Search Results

The 2.5-D and 3-D AUTIMO Systems are intended for the fabrication and positioning in radiotherapy of irregular shielding blocks, dose modifiers, and compensators.

The AUTIMO 2.5-D and 3-D models are computer-controlled cutting tool systems for producing customized shielding blocks for use in radiotherapy. The computer accepts files from existing treatmentplanning system operating on a LAN. The GE-Target, Siemens Helax, and Theratronics Theraplan systems are examples of such treatmentplanning software. The computer interprets the files from the planning system and communicates with the AUTIMO device through a serial port.

The provided document describes the 510(k) summary for the HEK AUTIMO 2.5-D and 3-D systems, which are computer-controlled cutting tool systems for producing customized shielding blocks in radiotherapy.

The document does not contain information related to software performance acceptance criteria or a study proving adherence to such criteria. Instead, it focuses on the device's substantial equivalence to a predicate device based on electrical safety and electromagnetic compatibility testing.

Therefore, I cannot provide the requested information in the format specified. The document explicitly states:

• "HEK Medizintechnik carried out testing to address the following issues: (1) electrical safety (2) eletromagnetic compatibility."
• "The results from these tests supported the safety and effectiveness of the 2.5-D and 3-D AUTIMO Systems and demonstrates that it is substantially equivalent to the predicate device."
• "The AUTIMO is simply a modification with updated hardware and cosmetic changes from the predicate device."

This indicates that the "study" mentioned in the document primarily pertains to hardware safety and EMC, rather than a clinical or performance study of an AI algorithm or software functionality that would necessitate the details requested (e.g., sample size for test/training sets, expert ground truth, MRMC study, standalone performance).

The "predicate device" mentioned is the MCP-70-SE (K844180), and the new AUTIMO system is deemed "substantially equivalent" based on its technological characteristics being the same as the predicate, with only updated hardware and cosmetic changes.

In summary, none of the specific information requested about acceptance criteria for device performance, study details (sample sizes, provenance, ground truth, expert review, MRMC, standalone), or training set data is present in this 510(k) summary because the device is a physical cutting tool system, not an AI/software-driven diagnostic or treatment planning system requiring such evaluations.

Ask a specific question about this device

The Orthosonics Duo-Son Ultrasound Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.

The Orthosonics Duo-Son Ultrasound Diathermy Device consists of a two-channel power module which generates the ultrasonic energy and provides overall control of the device, and a handpiece with cable. The applicator design allows the simultaneous delivery of ultrasonic energy to tissue at two frequencies, 1 MHz and 45 kHz.

The Orthosonics Duo-Son Ultrasound Diathermy Device is a medical device intended to apply ultrasonic energy to generate deep heat within body tissues. Below is a breakdown of its acceptance criteria and the study performed, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining and meeting specific analytical or clinical performance metrics in a traditional sense. The "acceptance criteria" here implicitly refer to meeting safety and effectiveness standards comparable to the predicate device.

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

The document does not specify a "test set" in terms of human subjects or a clinical dataset. The testing described primarily involved laboratory-based evaluations using a "phantom." Therefore:

• Sample size for the test set: Not applicable in the context of human subjects. The tests were performed on a phantom.
• Data provenance: Not explicitly stated, but implicitly laboratory-based testing conducted by Orthosonics, Ltd. in the UK. This would be considered prospective, as the tests were conducted specifically for this submission.

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

Not applicable. The ground truth for the device's performance was established through direct physical measurements on a phantom and compliance with regulations, not through expert review of data that required a ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" in the context of data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is not mentioned or implied in the provided text. The device is a physical therapy device (ultrasound diathermy), not an imaging or diagnostic device that would typically involve MRMC studies.

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

Yes, in essence. The testing described focuses on the device's inherent performance characteristics (electrical safety, EMC, temperature rise in a phantom) without human interaction influencing the core performance metrics being evaluated. The "algorithm" here refers to the device's functional operation.

7. The Type of Ground Truth Used:

The ground truth used was based on:

• Physical measurements: Directly measuring electrical safety, electromagnetic compatibility, and temperature rise in a phantom.
• Regulatory standards: Demonstrating compliance with 21 CFR 1050.
• Comparison to a predicate device: The performance observed in the Duo-Son device was compared against the known characteristics and performance of the legally marketed predicate device (Mettler Model ME-720) to establish substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device is an ultrasound diathermy device, not an AI/machine learning algorithm that requires a training set. The term "training set" is typically used in the context of machine learning model development.

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

Not applicable, as there was no training set for an AI model.

Ask a specific question about this device

The OSCAR Orthosonics System for Cemented Arthroplasty Revision is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.

The OSCAR Orthosonics Ultrasonic Cement Removal System consists of a power module which generates the ultrasonic energy and provides overall control of the device, a handpiece, a set of cement removal probes, and an ultrasonic cleaning system for part of the reprocessing procedures for reuse of the probes. Three independent power modules are included in each device and these are mounted in a cart for ease of use.

The provided 510(k) summary for the OSCAR Orthosonics System for Cemented Arthroplasty Revision does not detail acceptance criteria or a study proving the device meets specific performance metrics in the way modern AI/ML device submissions do. This document is from 1996, and the regulatory requirements and types of evidence presented were different.

However, based on the information provided, we can infer the "acceptance criteria" were related to safety and effectiveness, and the "study" was a series of engineering tests and a comparison to predicate devices, rather than a clinical trial with a defined test set and ground truth in the AI/ML context.

Here's an attempt to structure the information based on your request, highlighting what is present and what is absent, given the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any of the individual tests (temperature rise, bone damage, clinical experience, etc.).
• Data Provenance: The tests were carried out by Orthosonics. The provenance of clinical experience data (e.g., country of origin, retrospective/prospective) is not detailed in this summary.

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

• Not applicable in the AI/ML sense. Ground truth was not established by experts reviewing data for device performance. Instead, ground truth was implicitly defined by the physical or biological outcomes observed during the engineering and validation tests (e.g., measured temperature, observed bone damage, successful sterilization). Clinical experience would have involved medical professionals, but their role in establishing a "ground truth" for a test set is not described, nor are their qualifications.

4. Adjudication Method for the Test Set

• Not applicable. There was no "test set" in the context of human interpretation of data requiring adjudication. The tests were direct measurements or observations of the device's physical and biological interactions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No such study was conducted. This device is a surgical instrument, not an AI/ML diagnostic or assistive tool for human readers.

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

• Not applicable. There is no "algorithm" in this device. Performance was measured directly during operation or through validation studies.

7. The Type of Ground Truth Used

• Engineering/Biological Measures: For aspects like temperature rise, bone damage, EMC, electrical safety, and sterilization, the "ground truth" was established by direct measurement against predetermined safe limits or validated protocols.
• Clinical Observation: For "clinical experience," the ground truth would have been derived from observed patient outcomes and surgeon feedback, but no specific methodology is detailed.
• Predicate Device Comparison: A significant part of the "ground truth" for substantial equivalence was the established safety and effectiveness of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a training set as it is not an AI/ML product.

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

• Not applicable. No training set was used.

Ask a specific question about this device

The NICaS 2001 is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance) and ventilatory parameters (respiratory rate) in males and females needing cardiac output assessment, including patients with cardiovascular disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.

The NICaS 2001 is a noninvasive cardio-respiratory monitor which unlizes bioimpedance measurements from the blood circulatory system to calculate hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index and total peripheral resistance) and ventilatory parameters (including respiratory rate). The NCaS 2001 uses 4 electrodes that pick up the signals which are amplified inside the patient module. After signal amplification and filtration, the analysis is done by a powerful microprocessor. The microprocessor-driven software includes unique algorithms that reject artifacts and perform all required calculations for stroke volume (SV) and other derived parameters. The results are displayed on a PC screen. The software allows data storage, recall/review and printout. The electrodes are nondisposable (standard electrode by Nicolet) "strap" style attached to cable leads. These electrodes consist of two 55 cm electrode strips for the leg and two 25 cm electrode strips for the arm. The electrodes are attached to the two identified input connectors of the patient module. The patient module also connects with the computer.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the requested quantitative information. It primarily focuses on comparing the NICaS 2001 device with a predicate device and outlining its intended use and safety standards.

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

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

The document doesn't explicitly state quantitative acceptance criteria. Instead, it relies on a comparison to "standard invasive technique of thermodilution" for cardiac output and another physiological monitor for respiratory rate. Therefore, the "reported device performance" is essentially the correlation observed in these studies.

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

• Cardiac Output Study (Dr. H. Miller):
  • Sample Size: Not specified.
  • Data Provenance: Ichilov Hospital, Israel. The study type (retrospective/prospective) is not specified.
• Respiratory Rate Study (Dr. Michael Luchansky):
  • Sample Size: Not specified.
  • Data Provenance: Tel Aviv Medical Center. The study type (retrospective/prospective) is not specified.

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 ground truth was established by objective measurements:

• Cardiac Output: Standard invasive thermodilution technique (a measurement, not expert opinion).
• Respiratory Rate: Horizon 2000 Physiological Monitor (a device, not expert opinion).

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

Not applicable. No expert adjudication method was mentioned or would be relevant given the objective nature of the ground truth measurements (thermodilution and another device).

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 device is a standalone physiological monitor, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC study or AI assistance effect size is not relevant.

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

Yes, the studies described are standalone performance evaluations of the NICaS 2001 device itself, comparing its measurements to established methods. There is no indication of a human-in-the-loop component in these performance evaluations.

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

• Cardiac Output: Objective measurement from a "standard invasive technique of thermodilution."
• Respiratory Rate: Objective measurement from a "Horizon 2000 Physiological Monitor."

8. The sample size for the training set

The document does not mention any training set or machine learning aspects for this device. The "unique algorithms" for artifact rejection and calculations are inherent to its design, not explicitly trained on a separate dataset in the sense of modern AI.

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

Not applicable, as no training set is described. The device's "unique algorithms" are presumably based on established bioimpedance principles and modifications of the Kubicek algorithm.

Ask a specific question about this device