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The SnapHammer Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The SnapHammer Hammertoe Correction System is comprised of an additively manufactured titanium fixation device attached to a snap-off post. The snap-off post aids in a quick insertion and snaps off after implant has been threaded in. The implants are offered in Ø3.0mm and Ø3.50mm diameters and in lengths ranging from 12mm to 15mm. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.

The provided FDA 510(k) Clearance Letter for the "SnapHammer Hammertoe Correction System" describes a medical device, specifically a metallic bone fixation fastener. This document is a regulatory clearance for a physical medical device, not a software or AI-based medical device.

Therefore, the information requested in your prompt regarding acceptance criteria and studies for an AI/software medical device (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC study, standalone performance, ground truth, training set information) is not applicable to the provided document.

The document states:

• "No FDA performance standards have been established for the SnapHammer Hammertoe Correction System."
• The non-clinical testing performed focused on:
  • "Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)"
  • "The steam sterilization process has been validated per ISO 17665-1 & 17665-2 to a sterility assurance level of 10⁻⁶"
• The basis for equivalence is that the device "maintain[s] the same features as the previously cleared devices, but steam sterilization is being added as an alternative sterilization method."
• "This modification does not change the intended use or performance of the device and does not raise additional questions of substantial equivalence."

In summary, this clearance is for a physical orthopedic implant and is based on demonstrating substantial equivalence to a predicate device, primarily by showing that a new sterilization method does not alter its safety or efficacy, rather than AI/software performance metrics.

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The Multi-Drive Interference Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand /wrist. Specifically:

Shoulder:
Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Sepair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle:
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction

Knee:
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

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

Hand/Wrist:
Scapholunate Ligament Reconstruction, Unar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs. Ligament Reconstruction and Tendon Interposition

The Multi-Drive Interference Screw System is a family of interference screws for the reattachment and fixation of tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand /wrist. The interference screws are manufactured from HA Enhanced PEEK or titanium alloy in multiple lengths and diameters with key features including a threaded shank, cannulation hole, and multiple drive mating interface. The HA PEEK versions also incorporate tantalum pins for imaging visibility.

The provided text is a 510(k) summary for the Multi-Drive Interference Screw System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document, as a clinical study with detailed performance metrics was not performed or described.

Here's an analysis based on the information available in the text:

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

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on non-clinical testing to demonstrate substantial equivalence to predicate devices. The "performance" is implicitly that the device performs comparably to or within the established safety and effectiveness profile of the predicate devices.

• Insertion/removal torque
• Static axial pullout
• Engineering analysis comparison of mechanical strength |
  | Biocompatibility | - Pyrogenicity testing (LAL method), with

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The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

The Healix Compression Screw (HCS) System consists of cannulated, solid titanium allov. headless, headed screws and specialized instrumentation. This submission expands the Healix offering and includes longer screws ranging from 31 to 130mm in length for the 2.0 to 7.5mm diameters.

The provided text is a 510(k) summary for the Nvision Biomedical Technologies' Healix Compression Screw System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML or diagnostic performance.

Instead, this document is a regulatory submission for a physical medical device (bone fixation screws) and relies on mechanical performance characteristics and a comparison to existing predicate devices.

Therefore, I cannot extract the requested information (items 1-9) as it pertains to AI/ML device performance from the provided text. The document clearly states:

• "No FDA performance standards have been established for the Healix Compression Screw System."
• "The following was performed to demonstrate safety per methods of the previous submission: . Engineering analysis comparison of mechanical performance characteristics"
• "The results of the engineering analysis indicate that the Healix Compression Screw System is substantially equivalent to the predicate devices."

This indicates the evaluation was based on engineering analysis and comparison against physical predicate devices, not on a study proving a device meets acceptance criteria related to diagnostic performance, human-in-the-loop improvements, or ground truth establishment for AI/ML.

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The Trigon™ HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:

• Cotton (opening wedge) osteotomies of the medial cuneiform
• Evans lengthening osteotomies

The Trigon Ti wedges are intended for use with ancillary fixation.

The Trigon Ti Stand-Alone Wedge Fixation System is not intended for use in the spine.

The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.

When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation.

This document describes the Nvision Biomedical Technologies, Inc. Trigon HA Stand-Alone Wedge Fixation System, which is intended for internal bone fixation for bone fractures or osteotomies in the foot, specifically Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. It is not intended for use in the spine.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not specify explicit quantitative acceptance criteria for device performance in the same way a clinical trial would for a new drug or diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical testing. The "acceptance criteria" are implicitly met if the test results demonstrate equivalence and do not raise new issues of safety or efficacy.

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

The provided document describes non-clinical (bench) testing, not human studies or clinical trials with test sets involving patients.

• Sample size: The document does not specify the exact number of samples (e.g., number of wedges or screws) used for each non-clinical test (compression, expulsion, screw strength/pullout). It only lists the types of tests performed.
• Data provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective) as these are bench tests.

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

Not applicable. This is a 510(k) submission for a medical device cleared through substantial equivalence based on non-clinical (bench) testing, not a diagnostic algorithm requiring expert-established ground truth from patient data.

4. Adjudication Method for the Test Set

Not applicable for a non-clinical device submission based on bench testing.

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

No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool where human reader performance would be evaluated.

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

Not applicable. This device is a mechanical implant, it does not involve algorithms or AI.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the objective measurements and engineering standards (e.g., ASTM F2077 for compression) against which the device performance is measured to demonstrate substantial equivalence to predicate devices. It is thus engineering and mechanical testing standards.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a mechanical implant.

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

Not applicable. As there is no training set, there is no ground truth for it. The submission focuses on demonstrating equivalence of the mechanical properties of a new device to existing predicate devices.

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The Trigon™ Ti Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:

• Cotton (opening wedge) osteotomies of the medial cuneiform
• Evans lengthening osteotomies

The Trigon Ti wedges are intended for use with ancillary fixation.

The Trigon Ti Stand-Alone Wedge Fixation System is not intended for use in the spine.

The Trigon Ti Stand-Alone Wedge Fixation System is a family of additively manufactured titanium wedges used for angular correction of small bones of the foot. The wedges incorporate an organized lattice structure and two screw-receiving holes. The system rectangular and kidney shaped wedges may or may not include a window for containing grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter screws are designed in lengths of 10 to 20mm.

When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation. Windowless wedge designs that do not allow for graft placement should only be used with ancillary plating.

The provided text describes a medical device, the Trigon™ Ti Stand-Alone Wedge Fixation System, and its 510(k) premarket notification. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software.

The document primarily focuses on:

• Regulatory review: The FDA's substantial equivalence determination for the device.
• Device description: Physical characteristics, materials, and intended use of the bone wedge system.
• Predicate devices: Identification of similar devices already on the market.
• Non-clinical testing: Mechanical testing (compression, compression shear, expulsion, screw strength/pullout) to demonstrate substantial equivalence to predicates.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets those criteria, as it relates to AI/ML performance, because that information is not present in the provided text.

Specifically, the document does not mention or provide data for any of the following:

• AI/ML algorithm performance.
• Test sets, training sets, or data provenance.
• Experts establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies.
• Standalone algorithm performance.
• Types of ground truth (beyond mechanical test results for a physical device).

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