Search Results

The Trilliant Surgical Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.

The Sniper Staple is a mechanical osteosynthesis device allowing for fixation and compression of the bone fragments in order to encourage early bone healing. The staple is fabricated from a nickel-titanium alloy (Nitinol) and possesses super-elastic properties at room temperature. The staple offering is composed of staples consisting of a 1.5 mm x 1.2 mm diameter "U" shaped wire. The "U" shaped staple is available in 8 mm x 8 mm and 10 mm x 10 mm sizes.

This document is a 510(k) premarket notification for a medical device called the "Sniper Staple System." It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and AI/MRMC studies is not applicable to this type of document.

However, I can extract the relevant information from the document in the context of a traditional medical device (a surgical staple).

Here's the information that can be extracted:

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

For a traditional medical device like a surgical staple, "acceptance criteria" are typically defined by recognized standards and mechanical testing rather than a numerical performance metric like sensitivity/specificity for an AI. The document describes several non-clinical tests performed.

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

• Sample Size: Not specified in the document. For mechanical testing, sample sizes are typically determined by the specific ASTM standards referenced (e.g., F564, F2082, F2129).
• Data Provenance: Not applicable. These are laboratory-based mechanical and biological (pyrogenicity) tests performed on the device itself, not data from human subjects or clinical records.

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. Ground truth as typically understood for AI/diagnostic algorithms is not relevant here. The "truth" is established by the physical properties and performance of the device as measured by standardized engineering and biological tests.

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

• Not applicable. This concept pertains to human review of medical data for ground truth establishment, which is not relevant for this device's 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

• No. This is a traditional surgical staple, not an AI or diagnostic imaging device.

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

• No. This is a physical medical device, not an algorithm.

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

• For mechanical tests: Engineering standards (ASTM F564, F2082, F2129) define acceptable performance.
• For biocompatibility/safety test: Biological standards (e.g., maximum endotoxin level for pyrogenicity).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

Summary from the document for the Sniper Staple System:
The device's substantial equivalence to predicate devices is based on non-clinical testing, including:

• Four-point Bending (ASTM F564)
• Pull-out Testing (ASTM F564)
• Bend and Free Recovery Testing (ASTM F2082)
• Corrosion testing (ASTM F2129)
• Pyrogenicity testing (Limulus amebocyte lysate (LAL) assay)

The document states, "The results of these evaluations indicate that the Sniper Staple is equivalent to predicate devices," and for pyrogenicity, "The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device." No clinical studies were performed. The conclusion for equivalence is based on similarities in principles of operation, technology, materials, and indications for use.

Ask a specific question about this device

The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.

The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.

Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and the necessary instruments to facilitate the placement of these implants.

The provided text describes a 510(k) submission for the Gridlock Plating System, a medical device for orthopedic trauma and reconstructive procedures. Based on the document, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to predicate devices rather than meeting specific performance criteria against a predefined standard. The acceptance criteria essentially revolve around demonstrating that the new components (additional plates and screws) within the Gridlock Plating System do not alter the fundamental safety and effectiveness profile such that new clinical testing would be required.

Study Details

The provided document largely lacks information on clinical studies or detailed performance trials in the way one might expect for a novel device or one requiring extensive performance validation against acceptance criteria with empirical data.

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

   • No clinical test set was used. The document explicitly states: "No clinical studies were performed."
   • Data provenance: Not applicable.

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

   • Not applicable. No clinical test set or ground truth establishment by experts was performed for this 510(k) submission. The assessment relies on engineering analysis and comparison to predicate device characteristics.

3. Adjudication method for the test set:

   • Not applicable. No clinical test set or adjudication process was performed.

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:

   • No such study was performed. This device is a metallic bone plating system, not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not relevant.

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

   • Not applicable. This device is a physical implant, not a software algorithm.

6. The type of ground truth used:

   • Engineering Analysis and Substantial Equivalence to Predicate Devices: The "ground truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate devices (OsteoMed Foot Plating System K091614, and previous versions of Gridlock Plating System K121452, K123525). The new components are asserted to be similar enough to fall under the same safety and effectiveness profile.

7. The sample size for the training set:

   • Not applicable. No training set for an algorithm was used.

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

   • Not applicable. No training set was used.

Ask a specific question about this device

The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.

The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.

Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.

The provided text describes a physical medical device (Gridlock Plating System), not an AI/software device. Therefore, the questions related to AI/software performance criteria, ground truth, expert consensus, and multi-reader studies are not applicable.

This 510(k) submission is for a Special 510(k), meaning it's for a modification to a previously cleared device (Gridlock Plating System, K121452). The change from the predicate is the addition of two specific plates for the first metatarsal phalangeal joint. The submission aims to demonstrate substantial equivalence to the predicate device.

Here's the relevant information based on the provided text, modified to address the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria were based on substantial equivalence to predicate devices, particularly regarding mechanical performance.

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical data. For mechanical testing, the number of samples tested per condition is not provided.
• Data Provenance: The mechanical testing was performed in a laboratory setting. There is no mention of data from human subjects or retrospective/prospective studies.

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

Not Applicable. For a physical medical device proving mechanical equivalence, "ground truth" related to expert assessment of data is not relevant. The relevant "experts" would be engineering/materials scientists conducting and interpreting the mechanical tests according to standards.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert assessment of clinical data, which is not relevant here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. No clinical studies were performed. This submission relies on mechanical testing and substantial equivalence to a predicate device.

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

The "ground truth" for this device's performance demonstration is based on established engineering standards (ASTM F382-99) and comparison against the known performance of legally marketed predicate devices. In essence, the "truth" is that the new plates perform mechanically equivalently to the previously cleared plates.

8. The Sample Size for the Training Set

Not Applicable. No training set for an algorithm is involved.

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

Not Applicable. No training set for an algorithm is involved.

Ask a specific question about this device

The Hammer Toe System implants are intended for fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the lesser toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.

The Hammer Toe Implant is a threaded/spaded device used for bone fixation in the phalanges of the lesser digits in the foot and hand. The implant, which is a cannulated, threaded and spaded device, is offered in multiple diameters and lengths. The system will also consist of K-wires (K121008) to be used in the delivery of the implant and also for use of temporary stabilization of outlying joints.

Here's a summary of the acceptance criteria and the study information for the Trilliant Hammer Toe Implant, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not applicable. The study was non-clinical (mechanical testing) and did not use patient data. The test material was polyurethane foam.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth was established by physical properties and mechanical testing standards (ASTM F543).

3. Adjudication method for the test set: Not applicable.

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: No MRMC study was performed. This is a medical device (implant), not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone algorithm performance was assessed. This is a medical device (implant), not an AI diagnostic tool.

6. The type of ground truth used: Mechanical properties and performance evaluated against ASTM F543 standards, demonstrating equivalence to predicate devices. This is a form of engineering or physical ground truth.

7. The sample size for the training set: Not applicable. No training set was involved as this was a non-clinical mechanical performance study for a physical implant.

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

Ask a specific question about this device

The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.

The plates and screws are intended for single use only.

The Gridlock Plating System consists of various shape and size plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited bone contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters.

Materials:
CP Titanium per ASTM F67 Titanium alloy per ASTM F136

The provided document is limited to a 510(k) summary for the Gridlock Plating System, a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies typically associated with AI/ML diagnostic tools.

Therefore, the document does not contain information relevant to AI/ML device acceptance criteria or studies proving device performance in the context you've outlined. Specifically:

• No AI/ML components: The Gridlock Plating System is a metallic bone fixation appliance, not an AI/ML diagnostic or assistive device.
• No acceptance criteria for AI/ML performance: The testing described (static four-point bending, dynamic bending, pull-out, torque) are mechanical performance tests for implants, not metrics like sensitivity, specificity, or accuracy relevant to AI/ML.
• No data provenance, ground truth, expert review, MRMC studies, or training/test sets: These concepts are entirely absent because the device is a physical implant, not a software algorithm.
• No clinical studies: The document explicitly states, "No clinical studies were performed." Substantial equivalence was based on non-clinical (mechanical) testing.

In summary, the Gridlock Plating System is a traditional medical device, and the provided 510(k) summary does not contain any information related to the acceptance criteria or study methodologies typically associated with AI/ML-powered devices.

Ask a specific question about this device

The Trilliant Surgical K-wires are intended for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants.

K-wires are sharpened or blunt, smooth stainless steel pins. They come in different sizes and are used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction. Two diameters, Ø0.045" (Ø1.143 mm) and Ø0.062" (Ø1.57 mm), of the Trilliant Surgical K-Wires are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference.

Materials: 316L Stainless Steel per ASTM F138

Function: The K-wires are used to hold bone fragments together (pin fixation), to provide an anchor for skeletal traction and as guide pins for insertion of other implants.

The provided text indicates that no clinical studies were performed for the Trilliant Surgical K-wires. Therefore, there is no information available regarding acceptance criteria or a study proving that the device meets such criteria.

The submission states:

• Clinical Test Summary: "No clinical studies were performed"
• Conclusions Nonclinical and Clinical: "This summary concludes that Trilliant Surgical K-wires are as safe, as effective, and performs as well as the predicate device(s)."

This implies that the substantial equivalence determination was based on non-clinical data, such as a comparison of design, materials, and intended use with a legally marketed predicate device (K-Medic External Fixation Devices - K030336), rather than a performance-based clinical study.

Given the information provided in the input, I cannot fill in the requested table or detail a study that proves the device meets acceptance criteria.

Ask a specific question about this device

The Disco Subtalar Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.

The Disco Subtalar Implant consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, and corresponding instrumentation to facilitate insertion. The leading end of the implant is cylindrical in shape and is approximately half of the overall length of the device, with the remaining length being spherical. The full length of the implant incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. Internal threads are machined in the spherical end of the implant and are for use with a removal tool.

The Disco Subtalar Implant's 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria in the manner typically understood for AI/ML-based medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth). This is a traditional medical device, not an AI/ML diagnostic tool.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and design characteristics, rather than clinical efficacy studies.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The "tests" mentioned are non-clinical (static compression and pull-out testing on the device itself), not studies on a test set of patient data.
• Data Provenance: Not applicable. The data comes from mechanical testing of the device.

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

• Not applicable. Ground truth, in the context of diagnostic AI/ML devices, relates to patient outcomes or expert interpretations. For this mechanical device, "ground truth" relates to engineering specifications and material properties, which are verified through standard engineering tests.

4. Adjudication Method for the Test Set

• Not applicable. There was no 'test set' of patient data requiring adjudication.

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

• No. The document explicitly states: "No clinical studies were performed." This is a mechanical implant device, not a diagnostic tool typically evaluated with MRMC studies.

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

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

7. The Type of Ground Truth Used

• For mechanical properties: Engineering standards and specifications (e.g., ASTM F136 for material, established benchmarks for static compression and pull-out strength based on predicate devices).
• For intended use/function: Clinical consensus on the biomechanics of subtalar joint stabilization and correction of hyperpronation, as embodied by the predicate devices.

8. The Sample Size for the Training Set

• Not applicable. There is no training set as this is not an AI/ML device.

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

• Not applicable. There is no training set.

Summary of Device Acceptance:

The acceptance of the Disco Subtalar Implant by the FDA (as indicated by the 510(k) clearance K111834) was based on its successful demonstration of substantial equivalence to already legally marketed predicate devices (Trilliant Twist Subtalar Implant - K103183 and ProStop - K071456).

The study that "proves the device meets the acceptance criteria" in this context is the non-clinical testing summary where:

• Static compression and pull-out testing was performed.
• The results indicated that the Disco Subtalar system is equivalent to predicate devices in these mechanical properties.
• The device's materials (Ti-6Al-4V alloy per ASTM F136), function, intended use, and design (despite a geometry change from the predicate) were also considered substantially equivalent.

The FDA's decision letter confirms this equivalence, allowing the device to be marketed. No clinical studies were required or performed for this 510(k) submission, as per standard regulatory pathways for certain types of mechanical implants claiming substantial equivalence.

Ask a specific question about this device

The Tiger Headless Cannulated Screws are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.

Tiger Headless Cannulated Screws are headless, cannulated, self-drilling, self-tapping screws for the management of small bone orthopedic osteotomies and trauma. The system consists of multiple screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.

Here's an analysis of the provided text regarding the Tiger Headless Cannulated Screws, focusing on acceptance criteria and supporting studies:

It is important to note that the provided 510(k) summary is for a medical device (bone screw), not an AI/ML powered device. As such, many of the typical questions for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) do not apply to this type of device submission. The acceptance criteria and "studies" are based on non-clinical (mechanical) testing rather than clinical performance or AI/ML algorithm evaluation.

Here's a breakdown based on the provided input:

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

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

• Sample Size: Not specified in the document. For mechanical testing of medical devices, sample sizes are typically determined by engineering standards (e.g., ASTM, ISO) to achieve statistical significance for material properties and performance claims.
• Data Provenance: Not applicable. The "data" comes from laboratory-based mechanical testing, not human clinical data or patient records.
• Retrospective/Prospective: Not applicable. This refers to the nature of clinical data collection.

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 mechanical testing, "ground truth" is established by direct measurement against engineering standards and specifications. There are no human experts establishing a clinical ground truth for these tests. The tests themselves are the "truth." Engineers and lab technicians conduct the tests.

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

• Not applicable. Adjudication methods are used for resolving disagreements in human interpretation of data, typically in clinical studies or AI/ML evaluations. Mechanical testing results are quantitative and do not require 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

• No. An MRMC comparative effectiveness study is used to evaluate the performance of AI-assisted systems in diagnostic or interpretative tasks involving human readers. This device is a bone screw and does not involve AI or human interpretation in its function or evaluation in this 510(k) submission.

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

• Not applicable. This device is a bone screw, not an algorithm, so the concept of standalone algorithm performance does not apply.

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

• Mechanical Engineering Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is established by ensuring the device's mechanical properties (pull-out strength, torque, etc.) meet or exceed recognized standards for bone fixation devices and are comparable to the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This device does not use a training set as it is not an AI/ML algorithm.

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 a training set.

Summary of the Study Proving Acceptance Criteria:

The study conducted to prove the Tiger Headless Cannulated Screws meet acceptance criteria was a non-clinical mechanical testing program. This involved subjecting the screws to a series of tests:

• Static Axial Pull Out Test: Measures the force required to pull the screw out of a material designed to simulate bone.
• Static Axial Pull Through Test: Measures the force required to pull the screw head through a material.
• Driving Torque Test: Measures the torque required to drive the screw into a material.
• Failure Torque Test: Measures the torque at which the screw (or its interface) fails.

The results of these tests were then compared to the performance of legally marketed predicate devices (Tiger Cannulated screws K081510, and 2.4 and 3.0mm Headless Compression Screws K050636/K021556). The acceptance criterion was that the Tiger Headless Cannulated Screws demonstrate equivalent mechanical performance to these predicate devices, thereby establishing "substantial equivalence" in terms of mechanical safety and performance.

No human clinical studies were performed for this 510(k) submission, as stated in the document: "No clinical studies were performed." The substantial equivalence claim is based solely on the non-clinical mechanical testing and comparison to the predicate devices.

Ask a specific question about this device

The Trilliant Surgical Subtalar Implant is indicated for the use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, downward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.

The Trilliant Surgical Subtalar Implant consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. It is available in six sizes, Ø7mm to Ø12mm in 1mm increments.

The provided document, a 510(k) summary for the Trilliiant Surgical Subtalar Implant (K103183), describes the device and its substantial equivalence to predicate devices. However, it does not contain information related to acceptance criteria, device performance metrics, or the specific study details you've requested for proving acceptance criteria.

This 510(k) summary focuses on demonstrating that the Trilliiant Surgical Subtalar Implant is substantially equivalent to already legally marketed devices based on its intended use, design, materials, and function. The summary explicitly states:

• "No clinical studies were performed" (Section 8. Clinical Test Summary).
• "The following tests were conducted: Compression testing comparing predicate and Trilliant Surgical Subtalar Implant." (Section 7. Non-clinical Test Summary).

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study methodologies, and performance metrics as it is not present in the provided text.

Here's a breakdown of why each requested point cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance: Not provided. The document only mentions "compression testing" without detailing acceptance criteria or quantitative performance results.
2. Sample sized used for the test set and the data provenance: Not provided. The document mentions compression testing but doesn't specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies are reported.
4. Adjudication method for the test set: Not applicable, as no clinical studies are reported.
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 a medical device (implant), not an AI-powered diagnostic tool, and no clinical studies are reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical studies are reported. "Compression testing" would typically have a physical standard or engineering specification as a reference.
8. The sample size for the training set: Not applicable, as no AI/algorithm development is described.
9. How the ground truth for the training set was established: Not applicable, as no AI/algorithm development is described.

In summary, the provided 510(k) document is for a medical implant and relies on substantial equivalence to predicate devices, supported by non-clinical (compression) testing, rather than extensive clinical efficacy or AI-specific validation studies.

Ask a specific question about this device

The Tiger Cannulated Screw Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.

The Tiger Cannulated Screw System is comprised of screws used for bone fixation of the hand and foot following trauma or osteotomy. The system features 2.0mm diameter, 2.4mm diameter, 3.0mm diameter and 4.0mm diameter cannulated screws. System instruments include 2.0mm/2.4mm drill bit, countersink, driver, 3.0mm/4.0mm drill bit, countersink, driver, screw driver handle, depth gauge, screw remover and K-wires to facilitate the placement of screws.

This 510(k) summary for the Tiger Cannulated Screw System does not contain the information you requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is provided:

What the document does say:

• Device Description: The Tiger Cannulated Screw System is comprised of screws (2.0mm, 2.4mm, 3.0mm, and 4.0mm diameter) and instruments for bone fixation in the hand and foot following trauma or osteotomy.
• Materials: Screws are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.
• Intended Use/Indications for Use: Fixation of fractures, non-unions, arthrodeses, and osteotomies of the small bones in the hand and foot.
• Predicate Device: The Tiger Cannulated Screw System is substantially equivalent to similar previously cleared cannulated screws.
• No Testing: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, Trilliant Surgical believes that the Tiger Cannulated Screw Fixation System does not raise any new safety or effectiveness issues and does not require any nonclinical testing."

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided. The document explicitly states no nonclinical testing was required or performed because of substantial equivalence to predicate devices.
2. Sample sized used for the test set and the data provenance: Not applicable. No test set was used as no testing was performed.
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 was established as no testing was performed.
4. Adjudication method for the test set: Not applicable. No test set was used.
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 a medical device (screw system), not an AI-assisted diagnostic tool. No such study was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used: Not applicable. No ground truth was used as no testing was performed.
8. The sample size for the training set: Not applicable. No training set was used as no AI model was developed or tested.
9. How the ground truth for the training set was established: Not applicable. No training set was used.

In essence, for this 510(k) submission, the manufacturer leveraged the "substantial equivalence" pathway, arguing that the device is so similar to already-approved devices that no new performance testing or clinical studies were necessary to demonstrate its safety and effectiveness. Therefore, the document does not contain any of the detailed performance study information you've requested.

Ask a specific question about this device