(85 days)
The Harvester SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroillitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
The Harvester SI: Sacroiliac Fixation System (also called Harvest SI Sacroiliac Joint Fusion System and Harvester SI Fusion System) is comprised of threaded fusion implants for coupling and fusing the ilium to the sacroiliac fusion). The goal of the fusion arthrodesis is to immobilize the sacroiliac joint with two (2) or more threaded implants. The procedure may or may not be bilateral. The Harvester SI System Fusion implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Harvester SI Fusion System is offered in various diameters and lengths to accommodate patient anatomy. Instruments are provided that facilitate the insertion of the implants.
This document describes the Harvester SI: Sacroiliac Fixation System, a medical device intended for sacroiliac joint fusion. The information provided focuses on the device's technical characteristics, indications for use, and a comparison to predicate devices, supported by non-clinical performance data.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance for the Harvester SI: Sacroiliac Fixation System. Instead, it lists the types of non-clinical tests performed and states a general conclusion:
Test Performed Reported Device Performance Axial pullout per ASTM F543 Sufficient for intended use, substantially equivalent to predicate devices Torsional properties per ASTM F543 Sufficient for intended use, substantially equivalent to predicate devices Static cantilever bending per ASTM F2193 Sufficient for intended use, substantially equivalent to predicate devices Dynamic cantilever bending per ASTM F2193 Sufficient for intended use, substantially equivalent to predicate devices The "acceptance criteria" are implied by the statement "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This suggests that the device's performance in these tests met pre-defined thresholds or demonstrated comparable performance to existing, cleared devices. Specific numerical acceptance criteria are not provided in this document.
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Sample size used for the test set and the data provenance
The document describes non-clinical testing on the device itself (Harvester SI Sacroiliac Fixation System components). It does not mention any studies involving human subjects or patient data. Therefore, concepts like sample size for a "test set" in a clinical context or data provenance (country of origin, retrospective/prospective) are not applicable to the information provided. The "sample" here would refer to the number of device components tested for each mechanical property, which is not specified but is typical for mechanical testing standards like ASTM F543 and F2193.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This point is not applicable as the study described is non-clinical (mechanical testing) of a device, not a study evaluating an AI algorithm's performance against human expert consensus or a clinical ground truth.
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Adjudication method for the test set
This point is not applicable as the study described is non-clinical (mechanical testing). Adjudication methods are typically relevant for clinical studies or studies where expert consensus is needed to establish a ground truth.
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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
This point is not applicable. The document describes the mechanical testing of a physical medical device (sacroiliac fixation system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and effects on human readers are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable. The device is a physical sacroiliac fixation system, not an algorithm or software.
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The type of ground truth used
For the non-clinical performance data, the "ground truth" used is the mechanical performance standards (ASTM F543 for axial pullout and torsional properties, ASTM F2193 for cantilever bending) and the performance characteristics of legally marketed predicate devices. The device's performance is compared against these engineering standards and existing devices to demonstrate substantial equivalence, rather than a clinical ground truth like pathology or outcomes data.
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The sample size for the training set
This point is not applicable. The document describes mechanical testing of a physical medical device, not the development or evaluation of an AI algorithm that would require a training set.
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How the ground truth for the training set was established
This point is not applicable, as there is no training set mentioned or implied for an AI algorithm.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.