FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This 510(k) summary (K051181) describes a modification to an existing device, the Custom-Hip Tool™. As such, the submission primarily focuses on demonstrating substantial equivalence to the predicate device (Hip Tool™ Implant, K022139) rather than presenting a new clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria are met is not explicitly detailed in this document.

However, based on the provided text, we can infer some aspects and highlight what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary Goal: To demonstrate substantial equivalence to the predicate device (Hip Tool™ Implant, K022139).	The FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This implies that the Custom-Hip Tool™ performs comparably to the predicate for stabilizing bone grafts within the femoral head and neck to assist healing of an intraosseous fracture.
Functional Equivalence: The Custom-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture, consistent with the predicate device.	The FDA concurrence on "Indications For Use" confirms that the Custom-Hip Tool™ meets this intended use.
Safety and Effectiveness Equivalence: The modified device should not raise new questions of safety or effectiveness compared to the predicate.	The FDA's finding of substantial equivalence implicitly means that the device's safety and effectiveness profiles are considered equivalent to the predicate, as no new safety or effectiveness concerns were raised that would prevent clearance.

Missing Information:

Specific quantitative acceptance criteria: The document does not specify quantitative performance metrics (e.g., tensile strength, fatigue life, stability under certain loads, specific healing rates, or accuracy of placement) for the Custom-Hip Tool™ or the predicate device that were used to establish substantial equivalence.
Specific comparative performance data: No explicit data comparing the performance of the Custom-Hip Tool™ to the Hip Tool™ Implant (K022139) is presented in this summary. The substantial equivalence determination is a regulatory finding, not a disclosure of a full performance study report.

2. Sample Size Used for the Test Set and Data Provenance

This 510(k) summary does not describe a de novo study with a test set. The submission is for a device modification, relying on the substantial equivalence to a predicate device. Therefore, information on a "test set" in the context of an original clinical or performance study is not provided.

If there were any in vitro or in vivo bench testing performed to support the modification, the details (sample size, data provenance) are not included in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable or provided. Since no clinical or performance study with a test set (requiring ground truth) is described in this 510(k) summary, there is no mention of experts or their qualifications for establishing ground truth. The FDA's review for substantial equivalence is based on the information provided by the manufacturer, which typically includes device specifications, design comparisons, and potentially bench testing, rather than a new clinical study.

4. Adjudication Method for the Test Set

This information is not applicable or provided for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable or provided. The Custom-Hip Tool™ is a medical implant intended to stabilize bone grafts. It is not an imaging device or AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable or provided. The Custom-Hip Tool™ is an implantable device, not a software algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

This information is not applicable or provided. As there is no de novo study with a test set generating new "ground truth," this concept is not discussed in the summary. The substantial equivalence determination relies on the existing knowledge and regulatory history of the predicate device.

8. Sample Size for the Training Set

This information is not applicable or provided. The Custom-Hip Tool™ is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI model development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or provided for the same reasons as point 8.

Summary

Regulation Number and Section

§ 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.