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The OsteoMed Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.

The OSTEOMED Cannulated Screw System is comprised of screws and washers used for bone fixation of the hand and foot following trauma or osteotomy. The System features cannulated screws in the following dimensions:

2.0mm screw diameter - 6mm to 42mm screw length;

2.4mm screw diameter - 6mm to 52mm screw length;

3.0mm screw diameter - 10mm to 40mm screw length;

3.5mm screw diameter - 12mm to 52mm screw length;

4.0mm screw diameter - 12mm to 52mm screw length;

5.5mm screw diameter - 12mm to 52mm screw length;

6.5mm screw diameter - 20mm to 120mm screw length;

8.0mm screw diameter - 30mm to 140mm screw length;

The implants (screws and washers) of the OsteoMed Cannulated Screw System are made from Titanium alloy (ASTM F-136). Modifications to screws and washer of the subject system include redesign of the 4.0mm cannulated screw to increase the strength of the lag portion and addition of a 3.0mm diameter cannulated screw and washer.

The system instruments include depth gauges, screw drivers, drills, countersinks, k-wires, and preparation instruments to facilitate the placement of screws. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.

The provided text describes a Special 510(k) Summary for the OsteoMed Cannulated Screw System. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not detail a study proving the device meets acceptance criteria in the same way a diagnostic AI device would. Instead, it focuses on demonstrating equivalence to existing devices through performance testing.

Here's an analysis based on the provided text, addressing your questions to the best extent possible given the nature of the document:

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

The document states that the 3.0mm and 4.0mm cannulated screws underwent "verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use." It also says, "A performance comparison was performed and verified that the cannulated screws met required mechanical strength criteria for their intended use compared to the legally marketed predicate device and reference device listed in this summary."

However, the specific "required mechanical strength criteria" (i.e., the acceptance criteria) and the particular "reported device performance" values are not explicitly detailed in the provided text. The text only mentions that the criteria were met.

Therefore, a table cannot be fully constructed from the provided information.

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

The document mentions "verification evaluation" and "performance comparison" for the 3.0mm and 4.0mm cannulated screws. This implies a test set of physical screws was used. However, the sample size (number of screws tested) is not specified.

Regarding data provenance, the testing would have been conducted by OsteoMed, likely in-house or by a contracted lab. This would be prospective mechanical testing of newly manufactured devices. The country of origin for the data is not specified but is implicitly associated with OsteoMed (Addison, Texas, USA).

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

This question is not applicable in the context of this device. The OsteoMed Cannulated Screw System is a physical medical implant (bone screw). Its performance is evaluated through mechanical testing, not by expert interpretation of data or images. Therefore, clinical experts are not used to establish a "ground truth" for its mechanical performance.

4. Adjudication method for the test set

This question is not applicable. Since the device's performance is determined by objective mechanical tests (e.g., strength, torque), there's no need for human adjudication of results. The testing would follow established engineering standards and protocols.

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

This question is not applicable. The OsteoMed Cannulated Screw System is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance do not apply.

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

This question is not applicable. As stated above, this is a physical medical implant, not an algorithm or AI system.

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

For the mechanical testing performed, the "ground truth" would be objective measurements against established engineering standards or predetermined performance requirements for medical implants. For example, a certain screw might need to withstand a specific torsion force or bending moment. This is a physical, measurable ground truth, not a clinical or pathological one.

8. The sample size for the training set

This question is not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context. The manufacturing process involves quality control and established design principles, but not a data-driven training set for an algorithm.

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

This question is not applicable for the reasons outlined in point 8.

In summary, the provided document is a regulatory submission for a physical medical device (bone screws) and focuses on demonstrating substantial equivalence through mechanical performance testing to predicate devices, rather than clinical acceptance criteria or AI study data. The document states that the devices met required mechanical strength criteria, but the specific numerical criteria and results are not included in this summary.

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Intended for the re-attachment of the bone flap after a craniotomy. The OsteoMed Cranial Flap Fixation System is intended for single patient use only.

This submission describes the OsteoMed Cranial Flap Fixation System intended for the re-attachment of the bone flap after a craniotomy. The OsteoMed Cranial Flap Fixation System is intended for single patient use only. The OsteoMed Cranial Flap Fixation System is a clamping device which has a threaded post attached to an inferior disk and a threading superior disk that threads down the post to secure a sandwich fit of the Cranial Flap and cranium between the inferior and superior plate. The device locks into place once the desired fixation is achieved by the surgeon. The OsteoMed Cranial Flap Fixation devices are available in a range of 10mm to 22mm disk diameters.

The provided text describes a medical device, the "OsteoMed Cranial Flap Fixation System," and its 510(k) summary for FDA clearance. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, or any other details related to a study that proves the device meets specific performance criteria.

The document focuses on:

• Device Description: What the device is and how it works.
• Intended Use: For re-attachment of the bone flap after craniotomy.
• Predicate Devices: Identifying similar devices already on the market (MacroPore CraniLoc, Aesculap Craniofix Titanium Clamp System, Lorenz Rapidflap Cranial Clamp).
• Substantial Equivalence: The claim that the device is substantially equivalent to existing devices and raises no new safety or effectiveness issues due to similar materials and design.
• FDA Clearance: The 510(k) clearance letter from the FDA.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a detailed study as this information is not present in the provided text. The submission relies on "substantial equivalence" to predicate devices rather than presenting a performance study with detailed acceptance criteria.

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Indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; angular deformity; impaired function and stability; pain; impaired toe length ratio. Implants are single use only.

This submission describes the OsteoMed Interphalangeal Flexible Stabilizing Rod System intended for indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; anqular deformity; impaired function and stability; pain; impaired toe length ratio. OsteoMed Interphalangeal Flexible Stabilizing Rod Implants are intended for single use only.

The OsteoMed Interphalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the interphalangeal joints of the lesser toes. It is constructed of medical grade silicone elastomer. The OsteoMed Interphalangeal Flexible Stabilizing Rods are offered in diameters of 2.0mm through 2.5mm. Drills and sizers will also be a part of the system.

The provided document is a 510(k) summary and FDA clearance letter for a medical device, the OsteoMed Interphalangeal Flexible Stabilizing Rod System. This type of document is generally used for demonstrating substantial equivalence to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics as might be found for a novel device requiring clinical trials.

Therefore, this document does not contain the information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Explanation:

The 510(k) summary explicitly states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Sgarlato Laboratories Shaw-Ship Rod, Hammer Toe Implant." It also notes: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Interphalangeal Flexible Stabilizing Rod System does not raise any new safety or effectiveness issues."

This indicates that the clearance was based on substantial equivalence to an already legally marketed device, not on a new study demonstrating specific performance metrics against pre-defined acceptance criteria as would be required for a device for which no predicate exists or for a higher-risk classification device. The FDA letter confirms the substantial equivalence determination.

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Indicated for partial or complete dislocation of the lesser metatarsophalangeal joint; pain associated with either rheumatoid or osteoarthritis; repair for unsuccessful arthroplasties of the lesser metatarsophalangeal joint; stiffness at the lesser metatarsophalangeal joint associated with joint disease; hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state. Implants are single use only.

The OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the lesser metatarsophalangeal joints of the foot. It is constructed of medical grade silicone elastomer. The OsteoMed Metatarsophalangeal Flexible Stabilizing Rods are offered in diameters of 2.5mm through 3.0mm. Drills and sizers will also be a part of the system.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any acceptance criteria. The document is a 510(k) summary for a medical device called the "OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System." It primarily focuses on demonstrating substantial equivalence to a predicate device (Sgarlato Lesser Toe Implant K884739) based on similarities in intended use, material, design, and operational principle.

The document does not contain details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically associated with performance studies, especially those involving AI/ML devices or novel devices requiring more extensive clinical evidence. The provided document is a regulatory submission for a device deemed substantially equivalent to a predicate, which often does not require new performance studies if the safety and effectiveness are established through the predicate.

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Indicated for fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand. 1.2mm Auto-Drive Screws are intended for single patient use only.

The OsteoMed 1.2mm Auto-Drive Screw System is comprised of 1.2mm diameter screws in lengths ranging from 3.0mm to 6.0mm. System instruments include screwdrivers and driver bits.

This is a 510(k) premarket notification for a medical device called the "OsteoMed 1.2mm Auto-Drive Screw System." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, a traditional clinical study with acceptance criteria in the manner requested is typically not conducted or required for this specific type of regulatory submission. Instead, the performance is demonstrated through comparison to existing, already approved devices.

Based on the provided documents:

1. Table of Acceptance Criteria and the Reported Device Performance:

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the sense of performance thresholds from a clinical trial. The "performance" is demonstrated by showing similarity in intended use, material, design, and operational principles to predicate devices.

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

• Sample Size: Not applicable. This is a comparison for substantial equivalence, not a clinical study with a test set of patients.
• Data Provenance: Not applicable in the context of a clinical test set. The provenance of the predicate device information would be previous 510(k) submissions (K974785, K983485, and K970912), regulatory databases, and potentially internal company data.

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

• Not applicable. There was no clinical test set requiring expert ground truth establishment for this 510(k) submission.

4. Adjudication method for the test set:

• Not applicable. There was no clinical test set requiring an adjudication method.

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 a bone screw system, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

• Not applicable. This device is a mechanical medical implant, not an algorithm.

7. The type of ground truth used:

• Not applicable in the context of a clinical study. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices to which the OsteoMed 1.2mm Auto-Drive Screw System is being compared.

8. The sample size for the training set:

• Not applicable. There was no training set in the context of a machine learning model or a clinical trial for performance.

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

• Not applicable. No training set was used.

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Indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The OsteoMed Intraoral Mandibular Distraction System is intended for single patient use only.

The OsteoMed Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It features various curved and straight bars activated with a threaded wire that has screw holes that are fixed to bone via 1.6mm/2.0mm bone screws. The distractor is available in two sizes and in right and left versions. The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 35mm.

I'm sorry, but the provided text does not contain the information required to describe acceptance criteria or a study proving device performance. The document is a 510(k) summary and FDA clearance letter for the OsteoMed Intraoral Mandibular Distraction System. It details the device's intended use, description, and claims of substantial equivalence to predicate devices, but it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study with sample sizes, data provenance, ground truth establishment, or expert involvement.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The document states that "Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Intraoral Mandibular Distraction System does not raise any new safety or effectiveness issues." This suggests that the clearance was based on equivalence rather than new performance studies demonstrating against specific acceptance criteria.

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OsteoMed OSA Rigid Internal Fixation System is intended for a variety of pan facial indications. Specifically, the system is intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and mandible. Implants are single use only.

The OsteoMed OSA Rigid Internal Fixation System is comprised of various plates and screws. Plates, .8mm through 1.0mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm and 2.0mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 1.9mm and 2.4mm diameter. Depth gauges, screwdrivers, countersinks, pilot drills, and preparation instruments will also be a part of the system.

This 510(k) summary describes a physical medical device (OsteoMed OSA Rigid Internal Fixation System) and not an AI/ML powered software device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training set is not applicable to this document. The submission focuses on demonstrating substantial equivalence to predicate devices based on similarities in intended use, material, design, and operational principles.

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Indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall and midfacial fractures, and reconstructive procedures of the midface or craniofacial skeleton. The OsteoMed Bioresorbable Fixation System is not intended for use in and is contraindicated for: the mandible and/or full load bearing procedures; in cases of active or suspected infection or in patients who are immunocompromised; in cases where there is limitation of the blood supply or inadequate volume or quality of bone to place the system securely; in patients exhibiting disorders which would cause the patient to ignore the limitations of rigid fixation.

The OsteoMed Bioresorbable Fixation System is comprised of various plates, meshes and screws. Plates and meshes, 0.5mm through 1.2mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 2.0mm diameter in lengths of 4.0mm through 8.0mm. The implanted components of the device are manufactured from 70:30 poly L/D,L-lactide.

The provided 510(k) summary for the OsteoMed Bioresorbable Fixation System does not contain information about acceptance criteria or a study proving the device meets said criteria.

Instead, this document focuses on establishing substantial equivalence to previously cleared devices based on similarities in intended use, material, design, and operational principle.

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

Specifically, the document lacks information on:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set, data provenance, or details about a study.
3. Number of experts, their qualifications, or ground truth establishment for a test set.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance study.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a specific study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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