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The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.

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 ioint 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 Y-Knot® All-Suture Anchors are soft-tissue fixation devices with an expandable push-in design, provided preloaded on a flexible disposable inserter for the Y1802 (double-loaded). This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by two suture strands. The flat suture and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The disposable, flexible inserter has a stainless steel shaft supporting the forked shaped tip, with ABS handle, and is provided sterile, for single use. The disposable inserter device is removed at the end of the repair leaving behind an all suture construct. This device differs from the predicate in terms of the number of sutures threaded through its center (two) and in terms of the use of a flexible driver to implant the anchor.

The provided text is a 510(k) Summary for a medical device called the "Y-Knot Flex All-Suture Anchor." This document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

However, the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically in the context of a device that uses AI. The provided document describes a physical medical device (a surgical suture anchor) and its associated testing, which are standard for mechanical medical devices (fixation strength, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, and packaging/transportation).

This document does not contain information about an AI-powered device, nor does it address AI-specific acceptance criteria, a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance, as requested in the prompt.

Therefore, I cannot fulfill most of the detailed requirements of your request based on the provided text.

I can, however, extract the information relevant to the testing performed for this specific non-AI device, which is analogous to a "study" for this type of product:

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

The document states testing was performed but does not provide a specific table of acceptance criteria with corresponding performance values. It simply lists the types of tests conducted to demonstrate equivalence to the predicate device.

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

The document does not specify sample sizes for the tests nor the provenance of any data.

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, as this is a mechanical device and "ground truth" in the context of expert consensus (e.g., for image interpretation) is not relevant.

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

Not applicable.

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, as this is not an AI device.

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

Not applicable, as this is not an AI device.

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

For a mechanical device, "ground truth" would be established by engineering specifications, material properties, and biomechanical standards (e.g., pull-out strength measured against a predefined threshold). The document lists the types of tests done (fixation strength/pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, and packaging/transportation), implying these engineering and material standards serve as the "ground truth" or acceptance criteria.

8. The sample size for the training set:

Not applicable, as this is not an AI device and there is no "training set."

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

Not applicable.

Summary of what can be extracted for this mechanical device:

• Device Name: Y-Knot Flex All-Suture Anchor, w/ Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm
• Predicate Device: Y-Knot™ All-Suture Anchor (K111779)
• Purpose of Testing: To demonstrate substantial equivalence to the predicate device.
• Types of Testing Performed (analogous to "study"):
  • Fixation strength / pull-out
  • Cyclic loading
  • Insertion
  • Biocompatibility
  • Sterilization
  • Shelf-life
  • Packaging/transportation

The document does not provide quantitative acceptance criteria or detailed performance data for these tests, nor does it involve AI, expert consensus for ground truth, or MRMC studies.

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The D4000/D4000A 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, Neurological, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive, and Spinal surgical procedures.

The D4000/D4000A Drive System console functions as a powered instrument console for driving powered instruments and accessories used in the cutting of soft tissue and bone at the surgical site. The D4000/D4000A Drive System console is a non-sterile device and must be located in a non-sterile area of the operating suite. Additionally the D4000A console offers an irrigation pump that, when used with tubing sets, provides a sterile fluid supply to the blades, burs, and drill bits, at the surgical site, for lavage and cooling. The handpiece, handpiece cord, and irrigation tube sets are sterile. The handpiece is used in the sterile field with the cord connected to the console. The irrigation tube set is used on the handpiece in the sterile field with the cassette connected to the console. The footswitch is non-sterile and placed on the floor. The console provides two handpiece drive ports that are used with a variety of handpieces. Handpiece functionality can be controlled directly by the handpiece, and/or by a corded footswitch or wireless footswitch. Handpiece speed, direction, user settings, irrigation flow rate, and footswitch settings are controlled with the touch-screen displays. The D4000/D4000A is a rebranded update to the Advantage Turbo Drive System (D3000), which shares the same intended use, indications for use, conditions of use, and fundamental scientific technology with the predicate device. The D4000/D4000A powers a reduced set of the same handpieces, to the same performance specifications, as the D3000. Where applicable, these handpieces can also be activated by the same footswitches used in the previous system. The D4000/D4000A software was rewritten in order to accommodate the new internal circuitry layout and to support additional integrated components (i.e. touchscreens, wireless footswitch transceiver, etc.) as well as to send direct signal to 24k when shaver is operating. Further, the D4000 and D4000A are the same device except for the fact that, like the D3000, the D4000A incorporates a low-flow purpose of optional handpiece irrigation. The D4000A also includes a "Prime Button" on the front panel that is associated with the low-flow pump.

This is a 510(k) summary for a medical device (D4000/D4000A Drive System), not a study evaluating an AI device or presenting acceptance criteria for an AI algorithm. Therefore, much of the requested information (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or present in this document.

However, I can extract the general acceptance criteria and the type of study performed for this device based on the provided text.

Acceptance Criteria and Study for the D4000/D4000A Drive System:

This document describes a medical device clearance process for a powered surgical instrument system, the D4000/D4000A Drive System, rather than an AI algorithm with specific performance metrics like sensitivity, specificity, or AUC. The "acceptance criteria" here refer to demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device (ConMed Linvatec's Advantage Turbo Drive System, K050519) and meets safety and performance standards relevant to its intended use.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable in the traditional sense of an AI test set with case counts. The "test set" here refers to the device itself and its components undergoing engineering and functional testing. The document does not specify a numerical sample size for components or systems tested.
• Data Provenance: Not applicable. The "data" are results from internal engineering verification and validation tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The ground truth for this type of device (a powered surgical instrument) is established through engineering specifications, performance standards, and comparison to existing devices, not through expert consensus on medical images or clinical outcomes in the same way an AI diagnostic tool would. Design and testing would involve engineers and potentially medical professionals for usability/functional feedback, but not "experts establishing ground truth" in the AI context.

4. Adjudication method for the test set:

• Not applicable. This concept (e.g., 2+1, 3+1) is specific to situations where multiple human readers are interpreting data to form a consensus ground truth. Here, compliance is determined by meeting engineering specifications and regulatory requirements.

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:

• No, an MRMC study was not done. This type of study applies to diagnostic AI systems and is not relevant to a powered surgical instrument.

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

• Not applicable. This device is a console for powered surgical instruments; it is not an algorithm that operates in a standalone diagnostic capacity. Its function inherently involves human interaction (a surgeon operating the handpiece).

7. The type of ground truth used:

• The "ground truth" for this device's performance evaluation is based on:
  • Engineering Specifications: The device must meet predefined electrical, mechanical, and software performance criteria.
  • Regulatory Standards: Compliance with relevant medical device regulations (e.g., electrical safety, EMC, quality systems).
  • Predicate Device Performance: The new device must perform comparably to the legally marketed predicate device (Advantage Turbo Drive System, K050519) for its stated functions.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of machine learning. The software was rewritten to accommodate new hardware and features, suggesting a development and testing process, but not an AI training process.

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

• Not applicable, as there is no AI training set.

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The GENESYS PressFT Suture Anchor 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. Additional indications include acetabular labral repair and capsular repair in the hip.

The ConMed Linvatec GENESYS PressFT™ Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors manufactured of 96L/4D copolymer + B-TCP and one (1) or two (2) Hi-Fi® sutures manufactured of ultra-high molecular weight polyethylene. The device is bioabsorbable and is available in two sizes: 1) a 2.5mm diameter x 9.8mm length suture anchor that is utilized with a 2.1mm drill bit, and 2) a 3.0mm diameter x 10.6mm length suture anchor that is utilized with a 2.6mm drill bit. A disposable inserter is included to implant the suture anchor. The disposable inserter device has a stainless steel shaft with a polycarbonate handle that is provided sterile, for single use and is removed at the end of the repair leaving behind the suture anchor construct. 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 surgical instruments, including drill bits, guides and obturators, are Class I, non-sterile, reusable devices intended for transient use during orthopedic procedures.

This document describes the premarket notification (510(k)) for the ConMed Linvatec GENESYS PressFT™ Suture Anchor. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to independently prove specific performance against a predefined acceptance criterion study in the same way a PMA or a de novo submission might.

Therefore, the information presented is focused on demonstrating the GENESYS PressFT™ Suture Anchor's equivalence to existing devices through various types of testing, rather than a standalone clinical study against specific acceptance criteria for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of "acceptance criteria" against which a clinical performance study was conducted. Instead, it describes a series of engineering and biocompatibility tests conducted to demonstrate the safety and effectiveness of the device and its substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests.

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

The document does not specify the sample sizes for the individual engineering, biocompatibility, sterilization, shelf-life, or packaging tests.

• Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient for engineering and biocompatibility evaluations. These are typically benchtop or in-vitro tests, not human clinical trials.
• Data Provenance: The data is generated from laboratory testing conducted by the manufacturer, ConMed Linvatec. This is assumed to be prospective for the purpose of this submission, though it's in vitro or ex vivo testing, not human-patient data. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities (likely in the US given the submission to the FDA).

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

Not applicable. This is not a study requiring expert readers or ground truth establishment in the clinical diagnostic sense. The "ground truth" for these tests would be the specific pass/fail criteria for each engineering or biocompatibility test, typically defined by engineering standards, regulatory guidelines (e.g., ISO for biocompatibility), or internal company specifications derived from predicate device performance.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study involving interpretations by multiple experts. The "adjudication" is essentially the comparison of test results against predetermined engineering, biological, and functional specifications.

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

No. This is a medical device for orthopedic surgery (suture anchor), not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

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

Not applicable. This is a physical medical device (suture anchor), not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the "testing" section is based on:

• Engineering Standards: For fixation strength, cyclic loading, insertion, and driver strength, the "ground truth" refers to the mechanical and performance specifications derived from regulatory requirements, industry standards, and the performance characteristics of the predicate devices.
• Biocompatibility Standards: For biocompatibility, the "ground truth" conforms to recognized international standards (e.g., ISO 10993 series).
• Sterilization and Packaging Standards: For sterilization and packaging, the "ground truth" refers to validated processes and industry/regulatory standards for ensuring product sterility and integrity.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI algorithms, thus there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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The NANO™ Suture Anchor 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. Additional indications include acetabular labral repair and capsular repair in the hip.

The ConMed Linvatec NANO™ Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors manufactured of medical-grade PEEK and one (1) or two (2) Hi-Fi® sutures manufactured of ultra-high molecular weight polyethylene. The device is non-absorbable and is available in two sizes: 1) a 2.5mm diameter x 9.8mm length suture anchor that is utilized with a 2.1mm drill bit, and 2) a 3.0mm diameter x 10.6mm length suture anchor that is utilized with a 2.6mm drill bit. A disposable inserter is included to implant the suture anchor. The disposable inserter device has a stainless steel shaft with a polycarbonate handle that is provided sterile, for single use and is removed at the end of the repair leaving behind the suture anchor construct. 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 surgical instruments, including drill bits, guides and obturators, are Class I, non-sterile, reusable devices intended for transient use during orthopedic procedures.

The provided text describes a medical device submission (K112965) for the NANO™ Suture Anchor, a non-absorbable suture anchor system. The submission focuses on demonstrating substantial equivalence to predicate devices and detailing the device's design, materials, and intended use.

However, the provided document does not contain the requested information regarding acceptance criteria, specific study results, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established. The document generally states that "The verification and validation testing of the NANO™ Suture Anchor includes fixation strength, cyclic loading, insertion, driver strength, biocompatibility, sterilization, shelf-life, packaging/transportation and comparator testing qualifications." but does not provide any detailed results or methodologies for these tests.

Therefore, I cannot fulfill your request for the specific comparative data and study details as they are not present in the provided text.

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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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