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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 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. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.

This document is a 510(k) premarket notification for a medical device called the "SnapHammer Hammertoe Correction System." It aims to demonstrate the device's substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain information about a study that proves the device meets specific acceptance criteria based on human-in-the-loop performance, nor does it provide a table of acceptance criteria and reported device performance directly related to an AI/Software as a Medical Device (SaMD) product.

Instead, this document describes a hardware medical device (a bone fixation fastener) and the non-clinical (mechanical) testing performed to demonstrate its safety and efficacy.

Therefore, I cannot fulfill the request to provide:

• A table of acceptance criteria and reported device performance for an AI/SaMD.
• Sample size used for a test set or data provenance for an AI/SaMD.
• Number of experts or their qualifications for establishing ground truth for an AI/SaMD test set.
• Adjudication method for an AI/SaMD test set.
• MRMC comparative effectiveness study results.
• Standalone performance for an AI/SaMD.
• Type of ground truth used for an AI/SaMD.
• Training set sample size or how its ground truth was established for an AI/SaMD.

The document discusses "non-clinical testing" for the orthopedic implant, which includes:

• Mechanical Performance: Torsion, driving torque, and axial pullout (per ASTM F543), as well as static and dynamic bending.
• Additive Manufacturing: Tensile testing per ASTM F3001 and residual powder removal (particle analysis per ASTM F1877).

It concludes that based on these tests, the device does not raise new issues of safety or efficacy compared to the predicate devices. This implies that the acceptance criteria for these mechanical tests were met, demonstrating equivalence. However, the specific quantitative acceptance criteria or results for these mechanical tests are not detailed in this publicly available summary.

In summary, this document is about a physical medical device (hardware) and its mechanical testing, not a software or AI-based medical device. Therefore, the requested information regarding AI/SaMD acceptance criteria and study design is not present.

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The Vector 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.

The Vector Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.00mm, Ø3.50mm and Ø4.00mm and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria, as it relates to performance metrics of a device, particularly an AI/imaging device. The document is an FDA 510(k) clearance letter for a medical device called the "Vector® Hammertoe Correction System," which is a bone fixation system, not an imaging or AI-driven diagnostic device.

Therefore, I cannot provide the requested information from the given text.

The document discusses:

• Device Name: Vector® Hammertoe Correction System
• Regulation Number: 21 CFR 888.3040 (Smooth Or Threaded Metallic Bone Fixation Fastener)
• Regulatory Class: Class II
• Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
• Device Description: Sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device, K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.
• Predicate Devices: K201850 (Nvision Biomedical's Vector Hammertoe Correction System), K183055 (Nvision Biomedical's Vector Hammertoe Correction System), and K193645 (Nvision Biomedical's nva, nvt).
• Non-Clinical Testing: Primarily engineering analysis comparing device characteristics (materials, intended use, cleaning, sterilization) to predicate devices. It states no FDA performance standards have been established for this device and that the results indicate substantial equivalence. The key modification mentioned is the addition of steam sterilization as an alternative method.

None of the information required for explaining acceptance criteria for an AI/imaging device, such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, is present in this regulatory document.

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The Nextremity Solutions Nextra PEEK Hammertoe Correction System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

The Nextra PEEK Hammertoe Correction System consists of a two-part mating bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implants are available in diameters of 3.2mm and 4.2mm. The middle screw implant is available in diameters of 3.5mm, 4.25mm, and 5.0mm, with 0° and 10° angled options. The proximal and distal screw implants are manufactured from polyetheretherketone (PEEK) conforming to ASTM F2026. The system includes implant specific drivers and taps, and other necessary surgical site preparation instruments. The implants and instruments of the system are provided sterile for single use.

Here's a breakdown of the acceptance criteria and study information for the Nextra® PEEK Hammertoe Correction System, based on the provided FDA 510(k) summary:

This device did not undergo clinical testing to demonstrate substantial equivalence. Instead, the submission relies on non-clinical testing to compare its performance to predicate devices. This means that many of the typical elements of an AI/medical device performance study (like sample size, ground truth, expert adjudication, MRMC studies) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for the non-clinical tests beyond "worst-case implant construct" for mechanical testing. Data provenance is not applicable as this was non-clinical testing.

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 non-clinical testing (like material properties and mechanical strength) is established through standardized testing procedures and material specifications, not expert interpretation.

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, a multi-reader multi-case comparative effectiveness study was not done. This device is an implant, not an AI-assisted diagnostic or treatment planning tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation was based on:

• Standardized Endotoxin Limits: Defined by AAMI ST72, USP 161, and USP 85.
• Standardized Mechanical Testing Protocols: Defined by ASTM F2193-18a and comparison to the mechanical properties of legally marketed predicate devices.

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

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

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The Vector 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.

The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.0mm (cannulated), Ø3.50mm (cannulated and non-cannulated) and Ø4.00mm (cannulated and non-cannulated) and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The provided text is a 510(k) summary for the VECTOR™ Hammertoe Correction System. It describes the device, its indications for use, and its equivalence to predicate devices, primarily through engineering analysis. This document does not contain information about an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance in the context of AI/ML.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone (algorithm only) performance data
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document explicitly states: "No FDA performance standards have been established for the Vector Hammertoe Correction System. The following was performed to demonstrate safety per methods of the previous submission: Engineering Analysis comparison of mechanical performance characteristics." This indicates that the safety and effectiveness were demonstrated through mechanical performance characteristics engineering analysis and comparison to predicates, not through clinical or AI/ML performance studies with human readers or AI algorithms.

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The Vector 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.

The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.50mm and Ø4.00mm and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The VECTOR Hammertoe Correction System is a medical device designed for the fixation of osteotomies and reconstruction of lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The provided text describes the regulatory filing for this device, not a study evaluating its performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this document.

However, based on the "SUMMARY OF NON-CLINICAL TESTING" section, we can infer the types of tests performed to demonstrate safety and equivalence to predicate devices, which serve as the implicit acceptance criteria for this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify the sample size for individual tests (e.g., number of implants tested for torsion, pullout, etc.). It describes non-clinical laboratory testing. The data provenance is from laboratory testing conducted by the manufacturer, Nvision Biomedical Technologies, LLC. Since these are non-clinical (mechanical and biological) tests, "country of origin of the data" and "retrospective or prospective" are not directly applicable in the same way they would be for clinical studies with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical study involving mechanical and biocompatibility testing, not human expert evaluation of clinical images or diagnoses. The "ground truth" here is established by the specifications of the ASTM standards and regulatory limits (e.g., endotoxin levels).

4. Adjudication method for the test set
Not applicable. There was no expert adjudication process as this was non-clinical laboratory testing.

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 document describes the regulatory filing for a medical fixation device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI-based device.

7. The type of ground truth used
The "ground truth" for the non-clinical tests is based on:

• Engineering specifications and recognized consensus standards: Specifically ASTM F543, which outlines standard test methods for metallic medical bone screws.
• Regulatory limits for biocompatibility: Recommended Bacterial Endotoxins limits (20 EU/device).
• Comparison to predicate devices: The "substantially equivalent" determination implies that the test results met or exceeded the performance characteristics of the predicate devices.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.

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The Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

The Life Spine Hammertoe Correction System is an implant with a dual threaded design and is inserted between the proximal and middle phalanges, so the opposing threads fixate on the phalangeal canal of the toe and compress the joint. The implant is fabricated and manufactured from the following:

• 1. Titanium (Ti 6A1-4V ELI)
     All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the HAMMERTOE Correction System components with components from any other system or manufacturer. The HAMMERTOE Correction System implants should never be reused under any circumstances.

This appears to be a 510(k) summary for a medical device (Hammertoe Correction System), not a study evaluating an AI/ML powered medical device. Therefore, much of the requested information about acceptance criteria, study design for AI devices, sample sizes, expert ground truth, and MRMC studies is not applicable.

However, I can extract the information related to the performance data of this specific medical device.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance numbers for each criterion in the way it would for an AI/ML device. Instead, it states that various tests "were included to demonstrate the substantial equivalency" to predicate devices. This implies that the acceptance criteria are met if the device's performance is comparable to or better than the predicate devices for the measured parameters.

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

• Sample Size: Not specified for any of the individual tests (torsional strength, bending strength, axial pullout, driving torque).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). These are bench-top tests, so the concept of "country of origin of data" is less applicable than for clinical data.

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

• Not Applicable: This is a mechanical device, and its performance is evaluated through engineering tests (Finite Element Analysis, Bench Top Validations). "Ground truth" in the context of expert review for medical imaging or diagnostics is not relevant here. The "ground truth" is established by the physical properties and mechanical behavior of the device.

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

• Not Applicable: Adjudication methods are used to resolve disagreements among human reviewers (e.g., radiologists). This is a bench-top mechanical testing scenario.

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/ML device. MRMC studies are not relevant.

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

• Not Applicable: This is not an AI/ML algorithm.

7. The type of ground truth used:

• For the mechanical tests: The "ground truth" is defined by the physical and mechanical properties of the materials and the design as measured through various engineering tests and simulations (Finite Element Analysis, Bench Top Validations). The comparison is against predicate devices and established standards.
• For biocompatibility: Material standards (ASTM F136 for titanium) and specific bacterial endotoxin testing (BET) define the "ground truth" for material safety.

8. The sample size for the training set:

• Not Applicable: This is not an AI/ML device, so there is no "training set."

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

• Not Applicable: As there is no training set.

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The 2-Piece Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

The 2-Piece Hammertoe Correction System is a two-piece construct, each with a threaded shaft that is inserted in the proximal and middle phalanges, so that each implants threads fixate on the phalangeal canal of the toe and stabilize the joint. The implant is fabricated and manufactured from the following: 1) Titanium (Ti 6A1-4V ELI). All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the 2-Piece Hammertoe Correction System components with components from any other system or manufacturer. The 2-Piece Hammertoe Correction System components should never be reused under any circumstances.

The provided text describes a 510(k) premarket notification for a medical device called the "2-Piece Hammertoe Correction System." This document is a regulatory filing with the US FDA and does not contain detailed acceptance criteria, study data, or performance metrics in the way your request describes for assessing AI or diagnostic device performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them, including:

1. A table of acceptance criteria and the reported device performance: This document is a clearance letter, not a detailed study report.
2. Sample size used for the test set and the data provenance: Not applicable; no such test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable; this is a hardware device, not an AI or diagnostic tool.
6. If a standalone performance study was done: "Bench Top Validations" and "Custom Shear Testing" were performed for substantial equivalence, but the details (like specific performance metrics, sample sizes, or results against acceptance criteria) are not provided.
7. The type of ground truth used: Not applicable in the context of device performance metrics for diagnostic accuracy. For a mechanical device, performance would relate to strength, durability, biocompatibility, etc.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide is:

• Device Name: 2-Piece Hammertoe Correction System
• Indications for Use: "for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes."
• Material: Titanium (Ti 6A1-4V ELI) manufactured according to ASTM F136.
• Performance Data Mentioned: "Custom Shear Testing and Bench Top Validations were included to demonstrate the substantial equivalency of the 2-Piece Hammertoe Correction System." This indicates that some form of testing was done to support the claim of substantial equivalence to predicate devices, but the specific results and acceptance criteria are not detailed in this public FDA letter.
• Conclusion: The information demonstrates substantial equivalency.

This document serves as an FDA clearance letter based on a 510(k) submission, confirming that the device is substantially equivalent to a predicate device. It does not typically include the granular details of performance studies or acceptance criteria that would be found in a full clinical trial report or a detailed engineering validation document.

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Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

The ToeMATE® Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The implants are offered in three size options, x-small, small and large. The taper lock pin provides a press fit connection between the two screws with light contact pressure and is available in straight and angled configurations. The implant components are manufactured using implant grade titanium alloy and cobalt-chrome alloy.

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "ToeMATE® Hammertoe Correction System". This document focuses on the regulatory clearance process and establishing substantial equivalence to previously cleared predicate devices.

It does not contain information about acceptance criteria, device performance, or any specific study details such as sample sizes, data provenance, expert qualifications, ground truth establishment, or specific study types like MRMC or standalone performance. The document primarily discusses:

• Device Name and Regulation Information: ToeMATE® Hammertoe Correction System.
• Indications for Use: Small bone fusion, fractures, and inter-digital fusion of the fingers, toes, and small bones.
• Device Description: Two intramedullary bone screws, a taper lock pin, and instruments, made from implant grade titanium alloy and cobalt-chrome alloy.
• Substantial Equivalence: Claiming substantial equivalence to predicate devices (K130859, K101165, K120645) based on similar indications for use, operating principles, materials, instrumentation, packaging, and sterilization.
• Non-Clinical Tests: Lists "Device Comparative Analysis," "Mechanical Testing" (static and dynamic cantilever bending, torque to failure, insertion/removal torque, axial pullout, and disassembly), and a "Kinetic Chromogenic LAL Test" for bacterial endotoxins.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided document. The document states that the results demonstrated substantial equivalence but does not provide those results or the detailed methodology of how performance was assessed against any specified acceptance criteria.

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The Life Spine HAMMERTOE Correction System is indicated for small bone reconstruction limited to inter-digital repar and fusion of the lesser toes.

The Hammertoe Correction System is an implant with dual threaded design and is inserted between the proximal and middle phalanges, so the opposing threads fixate on the phalangeal canal of the toe and compress the joint. The implant is fabricated and manufactured from Titanium (Ti 6A1-4V ELI)

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Hammertoe Correction System components with components from any other system or manufacturer. The Hammertoe Correction System components should never be reused under any circumstances.

I am sorry, but based on the provided text, there is no information about an AI/ML-driven medical device, its acceptance criteria, or a study proving its performance. The document is an FDA 510(k) clearance letter for a mechanical medical device called "The Hammertoe Correction System."

The document primarily covers:

• The FDA's decision to clear the device based on substantial equivalence.
• The device's trade name, regulation number, regulatory class, and product code.
• Contact information for the manufacturer.
• Indications for use of the Hammertoe Correction System.
• A brief description of the device and its material (Titanium).
• Mention of performance data (Finite Element Analysis, Custom Shear Testing, and Bench Top Validations) used to demonstrate substantial equivalence to predicate devices, but no specifics about the results or how they relate to acceptance criteria are provided.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them because the provided text describes a traditional orthopedic implant, not an AI/ML device.

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