(85 days)
The Anorectal Analysis Module is a software program that has been designed to analyze pressure data recorded from the lower gastrointestinal tract in pediatric and adult populations.
The Polygram Software for Windows (K946322) was designed to record and handle/store physiological parameters. After a recording, the user is able to review the tracings on the computer screen and print the signal tracings or just parts of them. When reviewing the data on the computer screen, the user is able to mark certain segments and calculate certain parameters from the selected signal segments. These parameters include minimum and maximum values, length of selection. By adding the Anorectal Analysis Module to the Polygram Software for Windows, the user can also have all the pressure data analyzed in terms of physiological properties, comparison with normal values, etc. The analyzed data can thereafter be viewed on screen or printed out on a separate paper. The analysis report includes sections such as patient demographics; interpretation and comment (for user to insert); procedure summary; Anorectal tracing; analyses (as specified below); and physician signature section.
The provided 510(k) summary for the "Anorectal Manometry Analysis Module" (K972439) describes the device and its intended use, but it does not contain detailed information about specific acceptance criteria or a formal study proving the device meets those criteria, as typically understood in a clinical performance study for AI/ML devices.
Instead, the summary focuses on software validation and equivalence to a previously marketed DOS-based software. The "Performance Testing" section describes a typical software development life cycle's testing phases rather than a clinical performance study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (a software update/equivalence 510(k) from 1997), the acceptance criteria described are primarily related to software functionality and successful internal/external testing. Clinical performance metrics (e.g., sensitivity, specificity, AUC) are not mentioned.
| Acceptance Criteria (Inferred from "Performance Testing") | Reported Device Performance |
|---|---|
| Successful Integration Testing (Alpha Testing) | Met and passed specified objectives. |
| Successful Hospital Site Testing (Beta Testing) | Met and passed specified objectives. |
| Functionality identical to predicate device (Polygram Software (DOS)) | "identical, in function and types of analyses that can be performed" to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "hospital site testing" (beta testing) but does not provide details on the number of cases or patients used for this testing.
- Data Provenance: Not specified. It's implied that the beta testing would involve patient data from the participating "hospital site," but details on country of origin or whether the data was retrospective or prospective are absent.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document states the device is "under supervision of a trained physician," implying physician involvement in the use and evaluation during beta testing, but it doesn't detail their qualifications for establishing ground truth for the software's analytical results.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the era and the type of device (software for analyzing physiological data), formal multi-expert adjudication methods typically seen in image-based AI/ML devices are unlikely to have been detailed or even employed in the same manner. The "beta testing" likely involved clinical users validating the software's output against their own clinical assessment and expected results.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. There is no mention of an MRMC study comparing human readers with and without AI assistance. The device is an analysis module rather than an AI-assisted diagnostic aid in the modern sense.
6. Standalone Performance Study (Algorithm Only)
- Standalone Performance Study: Yes, in the context of software validation. "Alpha testing in terms of integration testing" and "beta testing" implicitly covered the standalone performance of the software's analytical functions. However, this is not a "standalone performance" in the sense of a clinical trial demonstrating diagnostic accuracy (e.g., sensitivity, specificity) of the algorithm without human oversight. It's about ensuring the software's calculations and reports are accurate and consistent.
7. Type of Ground Truth Used
- Type of Ground Truth: The document does not explicitly state the type of ground truth used. For this type of device, ground truth would likely refer to:
- Predicate Device Output: Verifying that the Anorectal Manometry Analysis Module generates the same analytical results as the predicate Polygram Software (DOS) for the same input data.
- Expected Physiological Principles/Clinical Judgement: During beta testing, clinical users (physicians) would likely assess if the analyses align with established physiological principles and their clinical expectations for the recorded pressure data.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable in the context of AI/ML. The "Anorectal Manometry Analysis Module" is described as software that performs predefined analyses (e.g., Vector Volume Analysis, Automatic Base Line Analysis). It is not an AI/ML device that learns from a training set to perform its functions. Its functions are deterministic based on programmed algorithms. Therefore, there is no "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of deterministic software. The algorithms for analysis would typically be based on established medical and physiological principles of anorectal manometry.
In summary, the 510(k) for the Anorectal Manometry Analysis Module (K972439) focuses on software validation and substantial equivalence to a predicate device rather than clinical performance studies demonstrating diagnostic accuracy with specific quantitative criteria and detailed ground truth establishment, as would be expected for a modern AI/ML medical device submission.
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510(k) Summary
K972439
P192
DRAERD 510(k) Summary of Safety and Effectiveness Information
| Submitter's name | Synectics Medical ABRenstiernas gata 12S-116 28 StockholmSweden |
|---|---|
| Synectics Medical Inc3850 Victoria Street NorthMail Stop V215Shoreview, MN 55126-2978 | |
| SEP 23 1997 | |
| Contact: Anna Pettersson | |
| Contact: Keith Jung | |
| Name of device | Anorectal Manometry Analysis Module |
| Name of equivalent device | Polygram Software (DOS environment)(included in 872712 - Polygraf) |
| The Anorectal Analysis Module is identical, in function and types of analyses that can be performed, to the Polygram Software (DOS). The main difference is that the Polygram Software (DOS) is written for the DOS environment and the Anorectal Analysis Module is written for the Windows environment. Polygram Software (DOS) works in the DOS environment and the Anorectal Analysis Module works in the Windows environment. | |
| Description of device | The Polygram Software for Windows (K946322) was designed to record and handle/store physiological parameters. After a recording, the user is able to review the tracings on the computer screen and print the signal tracings or just parts of them. When reviewing the data on the computer screen, the user is able to mark certain segments and calculate certain parameters from the selected signal segments. These parameters include minimum and maximum values, length of selection. |
| By adding the Anorectal Analysis Module to the Polygram Software for Windows, the user can also have all the pressure data analyzed in terms of physiological properties, comparison with normal values, etc. The analyzed data can thereafter be viewed on screen or printed out on a separate paper. | |
| The analysis report includes sections such as patient demographics; interpretation and comment (for user to insert); procedure summary; Anorectal tracing; analyses (as specified below); and physician signature section. | |
| Analyses: | |
| Vector Volume AnalysisAutomatic Base Line AnalysisIntepretation and Comments AnalysisRectal Balloon AnalysisTri-Level AnalysisRadial Pressure AnalysisAnal Canal Vector Volume AnalysisTracing Clip-Out AnalysisQuick Calculation Analysis | |
| The analysis report can then serve as a tool for the physician's diagnosis and |
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The analysis report can then serve as a tool for the physician's diagnosis and post treatment evaluation.
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| PerformanceTesting | The Anorectal Analysis Module has been thoroghly tested during thedevelopment phase, that is, alpha testing in terms of integration testing has beenperformed and documented and beta testing in terms of hospital site testing hasbeen done and documented.It has been concluded that the alpha and beta testing has meet and passed thespecified objectives and should therefore be released to the market. |
|---|---|
| Statement ofintendeduse/indicationfor use | The Anorectal Analysis Module is a software program that has been designed toanalyze pressure data recorded from the lower gastrointestinal tract in pediatricand adult populations. |
| The Anorectal Analysis Module includes the following analyses: | |
| • Vector Volume Analysis | |
| • Automatic Base Line Analysis | |
| • Intepretation and Comments Analysis | |
| • Rectal Balloon Analysis | |
| • Tri-Level Analysis | |
| • Radial Pressure Analysis | |
| • Anal Canal Vector Volume Analysis | |
| • Tracing Clip-Out Analysis | |
| • Quick Calculation Analysis |
The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physician. The analyzed data can be viewed on the computer screen or printed out on a separate paper.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micael Hamberg Medtronic Synectics Synectics Medical AB Renstiernas gata 12 S-116 28 Stockholm Sweden
Re: K972439 Anorectal Manometry Analysis Module Dated: June 26, 1997 Received: June 30, 1997 Regulatory Class: II SEP 2 3 1997 21 CFR 876.1725/Procode: 78 FFX
Dear Mr. Hamberg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification sobmission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) prematet notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
William Yu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K972438
Device Name: Anorectal Manometry Analysis Module
Indications For Use:
The Anorectal Analysis Module is a suflware program that has heen designed to analyse pressure duta recorded from the lower gastrointestinal tract in podiatic and adult populations.
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Concurrence of CDRH, Office of Device Evaluation (ONE)
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Prescription Use (Optional Format 1-2-96)
Over-The-Counter Use (Per 21 CFR 801 109)
Taher N. Rotting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).