(29 days)
The NuVasive™ Guided Spinal Arthroscopy System consists of a Surgical Navigator with adjustable cannula guides, and various percutaneous surgical cannulae and instrumentation. This System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerves, foramina, vertebra, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior, lateral, or posterolateral approach, where anatomical restrictions safely permit. It is intended for use under real-time, or near real-time (i.e., successive static image) radiographic visualization via image-intensified C-arm fluoroscopy. The System is designed for use with NuVasive™ spinal arthroscopes and percutaneous surgical instrumentation, but may be used with other arthroscopes and instrumentation having compatible diameter and length, and which are indicated for use in the spine.
The Hemi-Arc™ Surgical Navigator essentially serves as an instrument holder and guide which is intended to be aligned with the operative site using real time, or near real-time (i.e. success static images) image-intensified C-arm fluoroscopy. The Hemi-ArcTM guide frame is adjustable in several planes of motion, and their fluoroscopic alignment with spinal anatomical features provides the path of entry of subsequent arthroscopic instrumentation to be precisely controlled, thereby avoiding damage to surrounding tissues such as nerves or dura.
The NuVasive™ Hemi-Arc™ Surgical Navigator's 510(k) submission (K013257) does not include a detailed study with acceptance criteria and reported device performance in the way a clinical trial for a standalone diagnostic AI device would. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the provided information, addressing your points where data is available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) submission for the Hemi-Arc™ Surgical Navigator states that "a comprehensive program of verification and validation activities demonstrating that acceptance criteria were met, and that design output satisfied design input" was conducted. However, no specific acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) or reported performance metrics are detailed for the device itself. The focus is on the device's function as an instrument holder and guide for fluoroscopic alignment.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission refers to "verification and validation activities" but does not detail the size or nature of any test set used in these activities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given the nature of the device (a surgical navigator and guide), the "ground truth" would likely relate to the accuracy of instrument positioning, which would be assessed through design verification rather than expert consensus on diagnostic images.
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, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not applicable to this device. This device is a mechanical surgical navigator, not an AI or diagnostic imaging device that "reads" cases or assists "human readers." Its purpose is to guide surgical instruments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study in the context of an algorithm or AI was not done and is not applicable. The Hemi-Arc™ Surgical Navigator is a physical instrument that requires a human operator (the surgeon) and real-time fluoroscopic imaging for its intended use. It is not an autonomous device or an algorithm that performs without human interaction.
7. The Type of Ground Truth Used
The document does not explicitly state the "type of ground truth" used for testing in the typical sense of a diagnostic device (e.g., pathology, outcomes data). For a surgical guide, the "ground truth" during verification and validation would likely involve:
- Dimensional accuracy: Ensuring the guide delivers instruments to the intended anatomical location based on fluoroscopic guidance.
- Mechanical performance: Verification of adjustment mechanisms, stability, and compatibility with other instruments.
- User feedback/simulated use: Testing the ability of the device to facilitate controlled percutaneous access to spinal structures as intended.
These would be assessed through engineering tests and potentially cadaveric or simulated surgical environments, rather than pathology or clinical outcome data in the context of a "test set" for diagnostic performance.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This device does not employ machine learning or AI that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable, as there is no training set for this mechanical device.
Summary of the Study and Acceptance Criteria from the Document:
The provided document describes a Special 510(k) Premarket Notification for the NuVasive™ Hemi-Arc™ Surgical Navigator. The study that "proves the device meets the acceptance criteria" is broadly defined as:
- Design Control Activities: These included "a comprehensive Risk Analysis to identify potential risks and failures associated with operation of the device, any mitigations incorporated... and an assessment of residual risk."
- Verification and Validation Activities: The document states these activities "demonstrat[ed] that acceptance criteria were met, and that design output satisfied design input."
Crucially, no specific performance metrics, acceptance criteria thresholds, or quantitative results from these verification and validation activities are detailed in the publicly available 510(k) summary provided. The entire submission relies on establishing substantial equivalence to an existing predicate device (the Surgical Guide Frame currently manufactured by NuVasive™, Inc.).
The basis for FDA clearance is the assertion that:
- The device has "indications for use identical to those of its predicate."
- It "employs the same principles of operation."
- Due to this equivalency, "the device raises no new safety or effectiveness issues."
Therefore, the "study" demonstrating compliance is the design control and verification/validation process, which the FDA reviewed and found adequate for demonstrating substantial equivalence to the predicate device, rather than a clinical trial or performance study with defined acceptance criteria and reported results akin to an AI-powered diagnostic tool.
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OCT 3 0 2001
NuVasive™, Inc.
KO13257 Special 510(k) Premarket Notification Hemi-Arc™ Surgical Navigator
VII. 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular $807.92, the following summary of information is provided:
Submitted by: A.
Laetitia Bernard Manager of Regulatory Affairs NuVasive™, Incorporated 10065 Old Grove Road San Diego, California 92131 Telephone: (858) 271-7070 Telefacsimile: (858) 271-7101
B. Device Name
Trade Name: Hemi-Arc™ Surgical Navigator
Common or Usual Name: Arthroscope, Stereotaxic Frame
Classification Name: Arthroscope, Stereotaxic Instrument
C. Predicate Devices
The subject Hemi-Arc™ Surgical Navigator is substantially equivalent to the Surgical Guide Frame currently manufactured and distributed commercially in the U.S. by NuVasive™, Inc.
D. Device Description
The Hemi-Arc™ Surgical Navigator essentially serves as an instrument holder and guide which is intended to be aligned with the operative site using real time, or near real-time (i.e. success static images) image-intensified C-arm fluoroscopy. The Hemi-ArcTM guide frame is adjustable in several planes of motion, and their fluoroscopic alignment with spinal anatomical features provides the path of entry of subsequent arthroscopic instrumentation to be precisely controlled, thereby avoiding damage to surrounding tissues such as nerves or dura.
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Intended Use E.
The NuVasive™ Guided Spinal Arthroscopy System consists of a Surgical Navigator with adjustable cannula guides, and various percutaneous surgical cannulae and instrumentation. This System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerves, foramina, vertebra, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior, lateral, or posterolateral approach, where anatomical restrictions safely permit. It is intended for use under real-time, or near real-time (i.e., successive static image) radiographic visualization via image-intensified Carm fluoroscopy. The System is designed for use with NuVasive™ spinal arthroscopes and percutaneous surgical instrumentation, but may be used with other arthroscopes and instrumentation having compatible diameter and length, and which are indicated for use in the spine.
Comparison to Predicate Devices F.
The subject device has indications for use identical to those of its predicate, and employs the same principles of operation for alignment with the spinal operative site using real time, or near real-time (i.e. success static images) image-intensified C-arm fluoroscopy to provide access to subsequent arthroscopic instrumentation. Due to this equivalency, the device raises no new safety or effectiveness issues.
G. Summary of Design Control Activities
Design control activities employed to control the development of the modification to the Surgical Guide Frame included:
- a comprehensive Risk Analysis to identify potential risks and failures associated with ● operation of the device, any mitigations incorporated to reduce or eliminate those risks and failures, and an assessment of residual risk;
- a comprehensive program of verification and validation activities demonstrating that . acceptance criteria were met, and that design output satisfied design input.
H. Summary of Clinical Tests
(Not applicable.)
I. Conclusions
The subject device is substantially equivalent to the currently marketed predicate device, and its development has been adequately and appropriately conducted and validated under a comprehensive design control program complying with Title 21 CFR, §820.30.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
OCT 3 0 2001
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laetitia Bernard Manager of Regulatory Affairs Nuvasive, Inc. 10065 Old Grove Road San Diego, California 92131
Re: K013257 Trade/Device Name: Hemi-Arc™ Surgical Navigator Regulation Number: 882.4560, 888.1100 Regulation Name: Stereotaxic instrument Arthroscope and accessories Regulatory Class: II Product Code: HAW, HRX Dated: September 28, 2001 Received: October 1, 2001
Dear Ms. Bernard:
We have reviewed your Section 510(k) premarket notification of intent to market the device w one reviews 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 for ass sured in the encreases of 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 I ou may, ateres 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 - Ms. Laetitia Bernard
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" (21CFR 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,
Susa Welk, us
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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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Indications for Use Statement D.
510(k) Number (if known):
Device Name: Hemi-ArcTM Surgical Navigator
Indications for Use:
The NuVasive™ Guided Spinal Arthroscopy System consists of a Surgical Navigator with adjustable cannula guides, and various percutaneous surgical cannulae and instrumentation. This System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerves, foramina, vertebra, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior, lateral, or posterolateral approach, where anatomical restrictions safely permit. It is intended for posterelateral time, or near real-time (i.e., successive static image) radiographic visualization via image-intensified C-arm fluoroscopy. The System is designed for use with Nu Vasive™ spinal arthroscopes and percutaneous surgical instrumentation, but may be used with other arthroscopes and instrumentation having compatible diameter and length, and which are indicated for use in the spine.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) | OR |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K013254 |
|---|---|
| --------------- | --------- |
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§ 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).