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510(k) Data Aggregation
(28 days)
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(82 days)
The DORO LUCENT® Skull clamp is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging.
The DORO LUCENT® Skull clamp Pediatric Set is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The target patient population includes children over 5 years of age.
The DORO LUCENT® Skull Clamp ensures an adequate positioning of a patient's head and provides rigid fixation for neurosurgery. The device is suitable for intra-operative X-ray and CT based imaging procedures.
The DORO LUCENT® Skull Clamp consists of a fixed arm, an adjustable arm and modular pin holders. Thus, using the DORO LUCENT® Skull Clamp Pediatric Set, the skull clamp can be configured as three-pin or four-pin pediatric set up.
The provided text describes the 510(k) clearance for the DORO LUCENT® Skull Clamp and DORO LUCENT® Skull Clamp Pediatric Set. However, it does not contain information about a study based on AI/ML or any performance testing related to software or AI. The tests mentioned are for mechanical performance, usability, and reprocessing of the physical device.
Therefore, for aspects related to AI/ML device performance, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training, the information is not available in the provided document.
Here's a breakdown of what is available based on the mechanical device performance testing:
Device: DORO LUCENT® Skull Clamp (1101.001) and DORO LUCENT® Skull Clamp Pediatric Set (1101.040)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria / Benchmark (Implicit) | Reported Device Performance |
|---|---|---|
| Maximum Load Test (System Test) | The skull clamp must be capable of resisting the forces imposed by the patient and surgeon when in use and in locked position without movement in any connection, joint and/or plastic deformation. | Pass. The skull clamp is capable of withstanding the given force without movement in any connection, joint and/or plastic deformation. |
| Usability | The usability of the skull clamp must be given. | Pass. The usability of the skull clamp is given. |
| Static load (Latching teeth mechanism) | The skull clamp must be able to withstand a maximum static load for a given duration without signs of permanent deformation, fracture, or breakage. | Pass. The skull clamp withstands a static load for the given duration without signs of permanent deformation, fracture, or breakage. |
| Creep | The skull clamp must maintain the applied maximum force without a force deviation from the initially applied load by a defined value. | Pass. The skull clamp can maintain the applied maximum force without a force deviation from the initially applied load by a defined value. |
| Pin force accuracy | The skull clamp force delivery component must be verified at each force level throughout its range to deliver the stated force within the actual setting. | Pass. The skull clamp force delivery component is verified at each force level throughout its range to deliver the stated force within the actual setting. |
| Torque load resistance | The skull clamp must withstand a defined torque for a given amount of time without deformation or any structural failures. | Pass. The skull clamp withstands a defined torque for a given amount of time without deformation or any structural failures. |
| CT Evaluation | The skull clamp must produce fewer artifacts than the set benchmark for adequate imaging results. | Pass. The skull clamp produces fewer artifacts than the set benchmark as defined in the test report. |
| Reprocessing | Reprocessing must be validated according to specified standards (ANSI/AAMI ST98:2022, DIN EN ISO 17664-1:2021, DIN EN ISO 17664-2:2021, AAMI TIR 12: 2020) including accumulation of residue, cleaning effectiveness, and disinfection effectiveness. | Pass. The test data shows the reprocessing of DORO LUCENT® Skull Clamp is validated and a test report in support of the statement is provided. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each test. For mechanical/physical performance tests, the "sample size" typically refers to the number of units tested. The document indicates "Tests were performed and the results are shown in the table below," implying a sufficient number of tests were conducted to confirm performance.
- Data Provenance: Not specified in terms of country of origin or retrospective/prospective for these physical device tests. These are likely internal laboratory tests conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is a mechanical skull clamp, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these tests is the physical measurement and observation of the device's performance against defined engineering and safety standards.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is relevant for AI/ML diagnostic tools being compared to human performance, which is not the case for this mechanical device.
6. Standalone (Algorithm Only) Performance:
- Not applicable. There is no algorithm or software for standalone performance in this mechanical device.
7. Type of Ground Truth Used:
- Engineering and Safety Standards/Specifications: The ground truth for these tests is established by the device's design specifications and compliance with relevant industry standards (e.g., for mechanical strength, CT compatibility, and reprocessing).
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI/ML product developed through a training process with a data set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
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(119 days)
The DORO QR3 Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.
DORO® QR3 Headrest System consists of 3 components: 1. Skull clamp, 2. Swivel Adapter, 3. Adjustable Base Unit. DORO® QR3 Headrest System (Aluminum) is a cranial stabilization device, designed to provide rigid skeletal fixation. The DORO Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary. The Swivel Adaptor connects the Base Unit (by means of the Transitional Member) with the Skull Clamp. The Swivel Adaptor provides 360 degrees rotation. This allows a fully flexible adjustment of the DORO® Headrest System to the patient's position. The Base Unit is designed for patient positioning in prone or supine, lateral and sitting positions.
The provided document is a 510(k) premarket notification for a medical device called the DORO QR3 Headrest System (Aluminum). This document primarily focuses on establishing substantial equivalence to a predicate device and outlines performance testing for safety and effectiveness, rather than detailing clinical study results for an AI/algorithm-based device.
Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this submission.
Here's the information that can be extracted relevant to acceptance criteria and device performance based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Pass" results of the performance tests, indicating that the device met the established benchmarks for each test. The study performed is a series of engineering and usability tests.
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| System Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Torque Load Resistance Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Force Delivery Verification (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Creep Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Static Load Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Fourfold Load - Skull Clamp (in accordance with DIN EN 60601-2-46) | Pass |
| Fourfold Load - Interface Skull Clamp to Swivel Adaptor (in accordance with DIN EN 60601-2-46) | Pass |
| Usability Test (in accordance with IEC 62366 as well as FDA-2011-D-0469) | Pass |
| Automated cleaning including disinfection (in accordance with EN ISO 15883-1:2014 – 10, RKI Guideline: 2012, AAMI TIR 30: 2011, Guideline DGKH, DGSV, AKI: 2014) | Pass |
Additional Information:
- Sample size used for the test set and the data provenance: Not applicable. These were engineering performance tests of the physical device, not a test set of medical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for engineering tests is typically based on established physical standards and measurements, not expert human interpretation.
- Adjudication method for the test set: Not applicable.
- 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 document is for a physical medical device, not an AI/algorithm.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used:
- For engineering tests (Load, Torque, Creep, System Tests): The ground truth is the performance specified by the referenced ASTM and DIN EN standards. The "Pass" results indicate the device met these engineering specifications.
- For Usability Test: The ground truth would be adherence to the usability requirements outlined in IEC 62366 and FDA-2011-D-0469.
- For Cleaning and Disinfection Test: The ground truth is compliance with the referenced ISO, RKI, AAMI, and DGKH/DGSV/AKI guidelines for reprocessing medical devices.
- The sample size for the training set: Not applicable. This is for a physical device, not an AI/algorithm.
- How the ground truth for the training set was established: Not applicable.
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(174 days)
Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.
DORO® Sterile Disposable Skull Pins are a disposable device. These are delivered sterile (gamma-sterilization), ready for use, and are intended to be disposed after one use. DORO® Sterile Disposable Skull Pins are available in 2 different types (Stainless steel & Titanium) and 2 different sizes (Adult & Pediatric). DORO® Sterile Disposable Skull Pins are used together with the DORO ® Headrest Systems, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures. Two DORO® Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one single skull pin is inserted in the opposite side. DORO® Sterile Disposable Skull Pins (Titanium) are used when Intra-Operative X-Ray-, CTor MR Imaging of the patient is used.
The provided document is a 510(k) premarket notification for the DORO® Sterile Disposable Skull Pins. This document asserts the substantial equivalence of the new device to legally marketed predicate devices, rather than proving the device meets specific performance acceptance criteria through the kind of study described in the prompt.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, nor can I describe an MRMC comparative effectiveness study or details about the training set.
The document focuses on demonstrating substantial equivalence for a physical medical device (skull pins) by comparing its technological characteristics and performance testing results to those of predicate devices. It does not involve AI/ML components or studies of human reader performance.
However, I can extract information related to the performance data provided for the physical device:
1. Table of Acceptance Criteria and Reported Device Performance (as listed in the document for the physical device):
| Test | Acceptance Criteria (Implied by action 'Confirms ability to withstand' or 'Confirms acceptance', and 'Pass' result) | Reported Device Performance |
|---|---|---|
| DORO® Sterile Disposable Skull Pins (Stainless Steel & Titanium) | ||
| Axial Load, and Creep Test | Ability to withstand typical loads with additional safety factor without plastic deformation and with an accepted distension. | Pass: The Pins are able to withstand typical static loads w/ additional safety factor w/o plastic deformation and an accepted distension. |
| Shear Test | Ability of the skull pins and its interface with the cranial bone to withstand typical shear force with additional safety factor without spatial locomotion. | Pass: The Pins are able to withstand typical shear force w/ additional safety factor w/o spatial locomotion. |
| Transport Validation | Capability of the transport packaging as well as the product packaging to protect the skull pins against hazards, which may occur during handling, storage, and transport by air or ground. | Pass: The utilized packing system for the skull pins is capable to protect those against visible damage. |
| Packing Integrity Test | Capability of the sterile barrier system of the blister pack as well as the blister pack itself utilized for the skull pins whether it is effective, efficient and safe to use. | Pass: The utilized sterile barrier system as well as the blister pack was proven to perform efficiently, safely, and effectively. |
| System Handling Test | Safe and effective utilization of the skull pins with skull clamps without negative impact on utilized single-use gloves. | Pass: Skull Pins performed safely and effectively. |
| Input Materials | Acceptance of utilized materials of the skull pins for medical use prior biocompatibility test. | Pass: All utilized materials are accepted for medical use. |
| Biocompatibility Test | Biocompatibility of the skull pins by cytotoxicity test and chemical analysis of utilized materials (no cell growth inhibiting character, no chemical substance above harmful threshold). | Pass: The skull pins obtain no cell growth inhibiting character. No chemical substance above harmful threshold was detected. |
| Color Coding | Coloring of the plastic pin collets that enables the user to differentiate between MR conditional and MR unsafe skull pins as well as between skull pins for the adult population and pediatric population. | Pass: Differentiation between designated patient populations as well as different applications is possible due to different colors utilized for the plastic pin collets. |
| Sterility Test | Sterility of the skull pins as well as the maintained sterility of the skull pins at the end of the product's shelf life. | Pass: VDmax validation as well as dye penetration test have proven the sterility of the product at delivery status as well as at the end of shelf life. |
| DORO® Sterile Disposable Skull Pins (Titanium) | ||
| MR-Compatibility | MR-Compatibility of the skull pins dedicated for the utilization in conjunction with MRT scanner utilizing the worst-case product. | Pass: The skull pins are MR conditional. |
2. Sample size used for the test set and the data provenance:
The document describes performance testing of physical properties of the skull pins (e.g., axial load, shear, sterility, biocompatibility) and packaging, not a study involving a "test set" of medical images or patient data in the typical sense of AI/ML evaluation. The specific sample sizes for these engineering and material tests are not detailed in this 510(k) summary, beyond indicating that "worst-case product" was utilized for some tests. The data provenance is from the manufacturer's internal testing (Pro Med Instruments GmbH, Germany). The tests are not clinical studies, so terms like "retrospective or prospective" do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to the type of device and testing described. Ground truth for a physical device's performance tests would typically involve established engineering standards, material specifications, and validated laboratory procedures, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human interpretation or adjudication of medical 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 document is for a physical medical device (skull pins), not an AI/ML diagnostic or assistive device. Thus, there is no mention of MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the physical device, the "ground truth" for the performance tests would be defined by engineering specifications, material standards (e.g., ISO, ASTM), and validated test methodologies. For example, for the "Axial Load and Creep Test," the ground truth is the specified load and deformation limits that the device must withstand. For "Biocompatibility," the ground truth is the absence of cytotoxicity or harmful chemical substances as per established biocompatibility standards.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML model.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML model.
In summary, the provided document is a regulatory submission for a physical medical device focusing on substantial equivalence based on material properties, design, and mechanical performance testing, rather than an AI/ML device requiring clinical validation or human reader studies.
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(235 days)
The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used.
The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used.
The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.
The DORO LUCENT® iXI and iMRI Headrest System ensures an adequate positioning of a patient's head for neurosurgery. Additional intra-operative imaging can be performed.
The DORO LUCENT® iXI and iMRI Headrest System consists of the following: Skull Clamp, Skull Pins, Parallelogram Adaptor and Headplate. The Parallelogram Adaptor is used to connect the Skull Clamp (including Skull Pins) or the Headplate to the OR-Table/ Transfer Board.
Additional accessories like the Adjusting wrench and Transfer Collision Indicator supports the performance of the Headrest System.
These special Headrest Systems are developed for selected OR-Table/ MRI scanner combinations. They are separated in following sets:
- . 4003.200 DORO LUCENT® Headrest System TRUMPF for SIEMENS Aera/Skyra MRI Systems
- 4003.300 DORO LUCENT® iMRI Headrest System MAQUET for SIEMENS/PHILIPS/GE ●
- . 4003.500 DORO LUCENT® iXI Headrest System
By the use of the Navigation Adaptors the performance of the Headrest System is supplemented. The intra-operative navigation is feasible because of the provided interface to the navigation device.
The provided FDA 510(k) summary describes a medical device, the DORO LUCENT® iXI and iMRI Headrest System. This document focuses on the substantial equivalence of the new device to a predicate device rather than presenting a clinical study to evaluate diagnostic performance with a human-in-the-loop or standalone algorithm. Therefore, many of the requested criteria related to AI/algorithm performance and clinical study details are not applicable or not present in this submission.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally demonstrated through "Pass" results in various performance tests.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| DORO LUCENT® iXI and iMRI Headrest System | |
| Static load: Ability to sustain a certain load with an additional safety factor. | Pass |
| MR-Compatibility: Does not impair the function of the MRI system. | Pass |
| CT/Angio-Compatibility: No new or additional shadowing on the image. | Pass |
| X-Ray-Compatibility: No new or additional shadowing on the image. | Pass |
| DORO LUCENT® Skull Clamp | |
| Static load (Latching teeth mechanism): Ability to sustain a certain load with an additional safety factor without damage/malfunction. | Pass |
| Torque (Rocker Arm): Ability to resist applied torque without damaging, opening, or malfunction of the Open-Lock mechanism. | Pass |
| DORO LUCENT® Skull Pins | |
| Mechanical stability (scratch test): Withstands an applied radial force when an axial force is applied. | Pass |
| MR-Compatibility: MR conditional. | Pass |
| Sterility: Packaged sterile and stays sterile for shelf life. | Pass |
| Biocompatibility: Biocompatible. | Pass |
| DORO LUCENT® Headplate | |
| Static load: Ability to sustain a certain load with an additional safety factor without mechanical failure. | Pass |
| Biocompatibility: Biocompatible. | Pass |
2. Sample size used for the test set and the data provenance
This is a physical medical device (headrest system), not an AI/software device. The "test set" here refers to the physical units of the device and its components undergoing engineering and materials testing. The document does not specify the exact number of units or components tested for each criterion. The provenance of the data is from pro med instruments GmbH, the manufacturer, and the tests were likely conducted internally or by accredited third-party labs. The study is a prospective testing of manufactured devices against pre-defined engineering and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a physical device's performance often relates to instrumented measurements (e.g., force, torque, imaging artifacts) and material properties, not expert consensus as would be used for diagnostic imaging algorithms.
4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies for diagnostic accuracy, where expert opinions need to be reconciled. For device performance testing, results are quantitative or pass/fail based on pre-defined specifications.
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 not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
The ground truth for this device's performance is based on engineering specifications, material science, sterility standards, and regulatory requirements (e.g., MRI compatibility standards). For example, "MR-Compatibility" is verified against established standards for how metallic or non-metallic objects interact with MRI fields. "Static load" is verified against a specified weight with a safety factor.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve AI/machine learning training sets.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, no ground truth needs to be established for it.
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(90 days)
The DORO® QR3 XTom Headholder System is a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging with a CT-Scanner is used.
The DORO® QR3 XTom Headholder System ensures an adequate positioning of a patient's head for neurosurgery. Due to the utilized material the device can be used for intraoperative CT imaging procedures. The DORO® QR3 XTom Headholder System consists of the following: Skull Clamp, Skull Pins, Base Unit, Torque Screw Driver and U-Belt. The Base Unit is used to connect the Skull Clamp (including Skull Pins) to the OR-Table. Additional components like the Torque Screw Driver and U-Belt supports the performance of the Headholder System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DORO® QR3 XTom Headholder System.
It's important to note that the provided text is an FDA 510(k) summary for a mechanical support system (Neurosurgical Head Holder/Skull Clamp) and not an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects like training data, expert consensus for ground truth, MRMC studies, and various performance metrics like sensitivity, specificity, AUC are not applicable to this type of device. The acceptance criteria and performance are based on mechanical and usability testing.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied by "Pass" Result) | Reported Device Performance |
|---|---|---|
| DORO® QR3 XTom Headholder System (System Test) | Ability of the system to sustain a certain load without mechanical failure. | Pass: The System supports the static load without mechanical failure. |
| DORO® QR3 XTom Headholder System (Usability) | Usability of the System is given. | Pass: The usability of the System is given. |
| DORO® QR3 XTom Skull Clamp (Static Load - Latching teeth mechanism) | The interface must withstand the static load over the defined duration without damage or malfunction. | Pass: The interface must withstand the static load over the defined duration without damage or malfunction. |
| DORO® QR3 XTom Skull Clamp (Torque - Rocker Arm) | The Rocker Arm must withstand the torque without damaging, opening, or malfunction of the Open-Lock mechanism. | Pass: The Rocker Arm must withstand the torque without damaging, opening or malfunction of the Open-Lock mechanism. |
| DORO® QR3 XTom Skull Clamp (Creep Test) | The skull clamp must maintain the applied maximum force for a defined time without a force deviation from the initially applied load by a defined value. | Pass: The skull clamp must maintain the applied maximum force for a defined time without a force deviation from the initially applied load by a defined value. |
| DORO® QR3 XTom Skull Clamp (Force Delivery Accuracy Verification) | The skull clamp force delivery component must be verified at each major graduation throughout its range for a defined time to deliver the stated force within a defined range of the actual setting. | Pass: The skull clamp force delivery component must be verified at each major graduation throughout its range for a defined time to deliver the stated force within a defined range of the actual setting. |
| DORO® XTom U-Belt (Dynamic Load) | The Belt must withstand the dynamic load without breakage or opening of the Belt. | Pass: The Belt must withstand the dynamic load without breakage or opening of the Belt. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of units tested. It states "The devices have been tested as a system and single device," implying that at least one of each (system, skull clamp, U-Belt) was subjected to testing. For mechanical tests, the sample size might be small, typically 1 to 3 units, as per engineering testing standards, unless statistical significance for variability is a concern.
- Data Provenance: The manufacturer is "pro med instruments GmbH" located in "Freiburg im Breisgau, Germany." This suggests the testing and data likely originated from Germany. The document indicates these were direct performance tests on the physical device, not retrospective or prospective patient data studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable (N/A). As this is a mechanical device, ground truth for its performance is established through objective physical measurements and engineering standards, not through expert human interpretation or consensus like in AI/ML image analysis.
4. Adjudication Method for the Test Set
- N/A. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation (like radiology reads) to resolve disagreements or establish consensus. For mechanical performance tests, the results are quantitative and objective, not subject to human interpretation disagreement in the same way.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This type of study is relevant for diagnostic imaging AI/ML devices to assess the impact on human reader performance. This device is a mechanical support system, not an imaging interpretation aid.
- Effect Size: N/A, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- N/A. This is a mechanical device, not an algorithm or software. Its performance is inherent to its physical design, materials, and manufacturing, not dictated by an algorithm.
7. The Type of Ground Truth Used
- Objective Mechanical Measurements and Engineering Standards: The "ground truth" for this device's performance is derived from its ability to meet predefined physical requirements (e.g., load bearing, torque resistance, force accuracy, maintaining clamping force over time) as measured by calibrated testing equipment and adherence to established engineering principles and safety margins. The "Pass" results confirm it met these criteria.
8. The Sample Size for the Training Set
- N/A. This device does not involve machine learning; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- N/A. Since there is no training set, this question is not applicable.
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