(33 days)
The PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femur.
The PRECICE Intramedullary Limb Lengthening (IMLL) System is composed of the PRECICE Nail. locking screws, end cap, surgical instruments, and an External Remote Controller (ERC or ERC 2P). The nail is available in tibial and femoral models; with various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters, lengths, and thread styles. The PRECICE Nail is supplied sterile by gamma radiation; the locking screws and surgical instruments are supplied non sterile, and must be sterilized prior to use.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria with specific numerical targets. The "acceptance criteria" here are implied to be that the new device components (new screw thread styles) maintain the same or similar performance characteristics as the predicate device's existing components.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain substantial equivalence to predicate device (K160325) for overall system (nail, end cap, instruments, ERC). | Technological characteristics of subject PRECICE Nails, end cap, instruments, and External Remote Controller (ERC and ERC 2P) are identical to the predicate device. All previous testing on these predicate components is applicable. |
| New screw thread styles (partially threaded and fully threaded) integrate effectively into the system. | Assessment of substantial equivalence is based on mechanical testing previously performed on the same screws used in the reference device system (K160267). |
| Mechanical performance of new screws meets recognized standards. | Mechanical testing on locking screws previously performed according to ASTM F1264-14 and ASTM F543-13. |
| Device is sterile and non-pyrogenic. | Pyrogen testing performed per ANSI/AAMI ST72:2011 to ensure it meets pyrogen limit specifications for sterile implant devices. |
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" for this submission. The document states that testing was previously performed on the predicate components and on the same screws used in a reference device (K160267). The specific number of screws or nails tested in those prior studies is not mentioned.
- Data Provenance: Not explicitly stated. The document refers to prior testing, but doesn't specify the country of origin or if the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This submission focuses on engineering and biocompatibility testing (mechanical, pyrogen), not on clinical performance evaluated by experts with patient data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None. As this is not a clinical study involving expert interpretation, there is no adjudication method.
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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:
- Not applicable. This is a medical device for bone lengthening, not an AI-assisted diagnostic or therapeutic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical implantable device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth for Mechanical Testing: Adherence to established ASTM standards (material properties, strength, fatigue resistance, etc.) defining acceptable performance for orthopedic implants and screws.
- Ground Truth for Pyrogen Testing: Compliance with ANSI/AAMI ST72:2011 specifications for bacterial endotoxins.
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The sample size for the training set:
- Not applicable. This is a physical device, not a machine learning model that requires a training set.
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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.