Search Results

The Odyssey Micro Catheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Odyssey Micro Catheter is also intended to assist in the infusion of contrast media. The micro catheter is not intended to be used in the neurovasculature.

The Odyssey Micro Catheter is a single lumen catheter constructed using a PTFE liner inside of metallic coil and a polymer outer layer. The distal tip is a radiopaque polymer material and the distal 30 cm to 60 cm of the micro catheter has a hydrophilic coating. The key components of the catheter are the core, coil(s), tip, and coatings.

The provided text describes a 510(k) premarket notification for a medical device called the Odyssey Micro Catheter. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study in the typical sense of a novel AI/software medical device.

Therefore, the information requested for AI/software-centric studies (like sample sizes for test/training sets, data provenance, number/qualification of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this submission, as it concerns a physical medical device and its performance in in vitro bench tests.

However, I can extract the acceptance criteria (inferred from the tests performed) and summarize the study's findings:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list numerical acceptance criteria values for each test but states that the Odyssey Micro Catheter "met all predetermined acceptance criteria." The "reported device performance" is essentially that the device performed comparably or favorably to the predicate and met established standards.

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. The testing involved in vitro bench tests on the device itself. The number of units tested for each specific bench test is not detailed.
• Data Provenance: Not applicable in the context of human data. The "study" here refers to "Performance in vitro bench tests" conducted by the manufacturer, Heraeus Medical Components, LLC.

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

• Not Applicable. Ground truth, in this context, would refer to the validated methods and standards used for in vitro testing (e.g., ISO standards, internal validation of test equipment). This isn't about expert consensus on clinical data.

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

• Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or when establishing ground truth from expert readings. This was in vitro bench testing.

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 micro catheter, not an AI/software device that would assist human readers.

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

• Not Applicable. This is a physical medical device. "Standalone performance" in this context refers to the device's functional performance against engineering and safety specifications in vitro.

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

• The "ground truth" for the performance "study" was established by validated international standards (ISO 10555-1:2013, ISO10993-1:2009) and FDA guidance (G95-1) for in vitro functional performance and biocompatibility. The specific outcomes were measurements of physical and biological properties.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set."

Summary of the Study:

The "study" described in the 510(k) summary involves a series of in vitro bench tests designed to demonstrate the safety and effectiveness of the Odyssey Micro Catheter by proving its substantial equivalence to a legally marketed predicate device (ASAHI Corsair Microcatheter, K151103).

The key aspects of the study include:

• Tests Conducted: Biocompatibility testing (cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, in-vivo thrombogenicity, chemical characterization), particulate testing, corrosion resistance, dimensional inspection, sterile package integrity, tensile strength, torque strength, kink resistance, radiopacity, flow rate, and burst pressure/freedom from leakage.
• Standards Followed: ISO 10555-1:2013 (Intravascular catheters - sterile and single-use catheters - Part 1: General requirements) for functional testing, and ISO10993-1:2009 and G95-1 (FDA guidance) for biocompatibility testing.
• Outcome: The Odyssey Micro Catheter "met all predetermined acceptance criteria and compared favorably with the predicate device." The study supported claims of substantial equivalence based on indications for use, physical and technological characteristics, and comparative device testing, without raising new questions of safety and effectiveness.

Ask a specific question about this device

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control of the Catheterization Lab.

The Odyssey Workstation is an optional (large screen) display and user interface package which allows the clinician to view multiple diagnostic tool screens (e.g. Navigant, X-Ray, ECG, Carto, etc.) in the catheter lab. on one large flat panel monitor to view and interpret a variety of sources on a single screen. There are multiple view formats available, and the clinician can customize layouts to facilitate their specific workflow.

Here's an analysis of the provided text regarding the Stereotaxis Odyssey™ Workstation, focusing on acceptance criteria and study information:

Stereotaxis Odyssey™ Workstation Acceptance Criteria and Study Information

The 510(k) summary for the Stereotaxis Odyssey™ Workstation does not explicitly define acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy) for a diagnostic device. Instead, the "acceptance criteria" are implied through the comparison of the device's characteristics to a legally marketed predicate device (the Odyssey™ Workstation in Catheter Lab w/Niobe MNS). The study described is a comparison of technological characteristics to demonstrate substantial equivalence, rather than a performance study aiming to meet specific numerical thresholds.

The primary "study" is a comparison of the proposed device's characteristics against a predicate device to affirm substantial equivalence regarding safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this submission (a display and user interface package, not a diagnostic algorithm), the acceptance criteria are based on functional and technical characteristics, demonstrating equivalence to the predicate device. The "reported device performance" is the proposed device's characteristics.

Note: The "Acceptance Criteria" column represents the characteristics of the predicate device that the proposed device aims to be substantially equivalent to or improve upon without raising new questions of safety or effectiveness. The "Reported Device Performance" column shows the characteristics of the proposed Odyssey Workstation. The differences (e.g., expanded display options, removal of "keypad controls only Navigant") are presented as improvements or modifications that do not alter the fundamental safety and effectiveness.

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

The document does not describe a traditional "test set" with a defined sample size of patient data. The evaluation is based on comparing the technical specifications and functional capabilities of the new Odyssey Workstation to those of the predicate device. Therefore, there is no patient or image data used for a test set. This is a technical comparison, not a performance study on clinical data.

Data Provenance: Not applicable, as there is no clinical data test set.

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

Not applicable. This submission concerns a display and user interface system, not an AI or diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" here is the confirmed functionality and technical specifications of the device itself and its predicate.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or expert adjudication described.

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

No, an MRMC comparative effectiveness study was not done. The device is a display and user interface package, not a device that assists human readers in interpreting clinical cases.

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

Not applicable. The Odyssey Workstation is a display and control system for existing diagnostic tools, not an algorithm that performs a standalone diagnostic function. Its purpose is to consolidate existing information for a clinician, implying a human-in-the-loop scenario.

7. The Type of Ground Truth Used

The "ground truth" in this context is the verified technical specifications and functional capabilities of the device, confirmed through engineering design, testing, and comparison to the predicate device's established characteristics. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning algorithm and therefore does not have a "training set" in the conventional sense. Its functionality is based on software and hardware design, not data-driven learning.

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

Not applicable, as there is no training set.

Ask a specific question about this device

Indicated for use in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is indicated for use in Urinary, Gastroenterology, Pulmonary, Gynecology, and General Surgery procedures where fragmentation of stones and soft tissue incision, hemostasis, vaporization and ablation are indicated.

The Cook® Odyssey Holmium Laser System is used in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is a pulsed holmium YAG laser emitting laser radiation at 2100 nm with a 30 Watt maximum average power. The normal wavelength is strongly absorbed by water for tissue ablation with minimal lateral thermal damage. In the case of laser lithotripsy, laser energy vaporizes water in the calculus causing it to crack into small enough particles to pass easily. The system is a completely enclosed transportable unit.

This submission is for a medical device (Cook® Odyssey Holmium Laser System) and focuses on substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study involving AI or human reader assessment. Therefore, much of the requested information (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or cannot be extracted from the provided text.

Here is the information that can be gleaned from the provided text, primarily focusing on the regulatory assertion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The submission describes a regulatory pathway based on substantial equivalence, not a clinical trial with a specific test set of patient data. The "Test Data" mentioned refers to engineering and bench testing to demonstrate compliance with standards, not clinical performance data in human subjects for statistical analysis.

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

Not applicable. This is not a study involving expert assessment of medical images or data from a test set. The "ground truth" here is the regulatory equivalence established through technical and functional comparisons to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used to evaluate the impact of AI on human reader performance, which is not relevant for this device's 510(k) submission.

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

Not applicable. This device is a laser system, not an algorithm or AI product. Its performance is inherent to its physical operation, not an algorithm's standalone analysis.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the identified predicate devices (VersaPulse® Power Suite, Medilas H 20, Odyssey™ 30 Holmium Laser Systems). The Cook® Odyssey Holmium Laser System's performance and design were compared to these legally marketed devices to demonstrate substantial equivalence, rather than against a specific pathology or outcomes data from a clinical trial.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI-based device and no machine learning model was developed or trained.

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

Not applicable, as no training set is mentioned.

Ask a specific question about this device

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab.

The Odyssey Workstation is an optional (large screen) display and user interface package designed to augment the Navigation software system. The Odyssey Workstation allows the clinician to view multiple diagnostic tool screens (e.g. Navigant, X-Ray, ECG, Carto, etc.) in the catheter lab. on one large flat panel monitor to view and interpret a variety of sources on a single screen. There are multiple view formats available, and the clinician can customize layouts to facilitate their specific workflow.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Odyssey Workstation:

Summary of Acceptance Criteria and Device Performance for the Odyssey Workstation (K072371)

Detailed Study Information:

1. Sample size used for the test set and the data provenance:
   The provided document does not contain details about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary focuses on comparing the technological characteristics of the proposed device to a predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not mention any experts or the establishment of ground truth in the context of a performance study with a test set. The submission appears to be based on a comparison of technical specifications rather than a clinical performance study involving expert assessment.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Since no specific test set or performance study is described, there is no information about an adjudication method.

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 MRMC comparative effectiveness study was done as the device is not an AI-assisted diagnostic tool. The Odyssey Workstation is a display and user interface package.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   No standalone algorithm performance study was done. The device is a workstation designed to consolidate display and control in a catheter lab, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As there is no mention of a performance study requiring ground truth, this information is not applicable or provided. The basis for clearance appears to be substantial equivalence based on technological characteristics.

7. The sample size for the training set:
   The document does not mention a training set. This device is hardware with an interface, not an AI/ML algorithm that would typically require a training set.

8. How the ground truth for the training set was established:
   Since no training set is discussed, this information is not applicable or provided.

Conclusion on Study Evidence:

The provided 510(k) summary for the Odyssey Workstation (K072371) does not describe a traditional clinical performance study with defined acceptance criteria for accuracy, sensitivity, or specificity, nor does it detail a test set, ground truth, or expert involvement. Instead, the submission demonstrates substantial equivalence by comparing the technological characteristics of the proposed Odyssey Workstation against a legally marketed predicate device (Niobe MNS w/Navigant NWS). The conclusion states: "Based upon the documentation presented in this 510(k) it has been Performance data demonstrated that the Odyssey Workstation is safe and effective when used with the Niobe MNS w/Navigant NWS." This indicates that the clearance was based on demonstrating that the new device's features and performance are substantially similar to or improve upon the predicate device without raising new questions of safety or effectiveness. The "performance data" likely refers to the comparison of the technical specifications listed in the table, showing how the Odyssey Workstation meets or exceeds the capabilities of the predicate in key areas relevant to its intended use as a display and user interface.

Ask a specific question about this device

Dental Soft Tissue Indications: Dental, oral and soft tissue surgery including: Sulcular debridement of diseased or fibrous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown Lengthening Operculectomy Frenectomy Photocoagulation Laser Periodontal procedures, including: Laser soft tissue curettage Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

The Odyssey 2.4G Diode Laser is a device for delivering laser energy to surfaces within the oral cavity. This energy is generated by means of a solid-state diode which provides a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 5 watts of energy output. The laser energy is delivered to the surgical site by means of a proprietary optical fiber system, which allows for the safe transmission of laser energy to the surgical site without creating undue risk to the patient or operatory staff of collateral laser emissions. The device features some general user controls including an aiming beam, adjustable power output for user definable settings, and continuous or pulse delivery options. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip for emission with the device. Activation of the device is completed by use of a foot-activated switch.

The provided text describes the Odyssey 2.4G Diode Laser and seeks to establish its substantial equivalence to other legally marketed predicate devices, not to meet pre-defined acceptance criteria through a specific study. Therefore, a direct table of acceptance criteria and reported device performance, or details about a study explicitly proving it meets such criteria, cannot be extracted directly from this document.

However, based on the information provided, we can infer the basis for equivalence which acts as a form of "acceptance criteria" for regulatory clearance (510(k) pathway), and describe the comparison made.

Here's an attempt to structure the information as requested, interpreting "acceptance criteria" as the characteristics that demonstrate substantial equivalence to predicate devices:

1. Table of "Acceptance Criteria" (Basis for Substantial Equivalence) and Reported Device Performance

• Max. Power: 5 watts
• Delivery: Proprietary optical fiber system
• Controls: Adjustable power output, continuous/pulse delivery | - Wavelength: 810 nm (all predicates)
• Max. Power: 5-10 watts
• Delivery: Fiber delivery system
• Controls: Similar methods of control, operating controls |
  | Similar Operating Controls | Adjustable power output for user-definable settings, timing options for pulse delivery | Similar methods of control, operating controls |
  | Similar Delivery Systems | Proprietary optical fiber system (ensures safe transmission, prevents collateral laser emissions) | Fiber delivery system |
  | Similar Safety Features | Not explicitly detailed beyond safe transmission of laser energy and prevention of collateral emissions. Compliance with safety standards listed. | Not explicitly detailed, but implied by regulatory compliance and predicate device characteristics. |
  | Similar Performance Monitoring | Not explicitly detailed | Not explicitly detailed |
  | Similar Performance Specifications | - Wavelength: 810 ± 20 nm
• Max. Power: 5 watts | - Wavelength: 810 nm
• Max. Power: 5-10 watts |
  | Similar Energy Type | 810nm Diode Laser | 810nm Diode Laser (Solid-state diode) |
  | Compliance with Standards | 21 CFR 1040.10, 1040.11 (with Laser Notice 50), IEC 60601-1:1998+A1, IEC 60601-2-22:1995, IEC 2001, FCC Part 15 | Implied for predicate devices through their market clearance. |

Summary of Comparative Performance Data (from "PERFORMANCE DATA - Comparison Table"):

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

This document does not describe a test set in the traditional sense of a clinical or performance study where a defined sample of patients or cases is used. The "study" here is a premarket notification (510(k)) application for regulatory clearance, which relies on demonstrating substantial equivalence to predicate devices already legally marketed. The "data" used is primarily the technical specifications and indications for use of both the submitted device and the chosen predicate devices.

• No specific sample size for a test set is mentioned.
• "Data provenance" would refer to the characteristics of the predicate devices themselves, which are legally marketed in the US. This is not a study with specific data from patients or a defined cohort.

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 applicable. As noted above, there is no "test set" and thus no ground truth established by experts in the context of a performance study. The ground truth for the predicate devices' safety and effectiveness was established through their original regulatory clearance process.

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

Not applicable. There is no test set or adjudication process described.

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 a medical imaging AI device, nor is it a multi-reader multi-case comparative effectiveness study. It's a diode laser for dental soft tissue.

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

Not applicable. This is a physical medical device (diode laser), not an algorithm or AI.

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

The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices, as determined by previous FDA clearances. The applicant is asserting that their device is sufficiently similar in technological characteristics and indications for use that it raises no new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device. There is no "training set" as understood in that context. The "training" for the device's design and manufacturing implicitly comes from general engineering principles and medical device development best practices.

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

Not applicable. As above, there is no training set in the context of AI/ML. The "ground truth" for the device's design and manufacturing is based on established scientific principles, engineering standards, and regulatory requirements for medical devices.

Ask a specific question about this device

Odyssey is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

The Odyssey radiation treatment planning system is a collection of software modules that execute algorithms to produce radiation dose computations (estimations). The system includes functions for imaging, target and non-target delineation, beam planning, verification and quality assurance. An earlier version of the software was known as "OptiRad" (K993895). In addition to forward planning, users who have the Intensity Modulated Radiation Treatment (IMRT) module can perform inverse planning.

The provided text does not contain specific acceptance criteria or an analytical study proving the device meets them. Instead, it is a 510(k) summary for a medical device (Odyssey radiation treatment planning system) and related FDA correspondence.

Based on the document, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative metrics. The summary focuses on equivalence to predicate devices.
• Reported Device Performance: Not presented as quantitative performance metrics. The document states a general conclusion: "Odyssey is as safe, as effective, and is substantially equivalent to the legally marketed predicate devices."

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

• Sample Size (Test Set): Not applicable. No clinical testing was required or performed for this 510(k) submission.
• Data Provenance: Not applicable. No test set was used for clinical evaluation.

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

• Number of Experts: Not applicable. No test set requiring expert ground truth was used for clinical evaluation.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. No test set requiring adjudication was used.

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:

• MRMC Study: No. The document explicitly states: "Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of Odyssey." This implies no human reader studies were conducted.
• Effect Size: Not applicable.

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

• Standalone Study: No standalone clinical performance study was conducted. The "Summary of Non-Clinical Testing" mentions "Verification and Validation" and "Hazard Analysis and Failure Modes and Effects Analysis" were completed, demonstrating the device to be safe and effective, but these are typically internal engineering and software validation activities, not a standalone clinical performance study.

7. The type of ground truth used:

• Type of Ground Truth: Not applicable for clinical performance. For the described non-clinical verification and validation, ground truth would be based on engineering specifications, known algorithmic outputs, and safety standards.

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable. The device is a "Radiation Treatment Planning System" which uses algorithms to compute estimated radiation doses. It's not described as an AI/ML device that requires a training set in the contemporary sense. Its functionality is based on established physics algorithms, not learned patterns from data.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set. The algorithms would be based on well-established mathematical and physical models.

In summary, the document states that:

• Clinical testing was not required for the Odyssey device to demonstrate substantial equivalence.
• The device contains no technological characteristics not already present in its predicate devices (ADAC P3MRT and OptiRad).
• Non-clinical Verification and Validation, along with Hazard Analysis and FMEA, were performed to demonstrate safety and effectiveness.

This submission relies on substantial equivalence to predicate devices and internal verification, rather than clinical performance studies with specific acceptance criteria and ground truth.

Ask a specific question about this device

Ask a specific question about this device

The Odyssey ITM Dental Water unit with CAT filter is indicated for use as an in-line water disinfecting system to reduce microorganisms and particulate matter in the dental waterline.

Odyssey ITM Dental Water unit

I am sorry, but based on the provided document, I cannot answer your request. The document describes a 510(k) premarket notification for a dental water unit and focuses on regulatory approval rather than a study about the device's performance or acceptance criteria.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes, data provenance, or details of a test set.
• The number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Details about a standalone algorithm performance study.
• The type of ground truth used.
• The sample size for a training set.
• How ground truth for a training set was established.

Ask a specific question about this device

The ODYSSEY Instrumentation System is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with hemodialysis delivery systems. Water purification specialists may also use the ODYSSEY Instrumentation System to verify proper characteristics of the water used in hemodialysis. These parameters are key indicators of system performance that require periodic monitoring and adjusting to maintain safe and effective hemodialysis systems.

Not Found

The provided documents (K981294) are a 510(k) clearance letter and an Indications for Use statement for the "ODYSSEY Instrumentation System." This system is intended for measuring physical parameters of dialysate solution (conductivity, temperature, pH, and pressure) and water for hemodialysis. It is not a device that processes or analyzes medical images, clinical data, or makes diagnostic/AI predictions.

Therefore, the concepts of "acceptance criteria," "study," "sample size," "ground truth," "experts," "adjudication method," "MRMC study," and "standalone performance" do not apply in the context of this device. These terms are relevant for evaluating devices that generate or interpret clinical information, especially those incorporating AI or complex algorithms for diagnosis or prediction.

The ODYSSEY Instrumentation System is a measurement device. Its "performance" would typically be established through metrology studies, calibration, and validation against known standards to ensure accuracy, precision, and reliability of its measurements (conductivity, temperature, pH, pressure). The "acceptance criteria" for such a device would relate to the maximum permissible error, stability, response time, and other metrological specifications in comparison to established industry standards or a predicate device.

To provide an answer in the requested format, but acknowledging the mismatch in the nature of the device and the questions, I will state that the information requested is not applicable given this device's function.

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

• Not Applicable. The provided documents do not contain acceptance criteria or reported device performance data in the context of a clinical study for diagnostic accuracy or algorithmic performance. As a measurement instrumentation system, its performance would be defined by metrological specifications (e.g., accuracy, precision, linearity for conductivity, temperature, pH, and pressure), which are not detailed in these regulatory documents.

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

• Not Applicable. This device is a physical measurement system, not one that processes clinical data or involves a "test set" in the sense of clinical samples or imaging data for diagnostic evaluation.

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 Applicable. The device measures physical parameters. "Ground truth" for such a device would be established through calibrated standards and reference methods, not by expert consensus on clinical data.

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

• Not Applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies where human interpretation is involved. This device does not generate such data.

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-assisted diagnostic device, nor does it involve human readers interpreting clinical cases.

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

• Not Applicable. There is no "algorithm only" performance or human-in-the-loop component in the diagnostic sense for this device. It is a measurement instrument.

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

• Not Applicable. For a measurement instrument, "ground truth" would refer to NIST-traceable standards, certified reference materials, or highly accurate reference measurement systems for conductivity, temperature, pH, and pressure. These details are not provided in the submitted documents.

8. The sample size for the training set

• Not Applicable. This type of device does not involve a "training set" in the context of machine learning or AI.

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

• Not Applicable. As above, no training set is relevant for this device.

Ask a specific question about this device

Ask a specific question about this device