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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.

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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 OTIS-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 design of the self-tapping OTIS-C Plus screws (unmodified) allows easy and reliable one step locking, without counter-nut, 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.

This 510(k) submission describes a medical device, not a diagnostic AI/ML device. Therefore, the questions related to AI/ML specific performance criteria, ground truth, and expert evaluation are not applicable.

Here's an analysis of the provided text in the context of device acceptance criteria and study information:

Device Acceptance Criteria and Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The criteria are implicitly derived from the established safety and effectiveness of the predicate.

Study Description:

1. Sample size used for the test set and the data provenance: Not explicitly stated as this is a non-clinical, mechanical testing study. The "test set" would refer to the physical samples of the OTIS-C Plus device and its components used for the performance testing. The provenance of the data is from SCIENCE FOR BIOMATERIALS, a French company. The study is prospective in the sense that the testing was performed on the newly designed modified device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical engineering study, not an imaging or diagnostic study requiring expert interpretation for ground truth. The "ground truth" is established by the physical laws and engineering principles governing the materials and their interactions.
3. Adjudication method for the test set: Not applicable. This refers to consensus methods for expert opinions, which is not relevant for mechanical testing.
4. 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. This is not an AI/ML device or a diagnostic device involving human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
6. The type of ground truth used: For the mechanical performance tests (fretting corrosion, torsional yield strength, etc.), the "ground truth" is the established scientific and engineering principles for material properties and device performance under specified conditions, as measured by standard laboratory tests. For the Finite Element Method (FEM) analysis, the "ground truth" or reference for comparison is the mechanical behavior and fretting corrosion of the predicate device (K100604).
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

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LIGAFIX® interference screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX® / ComposiTCP® range of products consists of resorbable cannulated screws available in several models designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX® / ComposiTCP® interference bone screw is made of a ceramic (beta-TCP) / polymer (Poly Lactic Acid -PLA) composite.

LIGAFIX® / ComposiTCP® interference screw is available in several sizes and in two beta-TCP/ PLA ratios 60/40 (LIGAFIX® 60/ ComposiTCP® 60) and 30/70 (LIGAFIX® 30/ ComposiTCP® 30)

LIGAFIX® / ComposiTCP® interference bone screws are supplied sterile and individually packaged in double heat sealed pouches.

The provided text describes a 510(k) premarket notification for the LIGAFIX® / ComposiTCP® Resorbable Interference Screw. This document is a regulatory submission for a medical device seeking substantial equivalence to existing devices, not a study report proving the device meets an acceptance criterion with detailed findings. Therefore, much of the requested information regarding specific acceptance criteria and detailed study parameters for performance is not present in the provided text.

However, based on the information available, here's what can be extracted and what cannot:

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

The document states: "Biological, mechanical and biocompatibility tests confirmed that LIGAFIX® / ComposiTCP® screws are highly biocompatible and presents the requisite strength to provide sustained fixation of the graft. LIGAFIX®/ ComposiTCP® screws strength retention profiles are compatible with the healing process."

This is a high-level summary of the reported performance, but specific quantitative acceptance criteria (e.g., "tensile strength must be >X MPa") and corresponding reported numerical performance values are not detailed in the provided text.

2. Sample size 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. The text mentions "Biological, mechanical and biocompatibility tests" but does not detail the methodology, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature) of these tests.

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 information is not applicable as the document describes a regulatory submission for a physical medical device (interference screw) and not an AI/diagnostic software. "Ground truth" in the context of expert review for diagnostic accuracy is not relevant here.

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

This information is not applicable for the reasons stated above.

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 information is not applicable as the device is an interference screw, not an AI diagnostic tool.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable as the document pertains to a physical medical device. The "truth" for the performance claims would be established through laboratory testing (mechanical, biological) rather than expert review of images or pathology.

8. The sample size for the training set:

This information is not applicable as the document is for a physical medical device and does not involve AI or machine learning models that require training sets.

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

This information is not applicable for the reasons stated above.

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LigaFix® interference screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX® are resorbable cannulated screws made of ceramic (β-ΤCP) / polymer (Poly Lactic Acid) composite and designed for the interference fixation of grafts in anterlor cruciate ligament reconstruction.

To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of LIGAFIX Interference screws comprise:

• 2 material specifications: LIGAFIX® 30 (30% TCP/70% PLA) and LIGAFIX® 60 (60% o TCP/40% PLA)
• 3 head design: standard reduced -- rounded ಂ
• Diameters from 7 mm to 11 mm 0
• Lengths from 20 mm to 35 mm ಂ

LIGAFIX® interference screws are supplied sterile and individually packaged In double heat sealed pouches.

This 510(k) Special submission is for an extension of the range of products for the LIGAFIX® Resorbable Interference Screw. It focuses on demonstrating substantial equivalence to previously cleared devices (K050407 and K061262) rather than presenting a de novo study with new acceptance criteria and performance data for a novel device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating the performance of a new device, are largely not applicable in the context of this specific 510(k) submission.

This submission asserts that the expanded product range (new material specifications, head designs, diameters, and lengths) of the LIGAFIX® Interference Screws shares the "same fundamental scientific technology, operating principle and intended use" as the predicate devices. The review process for such a submission typically involves evaluating whether the new product variations introduce any new questions of safety or effectiveness that would necessitate new performance studies. Since this document is a 510(k) summary, it doesn't contain detailed study reports.

Here's a breakdown of why most of the requested points cannot be answered from the provided text, and what can be inferred:

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

• Not Applicable in this context. The document does not provide a table of acceptance criteria or reported device performance for a new study. The submission relies on the substantial equivalence to previously cleared devices which would have undergone performance testing during their initial clearance. The "performance" being demonstrated here is the similarity to the predicate devices.

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

• Not Applicable. No new test set or associated data provenance is mentioned as this is a Special 510(k) for an expansion of an existing device line, not a new device requiring a new clinical or performance study.

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. No test set or ground truth establishment by experts is described in this submission.

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

• Not Applicable. No test set or adjudication method is described.

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. This device is a resorbable interference screw, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies or AI-related effectiveness are entirely irrelevant.

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

• Not Applicable. As above, this is a physical medical device, not an algorithm.

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

• Not Applicable. No new ground truth is established for this submission. The "ground truth" for the clearance of the predicate devices would have been based on established engineering principles, biocompatibility testing, mechanical testing, and potentially animal or clinical studies to demonstrate safety and effectiveness for their intended use.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device; thus, there is no "training set."

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

• Not Applicable. No training set is involved.

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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.

The BIO 1-KIT ® BIOSORB® filled cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with the BIOSORB ® Resorbable Void Filler and deliver the material to the orthopedic surgical site.

BIOSORB ® bone void filler (BIO1 range of products) (K021963) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (βTCP) indicated for Bone Void Filling.

BIOSORB ® bone void filler presents a multidirectional interconnected porosity structure (45% and 70%), 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. The progressive resorption within 6-12 months prevents premature resorption and failed filling.

The impregnation of bone substitute with marrow is largely practiced by the surgeons. Usually this operation is done by immersion of the bone substitute in a container containing the osseous marrow. In order to facilitate this operation and to limit the contact of the mixture with the ambient air at the origin of the degradation of the cells and proteins contained in osseous marrow, S.B.M has developed a system allowing the and procession of autologous osseous marrow, the impregnation of the calcium phosphate pellets and the impaction of the mixture in the cavity to be filled. This system allows the impregnation of porous pellets with osseous marrow under aseptic conditions.

BIO 1-Kit® comprises :

• a pre-filled syringe of BIOSORB® (β-ΤCP porous ceramic pellets)
• a connector with an adapter and a needle
• a bone marrow aspiration needle

BIO 1-Kit® is delivered sterile and intended for a single use.

BIO 1-Kit® is available either with BIOSORB® granules (1.5 and 3.0 mm in diameter) or BIOSORB® blocks (4x4x4 mm) and in quantities ranging from 5 cc to 45 cc.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the BIO 1-KIT ® BIOSORB® filled cartridge:

Acceptance Criteria and Device Performance for BIO 1-KIT ® BIOSORB® filled cartridge

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining and meeting specific quantitative acceptance criteria for the BIO 1-KIT® BIOSORB® filled cartridge itself (the new device being reviewed). Instead, it relies heavily on the established safety and effectiveness of its main component, BIOSORB® bone void filler (which had its own prior 510(k) clearance, K021963), and the substantial equivalence of the new syringe system to a similar predicate.

Therefore, the "acceptance criteria" presented below are inferred from the types of tests performed and the claims made about the device's functionality and safety, especially regarding its new features (the cartridge system).

1. Table of Acceptance Criteria and Reported Device Performance

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

• For BIOSORB® (prior clearance K021963):
  • Sample Size: A "human clinical trial" was performed. The specific number of subjects/cases is not provided in this 510(k) summary.
  • Data Provenance: Not explicitly stated (e.g., country of origin). Since the submitter is French, it's possible this was an international or European trial, but no details are given. The trial was prospective, as it was conducted to investigate safety and effectiveness.
• For BIO 1-KIT® cartridge (new clearance K061022):
  • Sample Size: Not specified for the "compatibility," "aspiration," and "impregnation" tests. These appear to be bench or lab-based tests, not clinical trials.
  • Data Provenance: Not specified beyond being performed by S.B.M. (the manufacturer). Retrospective or prospective is not applicable for these bench tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• For BIOSORB® (prior clearance K021963):
  • No information is provided on the number and qualifications of experts involved in establishing ground truth for the clinical trial data discussed. The text refers to "clinical and radiological data" but doesn't detail the expert review process.
• For BIO 1-KIT® cartridge (new clearance K061022):
  • Not applicable as no clinical ground truth was established for the specific cartridge functionality tests described. These were likely internal engineering or quality control assessments.

4. Adjudication Method for the Test Set

• For BIOSORB® (prior clearance K021963): Not described.
• For BIO 1-KIT® cartridge (new clearance K061022): Not applicable, as there were no clinical test sets requiring adjudication described.

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

• No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence of a medical device (bone void filler cartridge) for its physical and functional properties, not on AI-assisted diagnostic or therapeutic interpretation by human readers. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant to this device submission.

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

• No, a standalone algorithm-only performance study was not done. This device is a physical medical product (a cartridge system for bone void filler), not a software algorithm or AI-driven tool.

7. The Type of Ground Truth Used

• For BIOSORB® (prior clearance K021963):
  • Clinical and Radiological Data: The summary mentions "Clinical and radiological data demonstrate the biocompatibility, the osseo integration and the resorption of BIOSORB® bone void filler." This implies a combination of direct clinical observations (e.g., patient outcomes, inflammatory response) and interpretation of medical imaging (e.g., X-rays to assess bone consolidation and resorption). Pathology results or specific outcome measures (beyond "stable osseous fusion") are not explicitly detailed as the ground truth, but rather general clinical/radiological findings.
• For BIO 1-KIT® cartridge (new clearance K061022):
  • Bench Test Results/Specifications: The ground truth for tests like "compatibility" (infra-red spectrometry) and "aspiration/impregnation" would be based on predefined physical or chemical specifications and successful functional operation, not clinical ground truth.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device. There is no mention of an algorithm or machine learning component requiring a "training set" in the context of AI.

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

• Not applicable, as no training set for an AI algorithm is involved.

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