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Plethysmography Module:
The device provides non-invasive measurement of pulse waveform and heart rate by photoclectric plethysmography.

Electrogastrography (EGG) Module:
A device that receives, records, and produces a visual display of the myoelectrical signal produced by the stomach as an aid to diagnosis of various gastric disorders.

The ACEM is an electronic accessory signal acquisition device. The ACEM includes five (5) signal conditioning circuits: respiration, plethysmograph, ECG and two channels of the EGG. Respiration and ECG have previous clearance under the InSight 510(k) K012232. The new plethysmograph accessory consists of a small, red LED placed against the finger and a photoelectric sensor to measure changes in the light intensity. The filter signal is amplified and digitized.

The added EGG signal conditioning unit receives signals from the body through standard pad electrodes. The signals are filtered and digitized.

Both the plethysmograph and EGG signals are forwarded to the Sandhill InSight System (K012232) for display.

The provided document is a 510(k) summary for the ACEM (Sensor Pac, signal acquisition) device. It describes the device's intended use and technological characteristics, as well as its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, ground truth establishment methods, or information about MRMC studies.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided document. The document primarily focuses on establishing substantial equivalence to predicate devices and electrical safety. It states:

• "Bench data confirms the plethysmograph and EGG channels meet the product specifications."

This implies that there were product specifications and that bench data was used to demonstrate adherence to them, but the specifications themselves and the exact performance results are not detailed.

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

This information is not present in the document. No specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) is described. The relevant section states:

• "Bench data confirms the plethysmograph and EGG channels meet the product specifications."

This suggests internal testing, but no details are given.

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

This information is not present in the document. There is no mention of human experts or ground truth establishment for a test set.

4. Adjudication Method for the Test Set

This information is not present in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

This information is not present in the document. The document does not describe any studies involving human readers or comparative effectiveness.

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

The device (ACEM) is a signal acquisition device that forwards signals to another system (Sandhill InSight System, K012232) for display. It is not an AI algorithm that produces an interpretation or diagnosis on its own. Therefore, the concept of "standalone performance" for an algorithm, as typically applied to AI, does not directly apply here. The "bench data" mentioned would likely be an assessment of the hardware's ability to accurately acquire and condition the physiological signals according to its specifications.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic AI models (e.g., pathology, outcomes data, expert concensus) is not applicable to this device in the context of the provided information. The ACEM is a signal acquisition device. Its "performance" would be related to the accuracy and reliability of signal capture and conditioning, likely verified against known physical inputs or established measurement standards, rather than a diagnostic "ground truth." The document states:

• "Bench data confirms the plethysmograph and EGG channels meet the product specifications."

This implies that the "ground truth" for this device's performance would be the expected electrical or physiological signals that the device is designed to measure, and its ability to accurately and reliably capture them.

8. The Sample Size for the Training Set

This information is not present in the document. As this device is a signal acquisition hardware and not an AI algorithm, a "training set" in the machine learning sense is not relevant.

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

This information is not present in the document, as it is not an AI algorithm, and therefore, a training set with established ground truth is not applicable in the context of this 510(k) summary.

Summary of Study Information Provided:

The document describes electrical safety testing and bench data testing to confirm product specifications.

• Acceptance Criteria (Implied): The device must meet IEC 60601-1 and IEC 60601-1-2 safety standards. The plethysmograph and EGG channels must meet their respective product specifications.
• Study Proving Acceptance Criteria:
  • Electrical Safety Testing: The ACEM was demonstrated electrically safe through testing and meeting IEC 60601-1 and IEC 60601-1-2 safety standards.
  • Performance Bench Testing: Bench data was used to confirm that the plethysmograph and EGG channels meet the product specifications.
• Sample Size for Test Set: Not specified, but likely refers to a series of controlled bench tests.
• Data Provenance: Implied to be internal bench testing.
• Experts for Ground Truth: Not applicable/not specified.
• Adjudication Method: Not applicable/not specified.
• MRMC Study: No.
• Standalone Performance (Algorithm): Not applicable, as it's a hardware signal acquisition device.
• Type of Ground Truth: For safety, adherence to international electrical safety standards. For performance, meeting "product specifications" through bench data, likely implying accuracy against known inputs.
• Training Set Sample Size: Not applicable.
• Training Set Ground Truth Establishment: Not applicable.

In essence, the 510(k) summary for the ACEM device is based on demonstrating substantial equivalence to predicate devices and verifying electrical safety and basic functional performance through bench testing, rather than a clinical trial or AI model validation study.

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Used as an indoor and outdoor mobility assistive device. Never used as a transportation tool on highways and freeways.

The Jupiter 50 electric scooter is a mobility assistive device for physically challenged people and elderly people. It is motorized by a 24V DC motor. Two or four 12 volt batteries supply electrical power. Jupiter 50 consists of seven major components: chassis, body covers, transaxle, seat, controller, batteries, and battery charger.

The provided text describes a 510(k) summary for the Jupiter 50 Scooter, a mobility assistive device. It focuses on demonstrating substantial equivalence to a predicate device (Pride Health Care Legend Scooter) rather than establishing novel acceptance criteria or conducting studies as would be performed for a new, high-risk medical device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or explicitly stated in this type of submission. The information provided is primarily for regulatory clearance based on substantial equivalence.

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

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

The submission does not define "acceptance criteria" in the typical sense of a clinical or performance study with pre-specified thresholds. Instead, it presents a comparison of the Jupiter 50's features and performance against a predicate device (Legend SC 300) to demonstrate substantial equivalence. The "performance" is reported by comparing specifications.

The device was also tested against and passed several ISO 7176 standards (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, and 16) and British Standard BS5852 (equivalent to California Bulletin 116 and 117 for fire retardantness). These standards represent performance and safety criteria, and passing them serves as evidence of meeting acceptance criteria for specific technical aspects.

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 the document. The submission references "The testing and comparative study" but does not detail the methodology, sample sizes, or data provenance for these studies beyond stating the device has been sold in China for over a year "with no safety problems".

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)

This information is not applicable as this is a mechanical device, not an AI or diagnostic device requiring expert interpretation for ground truth.

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

This information is not applicable as this is a mechanical device, not an AI or diagnostic device requiring expert interpretation for ground truth.

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

This information is not applicable. This is not an AI-based diagnostic device.

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

This information is not applicable. This is not an AI-based device.

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

For the technical specifications, the "ground truth" is measured physical and performance characteristics against established engineering specifications and predicate device performance. For safety and standards compliance, the ground truth is adherence to the requirements of the specified ISO standards and fire retardantness standards. The claim of "no safety problems" in China over a year could be considered a form of real-world outcomes data, though not a formal "ground truth" for a specific test set.

8. The sample size for the training set

This information is not applicable. This is not an AI-based device that requires a training set.

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

This information is not applicable. This is not an AI-based device that requires a training set.

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Used as an indoor and outdoor mobility assistive device. Never used as a transportation tool on highways and freeways

The Jupiter 50F electric scooter is a mobility assistive device for physically challenged people and elderly people. It is motorized by a 24V DC motor. Two or four 12 volt batteries supply electrical power. Jupiter 50F consists of seven major components: chassis, body covers, transaxle, seat, controller, batteries, and battery charger.

This document is a 510(k) summary for the JUPITER 50F SCOOTER, a motorized 3-wheeled scooter, by ACEME Technologies International, submitted to the FDA in 1998. It describes the device, compares it to a predicate device, and seeks substantial equivalence. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.

Here's an explanation of why the requested information cannot be extracted from the provided text:

• Medical Device vs. Mobility Device: The Jupiter 50F Scooter is classified as a "Motorized 3-wheeled Scooter" and a "mobility assistive device." While submitted to the FDA, the submission is focused on demonstrating substantial equivalence to a predicate device (Pride Health Care Legend Scooter) rather than presenting a performance study with specific acceptance criteria in the way a diagnostic or therapeutic medical device might. The "study" mentioned ("Our study has demonstrated that the Jupiter is substantially equivalent to the Legend 4-wheeled scooters.") refers to the comparative analysis presented in the 510(k) itself, not an experiment with a test set and ground truth.
• Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and performance data to the predicate, rather than establishing de novo acceptance criteria and then proving those through a new, large-scale clinical study as would be expected for novel or high-risk medical devices.
• Lack of Specific Performance Metrics and Study Details: The document lists several performance characteristics (e.g., maximum speed, slope capability, travel distance on a charge) and highlights specific improvements over the predicate device (e.g., headlight, turning lights, four-battery option, bigger front wheels). However, it does not present these as "acceptance criteria" with defined thresholds that were then quantitatively proven in a formal study with a defined sample size, ground truth, or expert adjudication. The statement "Our 4-wheeled Jupiter 50F did not show tip-over during its performance test" is the closest it gets to a "performance test," but it lacks any detail about the methodology, sample size, or formal acceptance criteria for "no tip-over."

Therefore, I cannot populate the table or answer the specific questions because the provided text does not include:

1. A table of acceptance criteria and reported device performance in that format.
2. Details about a test set sample size, data provenance, number of experts for ground truth, or adjudication methods for a specific performance study.
3. Information about an MRMC comparative effectiveness study or specific effect sizes.
4. Details about a standalone algorithm performance (as this is a mechanical device, not an algorithm).
5. The type of ground truth used in a formal study.
6. The sample size or ground truth establishment method for a training set (as this document describes a physical product, not a machine learning model).

The document is a regulatory submission for a physical product, not a clinical study report for an AI/ML device, which is what the provided template questions seem designed for.

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