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The CardioFocus Deflectable Sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The HeartLight® Deflectable Sheath is a sterile, disposable device which provides a conduit for catheter introduction into the vasculature and into the chambers of the heart. The Deflectable Sheath is able to move its distal section in one direction in a single plane and is activated by a rotating knob at the front of the device handle. The deflection of the sheath and the torquing of the device allow the distal end of the sheath to be positioned at the ostium of pulmonary veins.

The provided document describes the HeartLight Deflectable Sheath, a medical device, and its comparison to a predicate device for the purpose of a 510(k) premarket notification. The information pertains to engineering testing and biocompatibility rather than the performance of an AI/ML powered device impacting diagnostic accuracy. Therefore, many of the requested elements for an AI/ML study, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable in this context.

However, I can extract the acceptance criteria and performance data as presented for this device.

1. Table of Acceptance Criteria and Reported Device Performance

The document details performance and functional requirements testing for the HeartLight Deflectable Sheath, primarily through a comparison to the predicate device, FlexCath® Advance™ Steerable Sheath (K123591), and a reference device, HeartSpan® Steerable Introducer (K132164). The acceptance criteria are generally implied by stating "Same" or "Similar" to the predicate, with specific values provided where there are differences.

Study Proving Device Meets Acceptance Criteria:

The study involved a series of Design Verification tests and Biocompatibility tests.

The document states: "Design Verification testing were performed for the HeartLight 12F Deflectable Sheath to verify that design outputs meet relevant performance and functional requirements and conforms to the intended use of the device." And "The device specification requirements for functionality, performance specifications, physical characteristics, safety characteristics, labeling, packaging and shipping, shelf life, and sterilization all passed the specific tests and engineering evaluations. The testing demonstrates that the device does not raise questions of safety or effectiveness when compared to the predicate."

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

• Test Set Sample Size: The document does not specify the exact sample size for each performance test (e.g., how many sheaths were tested for deflection, kink resistance, etc.). The testing appears to be bench testing of the device itself rather than human-subject data.
• Data Provenance: The data is generated from bench testing and laboratory biocompatibility studies of the device components. There is no information regarding country of origin of the data as it's not human subject data. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission.

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

• Not Applicable. This is a medical device clearance based on engineering performance and biocompatibility bench testing, not an AI/ML diagnostic or prognostic device requiring expert-established ground truth from patient data.

4. Adjudication method for the test set:

• Not Applicable. As above, no human expert adjudication on clinical cases was involved. The evaluation relied on predefined engineering specifications and ISO standards for biocompatibility.

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 powered device.

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

• Not Applicable. This is not an AI/ML powered device. The "standalone" performance here refers to the device's physical and functional attributes in bench tests.

7. The type of ground truth used:

• Engineering Specifications and ISO Standards: For performance testing (e.g., deflection angle, usable length, hemostasis, kink resistance), the "ground truth" was the predefined engineering specifications and criteria that the device needed to meet, often referenced against the predicate device's characteristics.
• ISO 10993-1 Standards: For biocompatibility, the "ground truth" was compliance with the requirements outlined in ISO 10993-1 for an external communicating device in contact with circulating blood for less than 24 hours. Specific tests included: C3a Complement Activation Assay, SC5b-9 Complement Activation Assay, ASTM Partial Thromboplastin Time, USP Pyrogen Study, ISO Systemic Toxicity Study in Mice, ISO Intracutaneous Study in Rabbits, ASTM Hemolysis Study, Cytotoxicity Study Using the ISO Elution Method, ISO Guinea Pig Maximization Sensitization Test, and Thromboresistance Study in the Sheep (Heparinized Model).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML powered device. The device itself is manufactured; it does not have a "training set" in the AI/ML sense.

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

• Not Applicable. See point 8.

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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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The Malleable Surgical Lightstic™ 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece). Its intended use is identical to the current Surgical Lightstic™ 180 (K011988).
Coagulation of Cardiac Tissue

Malleable Surgical Lightstic™ 180

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/medical device performance evaluation (e.g., sensitivity, specificity, accuracy, F1 score).

Instead, this document is a 510(k) summary for a Malleable Surgical Lightstic™ 180, a medical device that appears to be a surgical laser instrument accessory. The 510(k) process in the US FDA focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive performance studies against pre-defined acceptance criteria in the way AI algorithms are evaluated.

Therefore, most of the information requested in your prompt (sample size, experts, adjudication, MRMC study, standalone performance, training set details) is not applicable or not found in this type of regulatory submission. The summary explicitly states: "Performance Data: None required."

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. The submission states "Performance Data: None required." The device is cleared based on substantial equivalence to a predicate device, not on a test set evaluation with specific performance metrics.

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

• Not Applicable. No test set or ground truth establishment by experts is mentioned or required for this type of 510(k) submission.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or adjudication process is mentioned.

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

• No. An MRMC study was not done, as indicated by "Performance Data: None required."

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

• Not Applicable. This is not an AI algorithm; it's a physical medical device (a surgical lightstic). Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

• Not Applicable. No "ground truth" in the context of diagnostic or interpretive performance data is mentioned or used. The basis for clearance is substantial equivalence to an already legally marketed device (K011988), which implies that its safety and effectiveness are established through that predicate.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI algorithm, so there is no training set.

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

• Not Applicable. There is no training set or AI algorithm involved.

Summary of Regulatory Approach:

The K013901 submission for the Malleable Surgical Lightstic™ 180 is based entirely on demonstrating substantial equivalence to an existing predicate device (Surgical Lightstic™ 180, K011988). The submitter, CardioFocus, Inc., explicitly states that the device is "identical to the current Surgical Lightstic 180 (K011988), and substantially equivalent for indications for use in cardiac tissue." They also claim "the minor differences... should not raise any concerns regarding the overall safety and effectiveness." Because of this substantial equivalence claim for a physical device, no primary performance data or clinical studies were required by the FDA for this particular clearance, as noted by "Performance Data: None required."

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The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece).

The Surgical Lightstic™ 180 is indicated for use in laser medicine and surgery with 980-1064 nm wavelength laser energy in the following surgical specialties: general surgery, cardiothoracic surgery(recommended 980nm), plastic surgery and dermatology.

Expanded for: Coagulation of Cardiac Tissue

These are additional indications to the already cleared indications for market release in K993834.

Not Found

The provided text ("Surgical Lightstic™ 180" 510(k) Summary) explicitly states "Performance Data: None required." (Section 1). This means that a specific study proving the device meets acceptance criteria was not conducted or submitted for this 510(k) premarket notification.

The FDA's review for this device (K011988), as indicated in the correspondence (Section 2 and 3), determined it to be "substantially equivalent" to predicate devices (K993834 and K980668). Substantial equivalence means that the device has the same intended use as legally marketed predicate devices and the technological characteristics do not raise different questions of safety and effectiveness.

Therefore, since no performance data or study was required or provided, the following information cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable as no performance data was required.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone study was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the 510(k) clearance for the Surgical Lightstic™ 180 was based on a finding of substantial equivalence to existing devices, not on new performance data demonstrating its ability to meet specific acceptance criteria through a dedicated study.

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The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece).

The Surgical Lightstic™ 180 is indicated for use in medicine and surgery with 980 - 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Plastic Surgery, and Dermatology.

Not Found

This document is a 510(k) summary for the Surgical Lightstic™ 180, a laser fiber device. It demonstrates substantial equivalence to predicate devices. The document explicitly states: "Performance Data: None required."

Therefore, based on the provided text, there is no acceptance criteria or study described proving the device meets acceptance criteria. The submission relies on demonstrating substantial equivalence to predicate devices, which means it asserts that its technological characteristics and intended use are similar enough to already legally marketed devices that it does not raise new questions of safety or effectiveness.

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