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The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo Cortical Bone Screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The design and materials for the Osteo Compression Hip Screw System are determined to be substantially equivalent via 510(k)s #K971654, #K971321 and #K920037, and remain unchanged from these previous submissions.

AI/ML Overview

The provided 510(k) Premarket Notification for the Osteo Compression Hip Screw System - Expanded Indication does not contain the typical information required to describe acceptance criteria and a study proving device performance as it relates to software or AI/ML-based medical devices.

This submission is for a mechanical medical device (an implantable hip screw system) and therefore the evaluation for its expanded indication focuses on demonstrating substantial equivalence to a predicate device, rather than performance metrics of a diagnostic or predictive algorithm.

Therefore, most of the requested information (items 1-9) about acceptance criteria, study sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training sets is not applicable to this type of device submission.

Here's an explanation based on the content provided:

1. A table of acceptance criteria and the reported device performance

Not Applicable. Mechanical devices like the Osteo Compression Hip Screw System are not typically evaluated using performance metrics like sensitivity, specificity, or accuracy in the same way software devices are. The "acceptance criteria" for such a device largely revolve around demonstrating substantial equivalence in design, materials, and intended use to a legally marketed predicate device, and ensuring it meets relevant safety and performance standards (e.g., mechanical tests, biocompatibility). The document does not report performance data in the context of clinical outcomes or diagnostic accuracy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. There is no "test set" of patient data in the context of evaluating a diagnostic or predictive algorithm. The device is a physical implant. The evaluation is based on engineering principles, materials science, and comparison to a predicate device, not clinical data demonstrating diagnostic performance on a test set.

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)

Not Applicable. Ground truth, in the context of diagnostic performance, is not established for this type of mechanical device. The "truth" in this context is the safety and effectiveness of the device as an implant, which is assessed through a regulatory pathway of substantial equivalence and adherence to engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As there is no test set for diagnostic performance, there is no adjudication method.

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

Not Applicable. An MRMC study is relevant for evaluating the impact of AI/software on human diagnostic performance. This device is a surgical implant and does not involve human "readers" or AI assistance in diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a mechanical surgical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable. Ground truth in the diagnostic sense is not used here. Device safety and effectiveness are established through demonstrating substantial equivalence, mechanical testing, and biocompatibility, not by comparing its "readings" to a ground truth.

8. The sample size for the training set

Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. No training set exists for this type of device.

Summary of the Provided Information for this Mechanical Device:

The document describes the Osteo Compression Hip Screw System as a proximal fracture fixation system for hip fractures.

Intended Use: To provide strong and stable internal fixation with minimal soft tissue irritation for various femoral fractures.
Expanded Indications: The current submission seeks to expand the indications to include extracapsular fractures of the proximal femur (basal neck, trochanteric, and subtrochanteric fractures).
Predicate Device: Synthes DHS® Dynamic Hip Screw System.
Basis for Acceptance: The submission relies on demonstrating substantial equivalence in intended use, design, and materials to previously cleared Osteo Compression Hip Screw System components (K971654, K971321, K920037) and to the predicate Synthes DHS® Dynamic Hip Screw System for the expanded indications. The FDA's letter (K982553) confirms this finding of substantial equivalence.
Safety and Performance: While not explicitly detailed in the provided snippets, for mechanical devices, "acceptance criteria" would typically involve:
- Material compatibility: Biocompatibility testing to ensure the materials are safe for implantation.
- Mechanical strength and fatigue testing: To ensure the device can withstand the physiological loads it will be subjected to without failure.
- Design similarities: Comparison of design features (e.g., screw threads, plate geometry, dimensions) to predicate devices to argue for similar performance and safety profiles.
- Manufacturing quality: Adherence to Good Manufacturing Practices (GMP) and Quality System Regulation (QS) indicated by the FDA's notice.

The study proving the device meets its "acceptance criteria" in this context is the substantive comparison to predicate devices and established standards, not a clinical study yielding performance metrics against a ground truth as would be done for an AI/ML device.

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K Number

K971654

Device Name

OSTEO COMPRESSION HIP SCREW SYSTEM

Manufacturer

OSTEONICS CORP.

Date Cleared

1997-07-09

(64 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide internal fixation with minimal soft tissue irritation. It is a system which optimally engages the femoral head and permits impaction of bone fracture fragments. Osteo Cortical Bone Screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The Osteo Compression Hip Screw System is indicated for the following proximal fractures of the femur:

Intracapsular fractures of the femoral neck. .
Intertrochanteric fractures of the femur. .

Device Description

Osteo Compression Hip Screw Plates:
The subject Osteo Compression Hip Screw Plates are part of the Osteo Compression Hip Screw System. These plates are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile and sterile.

130° Compression Hip Screw Plates: The Osteo 130° Compression Hip Screw Plates are available in three lengths (75mm, 91mm, and 107mm) with 4, 5, and 6 screw holes, respectively, for varied clinical situations. All plates have a 38mm barrel length and feature a 130° barrel angle. The barrel slides over the inserted lag screw; a compression screw may be used for additional compression of the fracture area. These plates have round holes which accommodate Osteo Cortical Bone Screws with a 4.5mm diameter.

Short Barrel Compression Hip Screw Plates: The Osteo Short Barrel Compression Hip Screw Plates are available in lengths of 75mm and 107mm, with either 4 or 6 screw holes, and two barrel angles (135° and 150°) for varied clinical situations. All plates have a 25mm barrel length.

Osteo Super Lag Screw:
The Osteo Super Lag Screw is available in lengths from 50mm to 145mm. All Osteo Super Lag Screws feature a 22mm thread length,14mm thread diameter, and self tapping thread. These lag screws are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile and sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Osteo Compression Hip Screw System - Product Line Extensions. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study with acceptance criteria.

Therefore, many of the requested sections about explicit acceptance criteria and a study proving those criteria are not directly available in this type of submission. 510(k) submissions for devices like this typically rely on comparison to existing legally marketed devices, material testing, and design features to demonstrate safety and effectiveness, rather than clinical efficacy studies with specific performance metrics and acceptance criteria.

However, I can extract information related to the device description and intended use, and explain why other sections are not present.

Acceptance Criteria and Reported Device Performance:

No explicit acceptance criteria or reported device performance metrics are provided in this 510(k) submission. The submission is based on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance targets from a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not applicable - 510(k) submission focuses on substantial equivalence rather than explicit performance criteria.	Not explicitly reported as a performance study was not conducted for this 510(k) clearance.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not applicable. This 510(k) submission does not describe a clinical performance study with a test set.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This 510(k) submission does not describe a clinical performance study requiring expert adjudication for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi-reader multicase (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 device is a mechanical orthopedic implant, not an AI-driven diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a mechanical orthopedic implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. As a mechanical orthopedic implant demonstrating substantial equivalence, "ground truth" in the context of diagnostic accuracy or clinical outcomes is not the primary focus of this 510(k) submission. The "truth" here relates to the safety and mechanical function being similar to the predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established:

Not applicable.

Additional Information from the Submission:

Device Description: The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw. It is intended to provide strong and stable internal fixation with minimal soft tissue irritation for intertrochanteric and intracapsular femoral neck fractures.
Predicate Device: The Howmedica Omega Plus Compression Hip Screw System.
Basis for Clearance: Substantial equivalence in design, materials, and intended use to the predicate device. The materials are ASTM F-138 Stainless Steel (Grade 2, 316LVM).
This 510(k) is for "Product Line Extensions" of an existing system, indicating that the core technology was likely cleared previously.

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