(15 days)
The intended use of the device is to support and aid in positioning a patient during radiation therapy.
The HexaPOD consists of two platforms, which are connected by six linear, rigid but length adjustable elements which are powered. By appropriate coordinative adjustment of these elements, the system is able to move the upper platform relative to the lower one. The movement can occur in all three dimensions in space. Additionally the upper platform can rotate around these three axes which results in a tilt or a rotation of the upper platform relative to the lower one. Finally an accurate positioning within all six degrees of freedom (6DOF) can be provided. The HexaPOD consists of a controller unit which is directed by a cable connected teach pad. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.
The provided document is limited to the HexaPOD™ RT CouchTop, a medical device designed to support and position patients during radiation therapy. It is a 510(k) submission to the FDA, which focuses on demonstrating substantial equivalence to existing devices rather than new clinical trials for safety and effectiveness.
As such, the document does not contain the detailed information required to fill out most of the points in your request. Specifically, it states:
- "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."
This means there was no specific study conducted to prove the device meets acceptance criteria in the way you've outlined for performance metrics (sensitivity, specificity, accuracy, F1 score). The 510(k) process for this device relies on demonstrating that its technological characteristics are "substantially equivalent" to predicate devices, and therefore it is considered safe and effective for its intended use without new clinical performance studies.
Therefore, I cannot provide a table of acceptance criteria with reported device performance, nor can I provide information on sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth for the training set.
Here's what can be extracted from the document based on your request, with the understanding that performance data as typically defined for AI/diagnostic devices is not applicable here:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For a 510(k) submission, the primary acceptance criterion is substantial equivalence to legally marketed predicate devices. This means the device must have the same intended use and either the same technological characteristics or, if different, those differences must not raise new questions of safety or effectiveness. The document asserts that the HexaPOD does not have technological characteristics that raise additional types of questions related to safety and effectiveness.
- Reported Device Performance: The document explicitly states, "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)." Therefore, there are no reported performance metrics like sensitivity, specificity, or accuracy in the context of diagnostic or AI-driven decision-making. The "performance" in this context is implicitly deemed acceptable by virtue of its substantial equivalence to predicate devices, which are already on the market.
| Acceptance Criteria (for 510(k) Equivalence) | Reported Device Performance (as per document) |
|---|---|
| Substantial Equivalence to Predicate Devices (Med-Tec Inc.'s "Med-Tec 6 Degree Axis Couch" and Elekta Instrument Inc.'s "Elekta Oncology Systems Precise™ Treatment Table") in terms of: | The HexaPOD is determined to be "substantially equivalent" to the identified predicate devices. |
| - Intended Use: Support and aid in positioning a patient during radiation therapy. | The HexaPOD's intended use is identical: "to support and aid in positioning a patient during radiation therapy." |
| - Technological Characteristics (not raising new questions of safety/effectiveness). | "It is our opinion that the HexaPOD does not have technological characteristics that raise additional types of questions related to terms of safety and effectiveness." |
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: The document states that no performance data was required or requested. Therefore, there was no "test set" in the context of evaluating performance metrics.
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)
- Not Applicable: No performance data or test set that would require expert ground truth was mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No performance data or test set was mentioned.
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: This device is a patient support assembly, not an AI or diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a mechanical patient support system. It does not have an "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: No ground truth in the context of disease detection, diagnosis, or outcome prediction was established or used, as this is a mechanical patient positioning device.
8. The sample size for the training set
- 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
- Not Applicable: There is no mention of a training set or ground truth for such a set.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Intelligence Medizintechnik GmbH % Mr. Stefan Preiss 510(k) TPR Project Manager TÜV Product Service, Inc. 1775 Old Highway 8 NW, Suite # 104 NEW BRIGHTON MN 55112
Re: K041448
Trade/Device Name: HexPod™ RT Couch Top Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: 90 JAI Dated: May 28, 2004 Received: June 1, 2004
OCT
5 2004
. Dear Mr. Preiss:
This letter corrects our substantially equivalent letter of June 16, 2004 regarding the HexPod™ RT Couch Top and the incorrect regulation number, name and product code.
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 (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 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
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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.
This letter will allow you to continue 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) 276-0120. 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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HexaPOD™ RT CouchTop
Product documentalion
Medical Intelligence Medizintechnik GmbH
Image /page/2/Picture/3 description: The image shows a logo with the words "Medical Intelligence" to the right of a symbol. The symbol is a circle with a dollar sign inside of it. The dollar sign has a snake wrapped around it.
FDA 510k submission
Ko41449
JUN 16 2004
510(k) SUMMARY
Applicant:
| 2. | Address: | Feyerabendstrasse 13 – 1586830 SchwabmünchenGermany |
|---|---|---|
| 3. | Contact Person: | Christian HieronimiTel. +49 (0) 8232 9692-0 |
| 4. | Preparation Date: | February 10, 2004 |
| 5. | Device Submitted: | HexaPOD™ RT Couch Top |
-
Proprietary Name: HexaPOD™ RT CouchTop
-
Common Name: Hexapod
-
Classification Name: Couch, Radiation Therapy, Powered Powered radiation therapy patient support assembly Product Code JAI
். Substantial Equivalence: The HexaPOD is substantially equivalent to the following legally marketed devices: Med-Tec Inc.'s "Med-Tec 6 Degree Axis Couch", and Elekta Instrument Inc.'s "Elekta Oncology Systems Precise™ Treatment Table". The characteristics of this device are similar to those of the predicate devices identified on the comparison chart, which is provided with the premarket notification submission. It is our opinion that the HexaPOD does not have technological characteristics that raise additional types of questions related to terms of safety and effectiveness. 10. Device Description: The HexaPOD consists of two platforms, which are connected by six linear, rigid but length adjustable elements which are powered. By appropriate coordinative adjustment of these elements, the system is able to move the upper platform relative to the lower one. The movement can occur in all three dimensions in space. Additionally the upper platform can rotate around these three axes which results in a tilt or a rotation of the upper platform relative to the lower one. Finally an accurate positioning within all six degrees of freedom (6DOF) can be provided. The HexaPOD consists of a controller unit which is directed by a
cable connected teach pad. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.
Intended Use: 11. The intended use of the device is to support and aid in positioning a patient during radiation therapy.
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| HexaPOD™ RT CouchTop | Part H 02 | Image: Medical Intelligence logo |
|---|---|---|
| Product documentation | ||
| FDA 510k submission | K041448 | |
| 12. Biocompatibility: | The HexaPOD is not in contact with patient. At anytime when in use a sheet is to be placed between thepatient's skin surface and the treatment support whenin use. Additionally there are no new materialsintroduced in the manufacture of the HexaPOD.Therefore, no biocompatibility studies wereundertaken for this device. | |
| 13. Performance Data: | No performance data is required for this Class IIdevice nor requested by the Food and DrugAdministration (Office of Device Evaluation). |
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Indications for Use
1041448
510(k) Number (if known):
Device Name:
HexaPOD™ RT CouchTop
Indications For Use:
The intended use of the device is to support and aid in Intended Use: positioning a patient during radiation therapy.
Prescription Use _YES (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)
David R. Legron
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Number .
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.