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The Symphion Operative Hysteroscopy System and accessories are intended for resection and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device by distending the uterus with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and providing fluid management through either the closed loop recirculation of filtered distension fluid or non-filtered distension fluid.

The Symphion Operative Hysteroscopy System is comprised of the following:

• Controller with IV Pole and Footswitch
• Resecting Device
• Fluid Management Accessories (INFINITY FMA and EXPRESS FMA)
• Fluid Deficit Readout Optional Accessory

The Symphion Operative Hysteroscopy System provides an integrated control system with bipolar radiofrequency outputs (cut and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a bipolar radiofrequency device configured for the resection and aspiration of the uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories. The Symphion Controller, with software version 3.0.0 or higher, is designed to be used in either a recirculating (closed-loop) or non-recirculating system configuration. The Fluid Manaqement Accessories are disposable tubing sets and are available in two models, INFINITY FMA and EXPRESS FMA. The FMAs are designed to assist with the delivery, monitoring, and control of the amount of distention media delivered to the uterine cavity when used with the Symphion controller. When the controller is used with the INFINITY FMA, the system components form a closed-loop recirculating system configuration. Alternatively, when the controller is used with EXPRESS FMA, the system components form an open, nonrecirculating, system configuration. The INFINITY FMA is designed to be used in all types of intrauterine pathology whereas the EXPRESS FMA, lower cost alternative, may be more suitable for softer type tissues or in procedures that require a shorter resection time such as polypectomy, visual D&C and similar.

The integrated peristaltic pumps are operated by a software pressure control algorithm, specific to use with either INFINITY FMA or EXPRESS FMA configurations, that measures and controls intra-uterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection when using the Resection Device. The Symphion Controller Graphical User Interface has two options for initial set up depending on which FMA configuration is being used during the procedure. There are fluid control settings which allow the user to toggle infusion ON/OFF and to set the target cavity pressure from 45-125mmHg. Subsequent to the initial setup GUI, all procedure and control settings are identical regardless of which FMA configuration is being used. The system includes an optional Fluid Deficit Readout accessory device which is an independent saline bag measurement scale to present the user with a digital real-time fluid loss/fluid deficit reading during the Symphion procedure.

The provided document is a 510(k) premarket notification decision letter from the FDA regarding the Minerva Surgical Symphion Operative Hysteroscopy System. It details the device, its intended use, comparison to predicate devices, and a summary of non-clinical testing. However, it does not contain the specific acceptance criteria, reported device performance data, sample sizes, expert qualifications, or adjudication methods typically found in a clinical study report. It states that "Clinical Testing was not required."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The document only summarizes that:

• A range of non-clinical performance tests were conducted.
• These tests were performed at the system, component, and subassembly levels.
• The system met its performance specifications and performs as intended.
• "All results have been deemed acceptable" for various tests (Biocompatibility, Software Verification, Electrical Equipment Safety, Sterilization, Shelf Life Testing, Packaging and Transit Testing).
• For Performance Testing (Special Controls), which covers aspects like mechanical testing, pressure testing, fluid delivery, flow rate, simulated use, filtration, blood filtration capacity, tissue collection capacity, and filtrate characterization, "All results have been deemed acceptable."

Since clinical testing was not required for this 510(k) submission, there isn't a "study that proves the device meets the acceptance criteria" in the sense of a clinical trial with human subjects and associated statistical analyses as would be typically implied by your request. The provided text only confirms that non-clinical performance and design verification tests were completed and deemed acceptable.

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Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.

Generally recognized indications for diagnostic hysteroscopy include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic Pain

Generally recognized indications for use for operative hysteroscopy include:

• Directed endometrial biopsy
• Polypectomy
• Submucous myomectomy
• Transection of intrauterine adhesions
• Transection of intrauterine septa
• Endometrial ablation

Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the blader. When combined with accessory instruments, the user to perform various diagnostic and therapeutic procedures.

NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.

The LUMINELLE DTx Hysteroscopy System originally received 510(k) clearance in 2018 as a hvsteroscopic and cvstoscopic svstem (K181909). In addition, LUMINELLE DTx Hysteroscopy System received 510(k) clearance in 2019 for the addition of a sheath component, LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid to the system (K190827).

Based on user feedback for a thinner option for the disposable sheath for only diagnostic use, UVision360, Inc. (hereafter UVision) proposes the addition of a new accessory, the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), as part of an engineering performance change.

The LUMINELLE DTx Hysteroscopy System indications for use is identical to the previously cleared indications for use for the system. However, when the system is used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the indications for use are limited to diagnostic use only.

No changes are proposed for the previously cleared components of the LUMINELLE DTx Hysteroscopy System. The new LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) accessory is a modification of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid component of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827) with the following main changes:

• . The new accessory has one fluid line rather than the two fluid lines of the previously cleared component.
• . The new accessory has a combined channel for the scope and the fluid line rather than the separate channels of the previously cleared component.
• The new accessory has no operative channel available unlike the previously cleared . component, due to the fact that it is for diagnostic use only.

The provided text describes a 510(k) submission for the LUMINELLE DTx Hysteroscopy System, which includes the addition of a new accessory, the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic).

The study aims to demonstrate substantial equivalence to a previously cleared predicate device (LUMINELLE DTx Hysteroscopy System, K190827).

Summary of Acceptance Criteria and Device Performance:

The document primarily focuses on verifying the safety and effectiveness of the new accessory by demonstrating that the modified device remains as safe and effective as the predicate. It does not provide specific quantitative acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity for detecting specific conditions) for the new diagnostic sheath, as the intent of this 510(k) is an engineering performance change and limitation of use for the new accessory rather than a new diagnostic claim. Instead, the "acceptance criteria" are implied through the successful completion of various engineering, biocompatibility, and usability tests.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Detailed Information about the Study:

1. A table of acceptance criteria and the reported device performance: Refer to the table above.

   • Note: The document does not specify quantitative diagnostic performance metrics because the submission is for an engineering change and a limitation of use for an accessory, not a new diagnostic claim that would require clinical performance study. The "acceptance criteria" are primarily related to safety, sterility, shelf life, and basic functionality as a medical device to ensure equivalence to the predicate.

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

   • Test Set Sample Size: The document does not explicitly state specific sample sizes for the various tests (e.g., how many sheaths were tested for accelerated aging, how many "in vivo models" were used for usability). It refers to "all samples met specifications" or "packages were confirmed."
   • Data Provenance: The information provided is retrospective in nature, as it's a summary of testing already performed for a 510(k) submission. The country of origin for the data is implied to be within the scope of UVision360 Inc.'s operations (Raleigh, NC, USA), but not explicitly stated for the testing sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of submission. The "ground truth" for these engineering, biocompatibility, and usability tests is established by adherence to recognized standards (e.g., AAMI TIR28, ASTM F1980-16, ASTM D4169-16, ASTM F88-15, ASTM F2096-11, ISO 10993-10:2016, ISO 10993-5:2009) and predefined acceptance criteria set during the device's development and validation. Experts in relevant engineering, toxicology, and quality assurance fields would have designed and overseen these tests, but their specific number and qualifications are not detailed in this regulatory summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This document describes technical device performance testing (e.g., sterility, shelf life, biocompatibility, mechanical function), not clinical diagnostic performance requiring expert adjudication of patient cases.

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/ML-enabled device and no MRMC study was performed or needed for this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML-enabled device.

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

   • The "ground truth" for the tests described is the adherence to specified technical and safety standards (e.g., ISO, ASTM standards for biocompatibility, packaging integrity, and accelerated aging) and predefined functional specifications for the device. For the usability and design validation, it implicitly relies on objective performance measures and user feedback in "in vivo models" compared against "predefined acceptance criteria."

8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established: Not applicable.

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Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery. Generally recognized indications for diagnostic hysteroscopy include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic pain
  Generally recognized indications for operative hysteroscopy include:
• Directed endometrial biopsy
• Polypectomy
• Submucous myomectomy
• Transection of intrauterine adhesions
• Transection of intrauterine septa
• Endometrial ablation
  Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the user to perform various diagnostic and therapeutic procedures.

The LUMINELLE DTx Hysteroscopy System previously received 510(k) clearance (K181909) in 2018 as a hysteroscopic and cystoscopic system. To provide the user with a more rigid option for the RotoSheath and Introducer, UVision360, Inc. (hereafter UVision) proposes the addition of a new component to the system, the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid in addition to the currently available flexible Rotatable Disposable Sheath option cleared during the previous submission (K181909). No changes are proposed for the previously cleared components or the principles of operation of the LUMINELLE DTx Hysteroscopy System. The proposed change includes only the addition of a new component which is a modification to the previously cleared flexible LUMINELLE DTx 360° Rotatable Disposable Sheath.

The provided text describes a 510(k) premarket notification for a medical device called the LUMINELLE DTx Hysteroscopy System. This submission is for the addition of a new component, a rigid sheath, to an already cleared system. Therefore, the focus of the documentation is on demonstrating the substantial equivalence of the modified device, particularly the new rigid sheath, to the previous cleared flexible sheath version.

Based on the provided text, a formal study demonstrating the device meets a specific set of acceptance criteria in the conventional sense (e.g., accuracy, sensitivity, specificity for an AI/diagnostic device) is not explicitly detailed. Instead, the document describes design validation testing and other engineering tests to ensure the new component performs as intended and does not raise new questions of safety or effectiveness compared to the predicate device.

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

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

The document does not provide a specific table of acceptance criteria with corresponding performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that:

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: The document does not specify the sample size for the "in vivo models" used in design validation testing.
• Data Provenance: Not specified. The study is described as "design validation testing" using "in vivo models," which typically refers to animal or cadaveric models for medical devices, but specific details are absent. No information on country of origin or retrospective/prospective nature is provided.

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 not applicable to the type of testing described. The design validation testing focuses on confirming the sheath's functional performance and user operability, rather than diagnostic accuracy against a ground truth established by experts.

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

Not applicable. The testing described is functional and safety testing of a medical device component, not a diagnostic performance study requiring expert adjudication of results.

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 document describes a hysteroscopy system, which is an imaging device for direct viewing and performing procedures. It does not appear to incorporate AI or machine learning for diagnostic interpretation that would warrant an MRMC study.

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

Not applicable. This is not an AI algorithm.

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

The concept of "ground truth" in the diagnostic sense (expert consensus, pathology, outcomes) is not applicable here. The "ground truth" for the design validation testing would be the predefined functional and user performance specifications of the device component.

8. The sample size for the training set

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

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

Not applicable.

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Hysteroscopy: The Luminelle DTx Hysteroscopy System is used to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery.

Generally recognized indications for diagnostic hysteroscopy include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• · Evaluation of abnormal hysterosalpingogram
• · Intrauterine foreign body
• · Amenorrhea
• · Pelvic pain

Generally recognized indications for operative hysteroscopy include:

• · Directed endometrial biopsy
• · Polypectomy
• Submucous myomectomy
• · Transection of intrauterine adhesions
• · Transection of intrauterine septa
• · Endometrial ablation

Cystoscopy: The Luminelle DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.

The Luminelle DTx Hysteroscopy System is comprised of four components:

1. Luminelle DTx Hysteroscope - a non-sterile, reusable flexible hysteroscope with an integrated light source, light fiber bundle and CMOS sensor.
2. The Luminelle DTx 360° Rotatable Disposable Sheath - a sterile, two-part sheath installed over the insertion tube of the Hysteroscope and comprised of the Operative Introducer and the 360° RotoSheath. The Operative Introducer contains an operative channel for inserting surgical accessories, two fluid management lines (inflow/outflow), and a channel to protect the scope insertion tube. The 360° RotoSheath allows for rotational positioning of the camera and provides rigidity to the Scope/Introducer assembly.
3. Luminelle Communication Cable - a cable that provides both the power to the hysteroscope and transmits the image.
4. Luminelle Control Hub - the main power supply, image converter and visualization connection. The Control Hub has both HDMI and USB connectors for connection to a monitor and/or a PC. USB and HDMI cables are provided in the package.

The Luminelle DTx Hysteroscope, Communication Cable, Control Hub, USB and HDMI cables and power cord are provided together in a single package. The 360° Rotatable Disposable Sheath is provided in a separate sterile package. The 360º Rotatable Disposable Sheath is required for use with the Hysteroscope, therefore it is a component of the system and not an accessory to the system.

The CMOS sensor and fiber optic illumination bundles are contained in the Hysteroscope Insertion Tube. The insertion tube length is 29.8 cm (11.73 in.) and the outside diameter is 1.95 mm (0.077 in.). The Luminelle DTx Hysteroscope is packaged in a white form fit tray with a clear slide-on cover. The tray is made of high-impact polystyrene (HIPS). The clear cover is made of polyethylene terephthalate with glycol (PETG).

The Luminelle 360° RotoSheath has a working length of 24.0 cm (9.45 in.) with an outside diameter of 5.7 mm (0.244 in.). The Luminelle Operative Introducer has an outside diameter of 4.8 mm (0.189 in.) and the inside diameter of the operative channel is 1.85 mm (0.073 in.).

Both the Luminelle 360º RotoSheath and Luminelle Operative Introducer are supplied as a single assembled unit packaged in a bottom tray with retaining lid made of polyethylene terephthalate with glycol (PETG) and sealed with Tyvek. The assembled package is sterilized using ethylene oxide (EO).

The Control Hub supplies power to the Hysteroscope via a reusable Communication Cable. The CMOS sensors have a processor that converts the visual image into data to be transferred. A processor in the Control Hub converts this image data into streaming HDMI language, takes still images when the button is pushed, and also controls the light exposure during changing light conditions.

Visualization on a video monitor is provided via a HDMI cable, and image transfer to a PC is provided via a Type A USB cable. A 12V DC, 3A power adapter is also provided. Technical specifications for these reusable components are provided in the Instructions for Use.

The provided text describes the 510(k) premarket notification for the Luminelle DTx Hysteroscopy System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, effect sizes) is not present in this document.

However, based on the provided text, I can infer and extract information related to performance testing that was conducted to support the substantial equivalence claim.

Here's the breakdown of what can be gleaned:

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

The document doesn't present a table of specific quantitative acceptance criteria with corresponding performance metrics for image quality in a way that would be typical for an AI/ML device validating diagnostic accuracy. Instead, it refers to compliance with established standards for medical devices and compares features to predicates.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML test set with patient data. The performance testing described is primarily engineering and bench testing, as well as validation of reprocessing and sterilization.
• Data Provenance: Not applicable for AI/ML validation. The testing described is hardware and system functionality testing.

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 as this is not an AI/ML device requiring clinical diagnostic ground truth. The "ground truth" for the tests performed would be adherence to engineering specifications and regulatory standards.

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

• Not applicable as this is not an AI/ML device nor a clinical study involving human readers and image interpretation.

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 MRMC study was performed as this is not an AI-assisted diagnostic device. It is an endoscope for direct visualization.

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

• Not applicable, as this device does not contain an AI algorithm. It is an imaging system (hysteroscope/cystoscope).

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

• The "ground truth" for this device's performance validation is adherence to established international and FDA standards for medical devices (e.g., ISO, IEC). For example, electrical safety is validated against IEC 60601-1; biocompatibility against ISO 10993; optical resolution against ISO 8600.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device.

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

• Not applicable, as this is not an AI/ML device.

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The Hysteroscopy System is indicated for rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy. It has an additional feature of visualization.

The Hysteroscopy System is designed to visualize the uterus and to facilitate physicians in the procedure of vacuum aspiration of the uterine cavity during the first trimester of pregnancy. Components of the Hysteroscopy System include an EOsterilized single-use cannula and reusable image processing unit. The Hysteroscopy System is available in five sizes that differ in length and width. Each cannula includes an internal channel to draw vacuum or negative pressure up to 500 mmHg. The optical system, which includes a CMOS image sensor, lens, and 40 mW LED, is located at the distal end of the cannula. A lens cover shields the electronics from bodily fluids. The Hysteroscopy System has two connectors: one is an electrical/data connection and the second connection is for vacuum. The cannula is not indicated for use with any other accessories. The patient-contacting materials are medical grade stainless steel, polycarbonate, medical glue, and medical nylon.

This document does not contain an acceptance criteria table or a detailed study of device performance to meet such criteria. It is a 510(k) summary for a Hysteroscopy System. While it lists various performance tests conducted, it does not provide quantitative acceptance criteria or the specific results demonstrating compliance.

Here's a breakdown of what is available based on your request, and what is missing:

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

Missing. The document lists performance tests but does not define acceptance criteria (e.g., minimum tensile strength, maximum leak rate, specific image resolution targets) nor does it present the numerical results from these tests against any defined criteria. It only states, "The protocol and results of all performance testing were acceptable."

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

Missing. The document mentions various performance tests (e.g., biocompatibility, electrical safety, mechanical performance, image quality) but does not provide details on:
* The sample sizes used for any of these tests.
* The provenance of the data (e.g., country of origin, retrospective or prospective nature). These tests appear to be bench testing or material-level assessments, not clinical trials on human subjects.

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)

Missing. This type of information would typically be relevant for studies involving diagnostic accuracy or clinical interpretation. The performance tests described are largely engineering and safety evaluations (e.g., tensile strength, vacuum integrity, electrical safety, biocompatibility, image quality parameters like field of view, resolution). There's no indication of any expert-based ground truth establishment in the context usually meant by this question (e.g., for image interpretation or diagnosis).

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

Missing. Adjudication methods are typically used in clinical studies where multiple observers or methods are used to establish a definitive diagnosis or outcome. The performance tests listed are technical validations, not clinical outcome adjudications.

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

Missing. An MRMC study is not mentioned. The device is a "Hysteroscopy System" used for visualization and vacuum aspiration. There is no mention of AI or human-in-the-loop performance improvement in this document, as it describes a medical device, not an AI software.

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

Missing. Not applicable, as this document describes a physical medical device (Hysteroscopy System), not an algorithm or AI software requiring standalone performance testing in that context.

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

Missing. As noted above, the performance tests described are largely technical/engineering validations. For example, for "image quality testing," the ground truth would be objectively measured parameters such as actual field of view, photometric measurements for illumination, and resolution targets. For "mechanical performance testing," ground truth would be defined by engineering specifications (e.g., expected tensile strength, vacuum pressure). There's no mention of clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Missing. This is not an AI device, so there is no concept of a "training set" for an algorithm.

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

Missing. Not applicable, as there is no training set for an AI algorithm.

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Interlace Medical Operative Hysteroscopy System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The Interlace Medical Operative Hysteroscopy System is intended for use in visualizing the uterine cavity and performing operative hysteroscopy procedures. The Operative Hysteroscopy System includes an obturator, a sheath and a hysteroscope. The obturator is used to facilitate introduction of the sheath into the uterine cavity. The single use sheath includes a working channel to permit the introduction of instrumentation. The reusable fiber optic hysteroscope is designed with optical lenses for visualization and optical fibers for illumination. The obturator is inserted into the working channel of the sheath and the hysteroscope is inserted into a designated lumen of the sheath. The Operative Hysteroscopy System can be combined with a hysteroscopic fluid management system (not the subject of this submission) to provide continuous flow hysteroscopy capability. The hysteroscope can be used with standard O.R. camera couplers.

The provided text describes a 510(k) premarket notification for the Interlace Medical Operative Hysteroscopy System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not directly applicable or available in this document. The document specifically states that "The Interlace Medical Operative Hysteroscopy System does not raise any new safety and efficacy concerns when compared to the similar legally marketed device." and relies on "descriptive characteristics" to demonstrate substantial equivalence.

Here's a breakdown of why each specific point you asked for cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. There are no performance criteria established for this clearance, as it is based on substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No dedicated "test set" or clinical study data is presented for performance evaluation in this 510(k) 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): Not applicable. No ground truth establishment was conducted for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication process for a test set was 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: Not applicable. This device is a physical hysteroscopy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical hysteroscopy system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for a performance study.
8. The sample size for the training set: Not applicable. The device is not an AI/machine learning model needing a training set.
9. How the ground truth for the training set was established: Not applicable. The device is not an AI/machine learning model.

Summary of Device Rationale based on the provided text:

The Interlace Medical Operative Hysteroscopy System received 510(k) clearance by demonstrating substantial equivalence to the predicate device, the Smith and Nephew Hysteroscope and Accessories (K013870). The equivalence is based on:

• Same Intended Use: "to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures."
• Similar Technological Characteristics: "The Interlace Medical Operative Hysteroscopy System is substantially equivalent in design, materials, construction and intended use as that of the predicate. The principal of operation of both devices are exactly the same."
• No New Safety or Efficacy Concerns: The submission argues that due to the above similarities, the device "does not raise any new safety and efficacy concerns."
• Performance Testing: The only specific performance testing mentioned is that the system "meets electrical safety standards." This is a general safety requirement, not a clinical performance metric.

Therefore, the "study" that proves the device meets acceptance criteria in this context is the comparison to the legally marketed predicate device and the argument that no new safety or effectiveness questions are raised.

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