(85 days)
The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the central portion of the cornea. The Primary and only purpose of this device is to produce cuts necessary for the corneal transplantation.
Not Found
The provided text does not contain detailed information about specific acceptance criteria, device performance, or a study design in the way that would typically be presented for a modern AI-powered medical device submission. This document is a 510(k) summary for the ASMOTOM Automated Trephine System, approved in 2001, which is a physical medical device (a trephine), not an AI-powered diagnostic system.
Therefore, many of the requested categories for AI-specific performance evaluation cannot be extracted from this document, such as:
- Sample size for the test set and data provenance
- Number of experts and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
However, based on the information available, I can provide a response focusing on what can be inferred or directly stated from the document, particularly regarding the device's intended use and the comparison to a predicate device.
Acceptance Criteria and Study for ASMOTOM Automated Trephine System (K013151)
The provided K013151 document is a 510(k) Summary for a physical medical device, the ASMOTOM Automated Trephine System, and therefore does not include the detailed performance study information typically required for AI-powered diagnostic devices. The acceptance criteria for such a device at the time would primarily revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness, often through bench testing and mechanical comparisons rather than extensive clinical studies with human interpretion.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative format with corresponding reported performance metrics as would be seen for an AI device. Instead, the substantial equivalence hinges on functional similarity and material comparison to the predicate device. The implicit acceptance criterion is that the device performs its intended function (performing penetrating cuts of the cornea for transplantation) in a manner similar to the predicate device, without raising different questions of safety or effectiveness.
| Feature / (Implicit) Acceptance Criterion | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use | Same as predicate (Keratoplasty) |
| Method of Cut | Automatic - to preset depth (Predicate: Automatic - Step motor controlled) |
| Materials (Patient Contact) | Stainless Steel and Brass (Predicate: Stainless Steel, Plastic, Glass, Natural Diamond) |
| Blade Oscillation | Adjustable, Patient preset available (Predicate: Adjustable, with preset default) |
| Motor Speed | 16,500 RPM (Predicate: 5,000 - 20,000 RPM) |
| Vacuum | 0 - 800 mbar (Predicate: 0 - 1.0 bar (1000 mbar)) |
| Other Features | Suction Rings, Blades (6.0 - 8.2 mm), Off-Set Rings (0.2 - 1.2 mm), Hand Switch, Foot Switch (All comparable or within functional range of predicate) |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of clinical data for performance evaluation. For a device like a trephine, testing would typically involve bench testing (e.g., precision of cuts on artificial materials) rather than human patient data sets for diagnostic accuracy. No clinical data or test set provenance (country of origin, retrospective/prospective) is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a surgical instrument, not an AI diagnostic tool requiring expert-established ground truth on clinical images or data. Performance assessment would involve engineering and surgical precision measurements, not expert review of diagnostic interpretations.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set requiring adjudication in this 510(k) summary.
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 is not an AI-assisted device, and no MRMC study was conducted or is relevant to its approval.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a surgical instrument operated by a human, not an algorithm.
7. The type of ground truth used
For a physical device like a trephine, "ground truth" would relate to the physical measurement of cuts made (e.g., depth, diameter, consistency), likely established through engineering measurements and potentially ex-vivo tissue testing, rather than clinical outcomes or diagnostic accuracy. The document does not specify the methods used, but for substantial equivalence, it would involve demonstrating that cuts are comparable to those made by the predicate device.
8. The sample size for the training set
Not applicable. No AI/machine learning training set is relevant for this device.
9. How the ground truth for the training set was established
Not applicable. No AI/machine learning training set is relevant for this device.
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DEC 1 4 2001
K013151 510(K) SUMMARY
(as required by 807.92(c))
| Submitter of 510(k): | BKG Opthalmics USA, Inc.7334 Hollister Ave., Suite IGoleta, CA 93117 |
|---|---|
| Phone:Fax: | 805-685-9991805-685-1292 |
| Contact Person: | Les Vorosmarthy |
| Date of Summary: | October 29, 2001 |
| Trade Name: | ASMOTOM Automated Trephine System |
| Classification Name: | Trephine, AC-Powered |
| Product Code: | HRG |
| Regulation Number: | 886.4070 |
| Predicate Device: | Summit Technology K-B Microkeratome K980675 |
| Intended Use: | The ASMOTOM Automated Trephine System is intendedto perform penetrating cuts of the central portion of thecornea. The Primary and only purpose of this device is toproduce cuts necessary for the corneal transplantation. |
:
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Device Comparison Chart
| Feature | BKG OphthalmicASMOTOM | Summit K-BMicrokeratome |
|---|---|---|
| Indications forUse | Keratoplasty | Same |
| Method of cut | Automatic - to presetdepth | Automatic - Stepmotor controlled 0.1to 3.0mm/sec. |
| Materials(Patient Contact) | Stainless Steel and Brass | Stainless Steel,Plastic, Glass,Natural Diamond |
| Blade Oscillation | Adjustable, Patientpreset available | Adjustable, withpreset default |
| Manufacturer | Deutschmann -Medizintechnik | Gebauer GMBH |
| Motor | 12 V | 12 V |
| Speed | 16,500 RPM | 5,000 - 20,000 RPM |
| Weight | 200 g | N/A |
| Power Supply | 90 V - 240 V | 100 V - 240 V |
| Frequency | 50 - 60 Hz | Same |
| Vacuum | 0 - 800 mbar | 0 - 1.0 bar |
| Suction Rings | Yes | Yes |
| Blades | 6.0 mm - 8.2 mm | Various |
| Off-Set Rings | 0.2 mm - 1.2 mm | Programmable |
| Hand Switch | Yes | Yes |
| Foot Switch | Yes | Yes |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2001
BKG Opthalmics USA, Inc. c/o Mr. Arthur Ward, Consultant 962 Allegro Lane Apollo Beach, FL 33572
Re: K013151
Trade/Device Name: ASMOTOM Automated Trephine System Regulation Number: 21 CFR 886.4070 Regulation Name: Trephine, AC-Powered Regulatory Class: I Product Code: HRG Dated: November 9, 2001 Received: November 13, 2001
Dear Mr. Ward:
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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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 prematicate 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) 594-4613. 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" (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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): _
ASMOTOM Automated Trephine System Device Name:
Indications For Use:
The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the The ASMOTON of the cornea. The purpose of this device is to produce cuts necessary for the corneal transplantation.
(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) (Optional Format 1-2-96)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Dinas L. "C. Carter
(Division Sign-Off) Division of Ophthalmic Devices 101315 510(k) Number.
§ 886.4070 Powered corneal burr.
(a)
Identification. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.