Search Results

The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures and non-unions of the 5th metatarsal.

The Fracture and Correction System lag screws are intended to be used as screws, or in a plate-screw system for internal bone fraction for bone fractures, fusionies and non-unions of various bones, including humerus, radius, uha, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).

The In2Bones Fracture and Correction System is a system of plates, screws and washers used to treat fracture and reconstruction of the bones of the extremities.

The provided text describes the regulatory clearance for the "In2Bones Fracture and Correction System," a medical device consisting of plates, screws, and washers used for bone fixation. However, the document does not contain information about acceptance criteria, device performance metrics, or study design details in the way requested by the prompt (e.g., sample size, expert qualifications, adjudication method, MRMC studies, standalone performance, ground truth establishment, or training set details).

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through performance data confirming the mechanical properties of the device rather than clinical or AI algorithm performance.

Here's what can be extracted from the document regarding "performance data," albeit not in the format of AI algorithm acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

As per the document, the device underwent various mechanical tests to demonstrate its substantial equivalence to predicate devices. The specific acceptance criteria (e.g., minimum torque values, maximum displacement under load) are not explicitly stated in this summary but are implied by the statement that the testing "demonstrate[s] that the device is substantially equivalent to the predicate devices identified."

Missing Information (Regarding the original prompt's questions):

The document does not provide details for the following requested items as they are not relevant to a 510(k) submission for a mechanical bone fixation system:

2. Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing. "Test set" here refers to physical device samples, not patient data.
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 mechanical properties is established by engineering standards and measurements, not medical expert consensus.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI-assisted diagnostic device, but a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
7. The type of ground truth used: For mechanical tests, the ground truth is derived from engineering measurements and established standards.
8. The sample size for the training set: Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary from the provided text:

The In2Bones Fracture and Correction System demonstrated "substantial equivalence" to identified predicate devices (K123241, K983495, K131920, K160174) by undergoing mechanical performance testing, including pyrogenicity, static driving torque, static pullout, static torsion, static bending, and fatigue bending tests. The results of these tests (namely, that the device performed adequately to be deemed substantially equivalent) are reported, but the specific numerical acceptance criteria or detailed outcomes of each test are not provided in this 510(k) summary. The device's "acceptance criteria" were met by establishing that its technological characteristics and performance were comparable to legally marketed predicate devices, ensuring its safety and effectiveness.

Ask a specific question about this device

The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

The In2Bones CoLink™ Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the bones of the extremities.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each mechanical test. It only generally refers to "testing" being performed. The data provenance is pre-market (regulatory submission for 510(k) clearance), suggesting it's from studies conducted by the device manufacturer, In2Bones USA, LLC. The country of origin of the data is not specified but would typically be where the manufacturer's testing facilities are located or where contract research organizations (CROs) performed the tests. The studies are prospective in nature, meaning they were designed and conducted specifically to generate data for this regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The device being described is a mechanical bone fixation system (plates and screws), not a diagnostic or AI-driven device that requires expert-established ground truth for performance evaluation in a clinical or imaging context. The "ground truth" for this type of device is established through engineering and mechanical testing standards and simulations rather than expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons mentioned in point 3. The evaluation of mechanical test results typically involves adherence to recognized standards and objective measurements, not adjudication by human experts in the way clinical studies are adjudicated.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human readers in interpreting medical images or data. The Colink™ Plating System is a surgical implant, and its effectiveness is assessed through mechanical testing and, if applicable, clinical performance data (which is not detailed here beyond the substantial equivalence claim).

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

This information is not applicable. The Colink™ Plating System is a physical medical device, not an algorithm. Therefore, there is no "standalone" algorithm-only performance to assess.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through objective, standardized mechanical testing data (e.g., measurements of force, torque, displacement) against pre-defined engineering specifications and relevant industry standards for orthopedic implants. It is not based on expert consensus, pathology, or outcomes data in the context of this 510(k) summary, which focuses on substantial equivalence based on technological characteristics and mechanical performance.

8. The Sample Size for the Training Set

This information is not applicable. The Colink™ Plating System is an orthopedic implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data acquisition for AI model development.

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

This information is not applicable for the reasons mentioned in point 8.

Ask a specific question about this device

The In2Bones USA NeoSpan™ Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.

The In2Bones NeoSpan™ Compression Staple Implant w/instruments is a super elastic compression staple made of superelastic Nitinol. The devices are available in multiple sizes. The implant is designed to hold bones together until healing occurs.

This document is a 510(k) premarket notification for a medical device called the "NeoSpan™ Compression Staple Implant w/instruments." It's a regulatory submission to the FDA, not a study report demonstrating the device meets clinical acceptance criteria.

Therefore, the information required to answer your questions regarding acceptance criteria and a study proving the device meets those criteria, such as specific performance metrics like sensitivity, specificity, or accuracy, is not present in this document.

This document focuses on establishing substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating clinical efficacy or performance against specific acceptance criteria for an AI/device performance study.

Here's why the requested information cannot be extracted from the provided text:

• This is not an AI/Software as a Medical Device (SaMD) submission: The device is a physical implant (bone staple), not a software algorithm. Therefore, concepts like "ground truth," "expert consensus," "MRMC studies," "training set," or "test set" in the context of AI model performance are not applicable here.
• Performance Data Section VII: This section states, "Testing including pyrogenicity, corrosion, static bending, fatigue bending and pullout fixation was performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified." These are engineering and biocompatibility tests for a physical implant, not clinical performance metrics or acceptance criteria for a diagnostic/AI device.
• Acceptance Criteria and Device Performance Table: Since this is a physical device establishing substantial equivalence, there are no "clinical acceptance criteria" in the sense of predictive performance (e.g., sensitivity, specificity) for an AI model. The criteria are related to mechanical properties and biocompatibility. The document only broadly states "results of the testing demonstrate that the device is substantially equivalent," without providing specific numerical performance data against pre-defined acceptance thresholds for these engineering tests.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These terms and concepts are relevant to the validation of AI/ML models or diagnostic devices. They are not applicable to the 510(k) submission for a physical bone staple, which relies on engineering testing and comparison to a predicate.

In summary, the provided document is a regulatory submission for a physical medical device (bone staple) seeking 510(k) clearance based on substantial equivalence. It does not contain the type of study data or acceptance criteria relevant to an AI/ML diagnostic or prognostic device as implied by your detailed questions.

Ask a specific question about this device

The RTS Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of:

• Hallux limitus or hallux rigidus
• Painful rheumatoid arthritis
• Hallux abducto valgus associated with arthritis
• Unstable or painful joint from previous surgery

The RTS Flexible 1st MPJ Implant w/Grommets is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

This document is a 510(k) premarket notification for a medical device called the "RTS Flexible 1st MPJ Implant w/Grommets." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and a detailed study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as typically understood for a new clinical efficacy study, is largely not applicable in this context.

Here's why and what information can be extracted based on the document:

• No specific acceptance criteria or performance metrics are provided in terms of statistical thresholds for diagnostic accuracy, sensitivity, specificity, etc. This device is a surgical implant, not a diagnostic AI device. The "performance data" referred to are related to engineering, cleaning, packaging, and sterilization validation, not clinical performance metrics.
• No "study" as a clinical trial comparing device performance to acceptance criteria in the manner of an AI/diagnostic device is presented. The "study" here is essentially the demonstration of substantial equivalence.

However, I can extract the relevant information that is present in the document based on your request, highlighting where the requested details are not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document describes a 510(k) submission for a surgical implant, not a study involving a "test set" of data for algorithm performance. The "performance data" mentioned refers to engineering and validation testing (e.g., cleaning, packaging, sterilization), not clinical outcome data or diagnostic performance data. Therefore, there's no "sample size" or "data provenance" in the context of an AI/diagnostic algorithm test set.

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

• Not Applicable. As above, no "test set" for expert-derived ground truth is described in this 510(k) submission.

4. Adjudication method for the test set

• Not Applicable. No test set or related adjudication method is mentioned.

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 surgical implant, not a diagnostic AI device. Therefore, MRMC studies and concepts of human reader improvement with/without AI assistance are not relevant to this submission.

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

• Not Applicable. This is a surgical implant. There is no algorithm or AI component involved.

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

• Not Applicable. The "ground truth" in this context is the predicate device and its established safety and effectiveness. The current device aims to demonstrate "substantial equivalence" to this predicate, rather than generating new primary ground truth for clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

• Not Applicable. There is no training set mentioned, 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 or associated ground truth establishment process for a training set in this submission.

Ask a specific question about this device