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The SaberScope5 Laparoscope is intended to be used in diagnostic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.

The Articulating Xenoscope™ System is being renamed the SaberScope5 Laparoscope. The subject device contains two separate functioning components. First is the single-use, sterile SaberScope5 Laparoscope Device, which includes a 0° camera on 5 mm rigid shaft with a ± 90° articulating tip, 10 - 36 cm long shaft, and high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. The second is the XenoBox™, which converts the digital signal from the camera to HDMI signal for display onto the HD video screen for the surgeon to view.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Xenocor® SaberScope5 Laparoscope, addressing your specific points:

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

The document provides a comparative table (Table 2) between the predicate device (Articulating Xenoscope™ Laparoscope, K193315) and the subject device (SaberScope5 Laparoscope). The acceptance criteria implicitly are that the subject device's performance attributes are "Same" as the predicate device or demonstrate equivalent performance, with some notable differences.

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The Articulating Xenoscope is intended to be used in diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.

The Articulating Xenoscope™ System contains two separate functioning components. First is the single-use, sterile Articulating Xenoscope™ Laparoscope Device, which includes a 0° camera on 5 mm rigid shaft with a ± 30° articulating tip, 10 cm or 36 cm long shaft, and high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. The second is the XenoBox™, which converts the digital signal from the camera to HDMI signal for display onto the HD video screen for the surgeon to view. Together, the Xenoscope™ and the Xenobox™ comprise the Xenoscope™ Laparoscopic System and work synergistically together.

This submission is a 510(k) premarket notification for the Xenocor Articulating Xenoscope Laparoscope, which is an endoscope and accessories (21 CFR 876.1500; product codes GCJ, HET, GCQ). The new device is compared to the predicate device, K161838 - Xenocor®, Xenoscope™ Laparoscopic System.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes several verification and functional/safety tests. For each test, the document states that "All data met pre-determined acceptance criteria" or "All devices tested passed." However, the specific quantitative acceptance criteria are generally not explicitly stated in the summary, nor are the detailed quantitative results of the tests. Instead, it refers to the acceptance criteria being the same as the predicate device.

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

• Biocompatibility: The sample size for biocompatibility tests is not explicitly stated, but it follows ISO 10993-1 and FDA guidance, which typically involve specific numbers of samples for each test (e.g., cell cultures, animal models).
• Shaft Bend Strength Testing: "All devices tested passed." The specific number of devices tested is not mentioned.
• Accelerated Aging: "All devices were mechanically functional." The specific number of devices tested is not mentioned.
• Design Validation: The device was "evaluated by 10 physicians" for the subject device. The provenance of the data (country of origin, retrospective/prospective) is not specified, but design validation studies are typically prospective and conducted in a controlled environment (e.g., simulation labs).

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

• Design Validation: "10 physicians" were used to evaluate the device. Their specific qualifications (e.g., specialty, years of experience) are not provided beyond being "trained surgeons" and "intended users."
• For other tests (biocompatibility, mechanical testing), the "ground truth" is typically defined by standardized testing protocols and established scientific principles, rather than expert consensus on a test set.

4. Adjudication Method for the Test Set:

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for the test sets. For design validation, it states that "the subject device was evaluated by 10 physicians," implying individual evaluations against predetermined criteria, rather than a group consensus approaching a "ground truth" in the clinical sense. For the other tests, acceptance criteria are typically objective and measurable, not requiring adjudication.

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

• The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The design validation involved "trained surgeons" evaluating the device, which is a human evaluation, but it's not a comparative effectiveness study with an AI component as typically understood in medical imaging contexts. The Xenocor Articulating Xenoscope Laparoscope is a hardware device for visualization, not an AI diagnostic algorithm.

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

• This question is not directly applicable as the Xenocor Articulating Xenoscope Laparoscope is not an AI algorithm but a medical device for visual inspection during surgery. There is no "standalone algorithm performance" to assess.

7. The Type of Ground Truth Used:

• Biocompatibility, Shaft Bend Strength, Accelerated Aging: The "ground truth" is defined by adherence to international standards (ISO 10993-1), FDA guidance, and internal quality procedures which set objective pass/fail criteria. These are essentially engineering and material science standards and not clinical "ground truth" derived from patient outcomes or pathology.
• Design Validation: The "ground truth" for design validation is functional performance and usability as assessed by "trained surgeons" against predetermined criteria. This is a form of expert clinical opinion/assessment of device performance characteristics.

8. The Sample Size for the Training Set:

• This concept of a "training set" is not applicable to the Xenocor Articulating Xenoscope Laparoscope. This is a hardware device, not a machine learning model that requires training data.

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

• Not applicable, as there is no training set for this device.

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The Xenoscope™ is intended to be used in diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.

The Xenoscope™ System contains two separate functioning components. First, the Xenoscope™ Laparoscope Device is a 0° or 30°, 30 Fr (10mm), 10 - 36 cm long, singleuse, high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. Second, the Xenoscope™ Dongle (now termed as the Xenobox™), which converts the camera image onto the video display screen for the surgeon to use, is provided with the Xenoscope™. Together, the Xenoscope™ and the Xenobox™ comprise the Xenoscope™ Laparoscopic System and work synergistically together.

This looks like a 510(k) summary for the Xenocor Xenoscope Laparoscopic System, which is a medical device. Based on the provided text, it's difficult to extract the type of detailed information requested about acceptance criteria and a study proving the device meets them because this document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific performance metrics.

However, I can extract the information that is present and note where specific requested details are not provided.

Here's an attempt to answer your questions based only on the provided text:

Acceptance Criteria and Study for Xenocor Xenoscope Laparoscopic System

The provided document describes a premarket notification (510(k)) for the Xenocor Xenoscope Laparoscopic System. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to present a de novo clinical study with detailed performance metrics and acceptance criteria as one might see for a novel device or a PMA application.

Therefore, the "acceptance criteria" discussed are largely related to functional and safety testing designed to show that the new device performs comparably to the predicate and meets its own design specifications, rather than clinical performance against a specific disease state.

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

Missing Information: The document does not specify quantitative acceptance criteria (e.g., "imaging resolution must be X lines per mm" or "light output must be Y lumens") or the specific numerical results of these tests. It only states that "All data met pre-determined 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)

• Sample Size: Not specified for any of the tests mentioned (Biocompatibility, Software Verification, Shaft Bending Inspection, or Comparative Analysis). It's likely these were engineering or bench tests rather than patient studies with a "test set" in the clinical sense.
• Data Provenance: Not specified. Given the nature of a 510(k) for an endoscope, these are typically laboratory-based engineering and functional tests conducted by the manufacturer (Xenocor, Inc., USA). The document does not mention any clinical data, patient studies, or geographical origin of data.
• Retrospective/Prospective: Not applicable to the type of testing described. These were likely pre-market verification tests.

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

• Not applicable/Not specified. The "test set" described consists of functional/safety tests performed on the device itself, not a clinical set requiring expert interpretation for ground truth.

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

• Not applicable/None. This type of adjudication is relevant for clinical studies with subjective interpretations, which are not described here.

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

• No. An MRMC comparative effectiveness study was not done. This device is a laparoscopic system (endoscope), not an AI-powered diagnostic tool. The document describes functional and safety testing, and a comparison to a predicate device's intended use and fundamental technology, not a study comparing human performance with or without AI assistance.

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

• No. This is not an algorithm-only device. It's a physical medical instrument (laparoscope), and the "software verification" relates to an image rotation feature, not a standalone AI algorithm.

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

• Not explicitly defined in the context of a clinical "ground truth." For the functional and safety tests, the "ground truth" would be established by engineering specifications, relevant ISO standards (like ISO 10993-1 for biocompatibility), and design requirements.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the machine learning sense. The software verification mentioned refers to modifications for an image rotation feature, not a trainable AI model.

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

• Not applicable for the same reasons as point 8.

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The Xenoscope™ is intended to be used in diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.

The Xenoscope™ System contains two separate functioning components. First, the Xenoscope™ Laparoscope Device is a 0°, 30 Fr (10mm), 10 - 36 cm long, single-use, high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. Second, the Xenoscope™ Dongle, which converts the camera image onto the video display screen for the surgeon to use, is provided with the Xenoscope™. Together, the Xenoscope™ and the Xenoscope™ Dongle comprise the Xenoscope™ Laparoscopic System and work synergistically together.

The Xenocor® Xenoscope™ Laparoscopic System is a medical device intended for diagnostic and therapeutic procedures within the thoracic and peritoneal cavities, including female reproductive organs. The provided text outlines the acceptance criteria and supporting studies for its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Design Validation (Usability/Performance Test Set): 3 trained surgeons.
• Data Provenance: Not explicitly stated, but the "simulated use model in an environment that simulated the intended clinical settings" suggests a prospective, controlled study specifically for device validation. The "country of origin of the data" is not mentioned. For the other tests (Biocompatibility, Electrical Safety, EMC, Software), the data provenance is from laboratory testing adhering to international standards, not derived from clinical data sets.

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

• Number of Experts: 3.
• Qualifications of Experts: Described as "trained surgeons (intended users)". Specific experience levels (e.g., "10 years of experience") are not provided, but being "trained surgeons" implies relevant clinical expertise for evaluating a laparoscopic system.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the design validation study (e.g., 2+1, 3+1). It states that the "three (3) trained surgeons" performed the evaluation and the system "met all acceptance criteria." This implies a consensus or individual satisfaction with performance, but the process for resolving any potential disagreements among the three is not detailed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The documentation focuses on demonstrating substantial equivalence primarily through technical specifications and functional/safety testing against standards, along with a design validation study. There is no mention of comparing human reader performance with or without AI assistance. The device itself is an endoscope system, not an AI diagnostic tool that assists human interpretation.

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

Not applicable in the context of this device. The Xenocor Xenoscope is a laparoscopic system that is inherently designed for human-in-the-loop operation by a surgeon, not a standalone AI algorithm. The only "software" mentioned is firmware that converts a digital video signal for display, which does not operate as a standalone diagnostic algorithm.

7. Type of Ground Truth Used

The ground truth for the design validation study was based on the expert evaluation and feedback of the three trained surgeons using the device in a simulated clinical setting. For the other tests (Biocompatibility, Electrical Safety, EMC, Software), the ground truth was adherence to established international and national performance and safety standards.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI algorithm or model development. The Xenoscope is a hardware device with supporting firmware, not a machine learning system that requires a training set of data.

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

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable to the information provided in the document.

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