Search Results

NEOTIS Plate is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.

The NEOTIS plate is designed for medial approach High Tibial Osteotomy stabilization. Anatomically shaped, thin and short, the NEOTIS plate enables minimally invasive surgery. The changes brought by the NEOTIS plate are as follows (vs. OTIS-C Plus plate):

• The proximal temporary screw is replaced with a pin that offers a simpler and faster placement of the plate. The area of the cortical bone drilled through the process is also reduced.
• The distal temporary screw is replaced with an AO screw in order to maintain compression. The compression will be maintained by the 4 permanent 6.5 mm screws (OTIS screws).

The provided documentation describes a traditional 510(k) submission for the NEOTIS Plate and Screws, a medical device for bone fixation. Here's a breakdown of the acceptance criteria and the study information as extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions a "cadaver study" but does not provide details on the number of cadavers or specimens used.
• Data Provenance: The cadaver study is implied to be laboratory-based (non-clinical performance testing). The document does not specify the country of origin for the cadaver data, nor does it explicitly state if it was retrospective or prospective, though "non-clinical performance testing" typically implies prospective experimental testing.

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

• The documentation does not provide information about experts establishing ground truth for the cadaver study. The study appears to be a mechanical performance test rather than one requiring clinical interpretation by experts to establish ground truth.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. The study described is a non-clinical performance test, not a study involving human interpretation with adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The device is hardware (plate and screws), not an AI algorithm or diagnostic tool that would typically undergo an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, this is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

• For the cadaver study, the "ground truth" was the level of compression induced by the device during placement. This is a direct physical measurement/observation in a controlled experimental setting, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. The device is not an AI/ML algorithm.

Ask a specific question about this device

BIOSORB Resorbable Bone Void Filler is a resorbable calclum salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB Resorbable BoneVoid Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans.

In addition, when used with appropriate opening osteotomy system devices, plates and screws, BIOSORB Resorbable Bone Void Filler Is Intended to be used as a bone void filler in tiblal osteotomies.

BIOSORB bone void filler (K021963 and K071155) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (βΤCP) indicated for Bone Void Filling.

BIOSORB bone void filler presents a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. BIOSORB bone void filler implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues.

To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of BIOSORB RESORBABLE BONE VOID FILLER will comprise:

• 9 shapes: stick, granule, cube, block (6 shapes) o
• 3 material specifications: BIOSORB 30, BIOSORB 45 and BIOSORB 70 o
• 3 packaging: box, vial, syringe 0

The design modifications of the new NEOTIS set of wedges with respect to OTIS set of wedges include a sharper anterior area and a wider posterior area more fitting the natural tibia anatomy. 3 letters are printed to help the surgeon with the wedge orientation: A stands for Anterior, M stands for Medial and P for Posterior.

There are 50 NEOTIS parts instead of 10 OTIS parts, so that the range is increased.

Here's a breakdown of the acceptance criteria and study information for the BIOSORB Resorbable Bone Void Filler, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "cadaveric labs" but does not specify the number of cadavers or individual tests performed.
• Data Provenance: The cadaveric labs likely involved human cadavers. The country of origin is not specified, but the submitter is based in France. The study was prospective in the sense that new tests were conducted for this submission.

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

• Number of Experts: Not explicitly stated, however, the document refers to validation "by surgeons." This implies multiple surgeons were involved.
• Qualifications of Experts: "Surgeons" are the explicitly stated experts. No further details on their specific qualifications (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document only states that the enhanced anatomical fitting was "verified by surgeons." It doesn't detail how consensus was reached or how discrepancies (if any) were handled among the surgeons.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The study focused on verifying the anatomical fitting of the device through cadaveric labs, not on comparing human reader performance with and without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: No, this is not applicable. The device is a physical bone void filler, not an AI algorithm. The performance evaluation involved physical assessment by surgeons in cadaveric labs.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the device's enhanced anatomical fitting was based on expert assessment/consensus by surgeons through cadaveric labs.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The development of the device design would involve engineering and material science principles, possibly with iterative design and testing, but not a "training set" in the context of machine learning.

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

• Ground Truth for Training Set: Not applicable, as this is not an AI/ML device. The design evolution of the BIOSORB Resorbable Bone Void Filler was likely informed by clinical experience with previous versions (K021963 and K071155) and anatomical considerations.

Ask a specific question about this device