of origin of the data is implicitly the country where the manufacturer (T.A.G. Medical Products Corporation, Ltd, Israel) conducted or commissioned the tests.

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

• Not applicable. This information pertains to studies involving expert review for setting ground truth (e.g., for AI/ML algorithms). This device and its associated testing do not involve establishing ground truth from expert clinical review. The "ground truth" for non-clinical testing is typically defined by the test protocol, measurement standards, and device specifications.

4. Adjudication Method for the Test Set:

• Not applicable. This concept relates to reconciling disagreements among experts in setting ground truth for data. Non-clinical physical testing results are usually objective measurements, not subject to expert adjudication in the same manner.

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

• No. An MRMC study is relevant for comparing the performance of human readers, often with and without AI assistance, on diagnostic cases. This device is a surgical instrument, not a diagnostic tool requiring such a study.

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

• Not applicable. This refers to the performance of an AI algorithm in isolation. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used:

• For the non-clinical tests (leak testing, ISO 80369-7 compliance), the "ground truth" is defined by:
  • Established Test Standards: Adherence to the specified mechanical and performance characteristics outlined in the relevant ISO standard (ISO 80369-7).
  • Predicate Device Performance: Comparison to the performance characteristics of the legally marketed predicate device (K230058) for specific attributes like leak resistance.
  • Device Specifications: Meeting the manufacturer's own design specifications for the device.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of a physical medical device like a trocar. This concept applies to AI/ML algorithms that learn from data.

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

• Not applicable. As there is no training set, this question is not relevant.

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The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions.

Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures.

This document describes a 510(k) premarket notification for the "Bladeless Trocar - Artemis Lap Cannula." The submission seeks to prove substantial equivalence to a legally marketed predicate device (K032676, the ENDOPATH III Trocar System).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for performance metrics in a table format, nor does it provide detailed quantitative performance data for the Artemis Lap Cannula. Instead, the document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and nonclinical testing.

Here's a summary of the stated performance and comparisons:

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

The document does not explicitly state sample sizes for specific tests (e.g., biocompatibility testing might involve various samples for different analyses, and leak testing would have its own sample size).

• Test Set Sample Size: Not explicitly stated for each test.
• Data Provenance: Not explicitly stated whether retrospective or prospective. Given the nature of pre-market testing for medical devices (biocompatibility, reprocessing, performance testing), it is typically prospective testing conducted specifically for the submission. The country of origin of the data is not specified beyond the applicant's location (Israel).

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

This information is not provided in the document. The tests described (biocompatibility, reprocessing, ISO standard testing, leak testing) are primarily objective engineering/scientific tests, not typically reliant on expert interpretation for "ground truth" in the same way clinical imaging or diagnostic studies might be.

4. Adjudication Method for the Test Set

Not applicable for the types of nonclinical tests described. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes.

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. This type of study is relevant for AI-powered diagnostic or assistive devices, which the "Bladeless Trocar - Artemis Lap Cannula" is not. It is a surgical instrument.

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

A standalone performance study (algorithm only) was not done. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests (biocompatibility, reprocessing, ISO standards, leak testing) typically refers to established scientific methodologies, validated test methods, and pre-defined acceptance criteria based on industry standards and regulatory requirements. For example:

• Biocompatibility: Established ISO standards (e.g., ISO 10993 series) define the ground truth for evaluating biological response.
• Reprocessing: Ground truth is established by validated protocols demonstrating the device can be consistently cleaned and sterilized to meet sterility assurance levels.
• ISO 80369-7: Ground truth is the successful meeting of the dimensional and performance requirements defined in the standard.
• Leak Testing: Ground truth is the quantitative measurement of leakage and its statistical equivalence to the predicate, demonstrating it meets performance expectations for sealing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable. This is not an AI/machine learning device.

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The Artemis Proximal Femoral Nail System is indicated for fixation of stable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.

Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch.

The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur. The system includes single-use, sterile implants (Proximal Femoral Nail Kit Short, Proximal Femoral Nail Kit Long, Locking Screw, Lag Screw, and optional anti-rotational locking pins) as well as non-sterile, reusable, Class I and II surgical instruments.

The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK).

The Artemis Nails are available in short or long lengths from 180mm to 440mm and are cylindrical rods with preassembled Set Screws. The Nail is designed with holes, at the proximal and distal sections, for the insertion of a Lag Screw and Locking Screw, respectively. The Lag Screw has a diameter of 11mm and is available in various lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm and is available in various lengths ranging from 25mm to 110mm. Optional Anti-rotational Locking Pins are also available to aid in rotational stability.

The provided document describes the FDA 510(k) clearance for the Artemis Proximal Femoral Nail System. This document is a regulatory submission for a medical device that does not involve AI/ML components for diagnostic purposes, and therefore, the acceptance criteria and study proving device performance are based on mechanical and physical properties rather than algorithmic performance on image data.

Therefore, I cannot provide information on the following points:

• 1. A table of acceptance criteria and the reported device performance (in terms of AI/ML metrics): The document reports mechanical testing results, not AI/ML performance metrics.
• 2. Sample size used for the test set and the data provenance: There is no "test set" in the context of AI/ML for this device. The testing refers to mechanical and physical properties.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant for this type of device submission.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

However, based on the provided text, I can infer the "acceptance criteria" and "study proving device meets acceptance criteria" in the context of a non-AI medical device submission:

Acceptance Criteria and Study for the Artemis Proximal Femoral Nail System:

The acceptance criteria for the Artemis Proximal Femoral Nail System are based on its mechanical performance and material characteristics, demonstrating that the device is substantially equivalent to a predicate device. This is a common pathway for Class II medical devices where performance can be validated through engineering and physical testing, rather than clinical studies or AI algorithm performance.

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical/Material Focus):

Study Proving the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is primarily non-clinical performance testing, specifically mechanical testing.

• Type of Study: Mechanical Testing
• Specific Tests Conducted:
  • ASTM F1264: Standard Specification for Extramedullary Splints and Bone Plates (likely referenced for general principles or associated components, though the primary device is intramedullary).
  • ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws.
  • ISO 7206-4: Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components. (This standard refers to hip prostheses, but its principles for static and dynamic bending of constructs are applied to the femoral nail system).
• Data Provenance: The nature of mechanical testing means the "data provenance" is derived from laboratory tests conducted on samples of the device itself. This is typically done in a controlled, prospective manner. Country of origin of the data is not specified but would be the location of the GLW Medical Innovation's testing facilities or contracted labs.
• Sample Size Used for the Test Set: While not explicitly stated for each test, mechanical testing typically involves a sufficient number of samples (e.g., typically 3-6 or more samples per test condition, depending on the standard and variability) to ensure statistical significance and reproducibility of results for the physical properties being evaluated.
• Ground Truth: For mechanical testing, the "ground truth" is defined by the acceptance criteria established within the referenced ASTM and ISO standards. The device 'passes' if its performance (e.g., strength, fatigue life) meets or exceeds the minimum requirements specified in these industry standards for similar devices. There are no human experts establishing ground truth in terms of diagnostic interpretation or clinical outcomes for this specific submission.
• Clinical Data: The submission explicitly states: "No clinical data was necessary." This reinforces that the substantial equivalence determination was based entirely on non-clinical performance data (mechanical testing and comparison to the predicate).

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The Artemis Proximal Femoral Nail System is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.

The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur. The system includes single-use, sterile implants (Proximal Femoral Nail Kit Short, Locking Screw, and Lag Screw) as well as non-sterile, reusable, Class I and II surgical instruments. The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK).

The Artemis Nail is a cylindrical rod with a preassembled 4mm Set Screw, available in one size with a distal diameter of 11mm, a proximal diameter of 16.4mm, and a length of 180mm. The Nail is designed with holes, at the proximal and distal sections, for the insertion of a Lag Screw and Locking Screw, respectively. The Lag Screw has a diameter of 11mm and is available in various lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm and is available in various lengths ranging from 25mm to 110mm.

This FDA 510(k) premarket notification describes the Artemis Proximal Femoral Nail System, an intramedullary fixation system. It confirms that clinical data was not needed for this device. The information provided heavily relies on comparisons to predicate devices and mechanical testing, rather than studies involving human participants or AI performance. Therefore, many of the requested details about acceptance criteria and study design are not applicable in this context.

Here's a breakdown of the available and unavailable information based on your request:

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

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

Not applicable. This device is an implantable medical device, and its performance was evaluated through mechanical testing, not clinical studies with human test sets.

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

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement accuracy, not expert human interpretation.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic or AI-assisted performance evaluation, not for mechanical testing of an orthopedic implant.

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

Not applicable. This is not an AI-enabled device or a diagnostic tool.

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

Not applicable. This is not an AI-enabled device.

7. The type of ground truth used

For the safety and effectiveness assessment, the ground truth was based on:

• Mechanical Testing Standards: Adherence to established international and American standards such as ISO 7206-4, ASTM F1264, and ASTM F543.
• Predicate Device Performance: Performance data from legally marketed predicate devices served as a benchmark for comparison to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This document refers to the evaluation of a medical device (an intramedullary nail system), not an AI algorithm. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of device evaluation.

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The Artemis™ Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures.

The Artemis Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures. The System consists of two components:

• Artemis Eye a single-use neuro-endoscope consisting of a camera, two pathways for . irrigation and/or drain, and a working channel for a surgical tool.
• Artemis Eye Tablet a reusable component that connects to the Artemis Eye and . displays live imaging captured by the Artemis Eye camera.

This document is a 510(k) summary for the Penumbra Artemis Eye System, a neurological endoscope. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for algorithm performance.

Therefore, many of the requested details about acceptance criteria for device performance, especially those related to AI or algorithm performance, cannot be extracted directly from this document. The document primarily discusses non-clinical testing for manufacturing, safety, and physical performance of the neuro-endoscope itself.

Here's what can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related):

The document does not present a formal table of acceptance criteria with corresponding performance for the overall device's clinical efficacy or algorithm performance. Instead, it describes various non-clinical tests passed.

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

• This information is not provided in the document. The document describes non-clinical engineering and safety tests rather than performance evaluations on a patient test set.

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

• This information is not provided as the document does not describe a clinical study or an AI/algorithm-based performance evaluation involving expert ground truth.

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

• This information is not provided as there is no mention of a test set requiring adjudication in this document.

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 is not mentioned in this document. This document is for a neurological endoscope, not an AI-assisted diagnostic tool in the typical sense that would involve human readers.

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

• This document is for a physical medical device (neuro-endoscope) with associated software for display. It does not describe a standalone algorithm performance in the context of diagnostic AI. The software is for displaying live imaging, not for autonomous analysis or diagnosis.

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

• This information is not applicable in the context of this document, as it focuses on the substantial equivalence of device components and safety, not on diagnostic accuracy against a ground truth.

8. The sample size for the training set:

• This information is not provided as the document does not describe the development or training of an AI algorithm.

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

• This information is not applicable as the document does not describe the development or training of an AI algorithm.

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The Artemis™ Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.

Penumbra Aspiration Pump:
The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.

The Artemis™ Neuro Evacuation Device, is a surgical instrument designed to aid a physician in the removal of tissue and/or fluid during image-guided neurosurgery. The Artemis Wand has two functions. These functions are control and transfer of aspiration and generation of rotational energy. Aspiration is generated by a Penumbra Aspiration Pump, which the Artemis Wand connects to through its flexible tubing. The Artemis Wand has a rigid hypotube containing a wire to facilitate removing tissue and/or fluid with the assistance of rotational energy and aspiration.

The Artemis Wand is designed to be image-guided, allowing visualization of the procedure. The method of removal is vacuum aspiration, which draws the tissue and/or fluid into the lumen of the Wand hypotube. The integrated wire is fully contained within the lumen of the Wand hypotube, and has rotational capability facilitating movement of any tissue and/or fluid that may otherwise clog the hypotube lumen.

The provided text describes the Penumbra Artemis™ Neuro Evacuation Device and its substantial equivalence to a predicate device, the Apollo System. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting a comparative effectiveness study with human readers or a standalone algorithm performance study.

Therefore, the information required to answer the following points is not available in the provided text:

• A table of acceptance criteria and the reported device performance: While some tests are listed with "100% Pass" or descriptions like "Non-toxic," specific numerical acceptance criteria (e.g., minimum aspiration rates, maximum force tolerances) and their corresponding performance values are not detailed. The provided information summarizes categories of tests and their overall success.
• Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The text mentions "Design Verification (Bench-Top Testing)" and "Simulated Use" but does not specify the sample sizes (number of devices or simulated clots) used for these tests. Data provenance is also not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant to the non-clinical, bench-top testing described.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to the non-clinical testing.
• 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 study type is not mentioned or implied, as the device is a mechanical neuro evacuation device, not an AI diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a mechanical instrument.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be established engineering specifications and successful execution of the test methods (e.g., passing a specific force test, achieving a certain vacuum level, being non-toxic per ISO standards).
• The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

However, based on the provided text, here is a summary of the acceptance criteria and study information that is mentioned:

Acceptance Criteria and Reported Device Performance (Based on available summary data):

Additional Information from the text:

• Study Types: The studies conducted are primarily non-clinical bench-top testing and biocompatibility testing. This is a type of standalone performance testing in the sense that it evaluates the device's physical and biological properties in a controlled environment, not its performance in humans or with human interaction for diagnostic purposes.
• Ground Truth for Non-clinical Tests: For biocompatibility, the ground truth is established by the specified international and FDA guidelines (EN ISO 10993-1, 21 CFR, Part 58 Good Laboratory Practices). For bench-top testing, the ground truth is against pre-defined product specifications and engineering requirements.
• No Multi-Reader Multi-Case (MRMC) Study or AI/ML Algorithm Performance: The Artemis™ Neuro Evacuation Device is a physical medical instrument, not an AI-powered diagnostic tool. Therefore, studies involving human readers, AI algorithms, training sets, or expert consensus for image interpretation are not applicable and were not performed or reported in this document.

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