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The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person in age of 16 up to 85 year old.

The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that is powered by 25.2Vdc, 11000mAh, 277.2Wh (min) and 25.2Vdc, 11600mAh, 292.32Wh (typ) Lithium battery, equipped with four wheels, capacity of 253.5 lbs and a lightweight seat. It's a rear wheel drive scooter with theoretical driving ranges of 9.3 miles. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be folded/unfolded and is provided with an off-board battery charger. The maximum speed is 5 mph.

This document describes a 510(k) premarket notification for the "C.T.M. Mobility Scooter HS-268". The device is a motorized three-wheeled vehicle intended for transportation of disabled or elderly persons. The focus of the submission is to demonstrate substantial equivalence to a predicate device, the "Freerider Corporation Luggie Super (K151944)".

Based on the provided text, the device in question is a mobility scooter, not an AI/ML-based medical device. Therefore, many of the questions related to acceptance criteria and studies proving the device meets those criteria, particularly those concerning AI performance, ground truth, expert opinions, and multi-reader studies, are not applicable to this submission.

The acceptance criteria for this type of device are primarily met through the demonstration of adherence to recognized consensus standards for safety and performance, and through a comparison of physical and functional characteristics to a legally marketed predicate device.

Here's an attempt to answer the relevant questions based solely on the provided document, acknowledging the mismatch in the nature of the device and the requested AI/ML specific information:

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

The acceptance criteria are generally implied by the successful testing against the listed ISO, EN, and IEC standards, and the demonstration of "similar" or "same" characteristics when compared to the predicate device. The document does not provide specific numerical performance metrics for each criterion, but rather states that "All tests passed the requirement to demonstration that new device is as substantial equivalent as the predicate device."

2. Sample sizes used for the test set and the data provenance
The document refers to "bench tests" and "safety tests" performed in accordance with consensus standards. These types of tests typically involve testing of a specific number of manufactured units to verify compliance. The exact "sample sizes" (number of units tested) are not explicitly stated in this document but would be defined by the relevant testing standards. Data provenance is not described beyond "bench tests were performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" for this device is established through engineering and performance testing against objective standards, not through expert clinical interpretation or consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for studies involving human interpretation or subjective assessment, which is not the case for this type of device submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device is the objective performance and safety characteristics as defined by the technical standards (ISO, EN, IEC) and direct comparison to a predicate device's established characteristics. It is not based on clinical outcomes, pathology, or expert consensus in an interpretative sense.

8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device, and thus there is no training set or associated ground truth establishment process in that context.

Summary for this device:

The submission demonstrates substantial equivalence by showing that the C.T.M. Mobility Scooter HS-268:

• Has similar indications for use and classification to a predicate device.
• Underwent non-clinical safety tests (biocompatibility, electrical safety) and performance bench tests (stability, braking, speed, etc.) according to FDA-recognized consensus standards (ISO, EN, IEC).
• All these tests "passed the requirement to demonstration that new device is as substantial equivalent as the predicate device."
• Differences from the predicate device (e.g., slightly larger dimensions, different motor/battery specifics) were assessed and determined not to "affect the safety and performance after verified by safety and performance test."
• No clinical studies were utilized for this 510(k) submission, as stated, due to the nature of the device and the substantial equivalence pathway chosen.

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The C.T.M. Mobility Scooter HS-115 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-115 is an indoor/outdoor scooter that is powered by two 12Ah lead-acid batteries, equipped with three wheels, capacity of 115 kilograms and a lightweight adjustable seat. It's a rear wheel drive scooter with theoretical driving ranges of 10 kilometer. The movement of the scooter 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 off-board battery charger. The maximum speed is 4 m.p.h.

The provided text describes a 510(k) premarket notification for a medical device, the C.T.M. Mobility Scooter, HS-115. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical effectiveness or performance through the type of studies typically associated with AI-driven medical devices. Therefore, many of the requested categories (e.g., effect size of human readers with AI, adjudication methods for ground truth, sample size for training sets) are not applicable to this submission.

Here's an analysis of the available information:

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

The acceptance criteria for this device are its compliance with various recognized consensus standards (ISO, IEC, EN, and FDA). The reported device performance is that it met the requirements of these standards.

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

This information is not provided in a way that aligns with AI/software performance studies. The "test set" here refers to the specific physical device (C.T.M. Mobility Scooter, HS-115) that underwent the non-clinical bench tests. The data provenance would be "bench test results" from the manufacturer's testing or a certified lab. The document does not specify the number of units tested, but typically for such physical device testing, it would involve a representative sample or even a single prototype tested against specified standards. The country of origin of the device is Taiwan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" for this device's performance is established by the specified ISO, IEC, and EN standards, which define objective, measurable parameters and test methods. There are no human "experts" establishing a subjective ground truth similar to clinical diagnosis.

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

Not applicable. The tests are objective measurements against published standards, not subjective interpretations requiring adjudication.

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 and its submission does not involve AI or human "readers" (e.g., radiologists, pathologists).

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

Not applicable. This is not an algorithm-based device. The "standalone performance" refers to the device itself (the scooter) meeting the specified performance and safety standards.

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

The "ground truth" for the device's acceptable performance is defined by adherence to recognized international consensus standards (ISO, IEC, EN). These standards specify the methods and acceptable ranges for various physical and electrical properties, safety features, and performance capabilities.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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The C.T.M. Mobility Scooter HS-328 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-328 is an indoor/outdoor scooter that is powered by two 22Ah lead-acid batteries, equipped with four pneumatic wheels, capacity of 136 kilograms and a lightweight adjustable seat. It a rear wheel drive scooter with theoretical driving ranges of 17.5 kilometer. The movement of the scooter 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 off-board battery charger.

Based on the provided document, the device in question is the "C.T.M. Mobility Scooter, HS-328." This document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device (C.T.M. Mobility Scooter #HS-295), rather than proving that a new AI/algorithm-based device meets specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study design, ground truth establishment, expert involvement, and statistical analyses for an AI/algorithm performance study (like an MRMC study or standalone algorithm performance) is not available in this document. The document explicitly states:

"This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." (Page 10)

The "studies" mentioned are non-clinical bench tests and compliance with recognized consensus standards (e.g., ISO, IEC) for performance, electrical safety, biocompatibility, and EMC. These tests are conducted to show that the physical characteristics and basic functionality of the mobility scooter are safe and perform as expected, and that any differences from the predicate device do not raise new questions of safety or effectiveness. They are not the type of AI/algorithm performance studies you've asked about.

Given this, I cannot fill out the requested table or provide details for points 2-9 as they pertain to a type of study not conducted or reported in this document.

However, I can extract the closest information to "acceptance criteria" and "reported device performance" as presented for the physical device, primarily through comparison to its predicate.

Table of Acceptance Criteria (as implied by comparison to predicate) and Reported Device Performance

For the C.T.M. Mobility Scooter HS-328, "acceptance criteria" are implied by its substantial equivalence to the predicate device (HS-295) and its compliance with relevant standards. The "reported device performance" is essentially the specifications of the new device and the assertion that differences from the predicate do not affect safety or effectiveness.

• ISO10993-5 (Biocompatibility)
• ISO10993-10 (Biocompatibility)
• IEC60601-1 (Electrical safety)
• IEC60601-1-2 (EMC)
• IEC62304 (Software, by controller)
• ISO7176 series (various performance & safety aspects)
• Crucially, differences vs. predicate must not affect safety. | All safety tests performed and meet requirements of listed FDA Recognized Consensus Standards. "All the differences don't affect the safety and performance after verified by safety and performance test." |
  | Performance (via Non-Clinical Tests & Standards)| Compliance with ISO7176 series standards for:
• Static/dynamic stability
• Brake effectiveness
• Energy consumption/theoretical distance range
• Dimensions, mass, maneuvering space
• Maximum speed, acceleration, deceleration
• Wheel dimensions
• Static, impact, fatigue strengths
• Climatic tests
• Obstacle-climbing ability
• Power/control systems
• EMC | Bench tests performed in accordance with FDA Recognized Consensus Standards (ISO 7176 series). All tests passed requirements to demonstrate substantial equivalence. |
  | Key Performance Parameters | General equivalence or improvement over predicate without creating new safety/effectiveness questions.
  (Specific numerical criteria aren't provided beyond comparison table) | Overall Length: 1120 mm / 44" (vs. 1013 mm / 39.8" for HS-295)
  Overall Width: 590 mm / 23.2" (vs. 509 mm / 19.9" for HS-295)
  Overall Height: 935 mm / 36.8" (vs. 887 mm / 34.9" for HS-295)
  Product weight (With battery): 55 kg / 121.3 lbs (vs. 49 kg / 109 lbs for HS-295)
  Weight Of Heaviest Piece: 17 kg / 37.5 lbs (vs. 17.8 kg / 39.2 lbs for HS-295)
  Braking distance: 1.3m/51.2" (vs. 1.7m/66.9" for HS-295)
  Front & Rear Wheels: 225 mm / 9" (vs. 200 mm / 8" for HS-295)
  Maximum distance of travel on fully charged battery: 17.5 km / 10.9 Miles (vs. 10 km / 6.2 Miles for HS-295)
  Ground Clearance: 52 mm / 2" (vs. 40 mm / 1.6" for HS-295)
  Curb Climbable: 40 mm / 1.6" (vs. 32.5 mm / 1.3" for HS-295)
  Turning Radius: 1450 mm / 57.1" (vs. 1270 mm / 50" for HS-295) |
  | Technological Characteristics | Similar design features, rear-wheel drive, Electro-Mechanical brakes, dismantles for transport, Dynamic Rhino 50 controllers. Differences in motor size, capacity, and battery output must not affect safety/performance. | Has same 4 wheels, rear-wheel drive technology, Electro-Mechanical brakes, dismantles for transport. Uses Dynamic Rhino 50 controllers. Has a single motor and two batteries (22Ah). |

Regarding AI/Algorithm-Specific Study Information (Points 2-9):

As stated above and explicitly in the document, no clinical study was performed or utilized for this 510(k) submission to establish substantial equivalence. Therefore, the following points are not applicable to this document:

2. Sample size used for the test set and data provenance: N/A (no such test set for AI/algorithm performance was used).
3. Number of experts used to establish ground truth for the test set and qualifications: N/A.
4. Adjudication method for the test set: N/A.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: N/A.
6. Standalone (algorithm only without human-in-the-loop performance) study: N/A.
7. Type of ground truth used: N/A (Ground truth, in the context of diagnostic AI, implies a reference standard for a clinical condition, which is not relevant for a mobility scooter).
8. Sample size for the training set: N/A (no AI/ML training involved for this device submission).
9. How the ground truth for the training set was established: N/A.

In summary, this document describes a traditional medical device (mobility scooter) cleared through the 510(k) pathway by demonstrating substantial equivalence to a predicate device, relying on non-clinical bench testing and compliance with recognized standards for safety and performance, rather than clinical studies or AI/algorithm performance evaluations.

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The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor Mobility Scooter that is battery operated. It has a base with four wheels and a lightweight adjustable seat. The movement of the scooter 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 off board battery charger.

The provided text is a 510(k) summary for the C.T.M. Mobility Scooter HS-118. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through a study in the way a medical diagnostic AI device might.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, specific types of ground truth) are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted or deduced from the provided text, tailored to the context of this device:

Acceptance Criteria and Study for C.T.M. Mobility Scooter HS-118

The C.T.M. Mobility Scooter HS-118 sought 510(k) clearance by demonstrating "substantial equivalence" to predicate devices, namely the Go-Go Ultra X (K063389) and VCS S3T (K051131). The primary "acceptance criteria" were met by showing that its technological characteristics, intended use, and performance data were comparable to these predicates, and that any differences did not raise new questions of safety or effectiveness.

1. Table of "Acceptance Criteria" and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This was a submission for a physical device, not an AI/diagnostic algorithm tested on a dataset of patient samples. The "test set" in this context refers to bench testing of the scooter itself.
• Data Provenance: Not applicable in the traditional sense of clinical data. The "data" comes from bench testing of the physical scooter and comparison of its specifications to predicate devices. The country of origin for the data generation would be where C.T.M. Homecare Product, Inc. conducted its testing, likely in China or the US given the company's address and contact. The testing was prospective in the sense that it was performed on the device being submitted for clearance.

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

• Number of Experts: Not applicable. The "ground truth" for a mechanical device like a scooter is its physical performance against established engineering and safety standards. There isn't a concept of expert consensus for labeling a case as positive or negative.
• Qualifications of Experts: Not applicable. Testing would have been conducted by engineers or technicians familiar with relevant standards (e.g., ISO, ANSI, FDA guidance).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There's no "test set" of cases requiring adjudication by multiple readers or experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." MRMC studies are typically used for diagnostic devices to assess human reader performance with and without AI assistance.

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

• Standalone Performance: Not applicable. This is a physical mobility device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "bench testing," the ground truth corresponds to accepted engineering specifications and safety standards outlined in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995." Compliance with these predetermined thresholds and successful completion of the specified tests served as the "ground truth" for the device's functional and safety performance.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. There is no AI algorithm being "trained" in this context.

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

• Ground Truth for Training Set: Not applicable.

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The C.T.M. Mobility Scooter HS-515 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-515 is an indoor/outdoor scooter that is battery operated. It has a base with three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column allowing the rider to control the scooter. It can be disassembled for transport and is provided with an off-board battery charger.

The provided document is a 510(k) summary for the C.T.M. Mobility Scooter HS-515. This type of submission is for medical devices that are mechanical or physical in nature, not AI/software-driven diagnostics or imaging systems. Therefore, many of the requested categories related to AI/software performance, such as sample sizes for test sets, expert ground truth, MRMC studies, and standalone algorithm performance, are not applicable to this device and its 510(k) submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in the format typically seen for AI/software performance studies. Instead, the "acceptance criteria" are implied by compliance with established performance tests for mechanical scooters, as outlined in FDA guidance documents.

Study Information (as applicable to this device type)

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

   • N/A. This is a mechanical device. Performance testing involved physical tests on the scooter itself, not a "test set" in the data-driven sense. The document does not specify the number of units tested.
   • Data provenance: The tests were "conducted and the results included in the submission." The country of origin for the testing is not specified, but the applicant is C.T.M. Homecare Product, Inc. in Chino, CA, and the contact is in Eugene, OR.

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

   • N/A. Ground truth for a mechanical scooter primarily involves meeting engineering and safety specifications, which are assessed through direct physical testing and measurement, not expert review of data/images. The "ground truth" is adherence to established mechanical and electrical safety standards.

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

   • N/A. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert readings in diagnostic AI/software studies. This is not relevant for a mechanical scooter.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • N/A. This is a mechanical mobility scooter, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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

   • N/A. This device does not have an "algorithm" in the context of AI/software performance. It is a physical product.

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

   • For a mechanical device like a scooter, the "ground truth" for performance is based on objective measurements from engineering tests and compliance with established performance standards and safety regulations (e.g., stability, braking effectiveness, speed, battery life, weight capacity). The summary states that "Tests listed in the Guidance Document... were conducted."

7. The sample size for the training set:

   • N/A. This is a mechanical device, not an AI/software. There is no "training set" in the machine learning sense.

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

   • N/A. As there is no training set, this question is not applicable.

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The C.T.M. Mobility Scooter HS-528 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-528 is an indoor/outdoor scooter that is battery operated. It has a base with four wheels, a padded seat with adjustable armrests, and a steering column allowing the rider to control the scooter. It is capable of transport and is provided with an off-board battery charger.

This document is a 510(k) summary for the C.T.M. Mobility Scooter HS-528. It states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, there is no information in the provided text for acceptance criteria or specific study details proving the device meets those criteria.

However, the document does state: "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the submission." This implies that the device was tested against the standards outlined in that guidance document, even if the specific results are not provided.

Without the actual study results and acceptance criteria from the guidance document, I cannot complete the table or answer most of the requested questions.

Here's a breakdown of what can be extracted and what cannot:

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

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

• Sample Size for Test Set: Not provided.
• Data Provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as no clinical or comparative performance testing was submitted, and therefore no ground truth established by experts for a test set is mentioned.

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

• Not applicable as no clinical or comparative performance testing was submitted.

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

• No. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This device is a mobility scooter, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.

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

• Not applicable. This is a physical device (mobility scooter), not an algorithm.

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

• Not applicable as no clinical or comparative performance testing was submitted to require a ground truth. Performance would have been measured against engineering standards specified in the guidance document.

8. The sample size for the training set

• Not applicable. This is a physical device, and the testing described references compliance with guidance documents for physical product safety and performance, not machine learning model training.

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

• Not applicable for the same reasons as #8.

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The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that is battery operated, has three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column allowing the rider to control the scooter. It is provided with an off-board battery charger.

This document is a 510(k) premarket notification for a C.T.M. Mobility Scooter HS-628. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI-driven medical device.

The document states:

• "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
• The device is a "C.T.M. Mobility Scooter HS-628 or Orion Electric scooter Motorized three-wheeled vehicle."
• Its intended use is to "provide transportation for a disabled or elderly person."
• The 510(k) notification focuses on demonstrating "substantial equivalence" to a predicate device (C.T.M. Mobility Scooter HS-890) based on similar technological characteristics (e.g., both are battery operated, have two wheels, one motor, automatic braking systems).
• It mentions "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Wheelchairs and Scooters, and Motorized Three Wheeled Vehicles" were conducted, but the specific results or acceptance criteria are not detailed, nor are they framed as performance metrics for an AI system.

Therefore, I cannot provide the requested information for an AI-driven medical device, as this document pertains to a mobility scooter and explicitly states that comparative performance testing and clinical evaluations were not submitted. The questions you've asked are relevant for AI/ML-based medical devices or diagnostics, which this product is not.

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The C.T.M. Mobility Scooter HS-265 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-265 is an indoor/outdoor scooter that is battery operated. It has a base with three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column which allow the rider to control the movement of the scooter. It can be disassembled for transport and is provided with an on-board battery charger.

Here's an analysis of the provided 510(k) summary regarding the C.T.M. Mobility Scooter HS-265, focusing on acceptance criteria and study details:

This document describes a mobility scooter, which is a physical device, not an AI/ML device. Therefore, the majority of the questions related to AI/ML device testing (e.g., sample size for test sets, ground truth, experts, MRMC studies, standalone performance, training set) are not applicable to this submission.

The 510(k) summary explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This indicates that the regulatory pathway relied on demonstrating "substantial equivalence" to a predicate device (C.T.M. Mobility Scooter HS-235 cleared under K032918) through technological characteristics and adherence to recognized guidance documents, rather than independent performance studies with acceptance criteria in the typical sense for AI/ML or efficacy studies.

However, I can extract the information that is present and indicate where information is missing or not applicable based on the nature of the device.

1. Table of Acceptance Criteria and Reported Device Performance

For the following questions, please note that they are largely not applicable to this type of device submission (a physical mobility scooter) and the regulatory pathway chosen (510(k) based on substantial equivalence to a predicate without new clinical or comparative performance studies beyond adherence to guidance documents).

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

• Not Applicable (N/A). No specific "test set" in the context of AI/ML or comparative clinical performance was described. The testing mentioned refers to engineering/performance tests as outlined in a guidance document, not data-driven evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable (N/A). Ground truth and expert consensus are irrelevant for device performance testing of a mobility scooter. The "ground truth" for a mobility scooter's safety/performance would be adherence to engineering specifications and safety standards.

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

• Not Applicable (N/A). Adjudication methods are used in clinical trials or expert label review for data, which is not described here.

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 (N/A). This is a mobility scooter, not a diagnostic AI/ML device. Therefore, MRMC studies and "human readers" are not relevant.

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

• Not Applicable (N/A). This is a physical device, not an algorithm.

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

• Not Applicable (N/A). No ground truth in the context of data labeling or clinical outcomes was used for this type of submission. The "ground truth" for device performance would be physical measurements against engineering specifications and safety standards.

8. The sample size for the training set

• Not Applicable (N/A). There is no "training set" as this is a physical product, not an AI/ML model.

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

• Not Applicable (N/A). As there is no training set, this question is not relevant.

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The C.T.M. Mobility Scooter HS-310 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-310 is an indoor/outdoor scooter that is battery operated. It has a base with three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column which allow the rider to control the movement of the scooter. It can be disassembled for transport and has an on-board battery charger.

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) summary for the C.T.M. Mobility Scooter HS-310 explicitly states:

"Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

This indicates that the submission did not include a study designed to evaluate the device's performance against specific acceptance criteria. The clearance was based on substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-320) due to similar technological characteristics and intended use, rather than a direct performance study of the HS-310 itself.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, ground truth, experts, adjudication, MRMC studies, or standalone performance.

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The C.T.M. Mobility Scooter HS-250 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-250 is an indoor/outdoor electric scooter that is battery operated. It has a base with four wheels with a lightweight seat, armrests, and a front basket. The movement of the scooter 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 510(k) summary for the C.T.M. Mobility Scooter HS-250 does not include a table of acceptance criteria, detailed device performance, or a study proving that the device meets specific acceptance criteria in the way described for typical AI/ML medical devices.

Instead, this submission is for a physical medical device (a mobility scooter) and relies on a demonstration of substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-360) rather than a performance study against predefined acceptance criteria.

Here's an analysis based on the information provided, highlighting why a direct answer to your request is not possible with this type of document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics in the context of an AI/ML device. For this physical device, the "acceptance criteria" are implied by showing the device's technological characteristics are "very similar" to the predicate device and that it meets the "Intended Use" (providing transportation for disabled/elderly persons). The testing conducted refers generally to "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995," but specific performance targets or thresholds from that document are not detailed in this summary.
• Reported Device Performance:
  • Braking distance at maximum speed: 4.67 feet
  • Minimum turning radius: approximately 35.4 inches
  • Forward speed range: 0-4.1 mph
  • Reverse speed range: 0-1.5 mph
  • Heaviest single component: 27.7 pounds
  • Total weight with batteries: approximately 107 pounds
  • Motor: 250 watt, 3800 rpm
  • Batteries: two 12-volt 12Ah batteries
  • Battery Charger: 24-volt constant current charger, plugs into 110V or 220V socket.
  • Self-diagnostic signals: 9 distinct codes for problems like battery, motor, or brake malfunctions.
    The document does not state how these performance metrics were tested or what thresholds they had to meet. They are presented as characteristics of the device.

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

• Sample Size: Not applicable. This is a physical device, and the "testing" involved verifying its mechanical and electrical characteristics, likely in a laboratory or engineering testing environment, rather than a clinical study with a "test set" of patient data.
• Data Provenance: Not applicable for a typical AI/ML "test set." The testing was likely internal by the manufacturer following industry guidance for mobility devices.

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 the context of AI/ML, refers to validated data labels. For this physical device, "ground truth" would relate to engineering specifications and safety standards, which are typically established by engineers and regulatory bodies, not clinical experts for "ground truth labeling."

4. Adjudication method for the test set

• Not applicable. There is no mention of "adjudication" as would be performed in a clinical study for an AI/ML device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No background document in the input indicates a MRMC study. This is a physical mobility device and does not involve "human readers" or "AI assistance" in the sense of an AI/ML diagnostic or predictive tool.

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

• No background document in the input indicates standalone performance. This is not an AI/ML algorithm.

7. The type of ground truth used

• Not applicable in the AI/ML sense. For this device, "ground truth" implicitly relates to engineering specifications, safety standards, and functional requirements for mobility scooters. For example, the braking distance being 4.67 feet is a measured characteristic against an engineering design, not a clinical pathology or outcome.

8. The sample size for the training set

• Not applicable. There is no AI/ML model for which to describe a "training set."

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

• Not applicable. There is no AI/ML model for which to describe a "training set" or its ground truth establishment.

In summary: The provided 510(k) pertains to a physical medical device (mobility scooter) and therefore does not contain the information requested for an AI/ML device's acceptance criteria and study data. The regulatory pathway for this device is based on demonstrating substantial equivalence to a predicate device, supported by engineering tests rather than clinical performance studies with "test sets" or "training sets" in the context of AI/ML. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

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