(123 days)
Reprocessed Diamond Burs are indicated for use in patients requiring surgery involving bone and bony structures.
Diamond Burs are specially designed surgical accessories designed to help the surgeon cut and drill bone and bony structures during orthopedic procedures.
The provided text is a 510(k) summary for a reprocessed medical device, specifically Alliance Medical Corporation Reprocessed Diamond Burs. This document describes the device, its intended use, and the basis for its substantial equivalence to a predicate device, which is typically established through various performance tests.
Here's an analysis to extract the requested information, noting that the document structure for a 510(k) summary does not align with a detailed clinical study report often provided for AI/ML devices. Therefore, some information expected for AI/ML device studies might not be present or directly applicable.
1. A table of acceptance criteria and the reported device performance
The document lists categories of performance testing rather than specific quantitative acceptance criteria or detailed reported performance values.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Bench and laboratory testing demonstrated performance. |
| Validation of Reprocessing | Bench and laboratory testing demonstrated performance. |
| Sterilization Validation | Bench and laboratory testing demonstrated performance. |
| Function Test(s) | Each individual Diamond Bur is tested for appropriate function of its components prior to packaging and labeling. Bench and laboratory testing demonstrated performance. |
| Packaging Validation | Bench and laboratory testing demonstrated performance. |
Conclusion: "Performance testing demonstrates that Reprocessed Diamond Burs perform as originally intended." This indicates that the device met the established criteria for each test category, though the specific quantitative criteria are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data or patient cohorts as would be relevant for an AI/ML device. The testing described is bench and laboratory testing, which applies to the physical reprocessed burs themselves.
- Sample Size: Not explicitly stated for each test, but it implies a sufficient number of reprocessed burs were tested to ensure performance.
- Data Provenance: Not applicable as it's not clinical data. The tests were conducted internally by Alliance Medical Corporation.
- Retrospective or Prospective: Not applicable.
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)
This is not applicable to the type of device and testing described. The "ground truth" here is based on engineering specifications, test standards, and the original performance of new diamond burs, validated through bench and lab tests, not expert clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The described testing involves objective laboratory measurements and validations, not subjective clinical assessments requiring adjudication.
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 device is a surgical instrument, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by engineering specifications, material science standards, and functional requirements equivalent to the original, new device. This is confirmed through laboratory testing (biocompatibility, reprocessing validation, sterilization validation, function tests, packaging validation) to ensure the reprocessed device performs "as originally intended."
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm requiring a training set.
Summary of Device and Approval Context:
This 510(k) summary is for a reprocessed medical device. The core of the submission is to demonstrate that the reprocessed device is substantially equivalent to its predicate device(s). This is achieved by proving that the reprocessing methods restore the device to its original performance capabilities and safety profile. The "study" described is a series of bench and laboratory tests focusing on:
- Biocompatibility: Ensuring the materials, after reprocessing, remain safe for contact with human tissue.
- Validation of reprocessing: Demonstrating that the reprocessing steps (cleaning, decontamination) effectively remove contaminants and restore the device.
- Sterilization Validation: Confirming the device can be consistently sterilized.
- Function test(s): Verifying the bur's cutting ability, structural integrity, and other mechanical functions.
- Packaging Validation: Ensuring the packaging maintains sterility and integrity until use.
The conclusion is that these tests demonstrate the reprocessed burs perform "as originally intended," thereby establishing substantial equivalence. The document does not provide the detailed quantitative results or specific pass/fail criteria for each test, which would typically be found in the full submission but are summarized for the 510(k) public abstract.
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SECTION B: 510(k) SUMMARY
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044 | |
|---|---|---|
| Contact: | Eric VartyResearch and Development Manager(480) 763-5335 (o)(480) 763-5320 (f)evarty@alliance-medical.com | |
| Date of preparation: | July 15, 2004 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Diamond BursCommon or Usual Name: Diamond BursClassification Name: Dental Diamond Coated Bur, DentalDiamond Instrument, ENT diamond Coated bur | |
| Predicate device: | ||
| K#K901967 | Device DescriptionDendia Werk Burs and CuttingDiscs | Product CodeDZP |
| Device description: | Diamond Burs are specially designed surgical accessoriesdesigned to help the surgeon cut and drill bone and bonystructures during orthopedic procedures. | |
| Intended use: | Diamond burs are intended for use to cut and drill bone andbony structures during orthopedic procedures. | |
| Indicationsstatement: | Reprocessed diamond burs are indicated for use in patientsrequiring surgery involving bone and bony structures duringorthopedic procedures. | |
| Technologicalcharacteristics: | The design, materials, and intended use of ReprocessedDiamond Burs are identical to the predicate devices. Themechanism of action of Reprocessed Diamond Burs is identicalto the predicate devices in that the same standard mechanicaldesign, materials and sizes are utilized. There are no changesto the claims, intended use, clinical applications, patientpopulation, performance specifications, or method of operation.Alliance Medical Corporation's reprocessing of Diamond Bursincludes removal of adherent visible soil and decontamination.Each individual Diamond Bur is tested for appropriate function ofits components prior to packaging and labeling operations. | |
| Alliance Medical CorporationReprocessed Diamond BursTraditional 510(k) | 10 |
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Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Diamond Burs.
- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- Packaging Validation .
Performance testing demonstrates that Reprocessed Diamond Burs perform as originally intended.
Conclusion: Alliance Medical Corporation concludes that the modified device (the Reprocessed Diamond Bur) is safe, effective and substantially equivalent to the predicate devices as described herein.
Alliance Medical Corporation Reprocessed Diamond Burs Traditional 510(k)
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or feathers. The overall design is simple and recognizable, representing the department's role in health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2004
Mr. Eric Varty Research and Development Manager Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K041978
Trade/Device Name: Alliance Medical Corporation Reprocessed Diamond Burs Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: NLN Dated: November 10, 2004 Received: November 12, 2004
Dear Mr. Varty:
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. Eric Varty
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours,
Sincerely yours,
Mark N. Mikkelsen
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 2.
510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed Diamond Burs
Indications for Use: Reprocessed Diamond Burs are indicated for use in patients requiring surgery involving bone and bony structures.
Mark N. Miller
ion- Off Division of General, Restorative, and Neurological Devices
K041978 510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
or
Over-the-Counter Use ________
Alliance Medical Corporation Reprocessed Diamond Burs Traditional 510(k)
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).