(31 days)
Synthes Small Adjustable Clamps - MR Safe Line Extension are intended for fractures of the distal radius, fractures and dislocations of the hand, wrist, mandible and foot (including open and/or bilateral fractures); fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; and failed closed reduction and casting resulting in secondary deformity of the distal radius.
Synthes Small Adjustable Clamps - MR Safe Line Extension are components of an external fixation frame that forms a construct intended to treat the hand, wrist, mandible and foot. They are all made from nonmagnetic materials and are intended to be used in an MR environment. An MR environment is described as the general environment present in the vicinity of an MR Scanner and/or anywhere in the procedure room, including the center of the bore of the MR Scanner. When used in a frame construct, the Small Adjustable Clamp-MR Safe accepts Synthes 4.0 mm carbon fiber rods and Synthes 4.0/4.0, 4.0/3.0 and 4.0/2.5 mm Schanz screws.
The provided text is related to a 510(k) premarket notification for a medical device: "Synthes (USA) Small Adjustable Clamp – MR Safe Line Extension". The document focuses on establishing substantial equivalence to legally marketed predicate devices, rather than detailing a study proving the device meets specific performance acceptance criteria in the way described in the request.
Therefore, many of the requested details about acceptance criteria, study performance, sample sizes, expert involvement, and ground truth establishment are not available in the provided text. The document is about regulatory clearance based on substantial equivalence, not a performance study.
However, based on the information provided, here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
- Not Available. The document does not specify quantitative acceptance criteria or a performance study with reported metrics for the "Synthes (USA) Small Adjustable Clamp – MR Safe Line Extension" itself. It asserts that the device is "MR Safe" and provides an intended use. The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a predicate device, often through design comparison, material properties, and intended use, rather than a new clinical performance study with defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Not Available. No test set or data provenance details are provided as a performance study was not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Available. No ground truth establishment is described for a performance study.
4. Adjudication method for the test set:
- Not Available. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 mechanical clamp, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a mechanical clamp; it is not an algorithm.
7. The type of ground truth used:
- Not Available. The document does not describe the establishment of a "ground truth" in the context of a performance study. The "ground truth" for regulatory clearance is generally the safety and effectiveness of the legally marketed predicate device.
8. The sample size for the training set:
- Not Applicable/Not Available. There is no mention of a "training set" as this is not an AI/algorithm device.
9. How the ground truth for the training set was established:
- Not Applicable/Not Available. There is no mention of a "training set" or its ground truth.
Summary of available information from the document:
- Device Name: Synthes (USA) Small Adjustable Clamp – MR Safe Line Extension
- Intended Use: For fractures of the distal radius, fractures and dislocations of the hand, wrist, mandible and foot (including open and/or bilateral fractures); fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; and failed closed reduction and casting resulting in secondary deformity of the distal radius.
- Key Feature: "MR Safe" – meaning it is intended to be used in an MR environment. This "MR Safe" designation implies that specific testing (e.g., magnetic field interactions, RF-induced heating, artifact testing) would have been performed to support this claim, but the details of these tests (acceptance criteria, specific results) are not in the provided text.
- Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
- Predicate Devices: Synthes 4.0 mm Adjustable Clamp for Distal Radius Fixator - MR Safe; Synthes Small Combination Clamp - MR Safe; Synthes Small Adjustable Clamps - MR Safe.
In conclusion, the provided text is a regulatory filing for substantial equivalence for a mechanical medical device, not a performance study that would typically include the requested details about acceptance criteria and quantitative performance metrics. While the device claims to be "MR Safe," the specific test data and acceptance criteria for that claim are not included in this summary document.
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Page __ 1 __ of __ 1 3.0 510(k) Summary Synthes (USA) Sponsor: 1302 Wrights Lane East West Chester, PA 19380 (610) 719-5000 Synthes (USA) Small Adjustable Clamp - MR Safe Line Extension Device Name: Class II, $888.3030 -- Single/multiple component bone fixation appliances Classification: and accessories Synthes 4.0 mm Adjustable Clamp for Distal Radius Fixator - MR Safe Predicate Device: Synthes Small Combination Clamp - MR Safe Synthes Small Adjustable Clamps - MR Safe Line Extension are Device Description: components of an external fixation frame that forms a construct intended to treat the hand, wrist, mandible and foot. They are all made from nonmagnetic materials and are intended to be used in an MR environment. An MR environment is described as the general environment present in the vicinity of an MR Scanner and/or anywhere in the procedure room, including the center of the bore of the MR Scanner. When used in a frame construct, the Small Adjustable Clamp-MR Safe accepts Synthes 4.0 mm carbon fiber rods and Synthes 4.0/4.0, 4.0/3.0 and 4.0/2.5 mm Schanz screws. Synthes Small Adjustable Clamps - MR Safe Line Extension are intended Intended Use: for fractures of the distal radius, fractures and dislocations of the hand, wrist, mandible and foot (including open and/or bilateral fractures); fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement: and failed closed reduction and casting resulting in secondary deformity of the distal radius. Documentation is provided which demonstrates that the Synthes (USA) Substantial Equivalence: Small Adjustable Clamps- MR Safe Line Extension is substantially equivalent to other legally marketed devices.
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APR 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sheri L. Musgnung Sr. Regulatory Affairs Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania
Re: K050631
Trade/Device Name: Synthes (USA) Small Adjustable Clamp – MR Safe Line Extension Regulation Numbers: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: LXT Dated: March 10, 2005 Received: March 11, 2005
Dear Ms.Musgnung:
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 - Ms. Sheri L. Musgnung
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) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Stupt Plurdes
Miriam Provost, Ph.D.
Acting 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
510(k) Number (if known):
Synthes (USA) Small Adjustable Clamp - MR Safe Line Extension Device Name:
Indications for Use:
Synthes Small Adjustable Clamps - MR Safe Line Extension are intended for fractures of the distal radius, fractures and dislocations of the hand, wrist, mandible and foot (including open and/or bilateral fractures); fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; and failed closed reduction and casting resulting in secondary deformity of the distal radius.
Prescription Use X (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hught Charles
Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.