(54 days)
ASSISTO® Arm Systems consist of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 2.7mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.
Table-mounted self-retaining endoscope holder system consisting of stainless steel tubular, articulated arms that are connected to a vertical stand and are freely adjustable within the articulating radius according to the requirements of the particular surgical procedure. Accessories include endoscope holders for 2.7mm to 10mm scopes. The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
The provided text is a 510(k) summary for the ASSISTO® Arm Systems, describing its substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria or a study that quantitatively measures the device's performance against such criteria using a test set of data with ground truth. Instead, it focuses on demonstrating equivalence through design analysis and verification testing.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be extracted from this document, as they pertain to performance studies typically involving AI/software devices evaluated against ground truth. This document describes a mechanical device.
Here's a breakdown of what can and cannot be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document for a quantitative performance study. | "Design analysis and comparison as well as verification testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness." |
Explanation: The document states that verification testing confirms "basic functional characteristics" and "substantial equivalence." It does not provide specific, measurable acceptance criteria (e.g., accuracy thresholds, sensitivity, specificity) that would be relevant for a software or AI device. The device is a mechanical arm system, and its "performance" is assessed through engineering analysis and confirmation of functional equivalence to existing devices.
2. Sample sized used for the test set and the data provenance
- Sample size: Not specified. The verification testing mentioned likely refers to engineering tests on the physical device, not a test set of data.
- Data provenance: Not applicable, as there's no "data" in the sense of medical images or patient records being analyzed by the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
Explanation: Ground truth, in the context of AI regulatory submissions, typically refers to expert labels or confirmed diagnoses used to evaluate an algorithm's performance. This type of "ground truth" is not relevant for a mechanical device like the ASSISTO® Arm System.
4. Adjudication method for the test set
- Not applicable, as there is no "test set" or "ground truth" in the context of an AI/software performance study.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or decision-making systems, not for a mechanical endoscope holder.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a mechanical system, not an algorithm.
7. The type of ground truth used
- Not applicable. There is no ground truth in the sense of expert consensus, pathology, or outcomes data, as this is a mechanical device. The "ground truth" equivalent for such a device is likely compliance with design specifications and functional requirements through engineering tests.
8. The sample size for the training set
- Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary for the ASSISTO® Arm Systems based on the provided text:
The ASSISTO® Arm Systems is a mechanical device, an endoscope holder, and therefore the regulatory submission (510(k)) focuses on demonstrating substantial equivalence to predicate mechanical devices. This involves design analysis and verification testing to confirm its basic functional characteristics and safety, rather than performance metrics against a data-driven ground truth that would be relevant for AI or software devices. The document explicitly states: "Design analysis and comparison as well as verification testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness." This statement serves as the "proof" that the device meets the implied "acceptance criteria" of being functionally equivalent and safe.
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510(k) summary of safety and effectiveness
| Date: | September 15, 2005 | ||||
|---|---|---|---|---|---|
| Submitter: | Name: | Geomed Medizin-Technik GmbH & Co.Ludwigstaler Strasse 27Postfach 4047Tuttlingen, Germany 78532 | NOV 2 3 2005 | ||
| Contact Person: | Thomas HaugGeneral Manager | ||||
| Telephone:Fax: | +49.7461.93550+49.7461.935593 | ||||
| Product: | Trade Name: | ASSISTO® Arm Systems | |||
| Classification:Common Name:ClassificationName: | Class IIEndoscope HolderLaparoscope, General & Plastic Surgery (GCJ,876.1500)Endoscope, Neurological (GWG, 21 CFR 882.1480)Endoscope and/or Accessories (KOG, 21 CFR876.1500)Arthroscope (HRX, 21 CFR 888.1100) | ||||
| PredicateDevices: | NameArmand Endoscope HolderNeuroview Instrument Holder, Model300-33 | ManufacturerKLS-Martin L.P.Integra NeurocareLLC. | K-No.K050051K992006 | ||
| Abdominal Wall Retractor | Omni-Tract Surgical | K950214 | |||
| ASSISTO® Arm Systems are substantially equivalent to the predicatedevices since the basic features and intended uses are the same. | |||||
| DeviceDescription: | Table-mounted self-retaining endoscope holder system consisting ofstainless steel tubular, articulated arms that are connected to a vertical standand are freely adjustable within the articulating radius according to therequirements of the particular surgical procedure. Accessories includeendoscope holders for 2.7mm to 10mm scopes.The device is reusable and provided non-sterile. It must be cleaned andsterilized before use. | ||||
| IntendedUse: | ASSISTO® Arm Systems consist of a table-mounted endoscope holdersystem intended for use by surgeons to hold endoscopes and arthroscopeswith a diameter of 2.7mm to 10mm during general diagnostic andtherapeutic procedures. The device is also intended for use by qualifiedsurgeons for holding endoscopes during diagnostic and therapeuticneurologic procedures. | ||||
| PerformanceData: | Design analysis and comparison as well as verification testing confirm thatbasic functional characteristics are substantially equivalent to the predicatedevices cited and raise no new issues of safety and effectiveness. | ||||
| Conclusion: | Based upon the product technical information provided, intended use andperformance information provided in this premarket notification, theASSISTO® Arm Systems have been shown to be substantially equivalent to |
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NOV 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Geomed Medizin-Technik GmbH & Company c/o Angelika Scherp Business Support International Amstel 320-I Amsterdam 1017AP Netherlands
Re: K052745
Trade/Device Name: ASSISTO® Arm Systems Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG, GCJ Dated: September 28, 2005 Received: September 30, 2005
Dear Ms. Scherp:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Varbara Buehel
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K052745
Device Name: ASSISTO® Arm Systems
Indications for Use:
ASSISTO® Arm Systems consist of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 2.7mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buehrig
Division of General, Restorative, and Neurological Devices
510(k) Number K052745
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§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).