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The Epicor Medical UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery.

The items in the UltraCinch Accessory Pack are intended for use in the ablation of cardiac tissue during cardiac surgery.

Epicor Medical UltraCinch Tissue Ablation Device and Accessories

This document is a 510(k) premarket notification for the Epicor Medical UltraCinch Tissue Ablation Device and Accessories. It focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness criteria through specific performance goals and studies.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types cannot be fully provided from the given text. This type of submission relies on showing that the new device is as safe and effective as existing legally marketed predicate devices, often by demonstrating similar technological characteristics and performance in standard tests, rather than setting and meeting new, specific quantitative acceptance criteria for a novel clinical outcome.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific percentages, measurements, or clinical outcomes) that the device must meet. Instead, it states that "Results of in vitro testing, in vivo testing, and human clinical studies demonstrate that the Epicor Medical UltraCinch tissue ablation device and accessories are safe and effective for their intended use."

The device performance is generally reported as:

• "safe and effective for their intended use."
• "meet the requirements of ISO 10993-1." (for biocompatibility)

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

• Sample Size for Test Set: Not specified in the provided text. The document mentions "clinical studies" but does not give details about their size or structure.
• Data Provenance: Not explicitly stated. The document refers to "in vitro testing, in vivo testing, and human clinical studies." These could be retrospective or prospective, and the country of origin is not mentioned.

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

This information is not provided in the text. As this is a 510(k) submission focused on substantial equivalence, the "ground truth" (in the sense of a diagnostic or predictive AI model) is not the primary focus. The "ground truth" for the device's function would be the physical effect of ablation, which is assessed through the "in vivo testing" and "human clinical studies" mentioned in a general sense.

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

This information is not provided in the text.

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 is not applicable to this device. The Epicor Medical UltraCinch is a tissue ablation device, not an AI software or diagnostic imaging system that would involve human readers interpreting cases with or without AI assistance.

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

This is not applicable to this device. As explained above, this is a physical medical device for cardiac tissue ablation, not an algorithm or AI system.

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

For this type of device, the "ground truth" would likely relate to:

• Successful ablation: Confirmation of tissue destruction/modification.
• Clinical outcomes: Reduction of arrhythmias or other target conditions.
• Safety metrics: Absence of adverse events.

However, the specific methods for establishing this ground truth (e.g., pathology reports from ablated tissue, electrophysiological mapping results, long-term patient follow-up, etc.) are not detailed in the provided text.

8. The sample size for the training set:

This is not applicable as this is a physical medical device, not an AI/ML model that requires a training set. The "studies" mentioned would be for device validation, not model training.

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

This is not applicable as this is a physical medical device, not an AI/ML model that requires a training set.

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The CardioFocus Diode Laser System is intended for the delivery of 980nm laser light to soft tissue in contact or noncontact mode during surgical procedures including via endoscopes, introducers or catheters. Indications include the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue.

The CardioFocus Diode Laser Ablation System is a generator designed for the delivery of 980nm laser light and may be used in conjunction with surgical treatment for hemostasis, incision, ablation, coagulation and vaporization of tissue as required by the clinician. The instrument includes a diode laser module as the therapeutic energy source, as well as an internal thermal safety system for monitoring and disabling laser power output.

The provided text is a 510(k) summary for the CardioFocus Diode Laser System. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through demonstrating similar intended use, technology, and safety characteristics. It does NOT typically contain detailed clinical study data with acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies as you might find for a novel device or a Premarket Approval (PMA) application.

Therefore, many of the requested details about acceptance criteria and a "study that proves the device meets the acceptance criteria" are not present in this document. The document's primary "proof" is the demonstration of equivalence to legally marketed predicate devices, and adherence to recognized safety standards.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies that the acceptance criteria for the CardioFocus Diode Laser System are that it is substantially equivalent to the predicate device (Ceralas Diode Laser System) and that its safety characteristics are assured through conformance with applicable U.S. and International standards. These are not quantitative performance metrics in the typical sense of accuracy, sensitivity, or specificity for a diagnostic device.

• Reported Device Performance: Instead of specific performance metrics, the document states: "Both devices output optical energy at similar power levels and similar wavelengths, have similar intended uses and provide for safety though conformance to recognized standards." And, "When used in accordance with the directions for use, by qualified personnel, the CardioFocus Diode Laser System is safe and effective, as indicated, for its intended use."

  Acceptance Criteria (Implied)	Reported Device Performance
  Substantial equivalence to predicate device	"More similarities than differences" to predicate. Output optical energy at similar power levels and wavelengths. Similar intended uses.
  Conformance to applicable U.S. and International safety standards	Conforms to UL 2601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, IEC 1000, and 21 CFR 1040.10/.11.
  Safe and effective for intended use	"Safe and effective, as indicated, for its intended use."

Missing Information (Not provided in the 510(k) Summary):

The sections below require information typically found in clinical studies or performance validation reports, which are not detailed in a 510(k) summary for a device like this.

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
  • Not provided. This type of information would be relevant for a clinical trial demonstrating efficacy, which is generally not required for a 510(k) for a surgical laser system if substantial equivalence can be shown through technological comparison and adherence to standards.
• 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 provided. This implies a diagnostic or interpretive task that is not the primary focus of this laser system's 510(k) review.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
  • Not provided.
• 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 provided. This is not an AI-assisted diagnostic device, so an MRMC study is not applicable.
• 6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
  • Not provided. This is not an algorithmic device in the diagnostic sense.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
  • Not provided.
• 8. The sample size for the training set
  • Not provided. No "training set" in the machine learning sense is described.
• 9. How the ground truth for the training set was established
  • Not provided.

Study that Proves the Device Meets the Acceptance Criteria:

The "study" presented in this 510(k) summary is a comparative analysis of the CardioFocus Diode Laser System against legally marketed predicate devices, primarily the CeramOptec Ceralas D25 Fiber-Coupled Diode Laser System.

Key elements of this "study" (as presented):

• Objective: To demonstrate substantial equivalence of the CardioFocus Diode Laser System to predicate devices.
• Methodology:
  • Comparison of Technical Characteristics: The document outlines the general description, device characteristics (e.g., power levels, wavelength), and technical characteristics (e.g., system controller, thermal safety system, optics module, user interface, foot switch, diode driver, diode module, power supply) of the CardioFocus system.
  • Predicate Device Identification: The Ceralas Diode Laser System (K001975) is identified as the primary predicate.
  • Comparison Points for Substantial Equivalence:
    • Intended Use: Both devices are for "delivery of 980nm laser light to soft tissue in contact or noncontact mode during surgical procedures including via endoscopes, introducers or catheters. Indications include the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue." (Identical wording).
    • Technology & Theory of Operation: Both devices use diode laser technology. "Both the predicate devices use the same technology and theory of operation."
    • Power Levels & Wavelengths: "Both devices output optical energy at similar power levels and similar wavelengths." Specifics provided are 30W and 60W models for CardioFocus, and "three configurations for different power levels" for Ceralas. Both use 980nm wavelength.
    • Safety Standards Conformance: The CardioFocus device's safety is assured through conformance with several recognized U.S. and International standards (UL 2601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, IEC 1000, 21 CFR 1040.10/.11). The predicate device is also stated to conform to recognized standards.
• Results/Conclusion:
  • "There are more similarities than differences between the predicate device and the CardioFocus Diode laser System."
  • "Both devices output optical energy at similar power levels and similar wavelengths, have similar intended uses and provide for safety though conformance to recognized standards."
  • The FDA's decision letter (K013201) confirms the finding of "substantial equivalence (for the indications for use stated in the enclosure) to legally marketed predicate devices."

The 510(k) submission itself serves as the "study" demonstrating that the device meets the implicit acceptance criteria of substantial equivalence and safety through standard adherence. No separate clinical trial with specific performance metrics, ground truth, or expert review is detailed for this type of submission.

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