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The ConMed Linvatec Intercept implants are for attaching soft tissue to bone in orthopedic surgical procedures to be used in either arthroscopic or open surgical procedures: The Intercept implants are intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.

The ConMed Linvatec Intercept Implant is a device that is used to assist the surgeon in re-attaching soft tissue to bone via interference fixation. The system includes implants, manufactured of PEEK (polyetheretherketone) material, in a range of sizes from 5mm to 8mm diameters and 12mm to 23mm lengths. A disposable driver is also part of the system.

This document is a 510(k) summary for a medical device (ConMed Linvatec Intercept Implant) and does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor any clinical trial data relevant to the questions asked.

The document solely focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, principles of operation, and technical characteristics. It discusses:

• Device Name: ConMed Linvatec Intercept Implant
• Submitter and Contact Information
• Classification Information
• Predicate Devices: ConMed Linvatec Matryx Interference Screw (K063588) and Arthrex Interference PEEK Screw (K062466)
• Device Description: PEEK implants (5mm-8mm diameter, 12mm-23mm length) and a disposable driver.
• Intended Use/Indications: Attaching soft tissue to bone via interference fixation in orthopedic procedures (arthroscopic or open).
• Substantial Equivalence Claim: Based on design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicate devices.
• FDA Communication: Letter confirming substantial equivalence, general controls, and other regulatory requirements.
• Indications for Use Statement.

Therefore, I cannot provide the requested information from the provided text. The document describes a regulatory submission process (510(k)) that relies on equivalence to existing devices rather than a de novo clinical study with acceptance criteria and performance data as typically seen for new technologies or algorithms.

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The ConMed Linvatec Soft Tissue to Bone System is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The ConMed Linvatec Soft Tissue to Bone System includes anchors in a range of sizes and materials from 3.5 mm to 6.5 mm diameter and 15 mm to a 17 mm length with one (1) to three (3) non-absorbable suture configurations. The anchor sizes correspond to a series of general surgical instruments such as; bone taps, bone punches, drivers, and a suture passer.

This 510(k) premarket notification for the ConMed Linvatec Soft Tissue to Bone System indicates that substantial equivalence was demonstrated without a clinical study. The submission focuses on comparing the new device to legally marketed predicate devices based on design, manufacturing materials, intended use, principles of operation, and technical characteristics.

Therefore, many of the requested categories related to clinical study design and performance metrics cannot be filled.

Here's a breakdown of the available information:

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

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 clinical test set data is provided in this 510(k) submission.

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 clinical test set data or ground truth establishment by experts is mentioned.

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

• Not Applicable. No clinical test set, and therefore no adjudication, is mentioned.

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 medical implant (soft tissue to bone system), not an AI diagnostic tool. No MRMC study was performed.

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

• Not Applicable. This device is a medical implant, not an algorithm or AI system.

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

• Not Applicable. No clinical ground truth was established for this submission, as it relies on substantial equivalence to predicates.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device's submission, as it is a physical implant and not an AI or algorithm-based device.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for one.

Summary of Device and Acceptance:

The ConMed Linvatec Soft Tissue to Bone System is a nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures. The acceptance of this device by the FDA (as indicated by the 510(k) clearance K091549) was based on its substantial equivalence to three legally marketed predicate devices:

• LM Bone Anchor (renamed ConMed Linvatec Ultrafix RC®) (K963812)
• ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures (K073481)
• ConMed Linvatec Bio Mini-Revo® (K053561)

The FDA determined that the new device is substantially equivalent to these predicates in its design, manufacturing materials, intended use, principles of operation, and technical characteristics. Therefore, no new clinical studies or performance data were required or submitted to demonstrate its safety and effectiveness beyond this comparison to already cleared devices.

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The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.

The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in sufure anchor that is preloaded on a disposable inserter device with one nonabsorbable, braided, polyethylene suture. The Bio Mini-Revo suture anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The Copolymer is inert and non-collagenous through the absorption process. The device will be available in two versions: with or without colorant D&C violet #2.

This document is a 510(k) summary for the ConMed Linvatec Bio Mini-Revo Suture Anchor. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics for a new, unique device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted because such a study is not described in this 510(k) submission.

Key points from the document that explain why the requested information isn't available:

• Type of Submission: This is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with defined acceptance criteria.
• Focus on Substantial Equivalence: The document explicitly states: "The ConMed Linvatec Bio Mini-Revo Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices K053561, K072291 and K061863."
• Lack of Performance Data: There are no sections detailing specific performance metrics, clinical study results, or statistical analyses against defined acceptance criteria that would typically be found in a study proving a device meets certain performance thresholds.
• Device Type: The device is a Bioabsorbable Suture Anchor. The 510(k) generally relies on the established safety and performance of similar predicate devices and material characterization (e.g., bioabsorption properties of the PLA Copolymer) rather than a comparative study of its clinical performance against specific metrics.

In summary, this 510(k) submission successfully established substantial equivalence, allowing the device to be marketed, but does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance) that would be provided for a device with a novel mechanism requiring such demonstration.

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The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The ConMed Linvatec Paladin Suture Anchor is a bioabsorbable screw-in suture anchor that is preloaded on a disposable inserter device with two nonabsorbable, braided, polyethylene sutures. The ConMed Linvatec Paladin Suture Anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The copolymer is inert and non-collagenous through the absorption process. The device will be available in 5.0mm - 6.5mm in size with colorant D&C violet #2.

This document is a 510(k) summary for a medical device called the "ConMed Linvatec Paladin, Preloaded with two #2 Hi-Fi® Sutures." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific clinical performance acceptance criteria through a clinical study.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets them, as it is related to a clinical performance study. The document focuses on showing substantial equivalence based on design, materials, intended use, and technical characteristics to previously cleared devices (K042966 and K053561).

To elaborate on why the requested information is not present:

• Acceptance Criteria & Reported Device Performance: This document does not establish new performance acceptance criteria for clinical outcomes. Instead, it argues that the new device's technical characteristics and intended use are similar enough to existing cleared devices, implying similar performance.
• Sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set: All these points relate to the design and execution of a clinical performance study, which is not required or presented in a 510(k) submission for substantial equivalence based on the provided text.

The information provided outlines:

• The device name, common name, and classification.
• The predicate devices used for comparison.
• A description of the device (bioabsorbable screw-in suture anchor made from Self-Reinforced (96L/4D) PLA Copolymer, preloaded with two nonabsorbable sutures).
• Its intended use (reattaching soft tissue to bone in arthroscopic or open surgical procedures).
• A statement of substantial equivalence to the predicate devices in design, manufacturing, materials, intended use, principles of operation, and technical characteristics.

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The ConMed Linvatec Lightwave® Ablators are intended to be used for electrosurgical cutting and coagulation in arthroscopic procedures, using a conductive fluid environment. Additionally, the suction/aspiration versions of these devices have the capability for suctioning irrigation fluids. Electrosurgical cutting and coagulation may be performed in various joints such as the shoulder, ankle, wrist, elbow, knee, and hip.

The ConMed Linvatec LightWave® Ablators are comprised of a range of nonsuction and suction devices, operable by hand or foot control. The devices consist of an electrical, insulation-coated electrode and ceramic insulator attached to an integrated handle and cord set, allowing attachment to commonly available electrosurgical generators.

The provided text is a 510(k) summary for the ConMed Linvatec EL LightWave® Suction Ablator, which is a medical device application for market clearance. This type of document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets new acceptance criteria through a clinical study.

Therefore, the document does not contain the kind of detailed information about acceptance criteria, specific device performance against those criteria, or a study design (including sample sizes, ground truth establishment, expert qualifications, or MRMC studies) that you would typically find for an AI/CADe device.

The study mentioned is "Performance testing has demonstrated the devices conform to applicable sections of ANSI/AAMI HF18:2001 and IEC 60601-2-2:2006". These are electrical safety and electromagnetic compatibility standards, not performance standards related to diagnostic accuracy or clinical effectiveness for AI/CADe devices.

In summary, the provided document does not contain the information required to populate your table and answer your questions about a study proving the device meets acceptance criteria for an AI/CADe system. The device is an electrosurgical ablator, not an AI-powered diagnostic tool.

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The MicroPower Hand Piece: Medium Speed Drill, Saggital saw, Reciprocating saw, and Oscillating saw functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.

The MicroPower Hand Piece: Medium Speed Drill, Saggital saw. Reciprocating saw, and Oscillating saw device description is identical to the MicroChoice product line cleared in the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised.

The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A cord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.

This document is a 510(k) summary for a medical device (MicroPower Hand Piece) and does not contain the detailed information required to describe acceptance criteria and associated studies as requested. The 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, rather than a full demonstration of safety and effectiveness through detailed performance studies with acceptance criteria.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample sizes used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method for the test set.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone (algorithm only) performance study.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document states: "The changes made to the Universal Drive System have been tested to assure that the proposed modifications do not raise any new issues regarding safety and effectiveness." However, it does not detail what these tests were, what the specific acceptance criteria were, or the performance results. The focus of this submission is on the "substantial equivalence" of the new device to a predicate device (Universal Drive System, K971059) rather than a detailed performance study against pre-defined acceptance criteria for novel claims.

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The MicroPower Hand Piece: High Speed Drill, functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.

The MicroPower Hand Piece High Speed Drill device description is identical to the MicroChoice product line cleared in the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised.

The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A chord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.

The provided document describes a Special 510(k) submission for the Linvatec MicroPower Hand Piece High Speed Drill. This type of submission is for modifications to a manufacturer's own legally marketed device, asserting that the modifications do not affect the device's intended use, fundamental scientific technology, or performance specifications such that any new issues regarding safety and effectiveness are raised.

Therefore, the document does not present a traditional "study that proves the device meets the acceptance criteria" in the sense of a standalone clinical trial or a performance study with quantitative metrics against pre-defined acceptance criteria for a novel device. Instead, the "study" alluded to is the testing performed to ensure the modifications do not raise new safety and effectiveness issues and the assertion of substantial equivalence to the predicate device.

Here's an attempt to answer your request based on the provided text, acknowledging the nature of a Special 510(k) submission for a modified device:

Acceptance Criteria and Study for Linvatec MicroPower Hand Piece High Speed Drill

The MicroPower Hand Piece High Speed Drill is a modification of an existing device (MicroChoice product line, cleared under K971059). The acceptance criteria and "study" are framed within the context of demonstrating that these modifications do not introduce new safety or effectiveness concerns, and that the modified device remains substantially equivalent to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a separate "test set" with a numerical size. The "testing" refers to verification and validation activities conducted on the modified device itself.
• Data Provenance: Not applicable in the context of clinical data. The data provenance would be from internal engineering and design verification reports for the modified hand piece.
• Retrospective/Prospective: Not applicable to this type of submission. The evaluation is focused on the device's design and performance rather than clinical outcomes.

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

• This information is not provided in the document, as the submission does not involve clinical data with "ground truth" derived from expert consensus. The "ground truth" here is the established safety and effectiveness of the predicate device, and the demonstration that the modified device maintains those attributes.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of a formal adjudication method for a test set, as no clinical study or expert review of data is described. The "adjudication" is internal to the manufacturer's testing and review process, leading to the regulatory submission for substantial equivalence.

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

• No. An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or those involving human interpretation, to assess improvement with AI assistance. The MicroPower Hand Piece is a surgical tool.

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

• No. This question is also not applicable as the device is a physical surgical hand piece, not an algorithm or a decision-support system.

7. The Type of Ground Truth Used

• The "ground truth" is implicitly the performance, safety, and effectiveness of the legally marketed predicate device (MicroChoice Universal Drive System, K971059). The Special 510(k) argues that the modified device maintains these established characteristics due to the nature of the modifications not raising new issues.

8. The Sample Size for the Training Set

• Not applicable. The concept of a "training set" is relevant for AI/machine learning models. The MicroPower Hand Piece is a mechanical/electrical surgical instrument, not an AI-driven device.

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

• Not applicable for the same reasons as #8.

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The MicroPower Hand Piece: OralMax High Speed Drill, functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial.

The MicroPower Hand Piece: Oral Max High Speed Drill device description MicroChoice product line cleared is identical to the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised.

The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A chord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.

This document is a 510(k) premarket notification for a medical device, the MicroPower Hand Piece: Oral Max High Speed Drill. It declares that the device is substantially equivalent to a previously cleared predicate device (Universal Drive System, K971059) and does not contain information about a study proving the device meets specific acceptance criteria in the way described in the prompt.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence based on the device's design, intended use, and scientific technology being similar to a predicate device, rather than providing a performance study against acceptance criteria.

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The Advantage® Turbo Drive System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand, Medial Sternotomy, Neurosurgical, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive and Spinal surgical procedures.

The Advantage® Turbo Drive System device description is identical to the original submission except for the modifications listed below. The modifications described in this Special 510(K) are listed below: 1. A new motor has been installed which provides additional torque and speed to the handpiece. 2. The software, Version 7.0, has been modified to allow Advantage@ Turbo Drive System to run at a maximum forward/reverse speed of 10.000 RMP or 12,000 RPM. This maximum speed is selectable using an appropriate code during the calibration request. All other software parameters used to run the Advantage@ Turbo Drive System operate in the same manner as all pre-existing software versions.

The provided text is a 510(k) premarket notification for the Advantage® Turbo Drive System, which is an electric cranial drill motor. The document describes modifications to an existing device, primarily a new motor and updated software to increase speed and torque.

However, the document is a regulatory submission for a medical device that performs cutting of soft tissue and bone and does not involve any AI/ML components or software for diagnostic or screening purposes.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to AI/ML device performance (such as sample sizes, expert ground truth, MRMC studies, standalone performance, training data, etc.). The provided text does not contain any of that information because it describes a mechanical surgical tool, not an AI/ML algorithm.

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The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet provide tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet are cannulated, sterile, single-use bone screws made of an absorbable homopolymer derived from Poly (L-Lactic Acid). Two sizes will be available for the device, 8 x 35mm and 8 x 40mm. The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet, differ from the existing Linvatec BioScrew® XtraLok™ in that the major diameter is smaller. The violet colorant contained in this device, has been cleared for this product code and intended use by the FDA via color petition 8C0255 dated January 28, 1998. The modification does not affect the device's intended use, fundamental scientific technology or performance specifications.

This document is a 510(k) submission summary for a medical device called BioScrew® XtraLok®. It seeks to establish substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets such criteria. It is a regulatory submission for premarket notification rather than a performance study report.

Therefore, I cannot provide the requested information.

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