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Found 13 results
510(k) Data Aggregation
(83 days)
COMFORT ORTHOPEDIC CO. LTD.
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
The COMFORT Standing Wheelchair is an indoor / outdoor standup wheelchair that is manual wheelchair, not an electric power wheelchair, with an electric power standing wheelchair. The electric power is not used to move the wheelchair but to stand the patient.
Here's an analysis of the provided text regarding the COMFORT Standing Wheelchair, HERO series, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Testing) | Reported Device Performance |
|---|---|
| Mechanical Conformity to Standards: | |
| - ANSI / RESNA WC/Vol.2-1998 (Wheelchairs) | Not explicitly stated as "met," but implied by the statement: "The safety and performance functions of two systems [new and predicate device] are assured and validated. They are substantially equivalent." |
| Electromagnetic Compatibility (EMC) Standards: | |
| - CISPR 11: 1990 | "EMC Report" (indicating testing was performed). The statement "the electronic systems between the two devices are all passed by the UL certificated, for instance the electronic controller, batteries, and recharge" suggests conformity to electronic safety and performance standards, which would include EMC. The document explicitly lists CISPR 11: 1990 as a standard used for performance testing. |
| - EN61000-3-2: 1995 | Same as above. The document explicitly lists EN61000-3-2: 1995 as a standard used for performance testing. |
| - IEC61000-3-3: 1995 | Same as above. The document explicitly lists IEC61000-3-3: 1995 as a standard used for performance testing. |
| Ignition Resistance (Upholstery): | |
| - Resistance ignition test (by SGS) | "the back upholstery is the same material, and also passed the resistance ignition test by SGS." |
| Other Functional Equivalence: | |
| - Overall dimensions | "the overall dimensions and visional appearance are similar" to the predicate device. |
| - Electronic systems (UL certified) | "the electronic systems between the two devices are all passed by the UL certificated, for instance the electronic controller, batteries, and recharge." |
| - Suspension of cross brace, footplates, etc. | "the suspension of cross brace, footplates, incline degree 12°, armrest type, the size of tires, the weight limit, and warranty are all the same" as the predicate device. |
| - Intended use | The new device and predicate device "have the same intended use." This is crucial for substantial equivalence. |
| - Technological aspects | The new device and predicate device "have the same technological aspects." |
Study Proving Acceptance Criteria Met:
The provided document describes a substantial equivalence comparison study rather than a traditional research study with statistically significant endpoints against specific acceptance criteria. The primary method used to demonstrate device performance and safety is by showing its equivalence to a legally marketed predicate device, the COMFORT Standing Wheelchair, HERO 2 (K031618).
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this submission. The comparison is made against the predicate device based on its established performance and adherence to standards. The document doesn't describe a separate "test set" of patients or devices for a new clinical trial. Instead, it relies on testing the subject device against relevant engineering and safety standards and comparing its features and performance to the predicate device.
- Data Provenance: The device manufacturer, COMFORT ORTHOPEDIC CO., LTD., is located in Taiwan, R.O.C. The performance testing (EMC, ignition resistance) was conducted based on international standards (ANSI/RESNA, CISPR, EN, IEC) and by an accredited body (SGS for ignition resistance). This implies prospective testing of the new device against these standards. The comparison data for substantial equivalence is derived from the predicate device, K031618, which was previously cleared by the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This submission focuses on engineering and performance standards conformity and substantial equivalence to a predicate device, not on diagnostic accuracy requiring expert ground truth in a clinical sense. The "ground truth" here is adherence to recognized industry standards and the demonstrated safety and effectiveness of the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method is described as this is not a study involving human reader interpretations of data. The assessment is based on objective testing against technical standards and a direct comparison of specifications and features with the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices involving human interpretation of medical images or data. The COMFORT Standing Wheelchair is a physical medical device (wheelchair), 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 device is a physical standing wheelchair, not an algorithm or AI system. Its performance is inherent to its physical and electronic design and functionality, not a standalone algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this submission is primarily:
- Adherence to recognized international and national engineering and safety standards: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995, and general "UL certified" for electronic components.
- Demonstrated safety and effectiveness of the predicate device (K031618): The predicate device serves as the established benchmark for what constitutes an acceptable standing wheelchair. The new device's "sameness" in critical aspects to this predicate device forms the basis of its "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" described in the context of this device. This is not an AI/machine learning device that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth established for one.
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(36 days)
COMFORT ORTHOPEDIC CO. LTD.
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The COMFORT SCOOTER, LY-EW408 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The provided text describes the submission of a 510(k) premarket notification for a medical device, the COMFORT SCOOTER, LY-EW408. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with specific acceptance criteria and detailed performance metrics as one might find for an AI/ML medical device.
Therefore, many of the requested elements for acceptance criteria and study design are not applicable to this type of regulatory submission. The goal here is to show the new device is as safe and effective as a legally marketed one, not to quantify its performance against pre-defined accuracy thresholds using a clinical study involving experts and ground truth.
Here's an attempt to address your request based on the provided text, highlighting what is (and isn't) present:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The "acceptance criteria" in this context refer to the demonstration of substantial equivalence to a predicate device (COMFORT SCOOTER LY-EW415 (K063032)). The criteria are broad comparisons of features, safety, and functionality rather than specific statistical performance thresholds.
| Acceptance Criteria Category (Implied by Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use | Met: The device is intended for medical purposes to provide mobility to persons restricted to a seated position, which is the same as the predicate. |
| Technological Characteristics (Overall Dimensions & Appearance) | Met (with minor differences): Overall dimensions and visual appearance are similar. The new device has smaller dimensions, which is presented as an improvement (can fit into most ordinary car trunks, more convenient for moving and turning). This difference is not presented as a compromise in safety or effectiveness. |
| Technological Characteristics (Electronic Systems) | Met: Electronic systems (controller, batteries, recharger) are from the same suppliers and are UL certificated, ensuring safety and performance equivalent to the predicate. |
| Technological Characteristics (Materials) | Met: Back upholstery is made of the same material and passed the resistance ignition test by SGS, ensuring material safety is equivalent to the predicate. |
| Technological Characteristics (Mechanical Design) | Met: Suspension of cross brace, footplates, incline degree (12°), armrest type, and warranty are all the same, ensuring mechanical stability and user experience are equivalent to the predicate. |
| Performance (Safety & Functions) | Met: "The safety and performance functions of two systems are assured and validated." (This is a general statement rather than specific metrics, relying on the equivalence of components and design.) |
| Performance (Maximum Speed) | Met (with minor differences): 1.0 mph difference in maximum speed. This difference is deemed not significant because the throttle allows continuous adjustment, and operators can set adequate speeds for indoor/outdoor use. This difference is not considered to impact overall performance or safety negatively. |
| Performance (Battery Charger) | Met (with minor differences): Battery charger types are "almost the same," with a difference in output electric current (4A for new, 5A for predicate). This difference relates to charging period or battery capacity, not safety aspects, and is therefore considered substantially equivalent. The chargers are UL certificated as part of the overall electronic system. |
| Compliance with Standards | Met: Performance testing included EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (for Electrically Powered Wheelchairs, controller, and their chargers). These standards demonstrate compliance with recognized safety and performance requirements for such devices. |
Regarding the other desired information points:
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Sample size used for the test set and the data provenance:
- N/A. This submission is for a physical medical device (Electric Scooter) and does not involve an AI/ML algorithm or a "test set" of data in the manner implied by the question. Performance testing involved compliance with engineering standards (e.g., EMC, wheelchair standards) on the device itself, not on a dataset.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No "ground truth" establishment by experts on a test set of data is described. Device performance testing is against established engineering and safety standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set or adjudication method as described is applicable here.
-
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:
- N/A. This is a physical mobility device, not an AI-assisted diagnostic or clinical decision support tool. No human reader studies are described.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This does not involve an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. The "ground truth" for this device's performance is adherence to recognized engineering standards for safety and functionality, and verification of components' certifications (e.g., UL, SGS).
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The sample size for the training set:
- N/A. This is a hardware device, not an AI/ML algorithm requiring a training set.
-
How the ground truth for the training set was established:
- N/A. Not applicable for this type of device.
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(36 days)
COMFORT ORTHOPEDIC CO. LTD.
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The COMFORT POWERED WHEELCHAIR, LY-EB206 is an indoor / outdoor Electric Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
This 510(k) submission (K072711) describes a Powered Wheelchair (COMFORT POWERED WHEELCHAIR, LY-EB206). The submission focuses on demonstrating substantial equivalence to a predicate device (COMFORT Powered Wheelchair, LY-EB103, K030356), rather than establishing new performance criteria through a standalone study. Therefore, the information provided mainly pertains to the comparison with the predicate device and the standards met, rather than a traditional "acceptance criteria" and "study proving it meets acceptance criteria" as might be found for novel diagnostic AI devices.
However, I can extract the relevant information and present it in a structured way based on the provided text.
Here's an analysis of the provided information:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards)
Given that this is a 510(k) for a powered wheelchair, the "acceptance criteria" are implicitly defined by the safety and performance standards met by the device, as well as its substantial equivalence to a legally marketed predicate device. The "device performance" is primarily discussed in terms of meeting these standards and being comparable to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Standards & Predicate Comparison) | Reported Device Performance (COMFORT POWERED WHEELCHAIR, LY-EB206) |
|---|---|
| Intended Use (Mobility for persons restricted to a seated position) | Intended for medical purposes to provide mobility to persons restricted to a seated position. (Same as predicate) |
| Mainframe Strength & Fatigue | Mainframes meet strength and fatigue tests. (Similar to predicate) |
| Material Aspects | Similar mainframe materials to predicate. |
| Back Upholstery Ignition Resistance | Back upholstery passed resistance ignition test by SGS. (Same material as predicate) |
| Electronic Systems Safety (controller, batteries, motor, charger) | Electronic systems are the same as the predicate and all passed UL certification. (Same safety level assured) |
| EMC Compliance | Complies with EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995. |
| Maximum Speed (Under 6 mph limit) | Maximum speed is 4.75 mph. (Within the 6 mph limit, compared to predicate's 5.31 mph) |
| Maximum Range per Charge | Maximum range per charge is 23.8 miles. (Different from predicate's 20 miles, but considered substantially equivalent in real-life use) |
| Other Features (Suspension, footplates, incline degree 12°, armrest type, weight limit, warranty) | All are the same as the predicate device. |
| Overall Dimensions | Minor differences from the predicate, but not considered a safety aspect. |
| Tire Sizes | Differences in tire sizes from the predicate, but not considered a safety aspect. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a clinical test set for AI/diagnostic performance. The "test set" here refers to the device itself undergoing engineering and performance testing. The document describes the testing of the wheelchair as a single unit or representative units, not a patient-centric data set.
- Data Provenance: The referenced standards (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) are international and national technical specifications for power wheelchairs and electrical compatibility. The ignition resistance test was conducted by SGS, a global inspection, verification, testing, and certification company. The electronic components were UL certified. The manufacturing country is Taiwan, R.O.C. (Comfort Orthopedic Co., LTD.). This is a submission for a physical device, so "retrospective or prospective" data provenance regarding patient cohorts is not relevant.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For a physical device like a wheelchair, "ground truth" is established through engineering specifications, validated test methods (e.g., those specified in ANSI/RESNA, CISPR, EN, IEC standards), and certifications from recognized bodies (e.g., UL, SGS). There's no mention of human experts establishing a "ground truth" in the diagnostic sense.
- Qualifications of Experts: N/A. The "experts" are the engineers and technical specialists involved in the design, testing, and certification processes according to established industry standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is typically relevant for medical imaging or diagnostic AI where discordant expert opinions need resolution for ground truthing. For a physical device, compliance is determined by meeting predefined engineering specifications and passing standardized tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This submission does not include an MRMC study. MRMC studies are used to evaluate the diagnostic performance of a system (often AI-assisted) compared to human readers over a diverse set of cases. This is a submission for a physical medical device (powered wheelchair) where such studies are not typically performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Standalone Study: Not applicable. This device is a physical powered wheelchair, not an algorithm. Its performance is measured directly through mechanical, electrical, and safety tests, not through an AI algorithm operating in a standalone capacity. The "standalone performance" here would be the physical performance of the wheelchair itself as tested against the standards mentioned.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device is based on engineering specifications, compliance with recognized industry standards (e.g., ANSI/RESNA, CISPR, EN, IEC) for safety and performance, and certifications from accredited testing laboratories (e.g., UL, SGS). The primary "ground truth" for substantial equivalence is the performance and safety profile of the predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: N/A. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: N/A. There is no training set for this type of device.
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(62 days)
COMFORT ORTHOPEDIC CO. LTD.
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The COMFORT SCOOTER, LY-EW406 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The Comfort Scooter, LY-EW406, is a motorized three-wheeled vehicle intended for medical purposes to provide mobility to persons restricted to a seated position.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate Device K022369) | Reported Device Performance (LY-EW406) |
|---|---|---|
| Permissible Load Weight | 265 lbs | 265 lbs |
| Electronic Controller | UL Certified | UL Certified |
| Recharge System | UL Certified | UL Certified |
| Electrical Safety | ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 standards for electrically powered wheelchairs, controllers, and chargers | Compliant with ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 |
| Max Speed | 4.0 mph (predicate) | 4.2 mph |
| Intended Use | To provide mobility to persons restricted to a seated position | To provide mobility to persons restricted to a seated position |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not detail a "test set" in the context of clinical data or comparative performance against a predefined set of cases/patients. The performance testing referenced is against engineering standards and comparison to a predicate device.
Data provenance: Taiwan, R.O.C. (Manufacturer location). The nature of the testing suggests it is primarily engineering/bench testing rather than clinical data, therefore it would be considered prospective for the device under test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study does not involve human expert interpretation of data for ground truth establishment. The "ground truth" for this device's performance is compliance with established electrical and wheelchair performance standards, and comparison of specifications to a legally marketed predicate device.
4. Adjudication Method for the Test Set
Not applicable. This type of adjudication method is usually for clinical studies with expert reviewers, which is not relevant for this device's submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices involving human interpretation of medical images or data. The Comfort Scooter is a mobility device; its performance is evaluated against engineering standards and functional specifications rather than clinical diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (electric scooter), not an algorithm or AI system. Its performance evaluation is based on direct measurements and adherence to specified standards.
7. The Type of Ground Truth Used
The "ground truth" used for this device's acceptance is based on:
- Engineering Standards: Compliance with recognized international and national standards for electrically powered wheelchairs and electrical safety (e.g., ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3).
- Predicate Device Specifications: Direct comparison of key performance characteristics (e.g., load capacity, controller type, recharge system, maximum speed) to a legally marketed device (COMFORT AGILE SCOOTER LY-EW303, K022369) to establish substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no training set in the context of machine learning or AI for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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(13 days)
COMFORT ORTHOPEDIC CO. LTD.
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The COMFORT SCOOTER, LY-E'V415 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device c in be disassembled for transport and is provided with an onboard battery charger.
The provided text describes a 510(k) submission for the COMFORT SCOOTER, LY-EW415, and focuses on demonstrating substantial equivalence to a predicate device, the COMFORT WINDJOY SCOOTER LY-EW302 (K022369). The "acceptance criteria" here refer to the performance and design characteristics that the new device must meet to be considered substantially equivalent to the predicate device. The study proving the device meets these criteria is the comparison summary provided by the manufacturer.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the specifications of the predicate device. The study demonstrates that the new device (subject device) either meets these specifications directly or has differences that do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Predicate Device K022369) | Reported Device Performance (Subject Device K063032) | Justification/Comment |
|---|---|---|
| Intended Use: The device is intended for medical purposes to provide mobility to persons restricted to a seated position. | SAME | Substantially equivalent. |
| Overall Length: 48" | 59.8" / 152 cm | New device is larger; applicant states this is "NOT related to the safe aspect" and that "larger dimensions can hold more mass and possess more balance," leading to "more safety." |
| Overall Width: 24.4" | 28.3" / 72 cm | New device is larger; applicant states this is "NOT related to the safe aspect" and that "larger dimensions can hold more mass and possess more balance," leading to "more safety." |
| Max Loading: 265 lbs | 180 kgs / 400 lbs | New device has higher maximum loading capacity. Implies improved safety for heavier users. |
| Electronics: Dynamic Rhino series | SAME | Substantially equivalent. |
| Batteries Type: Sealed lead acid, 40Ah 12VDC | Sealed lead acid, 75Ah 12VDC | Same type, but new device has higher capacity (75Ah vs 40Ah). Applicant states batteries are from the "same supplier and they are certificated by UL." |
| Range per Charge: 28 miles | 75 km / 46.8 miles | New device has a significantly longer range per charge due to higher battery capacity. |
| Front Tires: 85 x 260 mm | 4.00-5 (pneumatic) | Different specified dimensions/types of pneumatic tires. No safety concern raised. |
| Rear Tires: 4.10 / 3.50-5" | 3.00-10 (pneumatic) | Different specified dimensions/types of pneumatic tires. No safety concern raised. |
| Maximum Speed: 5.5 mph | 8 km / 5.0 mph | New device has a slightly lower maximum speed (0.5 mph difference). Applicant states this difference does "not mean any performance differences" and that "the new device has lower maximum speed, thus leading to more safety and less hazard." |
| Turning Radius: 43.3" | 180 cm / 70.8" | New device has a larger turning radius. Related to overall dimension increase. No safety concern raised. |
| Back Upholstery: Fabric | SAME | Same material; applicant states it "passed the resistance ignition test by SGS." |
| Scooter Weight: 165 lbs (w/o battery) | 140 kgs / 308 lbs (with battery) | New device is heavier (with battery compared to predicate's weight without battery). Implies robust construction. |
| Recharger: DC 24V 5A Remote | DC 24V 8A Remote | Same resource, both UL certified; difference in output current (8A vs 5A) leads to "charging period differences or arise from the different battery capacity, not related with safety aspect." |
| Safe Climbing Angle: 12° | SAME | Substantially equivalent. |
| Warranty (Main Frame): 3 years | SAME | Substantially equivalent. |
| Warranty (Controller / Gear Motor): 1 year | (Implicitly same, as the controller/motor are the same or similar) | Substantially equivalent for main components. |
2. Sample size used for the test set and the data provenance
This is a design and performance comparison study against a predicate device, not a clinical study involving a test set of patients or data samples in the traditional sense of AI/diagnostic device evaluation. Therefore:
- Sample size for test set: Not applicable. The "test set" consists of the specifications and performance characteristics of the subject device being compared.
- Data provenance: Not applicable in the context of clinical data. The data originates from the manufacturer's engineering specifications, testing (e.g., EMC report, SGS ignition test), and component certifications (UL for batteries and chargers). The devices are manufactured in Taiwan, R.O.C.
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, refers to the established safety and performance of the predicate device, which has already been legally marketed. The assessment relies on engineering comparisons and regulatory standards, not expert clinical interpretation of test cases.
4. Adjudication method for the test set
Not applicable. There is no "test set" of cases requiring adjudication by experts. The comparison is based on objective specifications and performance 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 not an AI/diagnostic device. It's a mobility scooter.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/diagnostic device. Performance testing involved direct engineering measurements and compliance with standards like ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers -- requirements and test methods).
7. The type of ground truth used
The "ground truth" used for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (COMFORT WINDJOY SCOOTER LY-EW302, K022369), as well as compliance with recognized performance standards for electric wheelchairs.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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(244 days)
COMFORT ORTHOPEDIC CO. LTD.
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
Not Found
This document is a 510(k) premarket notification approval letter for a medical device, specifically a "Comfort Standing Wheelchair - Hero 1". It primarily addresses the device's substantial equivalence to predicate devices and provides regulatory guidance.
Therefore, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set, data provenance, or details about a test set.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- 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 (expert consensus, pathology, outcomes data, etc.).
- Sample size for a training set.
- How ground truth for a training set was established.
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(209 days)
COMFORT ORTHOPEDIC CO. LTD.
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a wheelchair, and it primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It briefly describes the intended use and target population of the "COMFORT Standing Wheelchair, HERO 2."
Therefore, I cannot extract the specific details you requested, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods for a test set.
- Information on MRMC comparative effectiveness studies or standalone performance.
- Types of ground truth used or sample sizes/ground truth establishment for a training set.
This document is focused on regulatory clearance, not on a detailed scientific study demonstrating performance against specific criteria.
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(106 days)
COMFORT ORTHOPEDIC CO. LTD.
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
COMFORT Powered Wheelchair, Traveller LY-EB103
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a "Comfort Powered Wheelchair, Traveller LY-EB103." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.
The letter does not contain:
- A table of acceptance criteria and reported device performance.
- Details about a study conducted to demonstrate performance, including sample sizes, data provenance, ground truth establishment, or expert reviews.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot provide the requested information.
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(106 days)
COMFORT ORTHOPEDIC CO. LTD.
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB202
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a powered wheelchair. It does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked. It generally states that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot extract the requested information from this document.
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(39 days)
COMFORT ORTHOPEDIC CO. LTD.
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a motorized three-wheeled vehicle (Comfort Agile Scooter, LY-EW303). It confirms that the device is substantially equivalent to legally marketed predicate devices.
The text does not include:
- A table of acceptance criteria or reported device performance.
- Details on sample sizes, data provenance, or study design.
- Information about experts, ground truth establishment, or adjudication methods.
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot provide the requested information.
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