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The BioactIF OSTEOTRANS™ Interference Screw is indicated for the fixation of bone-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery.

The BioactIF OSTEOTRANS"M Interference Screw is a stcrile, single-use interference screw manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Screws are provided with various sizes typical of other marketed fixation devices.

This is a 510(k) summary for a medical device called the BioactIF OSTEOTRANS™ Interference Screw. It's a bioabsorbable interference screw used for ligament reconstruction surgery. The documentation provided does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner you've outlined for performance studies (e.g., accuracy, sensitivity, specificity, or human improvement with AI).

Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. This is a common pathway for medical device approval where the new device is shown to be as safe and effective as a legally marketed device, rather than requiring extensive de novo clinical trials for performance metrics.

Here's a breakdown of why your requested information isn't present in this specific document:

• Type of Device: This is a mechanical implant (an interference screw), not a diagnostic or AI-driven device. Acceptance criteria for such devices typically involve mechanical strength, biocompatibility, degradation profiles, and manufacturing standards, not performance metrics like sensitivity, specificity, or human reader improvement.
• Regulatory Pathway: The 510(k) pathway for medical devices emphasizes substantial equivalence. This means the manufacturer compares their device to existing, legally marketed predicate devices. The "study" mentioned here is primarily this comparison and demonstrative data (e.g., strength testing) to show it's "as safe and effective" as the predicates.
• Focus of the Document: The provided text is a 510(k) summary and FDA letter, which details the device's intended use, description, and the outcome of the FDA's review (substantial equivalence). It doesn't contain the detailed study protocols or results of bench testing or clinical trials that might define acceptance criteria as you've requested for an AI/diagnostic device.

Therefore, many of your requested points are not applicable or cannot be extracted from this document.

However, I can provide what is available about how the device meets regulatory requirements based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

As noted, explicit "acceptance criteria" for performance metrics like sensitivity/specificity are not defined for this type of device in this document. Instead, the "performance" demonstrated is its equivalence to predicate devices in:

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

• This document does not specify a "test set" in the context of diagnostic performance. The "performance data" mentioned (strength, degradation) would typically come from bench testing (in vitro/ex vivo), not patient data.
• Data provenance: Not specified, but generally, bench testing would be conducted in a laboratory setting associated with the manufacturer or a contracted lab.
• Retrospective or prospective: Not applicable to the type of data discussed.

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. There is no diagnostic "ground truth" to be established by clinical experts for this device in this summary. The "ground truth" for a mechanical device is its physical and chemical properties as measured in a lab.

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

• Not applicable. No clinical expert adjudication is mentioned or relevant for this type of device and submission.

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 device is an implantable screw, not an AI-driven diagnostic tool or system designed to assist human readers.

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

• Not applicable. This is not an algorithm or AI system.

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

• For the performance data mentioned (strength, degradation), the "ground truth" would be established through laboratory testing and validated quantitative measurements according to established engineering and material science standards (e.g., ISO standards, ASTM standards).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that uses a "training set."

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

• Not applicable. See point 8.

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The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System is intended for use in trauma and reconstructive procedures of the craniofacial skeleton, including fracture of the cranium, infant craniofacial surgery (i.e. craniosynostosis, congenital malformations), pediatric reconstructive procedures, reconstructive procedures of the cranium, craniotomy flap fixation.

The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System devices are the sterile, single-use bone plates, meshes and screws manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Plates, meshes and screws are provided with various shapes and sizes typical of other marketed fixation devices.

Used properly, in the presence of adequate immobilization, the OSTEOTRANS" MX Bioabsorbable Bone Fixation System devices maintain accurate alignment of bone fractures and osteotomies.

The provided text describes the OSTEOTRANS™-MX Bioabsorbable Bone Fixation System and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria.

Instead, the document focuses on:

• Intended Use Statement: Listing the anatomical regions and conditions for which the device is indicated.
• Device Description: Explaining the materials (hydroxyapatite and poly-L-lactide HA/PLLA composites) and general form (plates, meshes, screws).
• Summary of Technology: Stating that the device has the "same technological characteristics (i.e., design and material) when compared to the predicate devices" and that "Performance data demonstrate that the OSTEOTRANS™-MX Bioabsorbable Bone Fixation System has the requisite strength and favorable degradation profile to provide sufficient and sustained bone fixation for intended uses."

The document relies heavily on demonstrating substantial equivalence to previously cleared predicate devices (K010352, K992355, K971870, K992905, K003549, K062819, K061881) rather than presenting new clinical study data with defined acceptance criteria. The statement about "Performance data" is generic and does not refer to a specific study detailed in this 510(k) summary.

Therefore, I cannot populate the requested table or answer the questions regarding sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, or ground truth establishment based on the provided text. The 510(k) process for this device appears to rely on demonstrating similarity to already approved devices.

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The OSTEOTRANS™-OT Pin is intended for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses or bone grafts, for example in the fixation of apical fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization.

The OSTEOTRANS™-OT Pins are the sterile, single-use bone pins manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Pins are provided with various shapes and sizes typical of other marketed fixation devices. Used properly, in the presence of adequate immobilization, the OSTEOTRANS™-OT Pins maintain accurate alignment of bone fractures and osteotomies.

The provided text is a 510(k) summary for a medical device (OSTEOTRANS™-OT Pin) seeking substantial equivalence to predicate devices. It focuses on device description, intended use, and comparison to existing products, rather than a detailed study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not present in the provided document.

This document describes a traditional medical device (bioabsorbable bone fixation pin) and its claims of substantial equivalence based on design and material similarities to predicate devices, and performance data demonstrating requisite strength and favorable degradation profile. It does not involve a software algorithm or AI, and therefore the concepts of test sets, ground truth established by experts, MRMC studies, or standalone algorithm performance are not applicable.

The "performance data" mentioned is likely related to bench testing of the pin's mechanical properties and degradation characteristics, not a clinical study with human subjects, or a study of an AI's diagnostic accuracy.

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The OSTEOTRANS™-OT Screw is intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or bone grafts, including phalangeal fractures, metacarpal fractures, carpal fusion and fractures, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies, and correction of hallux valgus.

The OSTEOTRANS™ OT Screw is a sterile, single-use bone screw manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). There are solid screws, cannulated screws and corresponding washers. Screws and washers are provided with various shapes and sizes typical of other marketed fixation devices.
Used properly, in the presence of adequate immobilization, the OSTEOTRANS™-OT Screws maintain accurate alignment of bone fractures and osteotomies.

The provided text describes a 510(k) premarket notification for a medical device, the OSTEOTRANS™-OT Screw. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, not primarily to prove device performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this document.

However, based on the provided text, we can extract some relevant information:

Acceptance Criteria and Reported Device Performance

The document states: "Performance data demonstrate that the OSTEOTRANS™ OT Screw has the requisite strength and favorable degradation profile to provide sufficient and sustained bone fixation for intended uses." This implies that the acceptance criteria for this device are related to its mechanical strength and degradation characteristics, ensuring it can adequately fix bones for its intended use and degrade favorably over time.

Study Details (Based on available information)

The document does not describe a clinical study with human patients, a test set, experts, or ground truth in the way one might for an AI/diagnostic device. Instead, it relies on performance data to demonstrate equivalence to predicate devices, which typically refers to non-clinical testing.

1. Sample size used for the test set and the data provenance: Not applicable. The document refers to "performance data," which in this context likely means mechanical and material testing, not human patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic or AI studies (e.g., expert consensus on images) is not relevant here. The "ground truth" for mechanical properties would be established by standardized testing methods.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to this device's submission.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. The device is a physical bone screw, not an algorithm.
6. The type of ground truth used: For a medical device like a bone screw, "ground truth" for demonstrating performance would likely be established through:
   • Mechanical testing standards: Adherence to established ISO or ASTM standards for implant strength, fatigue, torsional properties, etc.
   • Material characterization: Testing of the HA/PLLA composite for its chemical composition, degradation rate in simulated physiological environments, biocompatibility, etc.
   • Preclinical (animal) studies: Although not explicitly mentioned, these are sometimes used to assess biological response and degradation in vivo.
7. The sample size for the training set: Not applicable. There is no AI algorithm being trained.
8. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of the OSTEOTRANS™-OT Screw to existing predicate devices based on design, materials, intended use, and performance data (likely non-clinical mechanical and material properties testing). It does not involve a clinical study with human subjects, expert review, or AI performance metrics as typically seen in submissions for diagnostic algorithms.

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Comporus™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Comporus™ is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with new bone during the healing process.

Comporus™ is an osteoconductive biodegradable scaffold used as bone void filler. It is manufactured from a mixture of poly-D/L-lactide and hydroxyapatite and provided in granule, block and cylinder forms. They may be pressed into the surgical site by hand. Comporus™ was shown to be biocompatible. Used properly, the implant is resorbed and replaced with natural bone during the healing process. Comporus™ is sterile and intended for single use only. It is radiopaque and has the ability to be modified intraoperatively by trimming or thermal transformation to be adjusted to the shape of a defect.

The provided text details a 510(k) summary for a medical device called Comporus™, a resorbable synthetic bone void filler. This submission focuses on establishing substantial equivalence to legally marketed predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria in a quantitative manner. Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not available in the provided document.

Here's a breakdown of what can be extracted and what is missing:

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

Not Available. The document does not specify quantitative acceptance criteria. Instead, it asserts "similar compressive strength to the predicate devices and cancellous bone" and "similar technological characteristics (i.e., design and material)" as the basis for substantial equivalence. No specific performance metrics or thresholds are presented.

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

Not Available. The document mentions "Preclinical testing was performed" but does not provide details on the sample size (number of subjects, defects, or units tested) or the provenance (e.g., country of origin, retrospective/prospective nature) of this test data.

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

Not Available. The document does not describe the establishment of a "ground truth" for a test set, nor does it refer to experts involved in such a process.

4. Adjudication method for the test set

Not Available. As no detailed test set or ground truth establishment is described, no 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. Comporus™ is a bone void filler, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study or AI-related metrics are irrelevant to this device type.

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

Not Applicable. Comporus™ is a physical medical device (bone void filler), not an algorithm or AI system.

7. The type of ground truth used

Not Available. The document asserts "Preclinical testing was performed" and states that "Used properly, the implant is resorbed and replaced with natural bone during the healing process." This implies histological or imaging-based assessment of bone formation in a preclinical setting, but the specific type of ground truth (e.g., detailed pathology reports, quantitative imaging analysis, long-term outcome data) is not elaborated upon.

8. The sample size for the training set

Not Applicable/Available. The concept of a "training set" is relevant for AI/ML devices. As Comporus™ is a physical medical device, not an AI/ML algorithm, no training set is described.

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

Not Applicable/Available. See response to #8.

Summary of what the document does provide regarding the study:

The 510(k) summary focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study against specific acceptance criteria. Key points related to the "study" are:

• Evidence of Equivalence: The submission asserts that Comporus™ has:
  • The same intended use as predicate devices.
  • The same principles of operation as predicate devices.
  • "Very similar technological characteristics" (design and material) to predicate devices.
  • "Similar compressive strength to the predicate devices and cancellous bone."
  • The minor technological differences do not raise new safety or effectiveness issues.
• Preclinical Testing: "Preclinical testing was performed and demonstrates that the device is substantially equivalent to the predicate." This is a general statement without specific details on the nature, scope, or results of these tests, beyond the assertion of similar compressive strength and the claim that the implant resorbs and is replaced by new bone.
• Biocompatibility: Comporus™ was shown to be biocompatible.

In essence, the study described in this 510(k) summary is a comparative analysis intended to demonstrate that Comporus™ is as safe and effective as existing, legally marketed devices, rather than a de novo study proving its performance against predefined benchmarks.

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The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, which includes the facial cranium, mid-face, maxilla and mandible.

The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System devices are the sterile, single-use bone plates, meshes and screws manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Plates, meshes and screws are provided with various shapes and sizes typical of other marketed fixation devices.

Used properly, in the presence of adequate immobilization, the OSTEOTRANSMAN Bioabsorbable Bone Fixation System devices maintain accurate alignment of bone fractures and osteotomies.

The provided text is a 510(k) summary for a medical device (OSTEOTRANS™-MX Bioabsorbable Bone Fixation System) and the FDA's clearance letter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and intended use, often through performance data on strength and degradation. It does not contain the kind of detailed information typically found in a clinical study report that would address the acceptance criteria for algorithm performance, sample sizes for test/training sets, expert qualifications, or MRMC studies for an AI/ML device.

Therefore, I cannot provide the requested information from the given text. The text does not describe an AI/ML device or a study involving acceptance criteria for its performance.

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