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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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The InSight Model S980000 Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. It may be used for esophageal, biliary, and anorectal motility studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.

The Accessory Model MII, when used in conjunction with a pH probe, can he used as an aid in differentiating acid vs. non-acid reflux events. In addition, the Accessory Model MIT is intended to measure motor function of the proximal gastrointestinal tract including swallow effectiveness and directional bolus transport by means of intraluminal impedance recording,

The Accessory Model MII component of the InSight Gastrointestinal Motility System is not intended for use in biliary studies.

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I am sorry, but based on the provided document, there is no information available regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a device performance study.

The document is a 510(k) clearance letter from the FDA for the Sandhill Scientific InSight Model S980000 with Accessory Model MII. It states that the device is substantially equivalent to legally marketed predicate devices. It outlines the indications for use but does not contain a study report or data about performance.

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Used to measure intragastric and intraesophageal pH (hydrogen ion concentration) in pediatric patients

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Here's an analysis of the provided text regarding the Sandhill Scientific PediaTec™ pH Probe:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, no specific performance acceptance criteria or detailed device performance results are explicitly stated. The submission is for a modification to an existing approved 510(k) to add an indication for use with pediatric populations. It states that "There is currently no performance standard for pH probes."

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

The 510(k) summary does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a study proving the device meets acceptance criteria. The submission is primarily focused on demonstrating substantial equivalence to a previously cleared device (Sandhill Disposable Internal Reference pH probe cleared under K931963/A, September 28, 1994) for an expanded indication of use in pediatric populations.

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

There is no mention of experts or the establishment of ground truth for a test set in the provided document.

4. Adjudication Method for the Test Set

No adjudication method is described, as there's no mention of a test set or associated study in the provided text.

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

No MRMC study is mentioned. This device is a pH probe, not an imaging or diagnostic algorithm that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical pH probe, not an algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The document does not describe any specific ground truth for a study. For a pH probe, the "ground truth" would typically refer to the accuracy of its pH measurement against known standards. However, the document does not detail such testing for this submission.

8. Sample Size for the Training Set

No training set is mentioned as this is a physical medical device, not a machine learning algorithm.

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

Not applicable, as there is no training set for this device.

Summary of the Study (or lack thereof) to Prove Acceptance Criteria:

The provided 510(k) summary (K013951) for the Sandhill Scientific PediaTec™ pH Probe is a regulatory submission for a modification to an existing device (Sandhill Disposable Internal Reference pH probe, K931963/A) to expand its indication to pediatric populations.

Crucially, the document does not describe a clinical study or specific performance testing against acceptance criteria to "prove the device meets acceptance criteria" in the way a new, high-risk device or an AI/software device often would. Instead, the basis for approval is "Substantial Equivalence" to a legally marketed predicate device (K931963/A). The FDA cleared the device based on the assessment that it is substantially equivalent to the predicate device for the stated indications for use, without requiring new performance standards or a detailed clinical study for the pediatric population. The document explicitly states, "There is currently no performance standard for pH probes."

Therefore, the "study" proving the device meets criteria is implicitly the demonstration of similarity to the predicate device, rather than a new, comprehensive performance study outlined in the provided text.

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The Sphincter of Oddi Manometry Module is intended for use by Gastroenterologists or Surgeons to determine intraluminal pressures within the pancreaticobiliary ductal system and motor activity within the sphincter of Oddi zone. The InSIGHT Sphincter of Oddi Manometry Module includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.

The Sphincter of Oddi Manometry Module is intended for use by Gastroenterologists or Surgeons to determine intraluminal pressures within the pancreaticobiliary ductal system and motor activity within the sphincter of Oddi zone. The InSIGHT Sphincter of Oddi Manometry Module includes analysis software, but requires skilled interpretation by a physician to make a diagnosis. The SOM Module is intended for use only with the InSIGHT Model S980000 Gastrointestinal Motility system (K984444). The InSIGHT system consists of three basic subsystems: Signal conditioning and recording hardware, Analysis software, and Probes and transducers.

The provided text describes a medical device called the InSIGHT Sphincter of Oddi Manometry Module and its submission for 510(k) clearance. However, it explicitly states that no formal clinical testing was performed. Therefore, there is no study described that proves the device meets specific acceptance criteria based on performance metrics.

Here's a breakdown of the requested information based on the provided text, highlighting the absence of performance-based acceptance criteria and a corresponding study:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. No test set for performance evaluation was used as no formal clinical testing was performed.
• Data Provenance: Not applicable.

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

• Not applicable. No test set was used to establish ground truth for performance evaluation.

4. Adjudication Method for the Test Set

• Not applicable. No test set was used for performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No and Effect Size: No MRMC comparative effectiveness study was done. The submission explicitly states, "No formal clinical testing has been performed, nor is any believed to be necessary." Therefore, there is no reported effect size regarding human reader improvement with AI assistance. The device includes analysis software, but relies on "skilled interpretation by a physician to make a diagnosis," indicating a human-in-the-loop system, but its comparative effectiveness was not studied.

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

• No: The device "includes analysis software, but requires skilled interpretation by a physician to make a diagnosis." This indicates a human-in-the-loop system, and no standalone algorithm performance was reported or evaluated.

7. The Type of Ground Truth Used

• Not Applicable for Performance: Since no formal clinical testing or performance study was conducted, no ground truth (e.g., expert consensus, pathology, outcomes data) was established for validating device performance against clinical reality. The "ground truth" for the submission's claims revolves around comparison to technical specifications and general safety standards of predicate devices.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided: The nature of the device (a manometry recording system with analysis software, not explicitly an AI/ML algorithm requiring extensive training data in the modern sense) and the stated lack of formal clinical testing mean no training set sample size is provided or appears relevant to this submission.

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

• Not Applicable / Not Provided: As no training set is described in the context of performance-based ground truth, this information is not available.

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The InSIGHT Model S980000 Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. It may be used for esophageal motility and anorectal motility studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.

The InSIGHT Model S980000 Gastrointestinal Motility system consists of three basic subsystems. These are: Signal conditioning and recording hardware, Analysis software, and Probes and transducers.

The provided text does not contain a study that proves the device meets specific acceptance criteria in the manner requested. Instead, it describes a 510(k) Premarket Notification for the InSIGHT Model S980000 Gastrointestinal Motility System, which focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's an analysis based on the information provided, highlighting why many requested points cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

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 / No information provided. The document explicitly states: "No formal clinical testing has been performed, nor is any believed to be necessary." Therefore, there is no test set or related data provenance.

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

• Not applicable / No information provided. As no formal clinical testing was performed, there was no test set requiring expert ground truth establishment.

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

• Not applicable / No information provided. No test set, so no adjudication method.

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 / No information provided. The device is a "Gastrointestinal Motility System" with analysis software, not explicitly an "AI" device as typically understood in the context of MRMC studies comparing human readers with and without AI. No such study was conducted.

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

• Not applicable / No information provided. While the system includes "analysis software," it explicitly states it "requires skilled interpretation by a physician to make a diagnosis." There is no indication of standalone performance testing of just the algorithm without a human in the loop. The "non-clinical testing" mentioned focuses on safety standards (UL 2601-1) and internal design specifications, not diagnostic performance.

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

• Not applicable / No information provided. Since no formal clinical testing was performed to establish device performance against a diagnostic gold standard, no ground truth type is specified. The device's "effectiveness" is based on its functional equivalence to predicate devices which are already accepted diagnostic aids.

8. The sample size for the training set

• Not applicable / No information provided. There's no mention of an "AI" or machine learning component that would involve a training set as often discussed in the context of acceptance criteria for diagnostic algorithms.

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

• Not applicable / No information provided. As there's no mention of a training set, the method for establishing its ground truth is not applicable.

Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:

The document describes a bench testing and design verification approach, not a clinical study. The primary "study" that supports the device meets its "acceptance criteria" (which are fundamentally about safety and substantial equivalence to predicate devices) involves:

• Design Controls Procedures: Internal processes to ensure the device meets predefined specifications.
• Compliance with UL 2601-1: Meeting a recognized standard for medical electrical equipment safety. This was achieved through a "planned combination of internal design testing to written protocols and outside laboratories."
• Comparison to Predicate Devices: Demonstrating that the "technological characteristics... are the same as, or perform equivalently to, the predicate devices" (BioVIEW Model S960000 and Sandhill DMS). This comparison forms the basis of the "effectiveness" claim in the absence of clinical data.

In conclusion, this 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices and adherence to safety standards through non-clinical testing, rather than presenting results from a clinical study with defined performance acceptance criteria, test sets, or ground truth.

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The software only provides visual guidance for data interpretation. It is not considered in and of itself to be diagnostic without skilled interpretation.

Continuous recordings provide information in the form of amplitude versus time, but it is difficult to understand because of the visual complexity of the record due to channel separation and duration of the recorded traces and sporadic nature of the activity. The software reports arranges the information in concise, reproducible, consistent reports that are more consistent than visual analysis. The Small Bowel software adds no new information, but takes existing information and rearranges it to make it more accessible to interpretation. Source information has dimensions of amplitude and time while the software presents the same information including numerous calculated results, such as duration, mean, maximum and median, motility index, frequency and cycle values for contractions and clusters (groups of contractions).

This document (K942247) is a 1996 510(k) premarket notification for a software device. As such, it predates many of the modern requirements and best practices for clinical studies and algorithm validation that are standard in medical device submissions today. Consequently, most of the detailed information you've requested regarding acceptance criteria, study design, and performance metrics is not present in the provided text.

Here's an analysis based on the given input, highlighting what's available and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing:

• Specific quantitative acceptance criteria (e.g., target accuracy, precision, sensitivity, specificity, or inter-reader agreement improvement).
• Any quantitative performance metrics demonstrating the device meets these criteria. The statements are descriptive rather than data-driven.

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

Not Provided. The document describes the function of the software but does not mention any specific test set, sample size, or the provenance of any data used for evaluation.

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

Not Provided. There is no mention of a test set, ground truth establishment, or expert involvement for validation.

4. Adjudication Method for the Test Set

Not Provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document does not describe any MRMC study. It states the software "rearranges the information to make it more accessible to interpretation" and that reports are "more consistent than visual analysis," but it doesn't provide a comparative effectiveness study with human readers to quantify this improvement.

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

Not Applicable/Not Provided as a study. The device is explicitly stated to not be diagnostic on its own ("It is not considered in and of itself to be diagnostic without skilled interpretation."). Its function is to process and present data, implying it's an aid, not a standalone diagnostic. There is no mention of a standalone performance study in the context of diagnostic accuracy.

7. The Type of Ground Truth Used

Not Applicable/Not Provided. Given the nature of the device (data visualization and calculation tool for continuous recordings) and the lack of a formal clinical validation study described, there is no mention of "ground truth" in the modern sense (e.g., pathology, outcomes data) being used to validate its diagnostic capabilities. The "ground truth" for the software's calculations would inherently be the raw amplitude-over-time data from the sensors, which it processes.

8. The Sample Size for the Training Set

Not Provided. There is no mention of a training set, as the document describes a rule-based software for data manipulation and visualization, not an AI/ML model that would require training data.

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

Not Applicable/Not Provided. As it's not an AI/ML model, there's no concept of a training set or its associated ground truth establishment in this context. The software's "truth" is its adherence to the specified calculation methodologies (e.g., how it calculates mean, median, frequency).

Summary of Document K942247's Approach:

This submission relies on a "functional equivalence" and "safety" argument typical of older 510(k)s for software that primarily processes and presents data.

• Safety: Addressed by electrical isolation to UL544 standards.
• Effectiveness: Stated as providing information in a more accessible, consistent, and organized manner than manual visual analysis of raw continuous recordings. It's an information-processing tool, not a diagnostic algorithm in the modern sense, and therefore, extensive clinical performance studies with acceptance criteria for diagnostic accuracy were not described or likely required at the time for this type of device. The effectiveness is described in terms of its utility for interpretation by a skilled user, rather than a standalone diagnostic capability.

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