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The Extremity Medical Suture Anchor is intended for the fixation of soft tissue to bone in shoulder. foot/ ankle, knee, hand/wrist, and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift of Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.

Knee: Medial Collateral Ligament Repair. Lateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.

The Extremity Medical Suture Anchor is an implantable device manufactured from Titanium Alloy (6AL-4V ELI, per ASTM F136). The suture anchor is preloaded with two or three sutures depending on the size of the anchor. The suture material is Size #2 Teleflex Force Fiber. The device is recommended to be used for the repair of soft tissue to bone. The suture anchor and sutures are assembled to an inserter which is used to screw the anchor into bone. The product is provided pre-packaged and sterile via EtO sterilization.

The provided document is a 510(k) premarket notification for the Extremity Medical Suture Anchor, a medical device used for the fixation of soft tissue to bone. The document does not describe the acceptance criteria or the study that proves the device meets the acceptance criteria in the manner requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the information provided in the document, highlighting why the requested information about AI/algorithm performance and ground truth is not applicable or present:

The device in question, the "Extremity Medical Suture Anchor," is a physical implantable device, not an AI or algorithmic medical device. Therefore, many of the requested categories related to AI performance, ground truth, training sets, and expert adjudication are not relevant to this type of medical device submission.

However, I can extract information related to the physical device's testing:

Device Acceptance Criteria and Performance (as applicable for a physical medical device):

Explanation Regarding AI/Algorithm-Specific Questions:

1. 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 is a physical medical device. The "test set" in this context refers to bench testing of the physical implant, not a data set for an algorithm.

2. 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. There is no "ground truth" to establish for an AI algorithm. Bench testing for pull-out strength would involve engineering and materials science experts and validated testing methodologies, but not clinical "ground truth" in the AI sense.

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

   • Not Applicable. Again, this is for a physical device, not an AI algorithm.

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 device is not an AI diagnostic tool that human readers would interact with.

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

   • Not Applicable. This is a physical implantable device.

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

   • Not Applicable. The "ground truth" for a physical device's performance relies on validated engineering tests (e.g., ASTM standards for mechanical properties) and comparison to predicate devices, not clinical or pathological ground truth in the context of diagnostic algorithms.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, no training data for an algorithm.

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

   • Not Applicable. This is a physical device, no training data or ground truth for an algorithm.

Summary of what the document does state regarding testing:

• Study Type: Non-clinical bench testing was performed.
• Specific Tests: Pull-out strength testing was explicitly mentioned.
• Comparison: The results of the bench testing were compared to the predicate device (K083151 - Suture Anchor from Extremity Medical).
• Clinical Testing: "No clinical testing was performed."
• Conclusion: The submission concludes that the modified Suture Anchor is "substantially equivalent" to its predicate device based on indications for use, materials, design, and test data (including the unspecified pull-out strength results) and principles of operation. This "substantial equivalence" is the regulatory criterion met, rather than specific performance metrics against pre-defined acceptance criteria, which are not detailed in this summary.

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The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

The Extremity Medical Calcaneal Osteotomy Device is a bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery. The bracket is offered in height sizes of 6mm to 13mm. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

The provided document describes the FDA 510(k) premarket notification for the Extremity Medical Calcaneal Osteotomy Device. This device is a bone fixation device, not an AI/ML medical device, and therefore the concepts of acceptance criteria, device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in the context of AI regulatory submissions.

The document indicates that the device's substantial equivalence was based on non-clinical testing, specifically bench testing for static and dynamic bending, which was performed and compared to a predicate device. No clinical testing was performed.

The relevant information regarding this device's "acceptance criteria" (though not explicitly stated as such in the AI/ML context) would be its ability to demonstrate substantial equivalence to legally marketed predicate devices through its design, material mechanical properties, indications for use, and performance in these non-clinical bench tests.

To answer your request based on the provided document and keeping in mind it's for a physical bone fixation device:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implied): Substantial equivalence to predicate device in terms of design, material mechanical properties, indications for use, and performance in static and dynamic bending bench tests.
   • Reported Device Performance: "Bench testing static and dynamic bending were performed and compared to the predicate device." (Specific numerical performance data is not provided in this summary document.)

2. Sample size used for the test set and the data provenance: Not applicable as this is a physical device and no "test set" in the context of data for AI/ML is mentioned. The testing refers to physical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models is not relevant here.

4. Adjudication method 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: No, this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" for this physical device's performance would be its mechanical properties measured in bench tests and compared to the predicate device.

8. The sample size for the training set: Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcaneocuboid, Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies.

The EXTREMITY MEDICAL Screw and Washer System consists of two pieces, a Screw and a Washer, which couple together to provide stability and compression across an intended area of fusion.

The provided document describes a medical device, specifically the EXTREMITY MEDICAL Screw and Washer System, not an AI/ML-driven medical device. Therefore, many of the requested categories related to algorithms, AI performance, ground truth, and expert evaluation are not applicable.

However, I can extract the information pertinent to the acceptance criteria and the study performed for this device based on the document.

Acceptance Criteria and Device Performance for EXTREMITY MEDICAL Screw and Washer System

Given that this is a 510(k) submission for a traditional medical device (screws and washers), the acceptance criteria are generally based on demonstrating substantial equivalence to a predicate device in terms of design, materials, indications for use, and mechanical performance.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of an AI/ML algorithm. The "test set" here refers to the samples used in bench testing and cadaver studies.
  • Bench Testing: The document states "pull-out, torque and bending was performed." The specific number of screws/washers tested for each modality is not specified.
  • Cadaver Studies: "Clinical simulations in cadavers were performed." The number of cadavers or specific procedures performed is not specified.
• Data Provenance: Not applicable in the context of AI/ML data provenance (e.g., country of origin, retrospective/prospective). The data originated from in-vitro (bench testing) and ex-vivo (cadaver) studies conducted by the manufacturer.

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

• Not applicable as this is a mechanical device, not an AI/ML algorithm requiring expert ground truth for classification or detection. The "ground truth" for mechanical properties is established by engineering standards and measurements, and for surgical technique, by observed performance by qualified personnel (surgeons/engineers) during cadaveric trials. The specific number and qualifications of these personnel are not specified but would typically include bioengineers and orthopedic surgeons.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers for AI/ML ground truth. For this device, the "adjudication" would involve engineering analysis of the bench test data and expert assessment of the cadaveric simulations.

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 comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or prognostic tools, not for a mechanical bone fixation system.

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

• No, a standalone algorithm performance study was not done. This is a hardware medical device, not an algorithm.

7. The type of ground truth used

• Not applicable in the AI/ML sense. For this device:
  • Mechanical performance: Ground truth is based on established engineering standards and measurements (e.g., specific force required for pull-out, torque values, bending resistance).
  • Surgical technique: Ground truth is based on successful and stable fixation demonstrated in cadaveric models as assessed by trained professionals.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the AI/ML context.

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

• Not applicable. This device does not use a "training set" or require ground truth establishment in the AI/ML context.

Summary of the Study:

The study conducted to demonstrate the safety and effectiveness of the EXTREMITY MEDICAL Screw and Washer System was a non-clinical study. It consisted of:

• Bench testing: This involved mechanical testing such as pull-out, torque, and bending tests. The results of these tests were compared to the predicate devices to demonstrate equivalent mechanical properties.
• Clinical simulations in cadavers: These studies were performed to verify the surgical technique with the additional screw and washer options being introduced.

The conclusion drawn from these studies was that the device is substantially equivalent to its predicate device based on indications for use, materials, design, test data, and principles of operation. No clinical testing in live subjects was performed.

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The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints.

The EXTREMITY MEDICAL Screw System

The provided text describes a 510(k) submission for the EXTREMITY MEDICAL Screw System. This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way a diagnostic AI/ML device would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set, ground truth) are not applicable to this type of device and submission.

Here's the information that can be extracted or deduced from the provided text:

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

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. The "tests" here are bench tests and cadaveric simulations, not clinical trials with human subjects.
• Data Provenance: Not applicable in the context of clinical data provenance. The bench testing and cadaveric simulations would have been performed in a lab setting by the manufacturer.

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

Not applicable. This device is not a diagnostic tool that requires ground truth establishment by experts in the same way an AI/ML device would. The "ground truth" for mechanical properties would be derived from engineering standards and measurements, and for surgical technique from established surgical practices.

4. Adjudication method for the test set

Not applicable. There was no "test set" in the sense of patient data requiring expert adjudication.

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 not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is a physical medical device (screw system), not an algorithm.

7. The type of ground truth used

For Bench Testing (pull-out strength and torque): The "ground truth" would be the measured physical properties of the predicate devices based on established engineering test methods and standards.
For Clinical Simulations in Cadavers: The "ground truth" would be the expert assessment of the surgical technique's feasibility and success in relation to the intended use, likely by orthopedic surgeons.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The EXTREMITY MEDICAL Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies.

The EXTREMITY MEDICAL Screw and Washer System consists of a lag screw of five various diameters and lengths ranging from 10 to 100mm, as well as a mating washer component consisting of five various diameters and lengths ranging from 14 to 50mm. Both implant components are manufactured from Titanium alloy.

The EXTREMITY MEDICAL Screw and Washer System is a medical device intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The device received 510(k) clearance (K101700) from the FDA on October 12, 2010.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The device's acceptance criteria were primarily met through non-clinical bench testing and clinical simulations in cadavers, demonstrating substantial equivalence to predicate devices.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size for the bench testing (e.g., number of screws/washers tested for pull-out strength, torque, bending). For clinical simulations, it mentions "cadavers," implying a biological sample, but the specific number is not provided.
• Data Provenance: The data provenance is retrospective, as it involves testing performed on the device and comparator devices rather than on human patients in a prospective clinical trial. The country of origin of the data is not explicitly stated but is implied to be within the scope of the submitting company's operations, likely the USA given the FDA submission.

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 given document. The study primarily relies on objective mechanical testing and cadaveric simulations, not expert interpretation of results to establish ground truth in the way it would be for diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. "Adjudication method" typically refers to how disagreements are resolved among multiple human reviewers when establishing a ground truth, often in the context of diagnostic studies. The studies performed here (mechanical bench testing, cadaveric simulations) do not involve such a process.

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 comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human performance is compared with and without AI assistance. This device is a surgical implant system, not a diagnostic AI.

6. If a Standalone (i.e. 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 implant; it does not have an "algorithm-only" mode. The device's performance is inherently linked to its physical properties and how it's used in a surgical context by a human.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through:

• Bench Test Standards: Mechanical properties (pull-out strength, torque, bending) were measured against established engineering standards or direct comparison to the performance of legally marketed predicate devices. The "truth" is that the new device's performance met or exceeded the predicate device's performance.
• Cadaveric Verification: The "truth" in clinical simulation was the successful verification of the surgical technique in cadavers, confirming the device's usability and appropriate mechanical behavior within a biological model.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical medical implant, not an AI/ML algorithm, and therefore does not have a training set.

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

This information is not applicable. As explained above, there is no training set for this type of medical device.

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The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsalphalangeal and metacarpal-phalangeal joints.

The EXTREMITY MEDICAL Screw System consists of two metallic components a Metacarpal (distal) screw and a Lag Screw (proximal). The two components are designed to rigidly lock together to form an angle between the two components. The system includes common instrumentation for the application of surgical bone screws.

This 510(k) summary describes a medical device, the EXTREMITY MEDICAL Screw System, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of typical AI/software performance evaluation. The document focuses on the regulatory clearance for a physical medical implant.

However, based on the structure of your request and the provided document, I can deduce information related to regulatory acceptance and the studies performed (or not performed) for this physical medical device.

Here's an interpretation framed to address your questions as much as possible, re-interpreting "acceptance criteria" and "study" in the context of a 510(k) submission for a physical implant:

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

For a physical medical device seeking 510(k) clearance, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This is primarily done through showing similar indications for use, design, materials, and equivalent mechanical properties.

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

• Test Set Sample Size: Not applicable in the context of image data or an AI algorithm’s test set. For the bench testing, specific sample sizes for pull-out strength and torque tests are not provided in this summary. For clinical simulations in cadavers, the summary does not specify the number of cadavers used.
• Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective data as it relates to clinical or imaging datasets, since no clinical or imaging studies were performed for device performance evaluation. The "data" here refers to bench test results which are typically generated in a lab setting.

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

• Number of Experts & Qualifications: Not applicable. This summary describes a physical implant which establishes "ground truth" through direct measurement (e.g., of mechanical properties) rather than expert interpretation of data. The adjudication of substantial equivalence is done by FDA reviewers based on the engineering and design comparisons provided by the manufacturer.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses of datasets, which is not relevant for the bench testing and cadaveric simulations described for this physical device.

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

• MRMC Study: No. This type of study (MRMC, AI assistance) is completely irrelevant to the submission for this physical medical screw system.

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

• Standalone Performance Study: No. This is not an AI algorithm.

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

• Type of Ground Truth: For the mechanical properties, the "ground truth" would be established by direct physical measurement using calibrated lab equipment for metrics like pull-out strength and torque, and by comparing these values to those of the predicate devices. For surgical technique verification, the "ground truth" would be the successful and safe application of the device in cadaveric models as assessed by trained surgeons.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a physical implant.

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The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with:

• Localized pain and palpable crepitation at the base of the thumb on the "grind test" (circumduction with axial compression of the thumb)
• Decreased motion, pinch, and grip strength
• X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination.
• Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity

The EXTREMITY MEDICAL Trapezium Prosthesis

The provided text is a 510(k) summary for the EXTREMITY MEDICAL Trapezium Prosthesis. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or not present in this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics. The core "acceptance criteria" for K092548 is demonstrating substantial equivalence to predicate devices in terms of indications for use, materials, design, and principles of operation.
• Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, functional outcomes) are reported for the EXTREMITY MEDICAL Trapezium Prosthesis itself. The study's "performance" is its argument for substantial equivalence.

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

• Sample Size: Not applicable. This document is a regulatory submission for substantial equivalence, not a clinical study reporting on patient outcomes with a specific test set.
• Data Provenance: Not applicable for a test set of the device itself. The data provenance for the predicate devices would be from their original studies or regulatory submissions, which are not detailed here.

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

• Not applicable. There is no "test set" in the context of clinical performance evaluation described here, nor is there a ground truth established by experts for performance data of this specific device.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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. This is a medical implant, not an AI diagnostic tool. MRMC studies and "human readers improve with AI" are not relevant to this device.

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

• No. This is a medical implant, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this submission is the established safety and effectiveness of the predicate devices. The new device aims to demonstrate it is substantially equivalent to these already-approved devices, rather than establishing de novo safety and effectiveness through clinical trials with a primary ground truth (like pathology or outcomes data for a novel treatment).

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an algorithm being developed.

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

• Not applicable. See point 8.

Summary of what the document does provide regarding the "study" for acceptance:

• Study Type: This is a predator-based 510(k) submission, not a clinical or performance study of the subject device. The "study" here refers to the process of comparing the new device against legally marketed predicate devices.
• Acceptance Criteria (Implicit for 510k): The device is "accepted" (cleared for market) if it is found to be "substantially equivalent" to legally marketed predicate devices. This means it must have:
  • The same intended use as the predicate device.
  • The same technological characteristics as the predicate device; OR
  • Different technological characteristics from the predicate device that do not raise different questions of safety and effectiveness; AND
  • The information submitted to FDA, including appropriate scientific data, demonstrates that the device is as safe and effective as the legally marketed device.
• Device Performance (as presented): The document states: "The EXTREMITY MEDICAL Trapezium Prosthesis is substantially equivalent to its predicate devices. This conclusion is based upon the fact that this device is substantially equivalent in terms of indications for use, materials, design and principles of operation." No specific performance data (e.g., clinical outcomes, wear rates, complication rates) for the EXTREMITY MEDICAL Trapezium Prosthesis are presented. Performance is inferred from equivalence to the predicates.
• Predicate Devices Used for Comparison:
  • Wright Medical, Metallic CMC Spherical Implant K960534
  • Wright Medical, Orthosphere Ceramic Spherical Implant, K030319
  • Wright Medical, Swanson Titanium Carpal Scaphoid Implant, K864490
  • Wright Medical, Swanson Titanium Carpal Lunate Implant, K864491
  • Wright Medical, TIE-IN Trapezium, K033529
  • Wright Medical, Trapezium Implant, K781756
  • Ascension Orthopedics, PyroSphere, K042690
  • Ascension Orthopedics, PyroCarbon Lunate, K080997

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The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.

The EXTREMITY MEDICAL Midfoot Screw System

This document is a 510(k) Premarket Notification for the Extremity Medical Midfoot Screw System. It declares substantial equivalence to predicate devices and describes the intended use and technological comparison. However, it does not contain information about specific acceptance criteria or a study proving that the device meets such criteria because it's a submission for a medical device, not an AI/ML algorithm.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Summary of available information from the provided text:

Device: EXTREMITY MEDICAL Midfoot Screw System

Intended Use: Fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.

Basis for Clearance: Substantial equivalence to predicate devices (EXTREMITY MEDICAL Midfoot Screw System K082934 and 3.5 Fully Threaded Screw, Synthes K050683). The statement of technological comparison notes that the device and its predicate devices have the same indications for use, similar design, similar materials, and equivalent mechanical properties. The conclusion is based on indications for use, materials, design, test data, and principles of operation.

Note: While "test data" is mentioned, the specific details regarding what tests were performed, what the acceptance criteria for those tests were, and the results of those tests are not included in this summary document. This 510(k) summary focuses on demonstrating substantial equivalence, not on detailing a performance study against specific acceptance criteria in the way one would for an AI/ML device.

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The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints

The EXTREMITY MEDICAL Midfoot Screw System

The provided 510(k) summary for the EXTREMITY MEDICAL Midfoot Screw System (K082934) does not contain information about acceptance criteria or a study demonstrating device performance against such criteria for AI/ML device functionalities.

The document describes a medical implant system, which are physical devices used for fixation and arthrodesis of foot joints, not an AI/ML-driven device. Therefore, the requested information points, which are primarily relevant to AI/ML device validation, are not applicable or available within this 510(k) submission.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence to predicate devices based on design, materials, indications for use, and mechanical properties.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No test set for AI/ML performance is mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for AI/ML is mentioned.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The document indicates that the device's substantial equivalence was based on:

• Indications for use: Same as predicate devices.
• Materials: Similar to predicate devices.
• Design: Similar to predicate devices.
• Test data: Implies mechanical testing data, but specific acceptance criteria and detailed results are not provided in this summary.
• Principles of operation: Similar to predicate devices.

This 510(k) establishes substantial equivalence for a conventional medical device, not an AI/ML product.

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The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures

Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabılızatıon, Medial Stabılızatıon, Achılles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Reparr, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Filbow Biceps Tendon Reattachment, Tennis Elbow Repar, Ulnar or Radial Collateral Ligament Reconstruction

The EXTREMITY MEDICAL Suture Anchor

The provided text is a 510(k) summary for the EXTREMITY MEDICAL Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study for meeting specific acceptance criteria derived from device performance.

Therefore, the requested information regarding acceptance criteria, device performance testing, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for a study proving the device meets acceptance criteria cannot be found in the provided document.

This type of 510(k) submission generally relies on a comparison of design, materials, and intended use to existing legally marketed devices, rather than extensive clinical performance studies with specific statistical acceptance criteria. The "study" here is essentially the comparison to predicate devices, and the "acceptance criterion" is substantial equivalence.

Here's what can be extracted based on the nature of the document:

While the document doesn't present traditional "acceptance criteria" and a "study" to meet them in the context of device performance metrics (like sensitivity, specificity, accuracy for an AI device, or specific mechanical thresholds for a medical device), it does present the implicit acceptance criteria for its regulatory pathway: Substantial Equivalence to legally marketed predicate devices.

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

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

• Sample Size: Not applicable. This 510(k) summary does not describe a performance study with a "test set" in the traditional sense of clinical or technical data. The "test set" here is conceptually the comparison of the new device's characteristics against the predicate devices.
• Data Provenance: Not applicable. The data is descriptive of the device itself and its comparison to existing devices, not empirical performance data from patients or laboratory tests for this specific device in this document.

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

• Not applicable. Ground truth establishment by experts for a test set is not described in this 510(k) summary, as it's not a performance study.

4. Adjudication method 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 physical suture anchor, not an AI or imaging device, and therefore an MRMC study with human readers assisting AI is irrelevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable in the context of a performance study. The "ground truth" for the 510(k) substantial equivalence claim is the established legal marketing status and characteristics of the predicate devices.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is not a study involving machine learning or statistical modeling.

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

• Not applicable.

In summary, the provided document is a regulatory submission for substantial equivalence of a physical medical device, not a report on a performance study with quantitative acceptance criteria and a test set.

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