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The HOTWIRE is indicated for creation of an atrial septal defect in the heart.

The HOTWIRE™ is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE™ is intended to be used in conjunction with compatible third-party intravascular sheaths and/or dilators, and third-party RF electrosurgical generator(s). The HOTWIRE™ is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and also provides fluoroscopic and echogenic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with third-party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included Adapter Pin that connects to hand pieces used with compatible third-party RF electrosurgical generators.

The HOTWIRE™ + Handpiece Kit is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE™ + Handpiece Kit is intended to be used in conjunction with compatible third-party intravascular sheaths and/or dilators, and the HOTWIRE™ System RF Generator, which utilizes a commercially-available Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2, such as the Valleylab E7507DB (K822572). The HOTWIRE™ is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and also provides fluoroscopic and echogenic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with third-party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included handpiece that connects with the HOTWIRE™ System RF Generator.

This FDA 510(k) clearance letter and summary describe a physical medical product, the HOTWIRE RF Guidewire, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML system (which typically involves metrics like accuracy, sensitivity, specificity, AUC, and studies like MRMC with ground truth establishment) is not applicable here.

The document details the device's technical specifications, design, materials, and extensive non-clinical bench top and in vivo performance testing to demonstrate its safety and effectiveness and its substantial equivalence to a predicate device.

Key points from the document regarding the device's performance and testing:

• Acceptance Criteria & Performance (General): The document states: "All test requirements were met as specified by applicable standards and test protocols." and "The HOTWIRE™ met all specified criteria and did not raise new safety or performance questions." This implies that predefined performance criteria for each test were successfully achieved. While a specific table of quantitative acceptance criteria versus reported performance (like a sensitivity/specificity table for an AI) isn't provided, the text confirms successful completion of various engineering and in vivo tests.

• Study Type: The studies performed are primarily non-clinical benchtop testing and in vivo animal testing (porcine model). These are designed to verify the device's physical and functional properties, and its performance in a biological environment.

• Sample Size:

  • Test Set (In vivo): A "porcine model" was used for in vivo testing. The specific number of animals or trials is not explicitly stated.
  • Training Set (for manufacturing/design, not AI): Not applicable in the AI sense. The design and manufacturing process for the guidewire would be iterated and refined through various engineering tests and material evaluations.

• Data Provenance:

  • Benchtop Testing: Likely conducted in a lab environment.
  • In vivo Testing: Utilized a porcine (pig) model.
  • Retrospective/Prospective: Not applicable in the context of an AI study. These are experimental tests designed to evaluate hardware performance.

• Experts for Ground Truth / Adjudication / MRMC:

  • These concepts are not applicable for a physical medical device clearance. "Ground truth" for a physical device is established through engineering specifications, material properties, and direct measurement of its physical and functional performance (e.g., tensile strength, RF power delivery, ability to create a defect in a model).
  • MRMC studies are specifically for evaluating human reader performance (e.g., radiologists) with or without AI assistance in diagnostic tasks.

• Standalone Performance: The benchtop and in vivo tests can be considered a demonstration of the device's "standalone" performance, meaning its inherent functional capabilities independent of human interpretation or diagnostic aid. For example, the "Arc integrity test," "Tensile strength test," and "In vivo testing" directly assess the device's intended function and safety characteristics.

• Type of Ground Truth: For this device, the "ground truth" is based on:

  • Engineering Specifications: Defined parameters for dimensions, material strength, electrical insulation, etc.
  • Direct Measurement: Quantification of physical properties (e.g., tensile strength, torque strength).
  • Functional Validation: Assessment of the device's ability to perform its intended action (deliver RF power, create a defect) in a controlled environment (benchtop) and a biological model (in vivo).
  • Compliance with Standards: Meeting requirements of relevant industry and regulatory standards (e.g., IEC 60601-2-2 for the RF Generator, ASTM standards for packaging).

• How Ground Truth for Training Set was Established: N/A as this is not an AI/ML device. The "training" of the device itself refers to its design and manufacturing process, which is refined based on engineering principles and test results.

Summary of Relevant Performance Data from the document:

The document lists several categories of testing, highlighting that all requirements were met:

• RF Guidewire Testing:
  • Visual and dimensional inspection
  • Simulated use test
  • Arc integrity test
  • Tensile strength test
  • Torque strength test
  • Torquability test
  • Fracture resistance test
  • Flexing test
  • Tip flexibility test
• Handpiece Testing:
  • Cable flex test
  • Cable tensile strength test
  • EEPROM functionality test
  • Cable length dimensional inspection
  • Retention test
  • Activation button test
• In vivo Testing:
  • Utilized a porcine model.
  • Evaluated subject device design performance during normal intended use.
  • Included compatibility with commercially-available introducer sheaths, intracardiac echocardiography (ICE) catheters, and fluoroscopic visualization.
• Shelf life testing: Accelerated aging for 1 year, all acceptance criteria met.
• Packaging validation: Acceptance criteria met, ensuring protection and sterile barrier.
• Sterilization validation: Achieved an SAL of 10⁻⁶ using gamma radiation.

In conclusion, while the request's structure is tailored for AI/ML devices, the provided document outlines a comprehensive set of engineering and biological tests demonstrating the physical guidewire's safety and performance, affirming its substantial equivalence to a predicate device.

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RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece of RFMagik are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

RFMagik is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch.

There are three handpieces. RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece that delivers RF energy through the disposable electrode in the handpiece.

This document is an FDA 510(k) clearance letter for an RF Electrosurgical Device (RFMagik). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does NOT contain information about acceptance criteria, device performance results, sample sizes, expert ground truth establishment, or clinical study details. The section on "Clinical Testing" explicitly states: "Clinical testing is not a requirement and has not been performed."

The document focuses on:

• Regulatory details: Device classification, product codes, indications for use.
• Technological comparison: Detailed comparison of the subject device (RFMagik) with a primary predicate device (RFMagik Lite) and a reference device (AGNES). This comparison highlights similarities and differences in handpieces, electrodes, output power, etc., and explains why these differences do not affect substantial equivalence.
• Non-clinical testing: Biocompatibility, sterility, shelf-life, and performance bench testing. An "Ex Vivo Study" was conducted on tissue types (liver, skin, muscle) for thermal testing.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes for the test set, data provenance, number/qualifications of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, or how training ground truth was established. This information is typically found in specific study reports or sections of a 510(k) submission that go beyond what is published in the clearance letter itself.

The document indicates that the substantial equivalence was primarily demonstrated through bench testing and comparison to predicate devices, rather than clinical trials or extensive human-in-the-loop performance studies.

Summary of what CANNOT be provided from the given document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size for the test set and data provenance: No clinical test set. Ex vivo study mentioned, but specific sample sizes are not detailed.
3. Number of experts and qualifications for ground truth: Not applicable as no clinical study with expert ground truth review was performed.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only) performance: Not applicable as this is a physical electrosurgical device, not an AI algorithm.
7. Type of ground truth used: Not applicable for a clinical study. Ex vivo study used physical tissue, but no "ground truth" akin to medical image labeling.
8. Sample size for the training set: Not applicable as there is no mention of an AI/ML algorithm requiring a training set.
9. How ground truth for the training set was established: Not applicable.

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The Aqua Medical RF Vapor System is indicated for use in the coagulation and ablation 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 device is to be used in adults only.

The Aqua RF Vapor Ablation System is a catheter-based device that uses radiofrequency (RF) energy to produce heated water vapor for the coagulating and ablating tissue. The RF energy heats liquid as it flows through the catheter, creating steam that is directed to the target tissue. The system includes the following components:

• Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. The catheter connects, fluidically and electrically, to the generator. A foot pedal is used to control the RF energy and vapor delivery.
• Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7F (2.3 mm) with an outer catheter sheath that is 10.5F and a length between 145 cm and 210 cm. Catheters are designed to be used through an endoscope working channel diameter of 3.7mm. This submission included only the modified circumferential catheter.
• Cassette (Syringe and Tubing): Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.

This 510(k) clearance letter pertains to the Aqua Medical RF Vapor Ablation System. However, the provided document does not include acceptance criteria or the study details that prove the device meets such criteria.

The document states that "The proposed modifications do not introduce new safety and effectiveness concerns and support the company's substantial equivalency claim" and mentions "supporting non-clinical data" and "bench testing and scientific rationales." It lists various performance tests conducted for the Generator, Catheter, and Cassette components, but it does not provide any quantitative acceptance criteria or performance results from any clinical or even pre-clinical study testing the device's efficacy against specific metrics.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.

The information given is limited to:

• Device Name: Aqua Medical RF Vapor Ablation System
• Indications for Use: Coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract (e.g., Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE), Radiation Proctitis (RP)) in adults.
• Modifications: To the generator, Cassette (syringe and tubing), and circumferential catheter.
• Tests Performed (Non-Clinical):
  • Generator: EMC & Electrical Safety, Software validation, Generator Hardware Verification
  • Catheter: Hardware Verification Testing, Simulated-use tissue validation (Lean Beef Testing)
  • Cassette: Biocompatibility, Shelf-Life assessment, Sterilization Validation
• Conclusion: The device is substantially equivalent to the predicate device, and modifications do not raise new safety or effectiveness concerns.

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The Boston Scientific RFG-X1 (GX1) Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific GX1 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes

The Boston Scientific GX1 Radiofrequency (RF) Generator is a 50W RF lesion generator that supplies electrical power to associated RF Probes. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. The GX1 Generator is a product line extension of the Boston Scientific G4 Radiofrequency Generator which is FDA approved under 510(k) K082051.

The GX1 Generator is a small, portable unit (14.3" W x 10.8" H x 12.5" D, 24lbs) that can accommodate line Voltage between 100 and 240 Volts. The GX1 Generator has advanced functionality and a Graphical User Interface (UI) equivalent to the Boston Scientific RF Generator, its predicate device.

The provided FDA 510(k) clearance letter describes a medical device, the Boston Scientific GX1 Radiofrequency Generator, and its performance testing. However, the document does not contain information related to acceptance criteria, a study proving the device meets those criteria, or details regarding AI/ML components.

The GX1 Radiofrequency Generator is a hardware device used to create radiofrequency lesions, not a software or AI/ML device that would typically have acceptance criteria based on diagnostic performance metrics (like sensitivity, specificity, AUC) and require a clinical study with a test set, ground truth, and expert adjudication.

Therefore, I cannot fulfill most of your request as the information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as specific numerical targets for performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly "Pass" for compliance with electrical safety standards, electromagnetic compatibility, and various design verification tests.
• Reported Device Performance:

• RF Output Voltage Measurement
• RF Output Current Measurement
• RF Output Impedance Measurement
• RF Ramp Rate Control
• Stimulation Output Voltage
• Stimulation Output Current
• Ablation Temperature Measurement
• Contact Quality Measurement | Pass |
  | Packaging Testing | Conform to ASTM D4169 Standard Practice for performance testing of shipping containers and systems | Pass |
  | Mechanical Testing | - Tamper Resistant screws
• Cleaning Test
• Drop Test
• Impact Test
• Flammability
• Overbalance
• Durable Labels
• Ingress Protection
• Operational conditions (Temperature, Pressure and Humidity) | Pass |
  | Lesion Size Comparison Test | Compare lesions size in homogenous tissue using G4 (Predicate) vs GX1 System | Pass |
  | Dimension and Weight | Meet dimensional and weight specifications per product specification | Pass |
  | Software Verification | - User Workflow and Information Display
• Touch Screen
• Error Display
• Report/Diagnose Logging
• Security
• Language Translation
• Therapy Template | Pass |

Missing Information (Not present in the provided document):

2. Sample size used for the test set and the data provenance: Not applicable for this type of hardware device testing. There isn't a "test set" in the context of clinical data for diagnostic performance.
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 hardware performance is typically established through engineering specifications, calibrated measurements, and adherence to international standards.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth used for these technical tests are established engineering specifications, physical measurements, and compliance with recognized industry standards (e.g., IEC standards for electrical safety and EMC, ASTM for packaging).
8. The sample size for the training set: Not applicable, as this is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The Boston Scientific GX1 Radiofrequency Generator underwent a series of non-clinical bench testing to demonstrate its performance, safety, and effectiveness. These tests included:

• Electrical Safety Testing: To ensure compliance with IEC 60601-1 and IEC 60601-2-2.
• Electromagnetic Compatibility (EMC) Testing: To confirm compliance with IEC 60601-1-2.
• Performance Testing: A range of specific tests covering RF power, voltage, current, impedance, temperature measurement/control, stimulation output, contact quality measurement, and lesion size comparison with the predicate device (G4 RF Generator) in "homogenous tissue."
• Packaging Testing: To ensure integrity during shipping.
• Mechanical Testing: Covering various physical durability and environmental factors.
• Software Verification: To confirm user interface, error handling, security, and other software functionalities.

All tests "Passed," indicating that the device met its design input requirements and compliance standards. The study's conclusion was that the GX1 Generator is substantially equivalent to its predicate device (K082051) based on indications for use, technological characteristics, and acceptable results from verification and validation testing.

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The Codonics Safe Label System SLS 700i and related 610i, 620i, 630i series enabled to receive RFID features and safe and effective released SLS Software provides a simple computer-based bar code scanning/RFID & printing system to automatically verify drug identity from NDC and other drug vial UDI Barcodes and (when configured and available) RFID parenteral vial information and formulary information, and to print labels embedded with RFID tags for prepared drugs and other items in use on patients during surgical procedures. Drug information is human readable on labels, 2D & Linear barcoded on labels, and RFID encoded as part of secondary container medication labels.

Codonics Safe Label System SLS 700i and related 610i, 620i, 630i series enabled to receive RFID features is generally placed in, however not limited to, the peri-operative environment to identify syringes prepared for anesthesiology use during surgery. Additional uses include producing labels for IVs and other artifacts used during a surgical procedure. SLS can also be used to print "non-surgical environment" color & text labels as required. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians

Drug preparation and administration in the perioperative environment are integral aspects of pharmacy, patient care clinicians, and anesthesiologist's patient care responsibilities.

Drug selection, preparation, and administration errors occur at the point of care in association with parenteral vial identification, secondary CSP container labeling, and pre-administration selection. Machine readable drug IDs & information in the form of machine-readable barcode and RFID tags serve as additional means to confirm medications (beyond human readable labeling).

Best practices for safe medication preparation and labeling in support of reducing error includes font characteristics & readability, drug class/type color coding, machine readable bar and RFID codes & formulary confirmed information being part of creation & application of secondary container CSP labeling to assist pre-administration selection and dose delivery recording.

Codonics Safe Labeling System (SLS-1) 700i and related 610i, 620i, 630i, SLS-XXX RFID series is a simple, integrated system utilizing a bar code scanner and RFID reader & encoder to confirm drug identity from NDC and other drug ID Barcoded vials and safely & automatically print labels for prepared drugs and other items in use on patients during clinical and surgical procedures. In addition to K101439 series machine readable barcodes, the 700i and related 610i, 620i, 630i, SLS-XXX series configurations when equipped with suitable near field HF, UHF, or HF/UHF RFID modules & software, allows RFID information to be read and formulary information including 3rd party MDD ID content to be written ("encoded") to SLS label RFID tags (Passive) for use by third party applications. The labels are fully compliant with national standards and best practices focused on improving medication safety in the perioperative environment. As a MDD (Master Drug Database) intra-hospital networked device, emission & immunity safety as well as protections in the realm of cyber security is part of the safety and efficacy. The system is small enough to fit on the anesthesia supply cart and integrate seamlessly into the anesthesia workflow allowing use in the OR during patient care. Like the predicate SLS, barcode read NDC/UDI codes indexed to the approved formulary is retained as the "source of truth" for all drugs processed for labeling by SLS RFID series*.

The software components provide functions for scanning/reading vials, indexing against a "source of truth" hospital/healthcare environment managed/commissioned & verified formulary database, displaying on screen and audibly confirming drug type, printing color JCOAHO and ISO and ASTM compliant labels with 2-D barcodes and, when equipped with suitable HF, UHF, or HF/UHF RFID modules & software, RFID tagged information encoding on secondary container CSP labels. The system reads drug vial barcodes and produces waterproof, color labels compliant to FDA/ISMP, ASA, USP, ISO, ASTM, TJC, JCACHO.

*SLS RFID Series products maintain reliance on barcode scanned and formulary verified information to print secondary container labels and encode 2D and RFID tagged information to embedded SLS label RFID tags. The system label output can be integrated to function with 3rd party applications such as an AIMS system workflow to provide real-time documentation of drug administration when the syringe "2D Barcode" or RFID tag is read.

The Codonics Safe Labeling System (SLS) is designed to improve medication safety in perioperative and other clinical environments by verifying drug identity and printing compliant labels. The acceptance criteria and study proving its performance are detailed below, particularly focusing on the advancements in RFID technology.

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The non-clinical lab tests verifying NDC/UDI coded vials and RFID performance were conducted with a "Preliminary Verification Test SLS Configurations Safe Label System Confirmation of Functionality reporting greater than 10,000 RFID labels of 25 drugs in the various drug class colors and RFID payload."
• Data Provenance: The document states that both laboratory (non-clinical environment) and surgical (clinical) tests were performed. There is no specific mention of the country of origin for the data, but the regulatory compliance refers to US (FCC, ANSI, ASTM, Joint Commission, ASA) and international (ISO, IEC, TUV, CISPR) standards, suggesting a general applicability or data collected within these regulatory frameworks. The description implies prospective testing as part of product development and verification before market release.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish ground truth for the test set.
• Qualifications of experts: While not explicitly stated for the test set ground truth, the "Typical users of this system are trained professionals, including but not limited to physicians, nurses, pharmacists, and technicians" who ultimately control and review the device's output. The system's output is based on "site managed formulary lookup database" which is managed by "DOP pharmacy, anesthesiology, Dir Medical Staff, etc." These clinicians and department heads would collectively define the "source of truth" for the formulary.

4. Adjudication Method for the Test Set

• The document does not explicitly describe an adjudication method for the test set in the conventional sense (e.g., 2+1, 3+1 for image interpretation).
• The system uses a "source of truth" which is the "site managed formulary lookup database." The device's performance is verified against this established database for drug identification, concentration, and associated labeling information. "Input codes and output read content was confirmed," indicating a direct comparison against expected outputs derived from this ground truth.

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

• A MRMC comparative effectiveness study was not explicitly mentioned or described in the provided text. The device is described as a "scanning/RFID & printing system" and not an AI-assisted diagnostic tool that humans interpret. Its function is to automate and verify drug labeling, not to assist human readers in making diagnostic decisions where an "effect size of how much human readers improve with AI vs without AI assistance" would be relevant.

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

• The device's core function is an automated process of scanning, verifying against a formulary, and printing/encoding. The non-clinical lab tests verifying "error free NDC/UDI vial reading and labeling of prepared drugs to ASA/ISO standards" and "error free accuracy and precision" for RFID processing are effectively standalone performance evaluations of the algorithm and hardware.
• The document states, "No automated decision processes tied to patient care are involved with SLS operation. ... Medical personnel review the results and inputs processed by the Codonics SLS and offers ample opportunity for competent human intervention in the case of a malfunction or other failure." This confirms that while the device performs its functions autonomously, it operates within a workflow that includes human oversight.

7. Type of Ground Truth Used

• The primary ground truth used is the site-managed formulary lookup database. This database contains verified drug names, concentrations, expiration data, and site-specific rules.
• For barcode and RFID performance, the ground truth is the known, correctly coded/tagged information on the original drug vials and the intended output for the generated labels. This is based on established national and international standards (NDC, UDI, ASA, ISO, ASTM, TJC).

8. Sample Size for the Training Set

• The document does not specify a sample size for a training set. This is generally a concept applicable to machine learning algorithms. The SLS system appears to operate based on established rules, databases, and barcode/RFID standards rather than learning from a training dataset in the typical AI/ML sense. It is a deterministic system that performs verification and printing based on pre-defined information.

9. How Ground Truth for the Training Set Was Established

• As the system does not appear to use a training set for machine learning, the concept of establishing ground truth for a training set is not applicable in this context. The core "knowledge" for the device, the drug formulary, is established and managed by "DOP pharmacy, anesthesiology, Dir Medical Staff, etc.," and is a human-curated and verified database that the system utilizes.

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The Diode laser device is intended for use in dermatology procedures requiring coagulation. The indications for use for the Trio-Wavelength Handpiece include: The Fast Hair Removal (FHR) Mode is intended for temporary hair reduction. The HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the HR mode include: Benign vascular and vascular dependent lesions.

The 810nm wavelength handpiece is 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 I-VI), including tanned skin.(HR, and FHR Modes).

The Diode Laser device includes two handles with different laser band characteristics. One handle contains a single-band 808nm semiconductor laser, and the other handle contains a three-band (755nm/808nm/1064nm) semiconductor laser. The semiconductor lasers of the two handles are powered by the laser power supply in the host to emit laser of corresponding wavelength.

Working principle of semiconductor laser
Semiconductor laser uses semiconductor materials of different doping types as laser working substance, uses natural cleavage surface to form resonant cavity for laser oscillation and amplification, and adds forward voltage to PN junction area of semiconductor laser to form particle number inversion of non-equilibrium carrier between conduction band and valence band of semiconductor substance. When a large number of electrons and holes in particle number inversion state are recombined, excess energy will be released, and these energies will be expressed in the form of photons, that is, laser is formed. Due to resonance amplification of cleavage surface resonant cavity, the stimulated feedback is amplified, so that laser can be directionally emitted and output from semiconductor laser.

The Diode laser device consists of a main unit, a handheld, a foot switch and a power cord.

Mode Description

1. Trio FHR Mode
   The Diode Laser device Trio-Wavelength module with FHR mode is intended for temporary hair reduction.
   In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 10 Hz and energy fluence is 2-8J/cm2. The operator can adjust the parameters within this range according to the actual situation.

2. Trio HR Mode
   The Diode Laser device Trio-Wavelength module with HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the HR mode include: Benign vascular and vascular dependent lesions.
   In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 1-10 Hz and energy fluence is 2-60J/cm2. The operator can adjust the parameters within this range according to the actual situation.

3. 810nm wavelength
   The 810nm wavelength handpiece is 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 12months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI)including tanned skin. (HR, and FHR Modes)
   HR Mode: In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 1-10 Hz and energy fluence is 2-60J/cm2. The operator can adjust the parameters within this range according to the actual situation.
   FHR Mode: In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 10 Hz and energy fluence is 2-8J/cm2. The operator can adjust the parameters within this range according to the actual situation.

The FHR Mode of the two handpiece (810nm& Trio-Wavelength) is the fast hair removal mode. This mode means a quick option for pulse frequency. In the FHR mode, the frequency is fixed at 10Hz and cannot be adjusted. The FHR mode of the 810nm handpiece is used for permanent reduction in hair regrowth defined as a long term, while the FHR mode of the Trio -wavelength handpiece is used for temporary hair reduction.

The HR mode of the two handpiece (810nm& Trio-Wavelength) is designed to differentiate from the FHR mode in terms of parameters. The HR mode covers all pulse frequency ranges (frequency: 1 - 10 Hz), and the pulse frequency can be adjusted. The HR mode of the 810 nm handpiece is used for permanent reduction in hair regrowth defined as a long term, while the FHR mode of the Trio -wavelength handpiece is used for benign vascular and vascular dependent lesions.

4. Operation Differences:
   In terms of user operation, the software has two operation modes: HR mode and FHR mode. After startup, there will be a selection interface for these two modes. Users can select different devices to enter different interfaces. In the HR mode interface, can adjust the frequency and energy fluence through the up and down buttons. In the FHR mode interface, the frequency cannot be adjusted, and only the energy fluence can be adjusted through the up and down buttons. Other operations are the same for both modes.

The provided FDA 510(k) clearance letter for the Diode laser device (RF3120-BI) does not contain information about a study proving the device meets acceptance criteria related to AI or algorithm performance.

The document details the device's technical specifications, its intended use (dermatology procedures, hair reduction, benign vascular/vascular-dependent lesions), and comparisons to predicate devices in terms of technical parameters like spot size, energy fluence, and pulse frequency. It also lists several non-clinical tests the device has undergone to ensure electrical safety, laser safety, and biological compatibility (skin sensitization, irritation, cytotoxicity).

Crucially, the clearance letter explicitly states: "The clinical study is not applicable." This indicates that the regulatory pathway for this specific device did not require a clinical study demonstrating its performance in treating patients, nor does it mention any AI or algorithmic components that would necessitate such a study or associated performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot fulfill your request for information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI or algorithmic performance, as the provided document does not disclose any such study or AI component.

Based on the provided text, the device's acceptance criteria are based on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards (non-clinical tests), rather than clinical efficacy studies or AI performance metrics.

If the device did incorporate AI, the FDA clearance letter would typically describe a study to validate its performance according to specific acceptance criteria. Since that information is absent, it suggests the device does not rely on AI for its claimed indications.

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The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator.

The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-the-wire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise Multi-Use RF Adapter Cable (packaged separately – Model CW-1001) and a commercially available Electrosurgical Pencil.

This 510(k) clearance letter details the substantial equivalence of new models of the CrossWise RF Transseptal Access System to a previously cleared predicate device. It specifically states that the new models have minor modifications and leverage most of the performance data of the predicate device.

Therefore, the acceptance criteria and study details discussed below refer to the bench testing conducted for these minor modifications, as this is the only performance data explicitly mentioned for the subject device. The document does not contain information about clinical studies with human participants, expert ground truth adjudication, or AI performance, as it is related to a medical device's physical and functional equivalence, not an AI or diagnostic tool.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The provided 510(k) clearance letter details the acceptance criteria and the non-clinical performance data for the CrossWise RF Transseptal Access System line extensions (Models CW-1085C, CW-1085V, and CW-1013F). The study conducted to prove the device meets these criteria was a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

The letter explicitly states that the new models leverage most of the performance data of the predicate device. The following table summarizes the specific tests conducted for the minor modifications of the new models and the implied performance criteria based on the conclusion of substantial equivalence.

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

• Sample Size: Not explicitly stated in terms of a number of devices or units. The testing refers to "minor modifications" to the dilator hub and compatibility with new introducer sheaths. For bench tests like these, a statistically representative sample size would have been used for each test (e.g., n=3, 5, or 10 units per test configuration), but the exact numbers are not provided.
• Data Provenance: The data is non-clinical bench testing conducted by the manufacturer, Circa Scientific, Inc. The location of the testing is not specified, but it would have been conducted in a laboratory setting under controlled conditions. This is not retrospective or prospective in the clinical sense, as it does not involve patient data.

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

• Not applicable. This document describes the clearance of a medical device (a transseptal access system), not an AI or diagnostic tool that relies on expert interpretation of data to establish ground truth. The acceptance criteria are based on objective engineering and performance standards demonstrated through bench testing.

4. Adjudication Method for the Test Set

• Not applicable. As this is non-clinical bench testing of a physical medical device against engineering standards, there is no expert adjudication process in the manner of medical image interpretation or clinical outcomes. Test results would have been analyzed and verified by qualified engineering and quality personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is typically conducted for diagnostic devices or AI systems where human readers interpret patient cases. This clearance is for a physical medical device used in interventional cardiology.

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

• Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Engineering and Performance Standards: The "ground truth" for the bench tests would have been established by predefined engineering specifications, internationally recognized standards (e.g., ISO 80369-7, ISO 10993-1, ISO 11070-1), and the performance characteristics of the predicate device. For example, the ground truth for "Dilator Leak Test" would be "no leakage observed under specified pressure," and for "ISO 80369-7 Luer Testing" would be "full compliance with all requirements of the standard."

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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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