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510(k) Data Aggregation
(121 days)
The device is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The EQ10D scooter consists of an un-foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, two lead acid batteries with an off-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set.
The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.
This scooter is designed for use on firm, even surfaces such as concrete, asphalt and indoor flooring.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification for a motorized three-wheeled vehicle (scooter) and primarily focuses on establishing substantial equivalence to a predicate device.
It details:
- The FDA's decision regarding the 510(k) submission.
- Indications for use of the KYMCO EQ10D Scooter.
- A 510(k) summary, including device description, non-clinical testing performed (compliance with various ISO standards), and a statement of substantial equivalence.
- A detailed table comparing the KYMCO EQ10D Scooter to its predicate device (KYMCO EQ 20C, K130940) across numerous specifications and features to demonstrate substantial equivalence.
While non-clinical testing for compliance with ISO standards is mentioned (e.g., ISO 7176-1 to -16, -25, ISO 10993-1, -5, -10, ISO 14971), specific acceptance criteria values for a device's performance (like sensitivity, specificity, accuracy, etc.) and a study showing the device meets those specific numerical criteria are not described. The document focuses on showing the new device is "substantially equivalent" to an already marketed device, meaning it performs similarly and raises no new questions of safety or effectiveness, rather than demonstrating performance against a set of predefined acceptance criteria through a specific study with statistical outcomes.
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(186 days)
The device is a motor drive, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disable or elderly person limited to a seated position.
The EQ 20C scooter consists of an un-foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, two lead acid batteries with an on-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.
This 510(k) submission is for a mobility scooter, which is a medical device. The information provided heavily relies on a comparison to a predicate device rather than a comprehensive study with acceptance criteria in the way one might analyze a diagnostic or AI device. Therefore, many of the requested fields are not directly applicable or cannot be extracted from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a motorized three-wheeled vehicle), "acceptance criteria" are generally established through adherence to recognized national and international standards for safety and performance, and demonstrating substantial equivalence to a legally marketed predicate device. The performance is then related to how the device meets these standards and compares to the predicate.
| Acceptance Criteria (based on standards & predicate comparison) | Reported Device Performance (KYMCO EQ 20C scooter) |
|---|---|
| Intended Use: Provide mobility to a disabled or elderly person limited to a seated position. | Same as predicate (EQ 30) |
| Compliance with ANSI/RESNA WC Vol. 1 Sec. 7 & 8 | Complied with requirements |
| Compliance with ANSI/RESNA WC Vol. 2 Sec. 21 | Complied with requirements |
| Compliance with ISO 7176 series (e.g., -1, -2, -3, etc.) | Complied with requirements |
| Compliance with ISO 10993 series (e.g., -1, -5, -10) | Complied with requirements (Biocompatibility) |
| Compliance with ISO 14971 | Complied with requirements (Risk Management) |
| Compliance with EN 61000-4 series (e.g., -2, -3, -8) & CISPR 11 | Complied with requirements (EMC) |
| Substantial Equivalence to Predicate Device (KYMCO EQ 30 - K072630) for: | |
| - Maximum load capacity | 127 kg (280 lbs) (Predicate: 150 kg / 330 lbs) - Lower but acceptable difference |
| - Overall dimensions (Height, Length, Width) | 921 mm (36.3"), 1080 mm (43.5"), 520 mm (20.5") (Predicate: 1250 mm, 1240 mm, 560 mm) - Differences noted but not deemed to alter intended use |
| - Seat dimensions (Height, Width, Depth) | 550 mm (21.7"), 427 mm (16.8"), 350 mm (13.8") (Predicate: 756 mm, 455 mm, 400 mm) - Differences noted but not deemed to alter intended use |
| - Motor Rated power | 250 W (Predicate: 350 W) - Lower but not deemed to alter intended use |
| - Braking distance | Forward: 1.0 m (39.4") at max speed (Predicate: 1.24 m / 48.8") - Better braking distance reported |
| - Net weight with battery | 55.5 kg (122 lbs) (Predicate: 84.4 kg / 185.7 lbs) - Lighter |
| - Slope grade ability | 8 degree (Predicate: 10 degree) - Lower but not deemed to alter intended use |
| - Per-charge distance | Up to 21 km (13 miles) (Predicate: Up to 37 km / 23.1 miles) - Lower but not deemed to alter intended use |
| - Maximum speed | Up to 6.5 km/h (4.1 mph), variable (Predicate: Up to 8 km/hr / 4.7 mph), variable) - Lower but not deemed to alter intended use |
| - Turning Radius | 1200 mm (47.2") (Predicate: 1565 mm / 61.6") - Smaller turning radius (better) |
| - Maximum curb height | 50 mm (2") (Predicate: 80 mm / 3.14") - Lower but not deemed to alter intended use |
| - Other features (Lights, Horn, Anti-tip wheels, Operation mode, Armrest) | Similar functions, some stylistic differences or presence/absence of certain features (e.g., headrest, suspension) - Differences noted but not deemed to alter intended use |
Note: The "acceptance criteria" here are implicitly whether the device meets the safety and performance requirements of the cited standards and whether any differences from the predicate device are determined by the FDA to not raise new questions of safety or effectiveness, thus maintaining substantial equivalence. The document doesn't explicitly state quantitative thresholds for each parameter as "acceptance criteria," but rather demonstrates compliance with standards and compares specifications to the predicate.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of this submission. The "test" here refers to compliance with international standards and a comparison of specifications with a predicate device. There is no "test set" of patient data or algorithm performance data as would be used for AI/diagnostics.
- Data Provenance: The data comes from the manufacturer's own testing against the listed standards and their internal comparison of the EQ 20C with their predicate device, the EQ 30. No external patient data or clinical trial data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" established by experts in this context. The "truth" is established by adherence to engineering and safety standards and the direct measurement of device specifications.
4. Adjudication method for the test set
- Not applicable. There is no adjudication method described. Compliance with standards typically involves testing by qualified personnel (either internal or third-party labs) and documenting results against standard requirements.
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 mobility device, not an AI or diagnostic imaging device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. Refer to point 5.
7. The type of ground truth used
- The "ground truth" in this context is the established engineering and safety standards (e.g., ANSI/RESNA, ISO, EN, CISPR) and the specifications of the legally marketed predicate device (KYMCO EQ 30). Device performance is evaluated against these standards and compared to the predicate to establish substantial equivalence.
8. The sample size for the training set
- Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. Refer to point 8.
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(28 days)
KYMCO ForU EQ10 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
The KYMCO ForU EQ10 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided text is a 510(k) Summary for a medical device called the "KYMCO ForU EQ10 scooter." This document is a premarket notification for a Class II medical device, primarily focused on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials or performance studies with defined endpoints.
Therefore, most of the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not available in this type of regulatory submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as specific quantifiable metrics required for clinical or performance evaluation. The "acceptance criteria" in this context are for demonstrating substantial equivalence to predicate devices, focusing on intended use, technology, and safety/effectiveness profiles.
- Reported Device Performance: The document states "There are minor differences in performance specifications of the scooters," but does not provide a table or specific details of these differences or the KYMCO ForU EQ10's measured performance against any pre-defined criteria.
| Acceptance Criteria (from a medical device performance study) | Reported Device Performance (KYMCO ForU EQ10) |
|---|---|
| Not specified as quantitative performance benchmarks for a study in this document. | The document broadly states "minor differences in performance specifications" compared to predicate devices, but no specific performance metrics or values are provided. |
2. Sample size used for the test set and the data provenance:
- There is no test set, sample size, or specific data provenance (country of origin, retrospective/prospective) mentioned for a performance study.
- The comparison is based on the technical specifications and intended use outlined in the 510(k) submission, not on a study with human subjects or a defined dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "test set" and therefore no ground truth established by experts for a performance study. The 510(k) process relies on regulatory review of technical documentation and comparison to predicates.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is 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 device is an electrical scooter for mobility, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device (scooter), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. There is no "ground truth" established from clinical data or expert consensus for this 510(k) submission. The "truth" here is regulatory compliance and substantial equivalence to existing devices.
8. The sample size for the training set:
- Not applicable. This 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 or ground truth establishment is relevant to this type of device and regulatory submission.
Summary based on the document:
The 510(k) submission for the KYMCO ForU EQ10 scooter focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (AVANTICARE SA4022 (K051538) and LERADO CHINA LIMITED ForU EQ30 (K072630)). The core argument is stated as: "There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness."
This document is a regulatory filing, not a scientific publication detailing a performance study with acceptance criteria and a study design as you've outlined. Therefore, most of your questions are outside the scope of the provided text.
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(28 days)
KYMCO ForU EQ20 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.
The KYMCO ForU EQ20 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) summary and FDA approval letter for a medical device called the "KYMCO ForU EQ20 scooter."
The document focuses on:
- Device identification: Trade name, common name, classification, and intended use.
- Predicate devices: Listing two other scooters (AVANTICARE SA4022 and LERADO CHINA LIMITED ForU EQ30) as substantially equivalent.
- Substantial equivalence claim: Stating that minor performance differences do not alter the intended function, use, or safety/effectiveness.
- FDA approval: The letter confirms the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.
Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the given text. This document is a regulatory approval, not a scientific study report.
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(50 days)
KYMCO ForU EQ40 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.
The KYMCO ForU EQ40 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided 510(k) summary for the KYMCO ForU EQ40 scooter is part of a submission to demonstrate substantial equivalence to predicate devices, not an independent study aimed at proving device performance against specific acceptance criteria in the way a diagnostic AI device might.
Therefore, many of the typical sections requested for an AI device's acceptance criteria and study design are not applicable to this submission. This is a medical device (mobility scooter), and the regulatory pathway focuses on comparing its safety and effectiveness to already legally marketed devices, rather than establishing novel performance metrics.
Here's an analysis based on the information provided, highlighting why certain questions are not directly answerable in this context:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is not present in the 510(k) summary as the submission's goal is to demonstrate substantial equivalence to predicate devices, not to meet specific quantitative performance metrics like sensitivity, specificity, or accuracy for a diagnostic device. The "performance" here refers to functional characteristics of a mobility scooter.
| Acceptance Criteria (e.g., Performance Specification) | Reported Device Performance (KYMCO ForU EQ40) |
|---|---|
| Intended Use Equivalence: Provide transportation for disabled or elderly persons limited to a seated position. | Met: Intended use is identical to predicate devices. "KYMCO ForU EQ40 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position." |
| Technological Characteristics Equivalence: Battery-operated, tiller handle, thumb-operated potentiometer throttle control. | Met: Device description aligns with general functionality of predicate devices. "The KYMCO ForU EQ40 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions." |
| Differences in Performance Specifications do not alter intended function or raise new safety/effectiveness questions. | Met: The submission states, "There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." (Specific "minor differences" are not detailed in this summary, but would have been presented to the FDA). |
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical medical device (mobility scooter). The "test set" would typically refer to a clinical study or a dataset for evaluating a diagnostic algorithm. For this device, testing would involve engineering and functional performance evaluations for safety and efficacy in line with industry standards, not a "test set" in the context of an AI/diagnostic study. The provenance of data would be from engineering tests and comparisons to predicate device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for a mobility scooter is its functional performance, safety features, and specifications (e.g., speed, range, weight capacity, braking effectiveness), not an expert consensus on interpreting images or patient data. These would be assessed through engineering and physical testing, likely by engineers and quality control personnel, possibly against relevant national or international performance standards.
4. Adjudication method for the test set
Not applicable. This concept is relevant for studies involving human interpretation (e.g., radiologists reviewing images). For a physical device like a scooter, performance and safety are typically evaluated against pre-defined specifications and standards through objective measurements, not by adjudication of subjective interpretations.
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 type of study is specific to diagnostic aids, particularly those involving AI, where human readers (e.g., radiologists) interpret cases with and without algorithmic assistance. The KYMCO ForU EQ40 is a mobility scooter and does not involve human "readers" or AI assistance for diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The KYMCO ForU EQ40 is a non-AI, non-diagnostic physical device. There is no algorithm to be tested in a standalone fashion.
7. The type of ground truth used
For a mobility scooter, the "ground truth" consists of objective performance metrics and safety standards. This would include:
- Engineering Specifications: Measured values like maximum speed, turning radius, battery life/range, weight capacity, climbing ability, brake effectiveness, stability, electromagnetic compatibility (EMC).
- Safety Standards: Compliance with relevant international and national safety standards for powered wheelchairs and scooters (e.g., ISO, ANSI/RESNA, UL).
- Predicate Device Comparison: Data from testing predicate devices or manufacturer specifications for predicate devices to demonstrate equivalence.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model. There is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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(15 days)
The ForU EQ30 scooter is motor driven, indoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The ForU EQ30 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
This document is a 510(k) premarket notification for a motorized scooter (ForU EQ30 scooter) and does not describe a clinical study or evaluation of an AI/ML device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth establishment, or multi-reader multi-case studies.
The document primarily focuses on establishing "substantial equivalence" to a predicate device (AVANTICARE SA4022) by providing a comparison of specifications and intended use.
Here's a breakdown of why this document cannot fulfill your request:
- No AI/ML Device: The device is an "Electrical scooter," a physical motorized vehicle, not a software algorithm or AI/ML-driven medical device.
- No Acceptance Criteria for an Algorithm: The acceptance criteria in this document are for a physical product, primarily focusing on safety and performance specifications (e.g., maximum loading, speed, braking distance) compared to a predicate device, rather than diagnostic accuracy or performance metrics of an algorithm.
- No "Study" in the AI/ML Sense: The document refers to a "substantial equivalence comparison" which is a technical comparison of specifications, not a clinical study to prove the performance of an AI model against a ground truth.
Therefore, I cannot extract the requested information like sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document.
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(27 days)
The ForU KV10HB powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The ForU powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. But the ForU KV10HB is kind oh a new class of lightweight powered wheelchair. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
This document is a 510(k) premarket notification for the ForU KV10HB powered wheelchair, seeking substantial equivalence to a predicate device (CWD01, K062888). As such, it primarily focuses on comparing specifications to demonstrate equivalence rather than presenting an independent study with defined acceptance criteria and performance metrics for the ForU KV10HB in isolation.
Therefore, many of the requested elements regarding acceptance criteria, study details, and ground truth establishment are not directly applicable or explicitly stated in this type of regulatory submission. The goal here is to show similarity to an already approved device, not necessarily to prove independent performance against specific thresholds in a detailed clinical or technical study.
However, based on the provided text, I can extract information related to the comparison table and address the relevant questions.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in a 510(k) submission are implicitly defined by the specifications of the predicate device. The applicant essentially claims that their device's performance is "substantially equivalent" to the predicate, meaning any differences do not raise new questions of safety or effectiveness. The table below presents the comparative data provided. An "acceptance criterion" column is added, reflecting the predicate's performance, and the "reported device performance" reflects the ForU KV10HB.
| Feature / Performance Metric | Acceptance Criterion (CWD01 K062888) | Reported Device Performance (ForU KV10HB) |
|---|---|---|
| Intended Use | Medical purposes to provide mobility to persons restricted to a sitting position. | Motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. |
| Maximum Loading | 136 kg (300 lbs) | 165 kg (350 lbs) |
| Overall Height | 1130 mm (44.5") | 1140 mm (44.9") |
| Overall Length | 900 mm (35.4") | 1032 mm (40.6") |
| Overall Width | 650 mm (25.6") | 644 mm (25.4") |
| Motor Output | 260W x DC24V × 2Pcs | DC 24V, 200 W, 2 Pcs |
| Controller | Dynamic Shark | PG VR2 |
| Battery | Lead-Acid 12V × 35AH × 2PCs | Gel/Seal Lead-Acid 12V × 50AH × 2PCs |
| Charger | DC 24V 5A, off-board | DC 24V 5 AMP (Automatic Type) on-board |
| Front/Rear Wheel | 6" pneumatic tire × 2 PCs | 6" Solid tire × 2 PCs |
| Middle Wheel | 10" PU foaming tire × 2 PCs | 12.8" Solid tire × 2 PCs |
| Armrest | Removable | Fixed |
| Break system | Intelligent regenerative electromagnetic brake | Braking distance Forward: 0.9 m (35.4") at max speed |
| Net Weight (w/ batteries) | 83.5kg (183.7 lbs) | 98 kg (215.6 lbs) |
| Slope Grade Ability | 12 degree | 10 degree |
| Per-charge Distance | 40 km (24 miles) | Up to 37 km (23.1 miles) |
| Maximum Speed | 5 km/h (3.2 mph) | Up to 6.5 km/hr (4.1 mph), variable |
| Suspension | Cross brace | Front/Rear: No, Middle: Yes |
| Horn | Yes | (Not explicitly stated for ForU KV10HB in table, implying difference or absence) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a regulatory comparison for substantial equivalence, not a clinical trial or performance study with a "test set" of individuals or a defined dataset. The "data provenance" is the manufacturer's self-reported specifications for their device (ForU KV10HB) and specifications for the predicate device (CWD01) as understood from its 510(k) submission. Both devices are manufactured in Taiwan, suggesting the data originates from Taiwan. It is a comparison of device specifications, not retrospective or prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Applicable to clinical studies, not product specification comparisons. No experts were explicitly mentioned as establishing "ground truth" for the comparative data presented. The "ground truth" here is the published specifications of the predicate device and the manufacturer's own specifications for their new device.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" in the sense of clinical cases or data requiring adjudication. The comparison is based on published and self-declared device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a 510(k) submission for a physical medical device (powered wheelchair), not an AI or imaging device that would typically undergo 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 or AI device. The submission focuses on the physical and functional aspects of a powered wheelchair.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the published design specifications and performance characteristics of the predicate device (CWD01) and the newly submitted device (ForU KV10HB). This includes physical dimensions, motor specifications, battery type, speed, range, and weight.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. This is not a machine learning or AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
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