(228 days)
The SLIM System is intended as a temporary implant for alignment, stabilization of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes the femur, tibia, humerus, ulna and fibula of the pediatric population (child and adolescent) , and patients with small intramedulary canals affected by skeletal displasias, osteogenesis imperfecta or other bone diseases.
The Simple Locking IntraMedullary (SLIM) System consists of intramedullary fixation devices for use in long bones. The solid shaft and bevelled point are designed for quided insertion through the medullary canal. Anchorage of the device is achieved through a conical thread for a wedged fixation in the epiphyses or cortical bone, which aims to reduce the risk of migration. Internal features, such as a hexagonal drive and an internal mechanical thread in the device, allow for capture and quidance during insertion and retrieval. Additional proximal and distal locking holes provide supplementary pinning options when required. The SLIM, single-use, implants are manufactured in medical grade Stainless Steel (SS316L, ASTM F138). The rods are available in seven diameters: 2.0, 2.6. 3.2, 4.0. 4.8, 5.6 and 6.4 mm, from 80mm up to 400 mm in length.
The provided document is a 510(k) premarket notification decision letter and summary for a medical device called "The Simple Locking IntraMedullary (SLIM) System." This type of document establishes substantial equivalence to existing devices and generally does not contain detailed acceptance criteria and studies as would be found in a clinical trial report for an AI/CADe device.
Therefore, many of the requested details, particularly those related to AI/CADe performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment, are not applicable or not present in this document.
However, I can extract information related to the device's performance based on the non-clinical performance data section, which focuses on mechanical properties.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a mechanical device, the "acceptance criteria" are related to mechanical properties and equivalence to a predicate device. The document does not explicitly state numerical acceptance criteria in a pass/fail format but rather compares the SLIM system's performance to a predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (SLIM System) |
|---|---|
| Mechanical properties are equivalent or superior to the predicate device (Synthes SS Elastic Intramedullary Nail System [K081452]). | "The SLIM system's mechanical properties are superior to that of the Synthes SS Elastic Intramedullary Nail System." |
| Static four-point bending bench testing performance is equivalent to the predicate (STEN system). | "Results of the static ... four-point bending bench testing on the SLIM and STEN system have demonstrated that the SLIM system performed equivalently as the predicate STEN system." |
| Fatigue four-point bending bench testing performance is equivalent to the predicate (STEN system). | "Results of the ... fatigue four-point bending bench testing on the SLIM and STEN system have demonstrated that the SLIM system performed equivalently as the predicate STEN system." |
| Safety and effectiveness for intended use. | "As per the findings of the bench testing and the scientific literature review, the data supports the use of this product as safe and effective for its intended use; the anticipated benefits of such a system clearly outweigh the possible residual risks." |
Regarding the other requested information:
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2. Sample size for the test set and data provenance:
- Sample size: Not specified. The studies mentioned are "four-point bending bench testing" on the SLIM system and the STEN system. The number of samples (e.g., number of rods tested) is not provided.
- Data provenance: Bench testing results. Location of testing and design of the test samples are not mentioned.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for mechanical testing would be the measured physical properties, not expert consensus.
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4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Mechanical test results do not involve adjudication by experts in this context.
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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 physical intramedullary rod, not an AI/CADe system for image interpretation.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical performance data was objective mechanical measurements (e.g., strength, fatigue resistance).
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8. The sample size for the training set: Not applicable. There is no AI/machine learning component mentioned, thus no training set in the AI sense.
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9. How the ground truth for the training set was established: Not applicable.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.