(101 days)
The Vit Enhancer in conjunction with standard vitrectomy equipment is used to remove vitreous and other intraocular tissue.
Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting. The High Speed Vitreous Cutter is used with the Vit Enhancer.
The provided text is a 510(k) summary for the MID Labs Vit Enhancer, a vitrectomy device. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the context of an AI/ML device.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as it pertains to a different type of device clearance (a traditional medical device, not an AI/ML system).
Here's what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be directly extracted. The document does not define specific performance acceptance criteria for the Vit Enhancer in terms of quantitative metrics or clinical outcomes. The clearance is based on substantial equivalence to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The device is a physical instrument, and the 510(k) summary does not describe a clinical study in the way an AI/ML device would require one for performance validation on a test set. There is no mention of a "test set" in the context of data.
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 / Not provided. Ground truth establishment for a test set is not part of this 510(k) summary for a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or adjudication method is 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 relates to AI/ML performance improvement for human readers, which is not relevant to this traditional medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to AI/ML algorithm performance, which is not applicable to a physical vitrectomy device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. The concept of "ground truth" in the context of an AI/ML algorithm's output is not relevant to this device's 510(k) submission.
8. The sample size for the training set
- Not applicable / Not provided. This document does not describe an AI/ML algorithm or its training.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This document does not describe an AI/ML algorithm or its training.
Summary of Device and Approval Process from the Document:
- Device: Vit Enhancer (Vitreous Aspiration & Cutting Instrument)
- Intended Use: Used in conjunction with standard vitrectomy machine for vitreous cutting, to remove vitreous and other intraocular tissue.
- Predicate Device: MID Labs SupraVit® Vitreoretinal Surgical System (K932669)
- Approval Basis: Substantial equivalence to the predicate device. The 510(k) submission compares the Vit Enhancer's design, intended use, and functional components (guillotine cutter, user interface, energy source, pressure control, output valve, frequency control) to those of the SupraVit, demonstrating that it operates similarly and has the same fundamental technological characteristics.
- The FDA's letter states that the device is "substantially equivalent...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." This indicates that the clearance is based on demonstrating the new device is as safe and effective as a legally marketed predicate device, rather than proving novel clinical efficacy through extensive trials.
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DEC 1 0 1999
MID Labs Vit Enhancer Premarket Notification
510(k) Summary of Safety and Effectiveness
| Contact Person: | Linda UptonMID Labs, Inc.14477 Catalina StreetSan Leandro, CA 94577(510) 357-3952 |
|---|---|
| Date Prepared: | December 1, 1999 |
| Trade Name: | Vit Enhancer |
| Common Name: | Vitrectomy Device |
| Classification Name: | Vitreous Aspiration & Cutting Instrument(86 HOE, 21CFR 886.4150) |
Device Description/ Intended Use: Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting. The High Speed Vitreous Cutter is used with the Vit Enhancer.
Predicate Device: MID Labs SupraVit® Vitreoretinal Surgical System
| DeviceDescription | Vit Enhancer | SupraVit |
|---|---|---|
| 510(k) Number | current | K932669 |
| Intended Use | vitreous cutting | posterior segment ophthalmicsurgery, including vitreous cutting |
| Vitreous CutterType | guillotine | guillotine |
| User interface | Frequency setting and display onfront panel | Frequency setting and display onfront panel |
| Energy source | External input pneumatic energy | External input pneumatic energy |
| Internal pressurecontrol | Pressure regulator to control thecaptured pneumatic energy | Pressure regulator to control thecaptured pneumatic energy |
| Output valvetype | Solenoid valve | Solenoid valve |
| Output frequencycontrol | Electronic signal at user settablefrequencies | Electronic signal at user settablefrequencies |
Predicate Device Comparison Table
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1999
Ms. Linda M. Upton Medical Instrument Development 14477 Catalina St. San Leandro, CA 94577
Re: K992943
Trade Name: Vit Enhancer Regulatory Class: II Product Code: 86 HQE Regulation: 886.4150 Dated: November 22, 1999 Received: November 30, 1999
Dear Ms. Upton:
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 requirements, as set forth in the Quality System Regulation (QS) 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. Linda M. Upton
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) 594-4613. 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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Enclosure II
Page I of I
510(k) Number (if known): K992943
Device Name:_ Vit Enhancer
Indications For Use:
The Vit Enhancer in conjunction with standard vitrectomy equipment is used to remove vitreous and other intraocular tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Ophthalmic 510(k) Numb
(3-time 15-0 (3.00))
(Optional Format 3-10-98)
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.