(136 days)
Medline Renewal Reprocessed Synthes Small External Fixation System is intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for
- Preliminary fixation before ORIF
- Unstable fractures of the distal radius (both intra- and extra-articular)
- Open and/or comminuted bilateral fractures
- Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement
- Fracture dislocations
- Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations)
- Pediatric open fractures with bone loss and osteotomies.
Medline ReNewal Reprocessed Synthes Medium External Fixation System MR Conditional is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures.
Medline ReNewal Reprocessed Synthes Large External Fixation System is intended to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
- Stabilization of soft tissues and fractures
- Polytrauma/multiple orthopedic trauma
- Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
- Arthrodeses and osteotomies with soft tissue problems; failures of total joints
- Neutralization of fractures stabilized with limited internal fixation
- Non-unions/septic non-unions
- Intra-operative reductions/stabilization tool to assist with indirect reduction;
- Unilateral rectilinear bone segment transport or leg lengthening
Medline ReNewal Reprocessed Synthes Distraction Osteogenesis System MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
The Medline ReNewal Reprocessed Synthes External Fixation Systems, devices consist of various clamps, posts, and bars, which are used to construct external fixation frames in the treatment of various types of fractures.
This document, K171911, is a 510(k) premarket notification for Medline ReNewal Reprocessed Synthes External Fixation Systems. It focuses on demonstrating substantial equivalence to predicate devices, primarily through performance testing related to the reprocessing of the devices. The document does not describe an artificial intelligence (AI) device or a study involving human readers and AI assistance for diagnostic purposes.
Therefore, many of the requested items related to AI device performance, sample sizes for test/training sets, expert ground truth establishment, and multi-reader multi-case studies are not applicable to the content of this regulatory submission.
However, I can extract information regarding the performance testing conducted to prove the reprocessing meets the acceptance criteria for substantial equivalence to the original devices.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Medline ReNewal Reprocessed Synthes External Fixation Systems are based on demonstrating functional equivalence to the predicate (new, un-reprocessed) devices. The testing performed evaluates the integrity and cleanliness of the reprocessed devices.
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Functional Performance | Simulated use and artificial soiling | Determined to be substantially equivalent to the predicate device. |
| Structural integrity | Determined to be substantially equivalent to the predicate device. | |
| Carbon rod stiffness (pre-conditioning, 4-point bend test) | Determined to be substantially equivalent to the predicate device. | |
| Cyclical axial compression and tension bending test | Determined to be substantially equivalent to the predicate device. | |
| Carbon rod stiffness (post-conditioning, 4-point bend test) | Determined to be substantially equivalent to the predicate device. | |
| Disassembly and reassembly (pre- and post-sterilization) | Determined to be substantially equivalent to the predicate device. | |
| Cleaning | Visual inspection | Determined to be substantially equivalent to the predicate device. |
Please note: The document states "Determined to be substantially equivalent to the predicate device" for each test. It does not provide specific numerical results or pass/fail thresholds for these tests within the provided text. The implication is that the reprocessed devices performed comparably to new devices.
Study Details (as applicable to this non-AI medical device reprocessing submission)
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size (number of reprocessed units) for each test. These are typically bench tests.
- Data Provenance: The tests were conducted by Medline ReNewal (Surgical Instrument Service and Savings) as part of their 510(k) submission, implying an internal, prospective study to support regulatory clearance. The country of origin for the data is implicitly the USA, where Medline ReNewal is based and operates.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not directly applicable to the functional and cleaning tests performed on reprocessed medical devices. Ground truth here is defined by performance specifications for new devices, and the acceptance criteria are met if the reprocessed devices perform equivalently to these specifications. No "experts" in the sense of clinicians or radiologists establishing a diagnostic ground truth are mentioned or needed for these types of engineering/performance tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical or diagnostic studies to resolve discordant readings among multiple human annotators, which is not the nature of this submission's testing.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, which is not the subject of this 510(k) submission. This submission concerns the substantial equivalence of reprocessed surgical instruments to their new counterparts.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is not for an AI algorithm. The performance testing is for physical medical devices after reprocessing.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study is the established performance specifications and characteristics of equivalent new, un-reprocessed Synthes External Fixation Systems (the predicate devices). The reprocessed devices are tested to show they meet these same performance levels. It's a comparison to an accepted standard for new devices, not a diagnostic ground truth based on patient outcomes or expert reads.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
§ 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.