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The Matryx™ Interference Screw is intended for use in interference fixation of bone-patellar tendon -- bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.

The Matryx™ Interference Screw is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active sepsis or infection, 5) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs, which would not be appropriate for fixation with metallic screws.

The implant is composed of mixture of poly-96L/4D-lactide copolymer and tri-" calsium phosphate. The predicate device Osteo ACL Screw is made of the very same raw material. Lengths of implant are 20 30 mm - Diameters of implant are 7mm-9mm. - The only modifications that were made are: - Change of trade name. This change is updated in labelling. - Minor modifications and further definition of tolerances of screw design.

The provided text (K052080) describes a 510(k) premarket notification for the Matryx™ Interference Screw. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a submission to the FDA for substantial equivalence, focusing on comparisons to a predicate device (Linvatec Biomaterials Ltd Osteo ACL Screw, K032894) and minor modifications to an existing design. It discusses the device's composition, dimensions, intended use, and substantial equivalence to a cleared predicate device.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone (algorithm-only) performance study.
7. The type of ground truth used (pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in performance studies, validation reports, or clinical trial summaries, which are not present in this 510(k) summary document. The 510(k) process for this device focused on demonstrating substantial equivalence based on material composition and design similarity to a previously cleared device, rather than new performance studies with specific acceptance criteria that would require the detailed information you are requesting.

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SmartPin® is indicated for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization.

SmartPin® is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical Dearing 'oches, 'osteochonies and cancellous/non-load bearing fragments.

SmartPin® is not intended for use in and is contraindicated for: 1) Fractures and Sthart mis is not intended for assess cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) treatment of which patient co operation callier see effect of SmartPin® upon the healing of growth plate has not been tested clinically.

The device description of SmartPin® is as follows:

• Composed of poly-96L/4D-lactide copolymer -
• Tapered, smooth pins -
• Lengths 10 70mm -
• Diameters 1.1, 1.5, 2.0, 3.2 and 4.5 mm -

The dimensions and shape are completely identical with Linvatec Biomaterials The unnersholis and brin) (K010983), SmartPin® PDX (the previous PLGA Pin) (K003659) and Biofix SR-PGA Pin (K890902).

This document is a 510(k) premarket notification for a medical device called SmartPin®, submitted by Linvatec Biomaterials Ltd. in 2004. The purpose of a 510(k) is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and thus does not require a PMA (Premarket Approval). This type of submission does not typically involve the presentation of clinical study data with acceptance criteria for device performance as would be required for a novel device or one requiring a PMA.

The information provided describes the device, its intended use, and its similarities to previously cleared predicate devices. The FDA's letter (K041288) confirms that the device is substantially equivalent to the predicate devices and can be marketed.

Therefore, many of the requested categories related to clinical study data, acceptance criteria, and performance metrics are not applicable in this 510(k) context.

Below is an attempt to address your request based on the provided document, indicating where information is not applicable:

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

• Acceptance Criteria: For a 510(k) submission based on substantial equivalence, the primary "acceptance criterion" is demonstrating that the new device has the same or similar intended use, operating principle, basic design, manufacturing process, packaging, and sterilization as the predicate devices, and does not raise new questions of safety or effectiveness.
• Reported Device Performance: The document does not report specific quantitative performance metrics against pre-defined acceptance criteria, as this is a substantial equivalence claim rather than a de novo or PMA submission. The performance is implicitly considered equivalent 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. This 510(k) submission relies on demonstrating substantial equivalence to predicate devices, not on new clinical study data with a specific test set. The document leverages information about previously cleared devices.

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 new clinical study data with ground truth establishment is described in this 510(k) submission.

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

• Not applicable. No new clinical study data with adjudication is described in this 510(k) submission.

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 is a device for bone fixation, not an AI/imaging diagnostic device. No MRMC study was conducted or is relevant to this 510(k).

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

• Not applicable. This is a physical medical device (bone fixation pin), not an algorithm or software.

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

• Not applicable. No new clinical study data requiring ground truth is described in this 510(k) submission. The "ground truth" for this submission is the regulatory precedent set by the predicate devices.

8. The sample size for the training set

• Not applicable. No training set for an algorithm or new clinical data is described.

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

• Not applicable. No training set or ground truth establishment relevant to an algorithmic or novel device performance study is described here.

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The Osteo ACL Screw™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.

The Osteo ACL Screw™ is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active separas or infection, 5) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs, which would not be appropriate for fixation with metallic screws.

The implant is composed of mixture of poly-96L/4D-lactide copolymer and tri-calsium phosphate. The predicate devices like Mitek Biocryl Interference Screws (013572) and Biocomposites Ltd Biolok (K993630, K002070) are utilizing mixture of poly-L-lactide and tri-calsium phosphate.
Lengths of implant are 20 30 mm
-Diameters of implant are 7mm-11mm.

The only modifications that were made are:
Amendment of a new raw material option, mixture of poly-961/4D-lactide copolymer and tricalsiumphosphate (TCP).
Design of driver hole is adapted of Linvatec BioScrew implant (K933719, -K952831, K973758).
Thread profile is adjusted to fit with bone taps of Linvatec BioScrew implant -(K933719, K952831, K973758).
Reference numbers for these new screw versions. These changes are updated in labelling.
New trade name to separate it from SmartScrew ACL. This change is updated in labelling.
Revision of insert sheet concerning adaption of instrumentation of BioScrew. -

The provided document is a 510(k) summary for the Linvatec Biomaterials Osteo ACL Screw, an orthopedic device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The 510(k) summary is focused on:

• Device Identification: Trade name, common name, classification, product code.
• Predicate Device Comparison: Listing similar previously cleared devices.
• Intended Use and Contraindications: What the device is for and situations where it should not be used.
• Device Description: Material composition, dimensions, and modifications from previous versions.
• Substantial Equivalence Argument: A statement that the modified device does not raise new safety or efficacy concerns compared to the predicate devices.

There are no acceptance criteria or study results presented in this document concerning performance metrics like accuracy, sensitivity, specificity, or reader improvement with AI assistance, as this is not the purpose of a 510(k) premarket notification.

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