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The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196℃ requiring either active or passive venting during surgical procedures.

The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (eg. Barrett's Esophagus with high grade and/or low grade dysplasia) and malignant lesions.

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets them in the context of an Artificial Intelligence (AI) or machine learning (ML) device. The document describes a 510(k) premarket notification for the "truFreeze® System," which is a cryosurgical tool.

The document discusses:

• The indications for use for the truFreeze system, including the addition of Barrett's Esophagus with low-grade dysplasia.
• A clinical study conducted to support the effectiveness and safety of the truFreeze system for ablating Barrett's Esophagus with low-grade dysplasia. This is a study of a physical medical device, not an AI/ML algorithm.
• Data on the safety and effectiveness of the device, focusing on patient response (complete eradication of dysplasia - CE-D) and adverse events.
• Comparison to predicate and reference devices to establish substantial equivalence.

Therefore, I cannot extract the information required for the requested table and study details related to an AI/ML device's acceptance criteria and performance as the provided document does not pertain to such a device.

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The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia) and malignant lesions.

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

Console:
The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction. The console is the same as previously cleared for the predicate truFreeze System (K162695). Therefore, there are no new issues of safety or effectiveness raised.

Disposable spray kit:
There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit is provided with includes a carton of five (5) individually packaged sterile, single-use CDTs with associated tubing in individual pouches. Each carton within a spray kit contains the instructions for use. The disposable kit is the same as previously cleared for the predicate truFreeze System (K162695). Therefore, there are no new issues of safety or effectiveness raised.

Although the provided text heavily details the device and its testing, it does not contain acceptance criteria in the format of a table with specific metrics and thresholds. Instead, it presents a clinical study's results with the claim of "substantial equivalence" to predicate devices. Therefore, I cannot construct the requested table of acceptance criteria and reported device performance directly from the text.

However, I can extract and structure all other requested information about the study that proves the device meets its expanded indications.

Here's an analysis of the provided text, addressing your points:

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

The document does not provide a table of pre-defined acceptance criteria with specific numerical thresholds. It relies on a "substantial equivalence" argument, comparing the device's performance (safety and efficacy) to existing predicate devices and literature.

Implicit "Performance Metrics" and Reported Performance (derived from results):

Note on "Acceptance Criteria": The concluding statement in the "Discussion" section mentions: "This success rate is comparable to the success rate for the Barrx System and the Coldplay CryoBalloon™ Focal Ablation System among all phenotypes of BE patients, ranging from no dysplasia to early adenocarcinoma and across 3 different ablation doses." This suggests that the "acceptance criterion" was achieving a comparative efficacy and safety profile to these established devices, rather than a fixed numerical threshold.

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

• Test Set (Clinical Study Population):
  • Safety Population: 111 patients
  • Efficacy Population: 46 patients (a subset of the safety population, meeting specific inclusion/exclusion criteria for BE-HGD)
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the FDA submission suggests it's likely a US-based study given the regulatory context.
  • Retrospective or Prospective: "This post-marketing registry prospectively collected data on patients treated with the FDA-cleared cryotherapy device (truFreeze® System)." So, it was prospective.

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

The document does not specify the number or qualifications of experts used to establish the ground truth (e.g., histology results for Barrett's Esophagus with high-grade dysplasia). It merely states that there were "pre-therapy and post-therapy histology."

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

The document does not specify any adjudication method for the test set's ground truth assessment.

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

This section is not applicable. The device is a cryosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to human reader improvement with AI assistance was not conducted.

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

This section is not applicable. The device is a physical surgical intervention tool, not an algorithm. Its performance is measured by clinical outcomes (ability to ablate lesions, safety profile), not by an algorithm's standalone performance.

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

The primary ground truth for efficacy was established through histology (pathology): "Patients without a pre-therapy and post-therapy histology" was an exclusion criterion for the efficacy population. The outcome measured was "Complete Eradication of Dysplasia (CE-D)," which relies on pathological confirmation.

8. The sample size for the training set

This section is not applicable. The truFreeze System is a cryosurgical device, not a machine learning algorithm that requires a "training set." The clinical data presented is for validation of its expanded indications.

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

This section is not applicable as there was no "training set" for an algorithm.

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The HALO® Ablation Catheter (used with the HALOFER Energy Generator, model 1190A-115A) is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).

The HALO® (subject device) is a single-use bipolar device that delivers radiofrequency energy to the treatment tissue within the gastrointestinal tract. It is used solely with the HALOFES Energy Generator (model 1190A-115A), which provides the radiofrequency energy.

The HALO60 Ablation Catheter is a modification of the HALO90 Ablation Catheter, primarily involving a reduction in the copper electrode surface area. The submission is a Special 510(k) as the modification does not change the intended use or alter the fundamental scientific technology.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or numerical performance metrics for the HALO60 Ablation Catheter. Instead, it focuses on demonstrating substantial equivalence to a predicate device (HALO90 Ablation Catheter) based on the absence of new questions of safety or effectiveness.

The "performance" is implicitly demonstrated through the modifications and the conclusion of substantial equivalence.

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

The document does not describe a specific clinical "test set" with a sample size in the traditional sense of evaluating a new device's performance against clinical endpoints. The submission relies on design verification activities and a comparison to the predicate device's established safety and effectiveness.

• Sample Size for Test Set: Not applicable as a clinical test set for performance evaluation is not described.
• Data Provenance: Not applicable as a clinical test set for performance evaluation is not described. The document pertains to regulatory submission data.

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

This information is not applicable to this submission. The document focuses on engineering and design verification rather than clinical outcomes requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable to this submission as a clinical test set requiring adjudication is not 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

This information is not applicable. The HALO60 Ablation Catheter is a medical device for radiofrequency energy delivery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable. The HALO60 Ablation Catheter is a physical medical device, not an algorithm, and operates with human intervention during its use.

7. The Type of Ground Truth Used

The "ground truth" in this context is established through design verification activities against design input requirements, and based on the established safety and effectiveness of the predicate device (HALO90). The document highlights:

• Design Input Requirements: The modified device's design outputs were verified to meet these.
• Predicate Device's Established Performance: The HALO90's prior clearances (K093008, K083737, K062723) serve as the basis for demonstrating substantial equivalence.
• Failure Modes, Effects, and Criticality Analysis (FMECA): Used to analyze risks, implying that safety standards and risk mitigation served as a form of "ground truth" for design decisions.

8. The Sample Size for the Training Set

This information is not applicable. The HALO60 Ablation Catheter is a physical medical device; there is no "training set" of data in the context of machine learning or AI.

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

This information is not applicable for the reasons stated in point 8.

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