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

2.7 / 3.5mm Wise-Lock Superior Anterior Clavicle Plate with Lateral Extension Indicated for fixation of fractures, malunions, non-unions, and osteotomies for the clavicle.

3.5mm Wise-Lock S Clavicle Plate Indicated to provide fixation for fractures, fusion, or osteotomies for the clavicle.

Device Description

Clavicle and Scapula System consists various types of bone plates, Screws for implantation & fixation of Clavicle and Scapula bone fractures. The plates are designed to match the and Scapula bones with a limited contact low profile design. Scapula Plates are featured with only locking holes. However, Clavicle plates are featured with locking holes, combiholes, compression holes as well as static holes for better fixation of implant. All the plates and screws included in the system are available in both Stainless Steel as per ASTM F138 and Titanium material as per ASTM F136. The Scapula System consists of a medial border plate. It also consist of 3.5mm cortical screws, and 4.0 mm Cancellous screws for the fixation of bone plate to the bone. Similarly, the Clavicle system consists of Hook plate, and S Clavicle plate for fixation of clavicle bone. In this system for fixation of bone various lengths of 2.7 & 3.5mm cortical screws, 2.7 & 3.5 mm wise lock screws and 2.7 & 3.5mm AV wise lock screw are used.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Clavicle and Scapula System" by Auxein Medical Pvt. Ltd. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical study data for acceptance criteria.

Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, as it would for a novel device requiring more extensive clinical validation. The information provided heavily emphasizes comparison to predicate devices for substantial equivalence.

However, I can extract the information that is present and indicate where requested information is not available:

Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical or diagnostic context. Instead, it relies on demonstrating substantial equivalence through non-clinical testing.

Acceptance Criteria (Implied from testing)	Reported Device Performance (Non-Clinical Testing)
Equivalent mechanical properties to predicate device	Performed Static and dynamic four-point bend test (ASTM F384) on subject device and predicate device.
No significant changes in parameters compared to predicate.	"The test report of both the subject device and previewed and compared with each other on each parameter and there is no any significant changes between them."

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not explicitly stated as a "test set" in the context of clinical data. For the non-clinical static and dynamic four-point bend tests (ASTM F384), the sample size for the devices tested is not specified in this summary.
- Data provenance: For the non-clinical tests, the origin of the data (country where the tests were performed) is not stated. The type of testing is non-clinical/mechanical, not retrospective or prospective clinical data.
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)

Not applicable. The document describes non-clinical mechanical testing, not clinical evaluation requiring expert interpretation or ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study with image interpretations or other data requiring adjudication.
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

No MRMC study was done. This device is a bone fixation system, not an AI or imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of clinical "ground truth." For the non-clinical mechanical tests, the "ground truth" would be the engineering specifications and established mechanical properties of the predicate device as per ASTM F384.
The sample size for the training set

Not applicable. This device is a physical implant, not an AI/ML model that requires a training set.
How the ground truth for the training set was established

Not applicable. See 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.