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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The TEH LIN Powered Scooter, TL-560 is an indoor / outdoor Powered Scooter that It has a base with four-wheeled with a seat. is battery operated. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the The device can be disassembled for transport and is provided with steering column. an onboard battery charger.

The provided document is a 510(k) summary for the TEH LIN Power Scooter, TL-560. It focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving performance against those criteria. Therefore, much of the requested information cannot be extracted directly from this document.

However, I can provide the information that is available and explicitly state what is not.

Acceptance Criteria and Device Performance Study for TEH LIN Power Scooter, TL-560

This 510(k) submission primarily demonstrates substantial equivalence to a predicate device (TEH LIN POWER SCOOTER TL-821, K042011) rather than presenting a performance study against explicit acceptance criteria. The "Performance Testing" section refers to compliance with specific standards, which serve as the implicit acceptance criteria for safety and electrical compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the new device and the predicate device "have the same intended use, the same technological aspects and only minor differences exist. So the new device is substantially equivalent to the predicate devices in this aspect." This is the primary "performance" being demonstrated for regulatory purposes – equivalence to a device already deemed safe and effective. The safety level is assured because key components and characteristics (batteries, control systems, recharger, material resistance ignition tests) are the same or have passed relevant tests.

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

This document does not describe a performance study with a specific "test set" in the context of clinical or diagnostic performance. The "performance testing" mentioned refers to compliance with established engineering and electrical safety standards. Therefore:

• Sample size for the test set: Not applicable in the context of clinical/diagnostic performance. The tests would be performed on the device itself.
• Data provenance (country of origin, retrospective/prospective): Not applicable for the type of testing described (product standard compliance). The resistance ignition test was performed by "SGS," a global inspection, verification, testing, and certification company.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The document does not describe a study involving expert assessment or ground truth establishment for a clinical or diagnostic outcome.

4. Adjudication Method

This information is not applicable. No adjudication method is described as there is no clinical or diagnostic study involving multiple readers/assessors.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document does not describe any human-in-the-loop performance or comparison of human readers with vs. without AI assistance. The device is a powered scooter, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

No, a standalone performance study in the context of an algorithm or AI is not applicable or described. The performance testing refers to the device's compliance with engineering and electrical safety standards.

7. Type of Ground Truth Used

This information is not applicable in the typical sense for clinical/diagnostic devices. The "ground truth" for the performance testing mentioned (EMC, CISPR, EN, IEC standards) is the state-of-the-art engineering and safety requirements defined by those standards. For material properties, the ground truth is established by passing specific resistance ignition tests (by SGS).

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not applicable as there is no training set for an AI/machine learning device.

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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

The TEH LIN Powered Scooter, TL-360 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a 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 onboard battery charger.

The provided text is a 510(k) Pre-Market Notification for a powered scooter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document, as it describes a comparison to a predicate device and not a standalone performance study with specific acceptance criteria and ground truth establishment.

Here's what can be inferred or stated as not available based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing performance on a "test set" of data in the context of AI or diagnostic devices. It's a comparison of physical product specifications and certifications.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not relevant in this type of submission.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This is a medical device, but not an AI/diagnostic device that would involve human readers or AI assistance in interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is the established safety and performance characteristics of the predicate device, demonstrated through adherence to standards (EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995). The new device is deemed substantially equivalent based on matching key technical specifications and certifications.

7. The sample size for the training set: Not applicable. This document does not describe an AI/ML algorithm or a "training set."

8. How the ground truth for the training set was established: Not applicable.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The TEH LIN Powered Scooter, TL-821 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a 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 onboard battery charger.

This document is a 510(k) premarket notification for a powered scooter (TEH LIN Power Scooter, TL-821), not a study evaluating an AI/ML device. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML validation cannot be extracted or inferred from this document.

The document focuses on demonstrating substantial equivalence to a predicate device (TEH LIN POWER SCOOTER TL-588 (K022698)) based on:

• Intended Use: Both devices are for "medical purposes to provide mobility to persons restricted to a seated position."
• Technological Characteristics: Comparison of components like batteries (same brand/type, UL certified), control systems (Penny & Giles), rechargers (HP8204A, UL certified), frame, arm type, tires, seat size, warranty, and upholstery (same material, passed ignition test).
• Performance Testing: References to EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 for electrically powered scooters.

Minor Differences Noted and Justified:

• Overall Dimensions, Weight Limit, Weight Capabilities: "Small" differences, with the new device being larger.
• Cruising Range: TL-821 is 37 km, predicate is 40 km, attributed to smaller batteries, and deemed substantially equivalent in real-life use.
• Safety Climbing Abilities: TL-821 is 12°, predicate is 15°. The manual for TL-821 will state a maximum of 12°.
• Maximum Speed: TL-821 is 5.6 mph, predicate is 5 mph. Justified by continuous speed adjustment for user control.

The substantial equivalence argument implies that by meeting relevant performance standards for powered scooters and demonstrating comparable (or slightly different but safe) specifications to a legally marketed predicate device, the TL-821 meets the "acceptance criteria" for market clearance under 510(k). However, these are not the detailed AI/ML-specific acceptance criteria and study designs you've asked for.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The TEH LIN Power Scooter, TL-822 is an indoor / outdoor Power Scooter that is It has a base with four-wheeled with a seat. battery operated. 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 text describes a 510(k) submission for the TEH LIN Power Scooter, TL-822. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than full clinical efficacy studies with acceptance criteria based on patient outcomes.

Therefore, the input document does not contain the information requested in the prompt regarding acceptance criteria for device performance in a clinical or diagnostic context, nor does it detail a study that proves the device meets such criteria.

Specifically, the document discusses:

• Device Description: The TEH LIN Power Scooter, TL-822, is an indoor/outdoor, four-wheeled, battery-operated scooter for mobility.
• Intended Use: To provide mobility to persons restricted to a seated position.
• Performance Testing: It mentions "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995" which are standards related to electromagnetic compatibility and wheelchair/scooter requirements. These are engineering and safety standards, not clinical performance acceptance criteria.
• Substantial Equivalence: The primary focus is on establishing substantial equivalence to a predicate device (TEH LIN POWERED SCOOTER TL-588, K022698) based on having the same intended use, technological aspects, and only minor differences in appearance, dimensions, wheel size, maximum speed, and weight limit. The document explicitly states that "these differences for the two devices do not lead to any performance differences."

Based on the provided text, I cannot complete the table or answer the specific questions as they pertain to clinical or diagnostic performance criteria and studies, which are not detailed in this 510(k) summary.

Here's a breakdown of why each specific point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: The document only mentions adherence to safety/engineering standards (EMC/RESNA) and asserts that the differences from the predicate device do not lead to performance differences. There are no measurable "acceptance criteria" for clinical performance (e.g., accuracy, sensitivity, specificity) and no reported device performance against such criteria.
2. Sample size used for the test set and the data provenance: No test set (in a clinical sense) is described. The "performance testing" mentioned refers to engineering standards, not typical clinical study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for diagnostic devices, not mobility scooters.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI/software performance.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The TEH LIN Powered Scooter, TL-688 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a 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 onboard battery charger.

The provided text describes a 510(k) premarket notification for the TEH LIN Power Scooter, TL-688. It focuses on demonstrating substantial equivalence to a predicate device (TEH LIN POWER SCOOTER TL-588) rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical or performance study for AI/diagnostic devices would.

Therefore, many of the requested fields (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or cannot be extracted from this document, as they pertain to a different type of device evaluation process.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of quantitative acceptance criteria and performance metrics for a diagnostic or AI device, this submission relies on demonstrating similarity to a predicate device. The "acceptance criteria" here is effectively meeting the standards of the predicate and relevant industry performance tests.

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

• Sample Size for Test Set: Not applicable in the context of a 510(k) for a powered scooter where "testing" primarily involves engineering standards and comparison to a predicate, not a "test set" of patient data.
• Data Provenance: The document refers to engineering and safety standards (e.g., UL certification, SGS resistance ignition test, EMC standards) and the comparison to an existing device (TEH LIN POWER SCOOTER TL-588). The manufacturing origin is Taipei County, Taiwan R.O.C. The data is prospective in the sense that the testing was performed on the TL-688 model for this submission.

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

• Not applicable. This is not a diagnostic device relying on expert interpretation of data for ground truth. "Ground truth" here is established by engineering specifications, safety standards, and performance test results.

4. Adjudication Method for the Test Set

• Not applicable. (See #3)

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

• No. This type of study is not relevant for the regulatory approval of a powered scooter.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Ground truth is established through:
  • Compliance with recognized industry performance standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 for EMC).
  • Certifications from recognized testing bodies (e.g., UL for batteries and recharger, SGS for material resistance ignition).
  • Direct comparison to a legally marketed predicate device (TEH LIN POWER SCOOTER TL-588) regarding components, materials, and design features.

8. The Sample Size for the Training Set

• Not applicable. (See #2) This is not an AI/ML device that requires a training set.

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

• Not applicable. (See #2 and #8)

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The TEH LIN Powered Wheelchair, MDG-601 is an indoor / outdoor Powered 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 document describes the TeH LIN Powered Wheelchair, MDG-601, and its 510(k) submission for substantial equivalence to a predicate device. The information provided heavily focuses on regulatory approval and substantial equivalence, rather than detailed performance study reports with specific acceptance criteria and detailed device performance data.

Therefore, many of the requested elements for a detailed performance study description cannot be fully extracted from the provided text.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document describes "Performance Testing" against standards like ANSI / RESNA WC/Vol.2-1998. However, it does not specify a sample size for tested devices. Typically, such testing involves a limited number of production or pre-production units.
• Data Provenance: The testing was conducted by or on behalf of TEH LIN Prosthetic & Orthopaedic Inc. in Taiwan. The data would therefore be prospective in relation to the submission, but the location of the testing is not explicitly stated beyond the company's origin.

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

• This is not applicable in the context of this 510(k) summary. The "ground truth" for the performance testing is adherence to engineering and safety standards (e.g., ANSI / RESNA). This is determined by standardized test procedures and measurements, not by expert consensus on clinical findings.
• There are no "experts" in the sense of clinical reviewers establishing a ground truth for a diagnostic algorithm.

4. Adjudication method for the test set:

• Not applicable. Performance against engineering standards does not typically involve an adjudication method in the way a clinical study with human readers would. Results are objectively measured against defined criteria.

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, this was not done. The device is a powered wheelchair, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

• Not applicable. This device is a physical product (a powered wheelchair), not an algorithm. Its performance is inherent to its design and manufacturing, not an AI algorithm operating independently.

7. The type of ground truth used:

• The "ground truth" for this device's performance is compliance with established international and national engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3). These standards define objective test methods and acceptable performance limits.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML product that requires a "training set." It's a manufactured medical device.

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

• Not applicable. As above, there is no training set for this type of device.

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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Not Found

This document is a 510(k) clearance letter from the FDA for a powered wheelchair. It does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The letter confirms that the device, "The Lin Powered Wheelchair, Model MDG-201," is substantially equivalent to legally marketed predicate devices. This means that its safety and effectiveness are considered to be similar to other devices already on the market, but it does not detail specific performance studies or acceptance criteria beyond regulatory compliance.

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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a powered wheelchair. It does not contain information about acceptance criteria or a study proving the device meets those criteria. My analysis indicates that the letter confirms the device (Teh Lin Jupiter Power Chair, TL-320) is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. The letter is a regulatory approval, not a technical report detailing performance testing.

Therefore, I cannot provide the requested information. The document does not contain details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone (algorithm only) performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a motorized three-wheeled vehicle (Scooter Mars Series, Model TL-588). It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The letter explicitly states that the device is a "Motorized three-wheeled vehicle" and is regulated under "890.3800," which corresponds to "Motorized three-wheeled vehicle" in the FDA's classification database. This is a physical device, not a software-based AI/ML device.

Therefore, I cannot provide the requested information. The concepts of acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and standalone performance are relevant to AI/ML device evaluations, not to the traditional medical device approval process for a motorized scooter described in this document.

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