(24 days)
The Smith & Nephew Image Guided Surgical System for Knee Applications is indicated for use in total knee procedures, including but not limited to, primary and revision total knee arthroplasty and unicompartmental knee arthroplasty, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure, such as a long bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.
The Smith & Nephew Image Guided Surgical System for Knee Applications is intended to assust the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Smth & Nephew Image Guided Surgical System for Knee Applications uses image-guided arrays to transmit or reflect infrared LEDs (light emitting diodes) that are emitted by an IGS Platform System. Thus allows the instruments to be recognized and tracked in real time in the surgical field.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The submission is a 510(k) summary for the "Smith & Nephew Image Guided Surgical System for Knee Applications," which focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria.
However, based on the provided text, we can infer some general information about the device and its regulatory context:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numerical acceptance criteria or performance metrics are provided in the document. The filing relies on the concept of "substantial equivalence."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified, likely related to accuracy, precision, and safety of navigation systems as per predicate devices) | Performance data was provided to support the claim of substantial equivalence to predicate devices (K012938 and K012937). The specific performance metrics are not detailed in this summary. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not detail a specific "test set" or its sample size for a performance study. The statement "Performance data was provided to support the claim of substantial equivalence" suggests that some form of data was analyzed, but the specifics of that data (e.g., number of cases, retrospective/prospective, country of origin) are not disclosed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. Since the submission focuses on substantial equivalence, there is no mention of a ground truth established by experts for a specific test set.
4. Adjudication Method for the Test Set:
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, there is no mention of an MRMC comparative effectiveness study that assesses how much human readers improve with AI vs. without AI assistance. The device is an image-guided surgical system, not a diagnostic AI tool for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document does not detail a standalone performance study. The device is described as an "Image Guided Surgical System for Knee Applications" that "assists the surgeon," implying that it is a human-in-the-loop system designed to be used by a surgeon.
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used as it does not detail a specific performance study with a test set. For image-guided surgical systems, ground truth often involves highly accurate measurements of instrument tip position relative to anatomical landmarks, verified by external tracking systems or highly precise imaging techniques. Given the reliance on substantial equivalence, the "ground truth" for showing equivalence would be the established performance and safety profiles of the predicate devices.
8. The Sample Size for the Training Set:
This information is not provided. The document does not mention any machine learning or AI models with distinct training sets. The "Image Guided Surgical System" uses infrared LEDs to track instruments, suggesting a hardware and software system for navigation, not necessarily one that would typically involve a "training set" in the context of deep learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided, as there is no mention of a training set.
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AUG 1 9 2002
510(k) Summary
Smith & Nephew Image Guided Surgical System for Knee Applications
| Submitter's name: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's telephone number: | 901-399-6707 |
| Contact person: | Gino J. Rouss |
| Date summary prepared: | July 25, 2002 |
| Trade or proprietary device name: | Smith & Nephew Image Guided Surgical System forKnee Applications |
| Common or usual name: | Stereotaxic Instrument |
| Classification name: | Stereotaxic Instrument |
| Device Class: | Class II |
| Device Product Code: | HAW |
| Panel Code: | Neurology / 84 |
Subject device description:
The Smith & Nephew Image Guided Surgical System for Knee Applications is intended to assust the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Smth & Nephew Image Guided Surgical System for Knee Applications uses image-guided arrays to transmit or reflect infrared LEDs (light emitting diodes) that are emitted by an IGS Platform System. Thus allows the instruments to be recognized and tracked in real time in the surgical field.
Subject device intended use:
The Smith & Nephew Image Guided Surgical System for Knee Applications is indicated for use in total knee procedures, including but not limited to, primary and revision total knee arthroplasty and unicompartmental knee arthroplasty, in which the use of stereotactic surgery may be approprate, and where a reference to a rigid anatomical structure, such as a long bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.
Technological Characteristics:
The devices included in this 510(k) are substantially equivalent to the following devices: Smith & Nephew Image Guided Surgical Instruments for Knee Applications 510(k) K012938 Medtronic Surgical Navigation Technologies 510(k) K012937
Performance data was provided to support the claim of substantial equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2002
Smith & Nephew. Inc. Gino Rouss Clinical/Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116
Re: K022460
Trade/Device Name: Smith & Nephew Image Guided Surgical System for Knee Applications Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: July 25, 2002 Received: July 26, 2002
Dear Mr. Rouss:
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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Page 2 - Mr. Gino Rouss
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
for Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): -022460
Smith & Nephew Image Guided Surgical System for Knee Applications Device Name:
Indications For Use:
The Smith & Nephew Image Guided Surgical System for Knee Applications is indicated for use in total knee procedures, including but not limited to, primary and revision total knee arthroplasty and unicompartmental knee arthroplasty, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure, such as a long bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
b. Munk N. Milliken
(Division Sign Division of Restorative and Neurologic
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).