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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™ 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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This device is used for the correction of hallux valgus (bunion) and repair of metatarsal, metacarpal and phalangeal fractures.

Titanium Compression Anchor System

The provided text is a 510(k) clearance letter from the FDA for a device called "Titanium Compression Anchor System". This document confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert qualifications for AI/ML device validation.

Therefore, I cannot extract the requested information from the provided text. The questions posed are relevant to AI/ML device submissions, which this document is not.

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