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The 4.5mm Facet Compression Device, which is included in the Disposable Posterior Lumbar Stabilization Procedure Kit, is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.

The intended use of the 4.5mm Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm Facet Compression Device.

The 4.5mm Facet Compression Device(s) contained in the Disposable Posterior Lumbar Stabilization Procedure Kit is a double-helix screw with a compression-locking collar and self-retaining washer. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. Disposable surgical instruments for use in implanting the device are also included in the kit. The kit is provided "STERILE"; sterilization is by gamma radiation. The re-usable Compression Tool is provided separately in a "NONSTERILE" condition; sterilization is by moist heat (steam autoclaye) and is performed on-site.

Here's an analysis of the provided 510(k) summary regarding the Disposable Posterior Lumbar Stabilization Procedure Kit, focusing on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Triage Medical Disposable Posterior Lumbar Stabilization Procedure Kit (K062391) is a premarket notification for a Class II medical device. For such devices, the acceptance criteria are generally based on substantial equivalence to a previously cleared predicate device. This typically means demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

The document does not explicitly state numerical "acceptance criteria" in terms of performance metrics (e.g., a specific strength value that must be met). Instead, the performance is evaluated in comparison to the predicate device to establish substantial equivalence.

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

The 510(k) summary does not provide details on specific sample sizes for any mechanical or performance testing. It generally states "performance test results indicate..." without quantifying the number of units tested.

Regarding data provenance, the document does not specify the country of origin for the testing or whether the data was retrospective or prospective. Given the nature of a 510(k) for an orthopedic implant, the testing would typically involve in vitro mechanical testing and material characterization, rather than clinical data in the same way an AI/software device would generate.

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

This type of information is not applicable to this 510(k) document. The device is a physical medical implant (a facet screw and associated instruments). "Ground truth" established by experts, especially for a "test set" in the context of diagnostic or AI performance, is not a relevant concept for this type of device submission. The primary evaluation is based on engineering principles, material science, and mechanical testing, often performed by engineers and material scientists, not clinical experts establishing ground truth from patient data.

4. Adjudication Method for the Test Set

This is not applicable to this 510(k) document for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human expert disagreement needs resolution. This is not how the performance of a facet screw is assessed for a 510(k) submission.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret medical images, often assisted by AI. This device is a surgical implant; therefore, MRMC studies are not relevant to its evaluation.

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

This is not applicable. The device is a physical surgical implant and instruments; it does not involve an algorithm or AI.

7. The Type of Ground Truth Used

As mentioned, "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly relevant for the performance evaluation of this specific device for its 510(k) submission. The "ground truth" for the device's characteristics and performance would be derived from:

• Material specifications: Conformance to ASTM F-136.
• Mechanical testing standards: (Implicitly) demonstrating strength, fatigue resistance, and other biomechanical properties relevant to spinal stabilization.
• Predicate device's known performance: The BONE-LOK® 4.5mm Facet Screw, which serves as the benchmark for "substantial equivalence."

8. The Sample Size for the Training Set

This is not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set.

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

This is not applicable for the same reasons as point 8.

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The 3.8mm CS Facet Compression Device is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis and failed previous fusion. The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1.

The 3.8mm CS Facet Compression Device is a double-helix screw with a compressionlocking collar, and is provided with or without a self-retaining washer. It is available in various length ranges fabricated from either Titanium 6Al-4V, which meets the requirements of ASTM F-136 or stainless steel, which meets the requirements of ASTM F-138.

This document describes the 510(k) summary for the Triage Medical, Inc. 3.8mm CS Facet Compression Device. This device is a facet screw intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints.

The provided text describes a medical device submission for regulatory clearance (510(k) application) and details related to its non-clinical performance and a comparison to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria related to AI/software performance or diagnostic accuracy. The performance data mentioned is focused on mechanical and biocompatibility aspects, not AI-driven predictive or diagnostic capabilities.

Therefore, many of the requested sections about acceptance criteria, study details for AI performance, sample sizes for AI training/testing, ground truth establishment, and MRMC studies cannot be generated from the given text.

Here's the information that can be extracted and a clear statement about what is not available:

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

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

This information is not available in the provided text. The document refers to non-clinical mechanical and biocompatibility testing, not clinical studies or AI algorithm testing with a "test set" in the common sense for AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text. The device is a physical implant, and its evaluation relies on engineering tests and material standards, not expert-derived ground truth for AI performance.

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

This information is not available in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not available in the provided text. This device is not an AI-driven diagnostic or assistive tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

This information is not available in the provided text. This device is a physical facet screw, not an algorithm.

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

For the mechanical and biocompatibility performance, the "ground truth" would be established by engineering standards and test methodologies (e.g., ASTM standards for materials, recognized biomechanical testing protocols). This is not the typical "ground truth" concept as applied to AI/diagnostic devices.

8. The sample size for the training set

This information is not available in the provided text. There is no mention of an AI algorithm or a training set.

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

This information is not available in the provided text. There is no mention of an AI algorithm or a training set.

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The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.

The intended use of the 4.5mm LS Facet Compression Device with Polymer Washer is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.

The 4.5mm LS Facet Compression Device is a double-helix screw with a compressionlocking collar. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. The 4.5mm LS Facet Compression Device with Polymer Washer is intended for single use only.

Devices are provided "STERILE" and are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.

The provided text describes a 510(k) premarket notification for a medical device, the "4.5mm LS Facet Compression Device with Polymer Washer." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with acceptance criteria and device performance metrics in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested elements for an AI/algorithm-focused study are not directly applicable or present in this document. I will extract the information that is available and indicate where the information is not provided.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

This document does not present quantitative acceptance criteria or detailed device performance metrics in the format of a clinical study or algorithm validation. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, as determined by mechanical testing and biocompatibility.

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

Not applicable. This document is for a mechanical medical device, not a data-driven AI/algorithm. The "test set" would refer to the mechanical tests performed on the device. However, specific sample sizes for these tests are not provided in this summary. The data provenance would be from laboratory testing of materials and device mechanics.

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

Not applicable. This is not a study requiring expert consensus for ground truth.

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

Not applicable. This is not a study requiring adjudication of ground truth.

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-assisted diagnostic or imaging device.

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

Not applicable. This is a mechanical medical device.

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

For the mechanical performance and biocompatibility, the "ground truth" is defined by established material standards (e.g., ASTM, USP, ISO) and laboratory-based functional performance tests compared against the predicate device.

8. The sample size for the training set

Not applicable. This is a mechanical medical device, not an AI/algorithm that requires training data.

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

Not applicable. No training set is involved.

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The 4.5mm BONE-LOK® Facet Screw is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.

The intended use of the 4.5mm BONE-LOK® Facet Screw is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm BONE-LOK® Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to Sl.

The 4.5mm BONE-LOK® Facet Screw is a double-helix screw with a compressionlocking collar and a self-retaining washer. It is available as a 30-40mm range device fabricated from either stainless steel, which meets the requirements of ASTM F-138, or Titanium 6Al-4V, which meets the requirements of ASTM F-136.

This appears to be a 510(k) summary for a medical device (a facet screw), not an AI/ML medical device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria based on AI/ML metrics, sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance, are not applicable.

The provided document describes a 4.5mm BONE-LOK® Facet Screw and its substantial equivalence to a predicate device for safety and effectiveness. The "acceptance criteria" in this context would generally refer to the successful demonstration of this substantial equivalence through non-clinical performance data (mechanical and biomechanical testing) and biocompatibility, rather than clinical performance metrics for an AI algorithm.

However, I will extract information related to "acceptance criteria" and "study" as best as possible from the provided context, interpreting "acceptance criteria" as the requirements for substantial equivalence and "study" as the non-clinical performance evaluation.

1. Table of Acceptance Criteria and the Reported Device Performance

Explanation of the "Study" that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the (implied) acceptance criteria is a non-clinical performance evaluation consisting of:

• Mechanical Testing: To assess the physical properties and performance under stress.
• Biomechanical Testing: To evaluate how the device performs within a biological system context (e.g., in terms of stability, load-bearing).
• Biocompatibility Assessment: Based on the use of well-established, legally marketed surgical-grade materials (Stainless Steel and Titanium alloy) that meet ASTM standards (F-138 and F-136, respectively).

These tests collectively demonstrate that the device satisfies functional performance requirements and is safe for its intended use, establishing substantial equivalence to the predicate device.

Items 2-9 (Not Applicable to this type of device submission):

The following points are specifically relevant to the evaluation of AI/ML medical devices, which typically involve software algorithms processing data for diagnostic or prognostic purposes. The provided document concerns a Class II mechanical implant (a facet screw), not an AI/ML device. Therefore, these questions are not applicable in this context.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Not applicable for a mechanical implant.
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 for a mechanical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable for a mechanical implant.
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 for a mechanical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable; this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Not applicable for a mechanical implant.
8. The sample size for the training set - Not applicable; this is not an AI/ML model.
9. How the ground truth for the training set was established - Not applicable; this is not an AI/ML model.

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The BONE-LOK® MVP Cortical-Cancellous Compression Device is indicated for use in the general management of fractures and reconstructive surgery.

The BONE-LOK® MVP Cortical-Cancellous Compression Device is a double-helix screw with a compression-locking collar. It is available as 3.5mm or 4.5mm diameter device with a compression looking ochan 1978 - The BONE-LOK® MVP Cortical-Cancellous Compression Device is intended for single use only. Devices provided "STERILE" are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BONE-LOK® MVP Cortical-Cancellous Compression Device, structured to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" in this Context:

It's important to note that the provided 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a detailed list of specific numerical acceptance criteria for clinical or performance outcomes. The acceptance criteria here are implicitly:

• The materials used are biocompatible and commonly accepted for orthopedic devices.
• The mechanical performance is comparable to the predicate device.
• The device is safe for its intended use.

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

The provided 510(k) summary does not contain information about a test set with human or animal subjects, nor does it mention sample sizes for such a set. The document refers to "Performance test results" which are likely referring to mechanical or bench testing.

• Sample Size for Test Set: Not mentioned, likely not applicable in the context of human/animal outcome data for this type of submission.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not mentioned.

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

This information is not provided in the document. As there's no mention of a clinical test set requiring human interpretation or ground truth establishment in the traditional sense (e.g., for diagnostic accuracy), this section is not applicable.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable, as there's no mention of a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. This type of study (often seen in diagnostic imaging for AI) is not relevant for a bone fixation device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical bone fixation screw, not a software algorithm or AI tool. Therefore, a "standalone algorithm performance" study is not relevant. The "performance data" mentioned refers to mechanical testing.

7. Type of Ground Truth Used

Based on the document, the "ground truth" for the device's performance is established through:

• Compliance with Material Standards: Meeting ASTM F-138 (stainless steel) or ASTM F-136 (titanium) for biocompatibility. These are established industry standards for medical-grade materials.
• Mechanical Performance Bench Testing: The statement "Performance test results indicate that the device is safe and satisfies functional performance requirements" implies benchtop mechanical testing (e.g., strength, compression, fatigue) against established engineering specifications or comparison to the predicate device's known performance.
• Substantial Equivalence to Predicate Device: The ultimate "truth" for 510(k) clearance is demonstrating that the modified device is as safe and effective as a legally marketed predicate device.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical medical device, not an AI model or software algorithm that requires a training set of data.

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

This information is not applicable for the same reason as point 8.

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The BONE-LOK™ HP Washer is an accessory intended for use with the BONE-LOK™ HP Cannulated Helical Compression Anchor System, in the general management of fractures and reconstructive surgery.

The BONE-LOK™ HP Washer is intended for use with BONE-LOK™ HP Cannulated Helical Compression Anchor System in the general management of fractures and reconstructive surgery. The washer provides a bearing surface for the screw head against the bone and also prohibits migration of the screw head into the cortex.
The BONE-LOK™ HP Washer is fabricated from Titanium 6AI-4V ELI, which meets the requirements of ASTM-136.
The BONE-LOK™ HP Washer is provided "NON-STERILE" and will require subsequent sterilization on site. The BONE-LOK™ HP Washer will be supplied as a part of the BONE-LOK™ HP Instrument Kit or as individual units packaged in a labeled poly bag. The Instrument Kit is distributed in a custom autoclavable compartmentalized tray with a locking lid. Both the BONE-LOK™ HP Washer and the Instrument Kit may be sterilized by moist heat. The sterilization validation method is in conformance with international standards (EN 554 and ISO/ANSI/AAMI 11134). Sterilization instructions are included in the Instructions for Use.

Here's an analysis of the provided text regarding the BONE-LOK™ HP Washer, focusing on acceptance criteria and supporting studies:

This medical device submission (K040250) is for a mechanical washer, not a software or AI-powered device. Therefore, many of the typical acceptance criteria and study components you'd expect for an AI/software device (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.

The acceptance criteria for a mechanical device like this often revolve around material properties, mechanical performance, and biocompatibility, typically demonstrated through in vitro testing or by leveraging existing knowledge about similar devices and materials.

Acceptance Criteria and Reported Device Performance

Study Details (as applicable to this type of device)

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 in the sense of a test set for a software/AI device. The "testing" here refers to the inherent properties of the material and the established history of use for this type of device and material. No specific "test set" of cases or data is mentioned.

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" establishment in the context of image interpretation or diagnostic accuracy for this mechanical washer. The "truth" is based on material specifications and mechanical function.

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

   • Not applicable. No adjudication method is relevant for this type of device submission.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable. This is a mechanical washer, not an AI or software device.

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

   • Not applicable. This is a mechanical washer, not an algorithm.

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

   • Not applicable in the traditional sense. The "ground truth" for this device's safety and effectiveness is derived from:
     • Material specifications: ASTM-136 for Titanium 6Al-4V ELI.
     • Accepted engineering principles: For its function as a washer.
     • Established clinical use: Of similar devices and the material itself for biocompatibility.

7. The sample size for the training set

   • Not applicable. This is a mechanical device, not an AI model.

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

   • Not applicable.

Summary of the "Study" for the BONE-LOK™ HP Washer:

The core of the submission's "performance data" and "biocompatibility" sections relies on demonstrating substantial equivalence to predicate devices and leveraging well-established material properties and clinical history.

The document explicitly states:

• "Because the washer is fabricated from a material with specified mechanical requirements, is of limited functionality, and washers have been previously utilized in this capacity, additional testing is not required." (Performance Data)
• "Because its inertness and biocompatibility has already been established, additional testing is not required." (Biocompatibility)

This means the "study" demonstrating the device meets acceptance criteria is primarily a literature review and comparison to legally marketed predicate devices and established material standards, rather than de novo experimental studies with test sets, expert ground truth, or statistical analysis typical for AI/software. The substantial equivalence argument is the primary "proof" used here.

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This device is indicated for use in the general management of fractures and This device is indication for ass litht bearing applications with proper postoperative immobililzation.

Not Found

The provided document is an FDA 510(k) clearance letter for the Bone-Lok™ Bioabsorbable Compression Anchor. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The letter is a notification of the FDA's determination that the device is substantially equivalent to legally marketed predicate devices, allowing Triage Medical, Inc. to market the device. It focuses on regulatory compliance, general controls, and classification.

Therefore, I cannot provide the requested information based on the input document. The document primarily addresses regulatory clearance rather than detailed performance study results.

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This device is indicated for use in the general management of fractures and reconstructive surgery in non-weight bearing applications with proper postoperative immobililzation.

Bone-Lok™ Bioabsorbable Compression Anchor with Titanium Fixture and Bone-Lok™ Bioabsorbable Compression Anchor

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the Bone-Lok™ Bioabsorbable Compression Anchor, indicating that the device is substantially equivalent to legally marketed predicate devices.

The letter discusses regulatory aspects, such as compliance with the Federal Food, Drug, and Cosmetic Act, and general controls like good manufacturing practice and labeling. However, it does not detail specific performance characteristics, acceptance criteria, or any studies undertaken to demonstrate the device's efficacy or safety in relation to such criteria. The "Indications For Use" section merely states the general purpose of the device.

Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance or information about a study based on the provided text.

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This device is used in general management of fractures and reconstructive surgery.

Not Found

Since the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Triage Medical, Inc. Helical Compression Anchor), it does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth.

This document is a regulatory clearance letter, confirming that the device is substantially equivalent to a predicate device and can be marketed. It does not provide the technical details of any performance studies that would have been submitted to support this claim.

To answer your request, I would need access to the actual 510(k) submission or a summary thereof, which typically includes the performance data and methodology.

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These devices are used for the correction of hallux valgus (bunion) and repair of metatarsal, metacarpal and phalangeal fractures.

Helical Compression Anchor, Cannulated, Single and Double Helix

This document is a 510(k) clearance letter from the FDA for a medical device called the "Triage Medical, Inc. Helical Compression Anchor, Cannulated." It is not a study or a report detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information from the provided text.

The letter simply states that the FDA has reviewed the premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain any details about studies, acceptance criteria, sample sizes, ground truth, or expert qualifications.

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