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The CUSA® Excel+ Ultrasonic System is indicated for fragmentation, emulsification and aspiration of soft and hard (e.g .: bone) tissue in the following surgical specialties:

Neurosurgery, Orthopedic Surgery, Plastic and Reconstructive Surgery and the following specific uses:

Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy

General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures

Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

Gynecological Surgery - including removal of dysplastic genital or perianal epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis

The CUSA® Excel+ Ultrasonic Surgical Aspirator System (CUSA) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Excel+ System consists of a console which provides control and power functions, two surgical hand pieces which provide ultrasonic mechanical energy (23kHz and 36kHz), 18 titanium hand piece tips (variety of models), a flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA Excel+ system accommodates most commercially available suction canisters, and specimen traps (optional). A two-pedal footswitch is provided with the console. The CUSA Excel+ System may also be used with an external CUSA Electrosurgical Module (CEM), which provides optional electrosurgical capability.

This document is a 510(k) submission for a change to the labeling of the CUSA Excel+ Ultrasonic Surgical Aspirator System, specifically the removal of a debulking contraindication. It is not a submission for a new device requiring extensive performance testing against acceptance criteria for its primary function. Therefore, the information typically requested for such a device (like sensitivity, specificity, F1 score, etc.) and a full comparative study with human readers or a standalone AI algorithm is not provided.

However, based on the provided text, we can extract details regarding the study that justifies the labeling change, which acts as the 'proof' for meeting the modified 'acceptance criteria' (i.e., that the device remains safe and effective without the contraindication).

Acceptance Criteria and Reported Device Performance for the Labeling Change

The "acceptance criteria" here is implicitly that the device remains safe and effective for its indicated uses (including debulking) without the previously stated contraindication regarding the dissemination of malignant cells, and that the removal of this contraindication does not negatively impact the risk profile of the device.

Study Information (Supporting the Labeling Change)

The study justifying the removal of the debulking contraindication is a risk-benefit analysis.

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

   • Test Set (Data Sources): The risk-benefit analysis included:
     • Results from a previous bench study (K150682) assessing "misting."
     • Clinical literature review.
     • Post-market surveillance information relating to the use of the CUSA Excel+.
     • A risk assessment.
     • Clinical perspective.
   • Data Provenance: The document does not specify the country of origin of the clinical literature or post-market surveillance data. It suggests the data is a retrospective aggregation of existing information (clinical literature, post-market surveillance).

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

   • The document mentions a "clinical perspective" as part of the risk-benefit analysis. However, it does not explicitly state the number or specific qualifications (e.g., "radiologist with 10 years of experience") of experts involved in providing this perspective or establishing ground truth for the risk-benefit analysis.

3. Adjudication method for the test set:

   • Not applicable in the context of a risk-benefit analysis based on literature review and post-market data. There is no mention of an adjudication process for conflicting expert opinions or data points. The "clinical perspective" likely informed the interpretation.

4. 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:

   • No. This type of study (MRMC) is not relevant to this submission, which concerns a surgical device and a labeling change based on a risk-benefit analysis, not an AI diagnostic algorithm.

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

   • No. This is not applicable as the device is a surgical tool, not an AI algorithm.

6. The type of ground truth used:

   • The "ground truth" for the risk-benefit analysis was based on expert consensus (implied through "clinical perspective" and risk assessment), aggregated evidence from clinical literature, and real-world performance data from post-market surveillance. For the bench study, the ground truth was direct measurement of spray/misting.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set. The data used was for analysis, not for training a model.

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

   • Not applicable, as there is no training set mentioned or required for this type of submission.

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The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable. The CUSA Excel+ Ultrasonic Surgical Aspirator is indicated for use in:

Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:

Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy

General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures

Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The CUSA Excel+ Ultrasonic Surgical Aspirator System (CUSA) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Excel+ System consists of a console which provides control and power functions, two surgical hand pieces which provide ultrasonic mechanical energy (23kHz and 36kHz), titanium hand piece tips (variety of models), flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA Excel+ system accommodates most commercially available suction canisters. A two-pedal footswitch is provided with the console.

The provided text is a 510(k) summary for the CUSA® Excel+ Ultrasonic Surgical Aspirator System. It details the device, its indications for use, and how its substantial equivalence to a predicate device was established.

However, the document states that no non-clinical testing was required as the device itself was not modified. Instead, the justification for expanded indications for use for Gastrointestinal (GI) and Affiliated Organ, Urologic, General, and Laparoscopic surgeries relies entirely on peer-reviewed journal articles summarizing existing clinical evidence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a specific study designed to prove the device meets pre-defined acceptance criteria in the way typically expected for a new or modified device requiring such testing. The document explicitly states that the device itself was not modified, and the assessment is based on a literature review.

Here's what can be extracted and inferred based on your request categories:

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

This information is not available from the provided text in the traditional sense of a specific study with predefined acceptance criteria. The document relies on a review of existing literature to demonstrate that the CUSA Excel+ (and its predicate) is "safe and effective" and "successful" in various surgical procedures, which serves as the "performance" data.

However, based on the conclusions from the literature review, the implied performance characteristics that were deemed acceptable include:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The "test set" in this case is the cumulative data reviewed across numerous peer-reviewed journal articles.
  • Gastrointestinal and Affiliated Organ Surgery: Approximately 2,500 cases reported across 34 articles (focused on open hepatectomy and laparoscopic-assisted liver resection).
  • Urologic Surgery: 8 urologic resection cases and 71 cases of nipple valve formation (total 79 cases) reported across 6 articles.
  • General Surgery: 10 patients (carcinoma of the tongue) and 5 cases (PCSTP in children).
  • Laparoscopic Surgery: 131 laparoscopic cholecystectomies, 9 laparoscopic appendectomies, 3 laparoscopic colon resections, 2 laparoscopic partial gastrectomies, 6 laparoscopic esophagectomies, and over 150 laparoscopic hepatectomy procedures.
• Data Provenance: The data comes from peer-reviewed journal articles. The specific countries of origin are not mentioned in this summary, but such articles typically reflect global clinical practice. The nature of published journal articles means this is overwhelmingly retrospective observational data, summarizing past surgical outcomes.

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)

This concept of "experts establishing ground truth for a test set" does not directly apply here. The "ground truth" is implied to be the clinical outcomes and observations reported by the surgeon-authors and clinicians in numerous peer-reviewed studies. These clinicians would be the "experts," performing the procedures and reporting on safety and effectiveness. The summary does not quantify the number of individual experts or their specific qualifications beyond being authors of peer-reviewed articles on surgical procedures.

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

There was no formal adjudication method as part of a single, controlled test set. The "adjudication" is inherent in the peer-review process of the scientific articles themselves. Each article would have undergone peer review by other experts in the field, and the collective body of evidence across multiple articles provides a form of consensus.

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

No, an MRMC comparative effectiveness study was not done, and this device is not an AI-assisted diagnostic or interpretative tool. It is a surgical aspirator. The clinical evidence reviewed focuses on the device's performance in surgical procedures, not on human reader performance.

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

This refers to an algorithm's performance without human input. Since the CUSA Excel+ is a surgical device operated by a surgeon, this question is not applicable. The device inherently requires a human-in-the-loop for its operation.

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

The "ground truth" is primarily based on clinical outcomes data (e.g., successful tissue removal, reduced blood loss, reduced operating time, decreased morbidity, absence of adverse events, preservation of structures) as reported by expert surgeons in peer-reviewed literature. This relies on the expert judgment and observations of the clinicians performing the surgeries.

8. The sample size for the training set

Not Applicable. As no new non-clinical or clinical testing was conducted for the purpose of this 510(k) (because the device was not modified), there was no "training set" in the context of developing or optimizing a new medical device or algorithm. The review simply aggregated existing clinical data.

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

Not Applicable for the same reasons as #8.

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The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable:
• Neurosurgery • Gastrointestinal and Affiliated Organ Surgery • Urological Surgery • Plastic and Reconstructive Surgery • General Surgery • Orthopedic Surgery • Gynecological Surgery • Thoracic Surgery • Laparoscopic Surgery • Thoracoscopic Surgery

The CUSA Excel+ Ultrasonic Surgical Aspirator System is the current iteration of the previously cleared CUSA Excel Ultrasonic Surgical Aspirator System. Both product lines are owned by Integra LifeSciences; only the CUSA Excel+ is currently marketed in the United States. Like the CUSA Excel, the CUSA Excel+ is an ultrasonically vibrating surgical device which, in combination with irrigation, and aspiration, fragments, emulsifies and removes unwanted tissue. Minor modifications have been made to the device since the original CUSA Excel was cleared. The intended use and the fundamental scientific technology of the CUSA Excel+ are the same as the CUSA Excel.

This document is a 510(k) premarket notification for the CUSA® Excel+ Ultrasonic Surgical Aspirator System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain the specific information requested about acceptance criteria, device performance, and the details of a study proving those criteria.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document describes modifications to an existing device and tests to ensure safety and effectiveness after modifications, but it does not specify performance acceptance criteria or report a study's performance against them.
2. Sample size used for the test set and the data provenance: No information on a test set (e.g., patient data) for performance evaluation is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no performance evaluation test set described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is an ultrasonic surgical aspirator, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of surgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there's no performance evaluation test set described.
8. The sample size for the training set: Not applicable as there's no machine learning model or training set discussed.
9. How the ground truth for the training set was established: Not applicable.

The document states that "Non-clinical testing was performed to support modifications, ensuring the safety and effectiveness was maintained following device modifications." The tests listed are:

• Sterilization validations
• Electromagnetic Compatibility and Electrical Safety testing
• Noise reduction testing
• Non-patient contacting material change testing
• Power supply re-work testing

These tests are to ensure the modified device performs comparably to the predicate device and meets general safety standards, not to establish performance criteria for a novel diagnostic or AI device.

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The CUSA Shear Tip, an accessory of the CUSA EXcel Ultrasonic Surgical Aspirator System, is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

The CUSA Shear Tip is an additional tip that is used with CUSA EXcel system to fragment fibrous tissue. The distal end of the CUSA Shear Tip has a series of opposing angled lands, instead of a flat surface. This pattern promotes refracted longitudinal waves propagating in greatly different directions at the interface to coupled tissue. No changes to the console, handpiece or suction/irrigation system were needed.

The provided text outlines a 510(k) summary for the CUSA Shear Tip, an accessory to an ultrasonic surgical aspirator system. However, it does not contain the specific details required to answer your request regarding acceptance criteria and a study proving the device meets those criteria.

The document states: "Performance testing has been completed to demonstrate that the CUSA Shear Tip can better fragment fibrous tissue." This is a general statement and lacks all the specific information you've asked for.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or any other details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as none of that information is present in the provided text.

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The CUSA Excel Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including Neurosurgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery.

The CUSA Excel Ultrasonic Surgical Aspirator System (CUSA) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Excel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). A tip has been added to the CUSA Excel system to enable it to abrade bone. Testing was completed to demonstrate that the tip will abrade bone. The tip is manufactured from the same materials as in the other CUSA Excel tips.

The provided text is a 510(k) summary for the Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity), sample sizes for test sets or training sets, expert qualifications, adjudication methods, or results from comparative effectiveness studies.

The text simply states: "Testing was completed to demonstrate that the tip will abrade bone." This is a general statement and does not provide quantified performance data or details of a study that would establish specific acceptance criteria.

Therefore, I cannot fulfill the request to provide the detailed information required for the table and all the numbered points because the provided document does not contain this type of performance study data.

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The CUSA EXcel Ultrasonic Surgical Aspirator System is intended for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery The system may also be combined with electrosurgery using the optional CUSA Electrosurgical Module (CEM).

The CUSA EXcel Ultrasonic Surgical Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissues while preserving vessels, ducts and other delicate structures. The CUSA EXcel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy to the surgical site, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA EXcel System accommodates most commercially available suction canisters, and specimen traps (optional). A two-pedal footswitch is provided with the console. The CUSA EXcel System may be used with an external CUSA Electrosurgical Module (CEM), which will provide optional electrosurgical capability. The CEM module is a Force FX-8 Generator (FDA clearance was received for the Force FX Generator under K#944602). This provides the surgeon with the option of delivering cutting or coagulating current through the CUSA handpiece tip to the surgical site. The CEM function is controlled either with the Force FX-8 footswitch or by hand, using the CEM nosecone control button(s).

The provided text is a summary of safety and effectiveness information for the CUSA EXcel Ultrasonic Surgical Aspirator System, a medical device. It does not describe a study involving patient data, expert readers, or AI.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as they pertain to clinical or AI-based performance studies which are not detailed here.

The document focuses on:

• Product Description: Explaining what the device is and its features.
• Intended Use: Listing the surgical procedures for which the device is intended.
• Safety and Performance Data: Stating compliance with various electrical and biocompatibility standards. It mentions "Validation and verification... will be accomplished through a combination of analysis and testing," including a "Risk Analysis and an electro/mechanical performance test on prototype units." It also states, "Testing has verified the safe performance and proper function of the product."
• Substantial Equivalence: Comparing the device to previously marketed predicate devices.
• FDA Clearance Letter: Confirming the device's substantial equivalence and clearance for marketing.

Here is what can be extracted based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes compliance with recognized standards rather than specific quantitative performance metrics against clinical acceptance criteria.

• IEC 601-2-2 (1991), Medical Electrical Equipment Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment
• EN 60601-1-2 (1993) Medical Electrical Equipment, Part 1 General Requirements for Safety, 2 Collateral Standard: Electromagnetic Compatibility-requirements and Tests
• IEC 801-3 (1984), Radiated Electromagnetic Field Requirements
• CISPR11, Electromagnetic Compatibility for Industrial-process Measurement and Control Equipment: Emissions Requirements | The CUSA EXcel System has been designed to conform with these applicable standards. "Testing has verified the safe performance and proper function of the product." |
  | Biocompatibility | - ISO Standard 10993-1, Biological Evaluation of Medical Devices, Part 1 - Guidance on Selection of Tests, Device Category "External Communicating Device, Blood Path Indirect, contact duration A" | Materials unique to the CUSA EXcel System are "currently undergoing testing in accordance with ISO Standard 10993-1." (Note: The claim of meeting the standard is based on selected materials and ongoing testing for new materials, rather than a final comprehensive report for this specific submission). |
  | Functional Performance | - Electro-mechanical performance. | "Validation and verification... will be accomplished through a combination of analysis and testing. This process will include a Risk Analysis and an electro/mechanical performance test on prototype units. The safe performance and proper function of the hardware and external controls of the CUSA EXcel Console will be tested... The CUSA EXcel Handpiece and accessories will also be tested, both alone and in conjunction with the Console." "Testing has verified the safe performance and proper function of the product." |

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance: Not applicable. The document discusses device testing against standards and substantial equivalence, not a clinical study involving a "test set" of patient data. Testing was performed on "prototype units" and the "CUSA EXcel Handpiece and accessories."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical "test set" with ground truth established by experts is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 device is an ultrasonic surgical aspirator, not an AI or imaging diagnostic device, and no MRMC study is mentioned.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm or AI component is described. The "standalone" performance here refers to the device's functional and safety performance, which was verified through engineering tests.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. The "ground truth" for the device's safety and performance was compliance with established engineering and biocompatibility standards, and functional testing on prototype units.
7. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a medical device based on compliance with established safety standards and substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic or prognostic performance with a patient cohort.

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