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The Codman Disposable Perforator is for use in perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. When properly used, the Disposable Perforators are designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point. They are designed with a Hudson end and are available in three color-coded sizes:

• 14mm (blue ABS sleeve) – product number: 26-1221
• 11mm (green ABS sleeve) product number: 26-1222 ●
• 9mm (yellow ABS sleeve) product number: 26-1223 ●

This document describes a 510(k) premarket notification for "Codman Disposable Perforators," which are medical devices used to perforate the cranium. The submission aims to demonstrate substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

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

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

The document mentions a "full dose mapping study" but does not explicitly state the sample size used for this study. The data provenance is not specified, but given it's a regulatory submission for a medical device manufacturer (Integra LifeSciences Corp. in Mansfield, MA, USA), it's highly likely to be prospective data generated internally for the purpose of this submission.

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 is not applicable to this type of submission. The "ground truth" here is the adherence to sterilization standards (ISO 11137-1) for a physical device. Expert clinical or image-based review is not part of this evaluation. The expertise would lie in sterilization validation specialists who conducted and analyzed the dose mapping study.

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

Not applicable. This is a technical validation of a manufacturing process (sterilization), not a subjective assessment requiring adjudication. The study results are objectively measured against established standards.

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 submission is for a disposable perforator, a physical surgical tool. It does not involve AI, image analysis, or human readers.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the dose mapping study is the regulatory standard for sterilization (ISO 11137-1), which defines requirements for achieving a Sterility Assurance Level (SAL) of 10^-6. The study aimed to demonstrate that the new gamma radiation sterilization cycle meets this standard and achieves the required dose uniformity.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no training set. The "training" in the context of device manufacturing refers to process validation.

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the overall device's safety and effectiveness relies on its previous 510(k) clearances and the demonstration that the only change (the sterilization cycle) does not compromise those established safety and effectiveness parameters, as verified by adherence to international sterilization standards.

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The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.

The CereLink ICP Extension Cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

The CereLink ICP Monitor is intended for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:

• Displays mean pressure values
• Displays the pressure waveform
• Displays the historic mean pressure as a trend
• Displays trend statistics (Area Under the Curve (AUC), time above threshold, boxplot, histogram)
• Stores 14-days' worth of mean ICP values
• Stores 24 hours of pressure waveform
• Can capture and store screen-shots
• Can download various data to a USB device for printing or analysis

The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is sold with an external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (code 82-6845).

The CereLink ICP Monitor and CereLink ICP Extension Cable are intended to be used in conjunction with Codman's other neuromonitoring devices: the CereLink ICP Sensor Kits (codes 82-6850, 82-6851, 82-6852, and 82-6854 cleared via K173192) and the patient monitor interface cables (codes 82-6880, 82-6881, and 82-6882 cleared via K152670). The CereLink ICP Sensor converts the patients intracranial pressure to a voltage signal. The monitor provides power to the sensor, interprets the voltage signal from the sensor, and displays the corresponding pressure measurements taken by the sensor during a patient's treatment and during patient transport. There is no change to the currently marketed CereLink ICP Sensor Kits or the patient monitor interface cables as a result of the monitor modifications described in this submission.

The CereLink ICP Monitor is an intracranial pressure monitoring system. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various performance benchmarks the CereLink ICP Monitor was tested against. The "Reported device performance" uniformly indicates that all tests passed, demonstrating "substantial equivalence of the proposed device" or that the results were "All results passed."

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

The document does not explicitly state the specific sample sizes for each test set in the bench testing section beyond noting that for "Device Reliability and Mean Time Between Failure Calculation," no samples were required for execution of this test (analysis was based on materials and components).

For other bench tests, phrases like "All results passed" or "Testing was performed on final finished devices" imply that a sufficient number of devices were tested to validate the claims, but the exact count is not specified. The studies were likely internal verification and validation tests performed by the manufacturer on production-equivalent devices.

The provenance of this data is internal to Integra LifeSciences Corp. and is presented as part of their 510(k) submission. Therefore, it is retrospective in the sense that it was conducted prior to submission for regulatory clearance. There is no information regarding the country of origin of the data provided beyond the manufacturer's location (Mansfield, MA, USA).

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

N/A. This information is typically relevant for studies involving subjective interpretation (e.g., medical imaging diagnostics). For the CereLink ICP Monitor, the performance criteria are objective (e.g., electrical specifications, mechanical integrity, software functionality, physical measurements). The "Summative Usability Testing" involved clinicians, implying professional users, but it does not specify their number or qualifications, nor was their input used to establish "ground truth" in the diagnostic sense, but rather to assess usability and effectiveness of operation.

4. Adjudication Method for the Test Set

N/A. As the testing primarily involved objective performance metrics (electrical, mechanical, software functionality), an adjudication method (like 2+1 or 3+1 often used in clinical trials for diagnostic agreement) was not applicable. Test results were likely pass/fail based on predetermined quantitative criteria.

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

No MRMC comparative effectiveness study was mentioned or conducted. The device is an objective monitoring device, not a diagnostic tool requiring human interpretation with or without AI assistance. The submission focuses on demonstrating substantial equivalence to a predicate device through objective performance testing.

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

The device's core function is to monitor and display ICP. Its performance is inherently standalone in the sense that its measurements are objective and do not require human interpretation to generate the primary output (ICP values, waveforms, trends). The "algorithm" here refers to the internal processing of the sensor's voltage signal to display pressure measurements. The various "Bench Testing" and "Software Testing" categories evaluate this standalone performance. For example, "Electrical Performance Testing" and "System Validation Testing" directly assess how accurately the device measures and displays pressure from a sensor or simulator without human intervention affecting the measurement generation itself.

7. Type of Ground Truth Used

The ground truth for the performance tests was based on known physical or electrical standards and predefined functional requirements. For example:

• Pressure Accuracy: Likely tested against calibrated pressure simulators or reference devices with known pressure outputs. The acceptance criteria for input pressure accuracy are given as "+/- 0.5 mmHg over the range -50 to 50 mmHg and +/- 1% over the range 50 to 150 mmHg."
• Electrical Specifications: Tested against known voltage and current standards, expected battery life, and data storage capacity.
• Mechanical Integrity: Tested against engineering specifications for durability, drop resistance, and ingress protection.
• Software Functionality: Tested against software requirements specifications to ensure features operate as intended.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning. The CereLink ICP Monitor is an objective measurement device, not an AI/ML-driven diagnostic or predictive algorithm that typically requires large training datasets. Its functionality is based on established engineering principles and signal processing.

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

N/A. As there is no "training set" in the machine learning sense, the method for establishing its ground truth is not applicable. The device's operation is deterministic based on its hardware and firmware design.

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The Codman Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

This submission includes two additional configurations of the Codman Certas Plus Programmable Valve: Certas Plus Inline Small and Certas Plus Right Angle. The Codman Certas Plus Programmable Valves are sterile, single use, implantable devices designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

The Codman Certas Plus Programmable Valve is a pressure-regulating valve utilizing the ruby ball-in-cone principle with a pressure inducing spring design. Intraventricular pressure is maintained by the ball and cone valve seat design. As the differential pressure across the shunt increases, the ball further displaces from the cone, through which CSF flows, thereby increasing flow and re-establishing the selected pressure. The ball is manufactured of synthetic ruby, as is the matching cone. Together these components provide a precise fit for regulating the flow of CSF through the valve.

The valve is available with 8 different performance settings for constant intraventricular pressure and drainage of CSF. Seven (7) of the settings provide a change in operating pressure, with a range of 25 to 215 mmH2O. The eighth (8) setting provides a minimum opening pressure of '400' mmH20, thus allowing a physician to turn the valve "virtually off" without the need to surgically remove the valve to limit flow. The pressure of the valve is set preoperatively and can be noninvasively changed postimplantation by using the Codman Certas Tool Kit.

The provided document is a 510(k) premarket notification for a medical device, specifically the Codman Certas Plus Programmable Valve. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets acceptance criteria through an AI-based study or a multi-reader, multi-case (MRMC) comparative effectiveness study. The document primarily focuses on bench testing (Verification Testing) and simulated use (Validation Testing) to establish that the modified versions of the device perform equivalently to the predicate.

Therefore, many of the questions related to AI-specific study design (like ground truth establishment, expert consensus, MRMC studies, training/test set sizes, and specific performance metrics like AUC, sensitivity, specificity for diagnostic AI) are not applicable to this document.

However, I can extract information related to the physical device's performance, acceptance criteria for those tests, and the general approach to validating the device's functionality.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance for Codman Certas Plus Programmable Valve

The device is a non-AI, physical medical device (a CSF shunt) and therefore the typical "acceptance criteria" and "study" described in an AI context (e.g., AUC, sensitivity, specificity, MRMC studies) are not present. Instead, the document describes design verification and validation activities against established standards and internal criteria to demonstrate substantial equivalence to a predicate device.

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

The document states that "All samples in design verification testing met predefined acceptance criteria" and "test results demonstrated that the acceptance criteria were met." However, the specific numerical acceptance criteria for each test are not explicitly detailed in this summary. The results are reported as "PASS."

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

The document does not specify the exact sample sizes (number of units tested) for each verification and validation test. It generally refers to "all samples" meeting criteria. This is typical for 510(k) summaries where the detailed test protocols and sample sizes are provided in the full submission, but not always summarized in this public document.

Data provenance: The testing was conducted by Integra LifeSciences Production Corp. (manufacturer/applicant). The document doesn't explicitly state the country of origin of the data in terms of patient source, as this is bench and simulation testing, not clinical data from patients. The testing is retrospective in the sense that it's performed on manufactured devices, not derived from real-time patient observations.

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

This question is not applicable. For a physical device like a shunt, "ground truth" generally refers to the known physical properties and performance specifications, established through engineering and quality control benchmarks, and adherence to international standards (e.g., ISO). For the "System Safety Study" (validation), "clinicians" were involved, but their number and specific qualifications are not detailed. Their role was to evaluate the device in simulated use.

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

Not applicable. This concept is relevant for studies involving human interpretation of data, typically in diagnostic imaging or AI performance assessment. For physical device performance, reconciliation/adjudication is typically handled by senior engineers or quality assurance personnel reviewing failed tests, not by a formal multi-reader adjudication process.

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 a physical medical device, not an AI diagnostic or assistance system. The "System Safety Study" involved clinicians but was a usability/performance study in a simulated environment, not an MRMC study.

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

Not applicable. This is not an algorithm. The device functions mechanically.

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

The "ground truth" for this device's performance is based on:

• Adherence to international standards (e.g., ISO 7197:2009, ISO 17665-1: 2006, ISO 17665-2: 2009, ISO 11067-1: 2009, ISO11607-2: 2006, ISTA 3A).
• Predefined engineering specifications and performance characteristics (e.g., pressure-flow characteristics, strength, sterilization effectiveness).
• Comparison to the performance of the legally marketed predicate device (K152152) and reference device (K053107) to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

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The Codman Certas Plus Electronic Tool Kit allows the non-invasive reading or adjustment of the Codman Certas and Certas Plus Programmable Valves.

The Certas Plus Electronic Tool Kit is used to non-invasively read or adjust the setting of a Certas or Certas Plus Programmable Valve before and after implantation in the treatment of hydrocephalus. The Certas Plus Electronic Tool Kit consists of the following tools: Locator/Indicator Tool, Adjustment Tool and X-Ray Overlay Tool. The Locator/Indicator Tool facilitates correct placement of the Adjustment Tool over a pre-implanted valve in the packaging or a post-implanted valve, and measures the valve's magnetic field to display the valve setting. The Adjustment Tool adjusts the valve to one of the 8 valve settings. The magnets in the Adjustment Tool couple with the magnets in the rotating construct of the valve, causing the rotating construct to lift and follow the Adjustment Tool as it is rotated to one of 8 valve settings.

The Codman Certas Plus Electronic Tool Kit is a non-invasive device used to read and adjust the setting of Certas and Certas Plus Programmable Valves, which are used in the treatment of hydrocephalus. The device's substantial equivalence to a predicate device (Codman Certas Tool Kit, K143111) was established through comprehensive verification and validation testing, as detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample sizes for most of the verification and validation tests.

• Comprehensive Design Verification Study, Electrical Safety and Ingress Testing, Environmental Testing, Transit Testing, and Disinfection Compatibility, Force Tests: The document states that "All samples in design verification testing met predefined acceptance criteria," but does not specify the number of samples for each test.
• User Feedback Verification: The number of users involved is not specified, but the test aimed to "Measure the time to receive an indication from the device" and "Confirm that users receive appropriate feedback during adjustment."
• Biocompatibility Testing: Guinea pigs were used for sensitization testing, and animals were used for irritation testing. The exact number of animals is not specified but is implicitly compliant with ISO 10993 standards.
• Simulated Post-Implantation Use: This involved "clinicians" evaluating the device on a "simulated head model." The number of clinicians and simulated procedures is not specified.

Data Provenance: The studies appear to be internal company studies, likely conducted at Integra LifeSciences Corp. or its contract research organizations. The data provenance is retrospective for the purpose of the 510(k) submission, meaning the tests were performed prior to this submission to demonstrate the device's characteristics. The country of origin of the data is not specified, but given the company location (Mansfield, Massachusetts, USA), the studies were likely conducted in the USA or by international partners.

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

• Verification Testing (e.g., Comprehensive Design Verification, Electrical Safety, etc.): The "ground truth" for these engineering and performance tests is generally based on established engineering standards, specifications, and objective measurements (e.g., passing specific force thresholds, IP ratings, or electrical safety limits). No external experts are described as establishing ground truth in this context; rather, the device's performance is compared against predetermined engineering requirements.
• Biocompatibility Testing: The "ground truth" is established by the results of standardized biological tests (cytotoxicity, sensitization, irritation) and their interpretation against ISO 10993 standards. The qualifications of the personnel performing and interpreting these tests are not explicitly stated, but they would be expected to be trained professionals in toxicology and biocompatibility testing.
• Simulated Post-Implantation Use: For the "System Safety Study" and "Qualitative Assessment of Clinical Acceptability," "clinicians" were involved. Their exact number and specific qualifications (e.g., neurosurgeons, nurses, etc.) are not provided. The term "clinicians" suggests healthcare professionals who would typically use such a device.

4. Adjudication Method for the Test Set

For the engineering and biocompatibility tests, the adjudication method is typically objective measurement against defined quantitative or qualitative acceptance criteria specified in the test protocols or relevant standards. A "PASS" result indicates the criteria were met.

For the Simulated Post-Implantation Use involving clinicians:

• System Safety Study: Clinicians "evaluated the maximum acceptable rate for false positives and maximum success rate for completing a full procedure." This implies a consensus or pre-defined threshold for acceptable performance that the clinicians' observations were judged against. The specific adjudication method (e.g., majority vote, pre-set tolerance levels) is not detailed.
• Qualitative Assessment of Clinical Acceptability: Clinicians provided qualitative assessments. This often involves structured questionnaires or interviews where their feedback is aggregated. The document states "All acceptance criteria were met," indicating that their qualitative feedback was overwhelmingly positive or met predefined levels of satisfaction. The exact method of combining or adjudicating these qualitative responses (e.g., if multiple clinicians responded differently to a question) is not specified.

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

No MRMC comparative effectiveness study was explicitly described. The studies focused on demonstrating the device's performance against pre-defined functional, safety, and user-interaction criteria, establishing substantial equivalence to the predicate device. There is no mention of comparing human readers' performance with and without AI assistance, as this device itself is a tool for adjusting and reading existing programmable valves, not an AI diagnostic system.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Codman Certas Plus Electronic Tool Kit is a physical medical device (electro-mechanical tool) with a user interface, not a standalone AI algorithm. Its performance is intrinsically linked to its interaction with a programmable valve and a human user.

7. Type of Ground Truth Used

• Verification Testing: Ground truth was based on adherence to engineering design specifications, established industry standards (e.g., IEC 60601-1 for electrical safety, ISTA 3A for transit), and internal product requirements.
• Biocompatibility Testing: Ground truth was based on the results of standardized biological tests interpreted according to ISO 10993-1.
• Simulated Post-Implantation Use: Ground truth was derived from clinician evaluations on a simulated head model, comparing the device's operational characteristics (e.g., false positive rates, success rates, clarity of information, ease of use) against predefined acceptable clinical performance and user experience expectations.

8. Sample Size for the Training Set

No training set is mentioned in the context of the provided document. The device is not described as involving machine learning or AI that would require a distinct training set for algorithm development. The testing described focuses on validation and verification of a hardware device and its software components.

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

Not applicable, as no training set was mentioned or implied for this device.

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The CUSA® Excel+ Ultrasonic Surgical Aspirator 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 turnors 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 turnors 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 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, 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 describes the CUSA® Excel+ Ultrasonic Surgical Aspirator System and its indications for use. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance. The document is a 510(k) summary for a medical device, primarily focused on establishing substantial equivalence to a predicate device and expanding indications for use based on existing literature.

Here's a breakdown of what is and is not in the document, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided. The document does not specify quantitative acceptance criteria (e.g., minimum fragmentation rate, maximum aspiration volume, specific tissue selectivity percentages with thresholds) or present a table comparing these criteria to observed device performance in a formal study for the expanded indications.

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

• Test Set Sample Size:
  • For the bench study on spray patterns: Not explicitly stated, described as "A series of randomized experiments covering different settings."
  • For the clinical evidence (literature review): "over 500 patients in 34 articles published between 1988 and 2014."
    • Specifically: 230 patients with dysplasia, 101 patients with condyloma, 164 patients requiring debulking procedures, and 15 patients with endometriosis.
• Data Provenance:
  • Bench study: Performed by Integra (manufacturer).
  • Clinical evidence: Derived from "peer-reviewed clinical literature" (retrospective analysis of published studies). The country of origin of this literature is not specified.

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

• Not provided directly. For the bench study, there's no mention of experts establishing ground truth for spray pattern evaluation.
• For the clinical literature review, the "ground truth" is implied to be the published surgical outcomes and observations reported by the authors of the peer-reviewed articles. The qualifications of these original authors (surgeons, pathologists, etc.) are not detailed in this 510(k) summary.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided. No specific test set with an adjudication method (like 2+1, 3+1 for expert review) is described for the expanded indications. The clinical evidence relies on previously peer-reviewed and published clinical literature.

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

• No, not performed. The document does not mention any MRMC study or any comparison of human readers with vs. without AI assistance. The device is a surgical aspirator, not an AI diagnostic tool.

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

• Not applicable. The CUSA Excel+ is a physical surgical device, not an AI algorithm.

7. Type of Ground Truth Used:

• Bench Study (Spray Patterns): Direct observation and measurement of physical "spray" phenomena under controlled settings.
• Clinical Literature Review: "Clinical evidence" and "successful treatment outcomes" and "minimal complications" as reported in peer-reviewed medical publications. This implicitly refers to surgical observations, pathology reports (for tumor removal), and patient outcomes (healing, recurrence rates, cosmetic results).

8. Sample Size for the Training Set:

• Not applicable. The device is a physical surgical tool, not an AI algorithm that requires a training set. The "development" and "testing" are primarily engineering and bench testing, followed by clinical validation against existing practices and literature.

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

• Not applicable. (See point 8).

**In summary, the provided document is a regulatory submission for a medical device that highlights: **

• Its intended use as an ultrasonic surgical aspirator for fragmentation, emulsification, and aspiration of soft and hard tissue across various surgical specialties.
• Its technological characteristics as being the same as the predicate device.
• Support for expanded indications in gynecological surgery based on a review of existing peer-reviewed clinical literature (over 500 patients across 34 articles). This literature review discusses outcomes such as reduced scarring, effective reduction of recurrence rates, successful treatment outcomes for condyloma, dissection of unresectable tumor masses with minimal complications, and effective tissue removal while preserving vessels and nerves.
• A bench study on spray patterns that showed spray could be controlled to near-zero levels.

It does not provide the specific quantitative acceptance criteria or a formal study design that would fit the typical "acceptance criteria vs. reported performance" table format, which is often seen for diagnostic or AI-driven devices. The evidence provided is more descriptive and based on the aggregation of existing clinical outcomes from published studies.

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Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.

Integra® Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: with or without proprietary surface treatments; 1-6 mm bite sizes; 9 - 15.5 mm jaw openings; 40° and 90° up/down cutting angles: regular and thin/low profile footplates: standard and eiector tips: 4.75 -15" shaft lengths; and various handle and shaft styles, including Detach®. Integra® Kerrison Rongeurs are distributed under the following brand names: Jarit®, Ruggles™ -Redmond™, Miltex®, and MeisterHand®.

The provided text describes a 510(k) submission for Kerrison Rongeurs, focusing on a labeling change regarding sterilization instructions. It is not an AI/ML device, therefore, many of the requested categories related to AI performance, ground truth, and reader studies are not applicable.

Here's the breakdown based on the provided information:

Acceptance Criteria and Device Performance (Not applicable for AI/ML device)

This section would typically detail the specific performance metrics (e.g., sensitivity, specificity, AUC) the AI device needs to meet. Since this is a manual surgical instrument, these metrics are not relevant.

The acceptance criteria for this device, as indicated by the 510(k) submission, revolve around its substantial equivalence to a predicate device, particularly concerning its design, materials, intended use, and the safety and effectiveness of its sterilization methods.

Study Information

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

• Not applicable for an AI/ML device. The submission references sterilization validation testing, but it's not a "test set" in the context of AI/ML evaluation. The sterilization validation would have involved a specific number of test cycles and biological or chemical indicators, but the specific quantity is not detailed beyond "successful sterilization validation."

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

• Not applicable for an AI/ML device. Ground truth, in this context, would be external validation against disease or condition. For a medical device like a Kerrison Rongeur, safety and effectiveness are established through physical and mechanical testing, biocompatibility, and sterilization validation; not by expert consensus on diagnostic interpretations.

3. Adjudication method for the test set:

• Not applicable for an AI/ML device. Adjudication methods are used in AI/ML studies to resolve discrepancies in expert ground truth labels. This submission doesn't involve such a process.

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 a manual surgical instrument and does not involve AI assistance or human readers in the diagnostic sense.

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

• Not applicable. This is a physical medical instrument, not an algorithm.

6. The type of ground truth used:

• Not applicable in the AI/ML sense. For this device, the "ground truth" for its safety and effectiveness is established through:
  • Predicate device comparison: demonstrating that its design, materials, and intended use are substantially equivalent to a device already legally marketed.
  • Sterilization validation: adherence to recognized standards (ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009). This is a technical validation against established protocols.

7. The sample size for the training set:

• Not applicable. This device does not use machine learning or require a training set.

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

• Not applicable. This device does not use machine learning or require a training set.

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The Integra Licox PtO₂ monitor measures oxygen partial pressure (PtO2) and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement. Monitor values are relative within an individual, and should not be used as the sole basis for determining a diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.

The Integra® Licox® PtO2 monitor instrument is a diagnostic tool for continuously monitoring oxygen partial pressure (PtO2) in - brain tissue. Minimally invasive probes are implanted directly into the brain tissue and are connected to the Licox monitor.

The Integra Licox PtO2 Monitor displays both PtO2 and temperature in numeric format. The monitor will store PtO2 trend data from the most recent 5 days. The user can elect to extract the trend data stored on the monitor to an external memory device or stream the data to a compatible PC via the USB output. The device also provides analog output for display on compatible bedside monitors.

The provided text describes the Integra® Licox® PtO2 Monitor, an intracranial pressure monitoring device. It outlines the device's intended use, technological characteristics, and non-clinical testing performed to establish its safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission mentions "pre-defined performance and safety specifications" and that testing confirmed "all Design Inputs (requirements and specifications) have been met." However, it does not provide a specific table of acceptance criteria with numerical targets or thresholds for performance metrics like accuracy, alarm sensitivity, or trending precision. Instead, it lists the types of tests conducted:

Important Note: The document explicitly states that "All necessary testing has been completed... and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met." However, it does not provide the specific numerical acceptance criteria or the quantitative results of these tests.

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

The document mentions "production equivalent units" were used for testing. However, it does not specify the sample size for the test set.

Regarding data provenance, the document describes non-clinical testing performed on the device itself (e.g., accuracy, alarms, functionality). This is not data derived from patient studies or human subjects. Therefore, information about country of origin of data or retrospective/prospective nature is not applicable here as it relates to device performance testing, not clinical data collection.

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

This information is not applicable to the type of testing described in the document. The device performance tests (accuracy, alarms, etc.) typically rely on calibrated instruments and established engineering standards to determine "ground truth," not expert human adjudication of diagnostic outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to the non-clinical device performance testing described. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The device is a monitor providing physiological parameters, not an AI-assisted diagnostic tool for image interpretation or similar tasks requiring human readers.

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

The device itself is a standalone monitor, meaning it directly measures and displays PtO2 and temperature values. The testing described (PtO2 Accuracy, Temperature Accuracy, Alarm setting, etc.) assesses the performance of this standalone device/algorithm without human-in-the-loop performance. However, this is distinct from AI-driven algorithms where "standalone" usually implies the algorithm makes a decision independently. In this context, the device is the "algorithm" for measurement and display.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests like PtO2 Accuracy and Temperature Accuracy, the ground truth would have been established using calibrated reference standards or laboratory measurements that are known to be highly accurate. For other functional tests (alarms, trending, data export), the ground truth is defined by the device's functional specifications and expected behavior.

8. The Sample Size for the Training Set

This information is not applicable as the Integra® Licox® PtO2 Monitor is a measurement device, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable as the device does not use a training set in the context of machine learning.

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Integra™ (Jarit®, Ruggles™, R&B Redmond™(Redmond™), Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting bone during surgery involving the skull or spinal column.

Integra™ Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: with or without proprietary surface treatments; 1-6 mm bite sizes; 9 - 15.5 mm jaw openings; 40° and 90° up/down cutting angles; regular and thin/low profile footplates; standard and ejector tips; 4.75 - 15" shaft lengths; and various handle and shaft styles, including Detach®. Integra™ Kerrison Rongeurs are distributed under the following brand names: Jaril®, Ruggles™, R&B Redmond™(Redmond™), Miltex®, MeisterHamd®.

This document is a 510(k) summary for the Integra™ Kerrison Rongeurs. It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, clinical studies, or performance data.

Therefore, I cannot provide the requested information, specifically:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done and its effect size.
• If a standalone performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

This document focuses on regulatory approval based on substantial equivalence, not on specific performance studies or clinical trial data.

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Both the OSV II Lumbar Valve System and the OSV II Low Flow Lumbar Valve System are indicated as implantable systems used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.

The OSV II® Lumbar Valve System (OSV II Valve) and the OSV II® Low Flow Lumbar Valve System (OSV II Low Flow Valve) are implantable devices for controlled cerebrospinal fluid drainage (CSF) from the lumbar subarachnoid region to the peritoneal cavity. Unlike conventional valves, they are variable resistance valves which maintain a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure. They maintain a drainage rate around 20ml/hr for OSV II Valves and around 10ml/hr for OSV II Low Flow Valves.

The OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are provided with accessories including a 14G tuohy needle, a F5 lumbar catheter, a guidewire, a luer lock connector and a F8-F5 stepdown connector, which are required for using the valves in a lumbar approach. The designs of the accessories are identical to the accessories currently provided with the Integra H-V Lumbar Valve System.

Here's an analysis based on the provided text, outlining the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit acceptance criteria in the form of a table or specific quantitative benchmarks set for the OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System in a clinical study for this 510(k) submission.

Instead, the submission for these devices relies on demonstrating substantial equivalence to previously cleared predicate devices. The performance specifications are stated as being "the same as the predicate valves" because the new devices are designed the same as existing ventricular approach valves but adapted for a lumbo-peritoneal approach.

However, the operating principles define specific flow rate ranges at different differential pressures. These could be considered intrinsic performance specifications verified during manufacturing.

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

The document explicitly states: "…supported by the clinical evidence included in this 510(k)…". However, it does not provide details on the sample size used for a specific clinical "test set" in this 510(k) submission. The submission primarily relies on demonstrating substantial equivalence to existing devices.

The text does not specify the country of origin of any data, if clinical data were used, nor whether it was retrospective or prospective.

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

This information is not provided in the given text. The submission focuses on device design, materials, and equivalence to predicates, not on a clinical study that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given text, as no detailed clinical study with an adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This 510(k) submission is for an implantable medical device (CSF shunt valves), not for an AI or diagnostic imaging device that typically undergoes MRMC studies to evaluate human reader performance with and without AI assistance.

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

This is not applicable to the device described. The OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are physical implantable medical devices, not algorithms or AI systems. Therefore, a "standalone algorithm performance" evaluation would not be relevant.

7. The Type of Ground Truth Used

The primary "ground truth" for this 510(k) submission appears to be the established performance and safety profiles of the legally marketed predicate devices. The new devices are being cleared based on their substantial equivalence (same design, materials, principle of operation, and performance specifications) to these existing predicate devices (K971799, K081773, K042192 for the valves, and K944595 for the accessories).

Direct clinical outcomes data for the new devices for this specific 510(k) seem to be a supportive element rather than the primary ground truth for novel performance.

8. The Sample Size for the Training Set

This information is not applicable as the devices are physical medical devices, not algorithms requiring a training set.

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

This information is not applicable for the same reasons as point 8.

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INTEGRA™ Meshed Bilayer Wound Matrix is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. The device may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.

INTEGRA™ Meshed Bilayer Wound Matrix is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminonlycan with a polysiloxane (silicone) layer. The meshed bilayer matrix allows drainage of wound exudate and provides a flexible adherent covering for the wound surface. The collagen- glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.

The provided text describes a 510(k) premarket notification for the Integra™ Meshed Bilayer Wound Matrix. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish de novo safety and efficacy. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific study designs (like MRMC or standalone algorithm studies), sample sizes for test and training sets, and ground truth establishment, is generally not present in a 510(k) summary focused on material and processing equivalence.

However, I can extract the relevant information from the provided document regarding substantial equivalence and performance testing for this type of device.

Here's an analysis 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

The document does not detail a "test set" in the context of clinical performance data for the Integra™ Meshed Bilayer Wound Matrix. The primary demonstration is that it is comprised of identical materials and processed and sterilized by identical methods as its predicate device (Integra™ Bilayer Matrix Wound Dressing, K021792).

The biocompatibility testing was performed on the predicate device (Integra™ Bilayer Matrix Wound Dressing) in accordance with International Standard ISO 10993-1:1992 and Good Laboratory Practices. The document implies the "data provenance" for these biocompatibility tests would be the lab that conducted them, likely in the country where Integra LifeSciences Corp. operates (USA, given the FDA submission). This was a retrospective application of predicate data to the new device.

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

Not applicable. This type of 510(k) submission does not typically involve expert review of a "test set" in the sense of clinical images or patient outcomes for ground truth establishment. The ground truth for biocompatibility is established by standardized, objective laboratory tests.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring adjudication by experts.

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. This device is a wound matrix, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this type of medical device submission.

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

Not applicable. This device is a physical wound matrix, not an algorithm.

7. The Type of Ground Truth Used

• For Biocompatibility: The "ground truth" was established by standardized laboratory test results against established biological safety guidelines (ISO 10993-1:1992) for cytotoxicity, dermal sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemolysis.
• For Product Characterization: The "ground truth" for characteristics like pore size, helical content of collagen, C-6-S quantification, and degree of cross-linking was based on objective measurement techniques (SEM, Image Analysis, FTIR, visible spectroscopy, colorimetric assay) against internal specifications or established material properties.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set, there is no ground truth for a training set to establish.

Summary of the Study:

The "study" described for the Integra™ Meshed Bilayer Wound Matrix is primarily a comparative study for substantial equivalence to a predicate device (INTEGRA™ Bilayer Matrix Wound Dressing, K021792). The key findings are:

• The new meshed device uses identical materials and undergoes identical processing and sterilization methods as the cleared predicate device.
• Biocompatibility data for the predicate device, performed according to ISO 10993-1:1992 and Good Laboratory Practices, were found to be acceptable and are considered applicable to the new meshed product due to material and process identity.
• In vitro product characterization studies were performed on the new device (e.g., pore size, collagen helical content, C-6-S quantification, cross-linking degree) to confirm its physical and chemical properties.

The conclusion is that based on the in vitro product characterization studies, performance testing, and biocompatibility data (from the predicate), the Integra™ Meshed Bilayer Wound Matrix is safe and substantially equivalent to its predicate device. This demonstrates that the new device meets the regulatory acceptance criteria for substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission.

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