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The Soprano™ Cryo-Therapy System is intended for use in the surgical ablation of tissue by the application of extreme cold in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology.

The FemRx Soprano Cryo-Therapy System is designed to be a general use cryotherapy system for the destruction or cryoablation of tissue. The system allows the circulation of a cryorefrigerant from the console to the reusable cryoprobe.

This document is a 510(k) summary for the Soprano™ Cryo-Therapy System, indicating that the device has been reviewed and found substantially equivalent to predicate devices. However, the provided text does not contain detailed performance data, acceptance criteria, or a description of a study that proves the device meets specific acceptance criteria in the manner requested by the prompt for AI/ML device evaluations.

It states: "The results from the nonclinical tests indicate the Cryo-Therapy System is equivalent to the predicate devices in terms of safety and effectiveness." This is a general statement and not a detailed account of performance results against specific acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document does not list specific acceptance criteria or quantitative performance metrics.
• Sample sized used for the test set and the data provenance: No information on test set size or data origin is provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no expert-derived ground truth or test set is mentioned.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: The document does not mention such a study.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
• The type of ground truth used: Not applicable as no specific test data or ground truth establishment is described.
• The sample size for the training set: Not applicable as no training set is mentioned for this type of device.
• How the ground truth for the training set was established: Not applicable.

This 510(k) summary pertains to a physical cryo-therapy system and evaluates its substantial equivalence to predicate devices based on intended use, principle of operation, and control function, rather than the performance metrics typically associated with AI/ML-driven diagnostic devices.

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The FemRx™ Focused Monopolar (FMP) offersTAR™ System is intended for gynecologic hysteroscopic / electro-surgical use by trained professional gynecologists in hospital or office environments. It is used to resect and / or ablate endometrial tissue.

INDICATIONS: Abnormal Uterine Bleeding, Submucous Fibroids, Endometrial Polyps

The FemRx Focused Monopolar (FMP) @ERASTAR™ System [with Dispersive Electrode Option] is identical to FemRx's currently cleared FMP offRASTAR™ System with the exception that it includes the option of using a standard dispersive skin electrode. When used in this way it is basically identical to our original oreRASTAR™ System except that it incorporates a PEARL electrode (Physiologic endometrial ablation / resection loop). This loop is partially insulated to "focus" the current toward the tissue and avoid the reduction in effect associated with conventional devices. The use of isotonic solutions (e.g., NaCl or Ringers Lactate) is strongly recommended in order to reduce the risks associated with fluid overload.

The FMP offers TAR System differs from currently marketed bi-polar devices in that it continues to have a single active electrode (wire loop or Star loop) as opposed to two active electrodes. The return electrode (the metallic outer Morcellator housing of the device OR a standard dispersive pad located on the patients skin) has such a large surface area relative to the active electrode that there can be no tissue coagulating (much less cutting or ablating) effect at its surface.

This 510(k) summary (from 1997) for the FemRx Focused Monopolar (FMP) OPERASTAR™ System with Dispersive Electrode Option provides limited information regarding formal acceptance criteria or detailed study methodologies as would be expected from more recent submissions. Based on the provided text, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any study mentioned.
• Data Provenance:
  • "In vitro extirpated uteri studies" - suggests laboratory studies using excised human or animal uteri. No country of origin is mentioned.
  • "clinical testing" - prospective vs. retrospective is not specified. No country of origin is mentioned.

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

• This information is not provided. The summary mentions "in vitro extirpated uteri studies" and "clinical testing" but does not detail how ground truth was established for these studies, nor the number or qualifications of experts involved.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• This information is not provided.

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

• No MRMC study is explicitly mentioned. The studies focus on device performance equivalence rather than human reader improvement with AI assistance (as this is a medical device, not an AI/imaging device).

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

• This device is a surgical instrument, not an algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable here. The performance described is that of the physical device itself.

7. The Type of Ground Truth Used

• For the "in vitro extirpated uteri studies," the ground truth likely involved direct observation, measurement, and histological analysis of tissue effects (resection depth, ablation depth, coagulation patterns).
• For the "clinical testing," the ground truth for "equivalent performance" would likely have been based on clinical outcomes, such as efficacy of endometrial ablation/resection, safety profiles, and possibly physician reports of ease of use or tissue manipulation.

8. The Sample Size for the Training Set

• This concept is not applicable as this is a physical medical device, not a machine learning algorithm.

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

• This concept is not applicable as this is a physical medical device, not a machine learning algorithm.

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The FemRx Focused Monopolar (FMP) 07584STAR™ System is identical to FemRx's currently marketed of ERASTARTM System resectoscope in terms of outward appearance and basic tissue cutting, ablating and morcellating mechanism (electrocautery wire / Star loop and morcellator internal to the fluid return path). That is, high frequency current is applied to a single active electrode to either cut or coagulate tissue which is subsequently chopped up and aspirated via a morcellator internal to the fluid return path.

The FMP offers TAR System differs from our previously cleared device in that the return electrode has been moved from outside of the patient body (dispersive electrode pad attached to the patients back or leg) to the metallic body of the device (outer tube/housing the morcellator). (Reference the Device Description section of this submission for an "insulation diagram" and schematic drawing providing a diagrammatic representation of the electrical circuit effect of moving the return electrode.) This change in return electrode location makes it possible to use (indeed requires the use of) a conductive irrigant solution such as normal saline (0.9% NaCl). The use of an isotonic solution eliminates significant potential complications associated with non-isotonic solutions (e.g., Mannitol, Sorbitol, Glycine).

The FMP offers TAR System differs from currently marketed bi-polar devices in that it continues to have a single active electrode (wire loop or Star loop) as opposed to two active electrodes. The return electrode (the metallic outer Morcellator housing of the device) has such a large surface area relative to the active electrode that there can be no tissue coagulating (much less cutting or ablating) effect at its surface. Current densities near the surface of the morcellator housing have been measured to verify this physical impossibility.

The provided text does not contain information about acceptance criteria or a study designed to prove a medical device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device called the FemRx Focused Monopolar (FMP) 07584STAR™ System.

This summary primarily focuses on:

• Device Description and Comparison: Explaining how the FMP system is similar to and different from a previously cleared device (ERASTARTM System resectoscope) and other bipolar devices.
• Key Technological Change: Highlighting the move of the return electrode from outside the patient to the device body, enabling the use of isotonic saline.
• Safety Rationale: Emphasizing how the large surface area of the new return electrode prevents tissue damage at that site.
• Substantial Equivalence Claim: Stating that "in vitro and extirpated uteri studies comparing the resection and ablation performance of the Focused Monopolar device with the predicate confirmed that resection and ablation characteristics are substantially equivalent to currently marketed devices."

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth information, expert qualifications, adjudication methods, or MRMC study results) from the given text.

To provide the requested details, I would need a different type of document, such as a clinical study report, a regulatory submission with detailed performance data, or a scientific publication.

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The FemRx TURPSR™ System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection of tissue in the urethra, prostate and bladder.

The FemRx 100°SR™ System is a refined urologic resectoscope. A standard telescope is inserted into the device and coupled to an operative video camera system prior to use. The device is compatible with a variety of standard electro-surgery units (ESUs).

The system is designed to cut and coagulate prostate tissue by sliding the loop assembly in an axial manner relative to the handle/spring housing. Cutting and coagulation are accomplished by energizing the electrode with electrocautery current from an approved ESU. All cutting/coagulating occurs under visual control by a surgeon observing a video monitor displaying the view through the telescope. Cutting/coagulating is only performed while the device is moving towards the operator. Typically, the surgeon squeezes the finger rings to move cutting end distally; electrocautery is then applied and cutting/coagulating is accomplished by the active end as the spring returns the device to the most proximal resting location. The surgeon uses hand pressure to control the rate of sliding of the active end within the sheath. Separate channels are provided for irrigant inflow and outflow, permitting continuous fluid circulation for good visibility.

This document describes a medical device, the FemRx TURPSR™ System, which is a urological resectoscope. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and does not contain information related to acceptance criteria, a study proving performance against such criteria, or any of the detailed aspects requested in your prompt regarding AI/algorithm performance.

Therefore, I cannot extract the requested information from the provided text. The document describes a traditional surgical instrument and not a device incorporating AI or requiring performance validation against specific algorithmic metrics.

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The FemRx™ Morcellator System is virtually identical to the currently marketed Karl Storz STEINER™ Morcellator in terms of its tissue cutting and extraction mechanism. Both devices utilize a separate motor drive box and flexible drive a rotating cutting blade, internal to a cylindrical housing, used to cut or core tissue as it is drawn up through the central lumen of the device by the use of standard forceps.

The principle difference between the FemRx™ Morcellator and the Storz device is that the FemRx device incorporates a fixed cylinder inside the rotating cutter (see figure below). The fixed (non rotating) cylinder located on the inside of the cutter is designed to reduce the torsional or rotational force applied to the cored tissue fragments as they are pulled up through the central lumen of the FemRx™ device.

The FemRx™ Morcellator System also differs from the Storz device in that it is disposable and utilizes the Motor Drive Unit (MDU) that has been previously cleared as part of the FemRx™ ores STARTM and TORSTAR™ Hysteroscopic and Urological Resectosocipic Systems [510(k) numbers K954648 and K962506].

All tissue contacting materials are standard medical grade and non-toxic.

Based on the provided text, it appears that the FemRx™ Morcellator is being compared to the Karl Storz STEINER™ Morcellator, highlighting the FemRx's design difference (fixed internal cylinder) and disposability, and its use of a previously cleared motor drive unit.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert involvement, or any of the other specific details requested for a comprehensive study description.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study that proves the device meets specific criteria, as this information is entirely absent from the provided "Input" text.

If you can provide a different input that includes such study details, I would be happy to process it accordingly.

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The FemRx "00"STARTM System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection, morcellation and aspiration of tissue in the urethra, prostate and bladder.

The FemRx 700 STARTM System is a refined urologic resectoscope. The device consists of: 1) an electrode/tissue morcellator assembly including drive cable, 2) a sheath and; 3) a motor drive unit. A standard telescope is inserted into the device and coupled to an operative video camera system prior to use. The device is compatible with a variety of standard electro-surgery units (ESUs).

The system is designed to cut and coagulate prostate tissue by sliding the loop/morcellator assembly in an axial manner relative to the handle/spring housing. Cutting and coagulation are accomplished by energizing the electrode with electrocautery current from an approved ESU. All cutting/coagulating occurs under visual control by a surgeon observing a video monitor displaying the view through the telescope. Cutting/coagulating is only performed while the device is moving towards the operator. Typically, the surgeon squeezes the finger rings to move cutting end distally; electrocautery is then applied and cutting/coagulating is accomplished by the active end as the spring returns the device to the most proximal resting location. The surgeon uses hand pressure to control the rate of sliding of the active end within the sheath. Separate channels are provided for irrigant inflow and outflow, permitting continuous fluid circulation for good visibility.

This document is a 510(k) summary for the FemRx "00"STARTM System, a urological transurethral resection device. It describes the device's intended use, its components, and how it operates. However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any of the other details requested in questions 1 through 9.

The document states that "The system is identical (substantially equivalent) to the FemRx "EPSTARTM System used in gynecological applications." This implies that the device is being cleared based on its substantial equivalence to a previously cleared device, rather than through new performance studies specifically for the "00"STARTM System as a urological device.

Therefore, I cannot provide the requested information based on the input text. All of the requested information, such as acceptance criteria, study details, sample sizes, and ground truth methodologies, are entirely absent from the provided 510(k) summary.

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