(102 days)
The Ellipse Residual Limb Lengthening System is indicated for lengthening of the residual limb of the femur.
The Ellipse Residual Limb Lengthening (RLL) System is composed of the intramedullary RLL Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The RLL Nail has a 14 mm diameter with a telescoping distal end. The telescoping end has a 100 mm stroke length, making the RLL Nail capable of a maximum distracted length of 230 mm. The RLL Nail utilizes one distal and one proximal locking screw to secure the implant to the bone. The RLL Nail is supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Ellipse RLL System is a non-weight bearing device.
The provided text describes a 510(k) premarket notification for the Ellipse Residual Limb Lengthening System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that the device meets specific clinical acceptance criteria in terms of performance. The information provided heavily relies on non-clinical testing.
Therefore, many of the requested categories cannot be directly addressed from the given text, as they pertain to clinical performance studies.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., success rate of limb lengthening, complication rates within a defined threshold). Instead, it focuses on demonstrating equivalence through mechanical and functional tests.
| Acceptance Criteria Category (Implied) | Reported Device Performance (from non-clinical testing) |
|---|---|
| Mechanical Strength (Static Four Point Bend) | Met: Tested according to ASTM F1264-03, demonstrating equivalence to predicate. |
| Mechanical Strength (Dynamic Four Point Bend) | Met: Tested according to ASTM F1264-03, demonstrating equivalence to predicate. |
| Mechanical Strength (Static Torque to Failure) | Met: Tested according to ASTM F1264-03, demonstrating equivalence to predicate. |
| Sterilization Assurance Level (SAL) | Met: Gamma radiation sterilization cycle validated in accordance with ISO 11137-2, achieving SAL of 10-6. |
| Device Functionality | Met: Design verification and validation performed. |
| Biocompatibility | Met: Applicable testing from predicate (ISO 10993-1) applies due to similar materials/design. |
| Shelf Life (Packaging) | Met: Applicable testing from predicate applies due to similar packaging. |
| O-ring Seal Performance | Met: Applicable testing from predicate applies. |
| External Remote Controller (ERC) Functionality | Met: No changes to ERC, therefore predicate's testing applies to RLL System. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to non-clinical mechanical and functional testing. For these tests, sample sizes are typically determined by the specific ISO/ASTM standards referenced, but are not explicitly stated in this summary. There is no mention of a clinical test set, country of origin, or whether it was retrospective/prospective.
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 is not applicable as no clinical test set requiring expert ground truth or assessment is described in this 510(k) summary. The testing described is non-clinical.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as no clinical test set requiring adjudication is described.
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
This is not applicable. The device is an intramedullary limb lengthening system, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical implant system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described, the "ground truth" is defined by the specifications and requirements of the referenced ASTM/ISO standards and the device's design specifications. For example, the "ground truth" for sterilization is achieving an SAL of 10-6 as per ISO 11137-2. For mechanical tests, it's meeting the load and torque requirements defined by ASTM F1264-03.
8. The sample size for the training set
This is not applicable as the device is a mechanical implant system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
Summary based on available information:
The provided text focuses on demonstrating the substantial equivalence of the Ellipse Residual Limb Lengthening System to a legally marketed predicate device (Ellipse PRECICE® Intramedullary Limb Lengthening System K141023) through a series of non-clinical tests. These tests cover mechanical properties, sterilization, functionality, and biocompatibility, aligning with relevant ASTM and ISO standards. The "acceptance criteria" are implicitly set by these standards and the equivalence to the predicate device. The document does not contain information about clinical performance studies, expert assessment, or AI-related evaluations.
§ 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.