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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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