(174 days)
The SNN Scout is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN Scout is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.
The passive sensor feature is an addition to the SNN Scout image-guided surgical system. This feature is designed to improve the ergonomics of the user/device interaction by eliminating the cable connections between the tracked surgical instruments and the computer workstation.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the provided text does not contain a table of acceptance criteria or specific reported device performance metrics for the SNN Scout image-guided surgical system, particularly regarding the passive sensor feature. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on substantial equivalence to a predicate device rather than detailed performance specifications.
The 510(k) summary states: "The intended use and technological characteristics of the SNN Scout image-guided device including the passive sensor feature are substantially equivalent, in the opinion of I.S.G. Technologies, to those of the predicate device and do not pose any new issues of safety and effectiveness." This implies that the device is deemed acceptable because it performs comparably to an already cleared device, but it doesn't provide the specific performance criteria or results.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not disclose any information about the sample size used for a test set, nor does it mention data provenance (e.g., country of origin, retrospective/prospective study design). This type of detail is typically found in a more comprehensive clinical study report, which is not part of this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not mention any experts used to establish ground truth or their qualifications. As no specific performance study results for the SNN Scout are presented, there is no discussion of how ground truth might have been established for such a study.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method as there is no mention of a specific test set or performance evaluation in the clinical sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There is no discussion of human reader performance, with or without AI assistance, or any effect size.
6. Standalone (Algorithm Only) Performance Study
The provided text does not specifically describe a standalone (algorithm only) performance study. The device is an "image-guided surgical system" that includes a "passive sensor feature" to improve ergonomics. While its functionality relies on technology, the document focuses on its substantial equivalence to a predicate device rather than a detailed, quantitative standalone performance evaluation of an algorithm.
7. Type of Ground Truth Used
The provided text does not specify the type of ground truth used. Given the nature of the device (image-guided surgical system), if performance were evaluated, ground truth would likely be established through surgical outcomes, anatomical verification during surgery, or possibly highly accurate imaging modalities as a reference. However, these details are not present.
8. Sample Size for the Training Set
The provided text does not mention a training set sample size. This device documentation does not describe a machine learning model where a distinct training set would be explicitly referenced.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the provided text does not describe how ground truth for a training set was established.
Summary of Missing Information:
It's crucial to understand that 510(k) summaries, especially from 1998, often focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed, quantitative clinical study results with specific acceptance criteria and performance metrics as might be found in a modern premarket approval (PMA) application or a more recent 510(k) for an AI/ML powered device. The information provided heavily emphasizes the "substantially equivalent" argument from ISG Technologies.
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98,2570
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| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Submitter: | I.S.G. Technologies Inc. |
| Address: | 6509 Airport RoadMississauga, OntarioCanada L4V 1S7 |
| Contact: | Carol Nakagawa, Clinical Scientist |
| Telephone: | (905) 672-2100 |
| Date: | July 17, 1998 |
| Trade Name: | SNN Scout. |
| Common Name: | Image-Guided Surgical System. |
| Classification Name: | Accessory to Stereotaxic Device. |
| Predicate Device: | |
| Device Description: | The passive sensor feature is an addition to the SNN Scout image-guided surgical system. This feature is designed to improve theergonomics of the user/device interaction by eliminating the cableconnections between the tracked surgical instruments and thecomputer workstation. |
| Intended Use: | The SNN Scout, comprised of a medical workstation and anintegrated position-sensing instrument, is intended to be used pre-operatively and intra-operatively. |
| Comparison toPredicate: | The intended use and technological characteristics of the SNNScout image-guided surgical device including the passive sensorfeature are substantially equivalent, in the opinion of I.S.G.Technologies, to those of the predicate device and do not pose anynew issues of safety and effectiveness. |
510/k) Summarv of Safety and Effectiveness
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 1999
Ms. Carol Nakagawa Clinical Scientist ISG Technologies, Inc. 6509 Airport Road Mississauga, Ontario Canada L4V 1S7
K982570 Re: Trade Name: SNN Scout Regulatory Class: II Product Code: HAW Dated: November 5, 1998 Received: November 9, 1998
Dear Ms. Nakagawa:
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, 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Carol Nakagawa
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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,
f-Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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10. Indications for Use
The passive instrument feature does not change the indications for use of the SNN Scout image-guided surgical device compared with the predicate ISG Family of Viewing Wands. The statement of indications for use continues to be as follows:
"The SNN Scout is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN Scout is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured."
Prescription Use (Per 21 CFR 801.109)
P
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).