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OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.

The OTIS-C Plus plate is designed for the stabilization of High Tibial Osteotomy with a medial approach. Anatomically shaped, thin and short, the OTTS-C Plus plate enables mini-invasive surgery. Its locking system provides immediate compression of the graft as well as stable fixation, thus allowing early weight-bearing. The selftapping OTIS-C Plus screws allows easy and reliable one step locking, without counternut, in a simple and concise approach. With its range of twelve screws lengths, fixation can be either mono or bi-cortical, upon the choice of the surgeon.

The provided document is a 510(k) summary for a medical device (OTIS-C Plus) and does not contain information about a study with acceptance criteria often seen for AI/ML-driven devices. Instead, it describes non-clinical performance testing for a traditional metallic bone fixation appliance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information, ground truth types) are not applicable to the information provided in this document excerpt.

However, I can extract the relevant information regarding the performance claims and the type of testing performed.

1. Table of acceptance criteria and the reported device performance

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

This information is not provided in the document for the non-clinical performance testing. The "test set" in this context refers to the samples of the device components (plates and screws) used for mechanical and corrosion testing, not a clinical data 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)

This is not applicable. The ground truth for mechanical testing is derived from engineering standards and physical measurements, not expert consensus.

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

This is not applicable. Adjudication methods are typically used for clinical study data, not for non-clinical mechanical testing.

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

This is not applicable. This document describes a traditional medical device (bone plate and screws), not an AI/ML-driven diagnostic or assistive technology.

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

This is not applicable. This describes a physical medical device.

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

For the non-clinical performance testing, the "ground truth" (or reference standard) would be established by engineering standards, material properties, and validated testing methodologies (e.g., ISO, ASTM standards for material testing) to measure the mechanical properties of the device components.

8. The sample size for the training set

This is not applicable. This document describes a traditional medical device, not an AI/ML system requiring a training set.

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

This is not applicable. This document describes a traditional medical device, not an AI/ML system.

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BIOSORB® Resorbable Void Filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.

BIOSORB® Resorbable Void 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.

BIOSORB® is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (ßTCP) indicated for Bone Void Filling.

BIOSORB® implants are available in various shapes and sizes in order to fill various bone defect. Shapes are basic such as granules, cylinders, blocks and cubes.

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

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria in terms of specific numerical thresholds (e.g., "resorption rate must be X% by Y weeks"). Instead, the device is deemed acceptable through demonstrating substantial equivalence to predicate devices by meeting recognized standards and exhibiting similar performance for key characteristics.

Therefore, the table below reflects what appear to be the implicit acceptance criteria based on the comparisons made and the studies performed, and the reported performance.

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

The document describes several studies:

• Animal Studies:
  • Osseous Rehabilitation: Rabbit condyles were used for histo-morphometric analyses. No specific number for "test set" sample size (i.e., number of rabbits or samples) is provided. This data is animal (rabbit) provenance.
  • In Vivo TCP Dissolution: Rabbits were used to evaluate local calcium content around implants. No specific sample size is provided. This data is animal (rabbit) provenance.
• Human Clinical Trial: A human clinical trial investigated safety, effectiveness, achievement of stable osseous fusion, absence of inflammatory/septic response, and resorption/replacement by osseous tissues. No specific sample size for the test set (number of patients) is provided. This data is human, prospective clinical trial data.
• Retrospective Clinical Studies: Several published retrospective clinical studies support the use of BIOSORB beta-tricalcium phosphate ceramic. These include:
  • "Use of β -tricalcium phosphate in foot and ankle surgery: a report of 20 cases" (reported as 20 cases).
  • "Filling of bone defects with tricalcium phosphate beta in traumatology. In Ann Chir . 2000 Dec:125(10):972-81" (sample size not specified in this summary).
  • "Beta-tricalcium phosphate ceramic as a bone substitute in orthopaedic surgery in Int . Orthop 2002;26(2):109-15" (sample size not specified in this summary).

Data Provenance:

• Animal studies: Rabbit models.
• Human Clinical Trial: Human, prospective.
• Retrospective Clinical Studies: Human, retrospective (France for the 2000 and 2002 publications, if the "Ann Chir" and "Int Orthop" are French journals, or broader European/international for "Int Orthop").

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish ground truth for the test sets.

• For the animal histo-morphometric analyses, it would imply qualified veterinary pathologists or histologists.
• For the human clinical trial and retrospective studies, the ground truth (clinical outcomes, radiological findings) would be established by the treating physicians and radiologists involved in those studies. Their specific qualifications are not detailed in this 510(k) summary but would be part of the full study protocols.

4. Adjudication Method

The document does not specify any adjudication methods (e.g., 2+1, 3+1) for establishing ground truth in any of the described studies. The results from the clinical trial and published studies would likely rely on standard medical practice by the treating clinicians/radiologists.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size of human readers improving with AI vs. without AI assistance, is included. This device is a bone void filler, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study is mentioned, as this is a physical medical device (bone void filler), not an algorithm or software.

7. Type of Ground Truth Used

• Animal Studies:
  • Osseous Rehabilitation: Histological and morphometric analysis of tissue samples from rabbit condyles, directly observing new bone formation and integration. This is a form of direct biological/pathological ground truth.
  • In Vivo TCP Dissolution: Measurement of local calcium content in rabbit models, indicating biological activity and resorption. This is a biochemical/physiological ground truth.
• Human Clinical Trial: Clinical and radiological data, which includes patient outcomes, imaging findings (X-rays, etc.), and clinical assessment of inflammation, infection, fusion, and resorption. This combines clinical and imaging ground truth.
• Retrospective Clinical Studies: Patient case reports, clinical observations, and radiological follow-ups as documented in the published literature. This is clinical/imaging ground truth from real-world applications.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable as this is a physical medical device, not a machine learning model. The studies described are for validation and establishing substantial equivalence.

9. How Ground Truth for the Training Set Was Established

As there is no training set for a machine learning model, this point is not applicable.

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