(83 days)
The Arthrex Meniscal Dart System is intended for the repair of Meniscal tears that would otherwise be considered for standard repair using suture.
The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), osteochondral fragments (talus vault, femoral chondyle) and cancellous fragments (talus).
The Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex Chondral Dart are identical to the predicate devices. The Arthrex Meniscal Dart and Arthrex Meniscal Dartstick are intended to be use for the repair of meniscal tears. The Arthrex Chondral Dart is intended to be used for the fixation of small bone fragments. See the Indications for Use statements for specific indications.
The provided document is a 510(k) summary for the Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex Chondral Dart, which describes an "Extended Shelf Life" for these devices. It does not contain information about the performance criteria, clinical studies, or acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy, which are typical for AI/ML devices.
The submission claims substantial equivalence to predicate devices (K983577, Arthrex Meniscal Dart System and K991971, Arthrex Chondral Dart) based on "identical" features and intended uses, with "minor" differences not raising safety and effectiveness concerns. This implies that the acceptance criteria are met by demonstrating equivalence to previously cleared devices, particularly concerning an extended shelf life, rather than through a study proving specific performance metrics of an AI/ML component.
Therefore, many of the requested details are not applicable or cannot be extracted from this document, as it pertains to a traditional medical device modification (extended shelf life) and not an AI/ML device performance study.
Here's an attempt to address the points based on the provided document, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Based on the nature of this 510(k) (extended shelf life and substantial equivalence to predicates), the primary acceptance criterion is that the modified devices (with extended shelf life) maintain the same safety and effectiveness as the predicate devices. This is achieved by demonstrating that "differences between the Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex Chondral Dart in comparison to the cleared devices in K983577 and K991971 are considered minor and do not raise questions concerning safety and effectiveness" as stated in the Substantial Equivalence Summary. The specific criteria for extended shelf life (e.g., maintaining mechanical properties, sterility, biocompatibility over a longer period) are not explicitly detailed here but would have been part of the full 510(k) submission.
- Reported Device Performance: The document states that the devices are "identical to the predicates" in their basic features and intended uses. Performance would thus be considered equivalent to the predicate devices. No specific performance metrics (like accuracy, sensitivity, specificity for an AI/ML diagnostic) are reported as this is not an AI/ML device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary. Given that this is a traditional medical device and not an AI/ML system, a "test set" in the context of AI model evaluation would not apply. The "study" for extended shelf life would typically involve stability testing, which doesn't directly map to a "test set" as understood for AI/ML.
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 information is not available and is not applicable to this type of device modification. "Ground truth" in the context of expert consensus is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available and is not applicable to this type of device modification.
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
An MRMC comparative effectiveness study is not applicable and was not done, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm is not applicable and was not done, as this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
"Ground truth" as defined for AI/ML performance evaluation is not applicable here. The "truth" in this submission relates to the device's physical properties, sterility, and functional equivalence to its predicates over an extended shelf life. This would be established through bench testing, material characterization, and potentially animal/cadaver studies (for the original device, not necessarily for a shelf-life extension).
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device, and therefore, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device, and therefore, there is no "training set" or ground truth for one.
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DEC 3 0 2008
Arthrex SPECIAL 510(k): Extended Shelf Life for Meniscal and Chondral Dats
4 510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
|---|---|
| 510(k) Contact | Nancy HoftRegulatory Affairs AssociateArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1113Fax: 239/598.5508Email: nancy.hoft@arthrex.com |
| Trade Name | Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex ChondralDart |
| Common Name | Pin, Dart |
| Product Code -Classification Name | HTY-Pin, fixation, smooth MAI-Fastener, Fixation, Biodegradable, Soft Tissue |
| Predicate Devices | K983577, Arthrex Meniscal Dart SystemK991971, Arthrex Chrondral Dart |
| Device Descriptionand Intended Use | The Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and ArthrexChondral Dart are identical to the predicate devices. The ArthrexMeniscal Dart and Arthrex Meniscal Dartstick are intended to be usefor the repair of meniscal tears. The Arthrex Chondral Dart isintended to be used for the fixation of small bone fragments. See theIndications for Use statements for specific indications. |
| SubstantialEquivalenceSummary | The Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and ArthrexChondral Dart are identical to the predicates Arthrex Meniscal DartSystem and Arthrex Chondral Dart in which the basic features andintended uses are the same. Any differences between the ArthrexMeniscal Dart, Arthrex Meniscal Dartstick, and Arthrex Chondral Dartin comparison to the cleared devices in K983577 and K991971 areconsidered minor and do not raise questions concerning safety andeffectiveness. Based on the information submitted, Arthrex, Inc. hasdetermined that the Arthrex Meniscal Dart, Arthrex MeniscalDartstick, and Arthrex Chondral Dart are substantially equivalent tothe currently marketed predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2008
Arthrex, Inc. % Ms. Nancy Hoft Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K082999 Trade/Device Names: Arthrex Menical Dart System Arthrex Chondral Dart Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI, IITY Dated: October 6, 2008 Received: October 8, 2008
Dear Ms. Hoft:
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
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Page 2 - Ms. Nancy Hoft
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 100-100.
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 this, 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 Center for Devices and Radiological Health's (CDRH)'s) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Arthrex
AND THE THE SECTION CONSULTER COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION C
Arthree SPECIAL 510(k): Extended Shelf Life for Meniscal and Chondral Darts
Indications for Use Form
Indications for Use
510(k) Number:
Device Name:
Arthrex Menical Dart System
The Arthrex Meniscal Dart System is intended for the repair of Meniscal tears that would otherwise be considered for standard repair using suture.
Prescription Use _ X _ AND/OR Over-The-Counter Use _ er 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
Page 7 of 133
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Arthrex SPECIAL 510(k): Extended Shelf Life for Meniscal and Chondral DartsIndications for Use
| 510(k) Number: | K082999 |
|---|---|
| Device Name: | Arthrex Chondral Dart |
The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), osteochondral fragments (talus vault, femoral chondyle) and cancellous fragments (talus).
Prescription Use __ X_ AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| PAGE 1 of 1 |
(Division Signature)
Division of General, Restorative
and Neurology Devices
| 510(k) Number | K062999 |
|---|---|
| Page 8 of 133 |
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.