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The Osteomedics® Resorbable Small Fixation System is intended for use in selective trauma or for reconstructive procedures in the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures, and selective orthognathic surgery of the maxilla and chin. The Osteomedics® Resorbable Small Fixation System is intended to provide temporary stabilization and fixation of bone during the healing in conjunction with appropriate postoperative immobilization. The use is in both adult and pediatric patients' cases involving trauma or reconstruction.

The Osteomedics® Resorbable Small Fixation System, OsteoSorb® consists of a series of plates, screws, bone fasteners and meshes, which are made from poly (L-lactide-co-D, Llactide) 70: 30. The plates are designed in varying configurations and lengths, which are attached to the bone using screw or bone fastener fixation.

The provided text is a 510(k) summary for a medical device (Osteomedics® Resorbable Small Fixation System, OsteoSorb®) submitted to the FDA. It does not include information about acceptance criteria or a study proving the device meets said criteria.

510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting detailed efficacy studies with acceptance criteria in the way a PMA (Premarket Approval) submission would. The document mainly focuses on:

• Device Description: What the device is made of and what it's used for.
• Intended Use: The specific medical conditions and patient populations for which the device is designed.
• Predicate Device: Identifying existing, legally marketed devices that the new device is substantially equivalent to.
• Substantial Equivalence Justification: Highlighting similarities in intended use, design, operational principles, and materials to the predicate devices.

Therefore, I cannot provide the requested information from this document. The sections you asked for (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, ground truth types, training set size, and training set ground truth establishment) are not present in this 510(k) summary.

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Normed Titanium Calcaneus Plating with Locking Screw System intended for use in Intra and extra -artcular fractures, joint depression, non-displaced and tonque type, multifragmentary fractures, stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of calcaneus bones. The system can be used in both adult and pediatric patients.

Normed Titanium Calcaneus Plating with Locking Screw System consists of a series of plates in varying length; small, medium, long which are attached to the calcaneus bone using screw fixation. The plates are available in 1.3 mm plate thickness and have fourteen threaded holes and can be contoured as needed to fit the specific anatomy. The plates can be used on both the right and left of the calcaneus. The selftapping 3.5 mm screw diameters will be available in two designs, standard screw without threaded head and screw with threaded head.

The provided text is a 510(k) summary for the Normed Titanium Calcaneus Plating with Locking Screw System. It describes the device, its intended use, and the FDA's determination of substantial equivalence. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other details regarding studies proving device performance. The document focuses solely on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study data.

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Normed Distal Radius Reconstruction System intended for use in internal fixation of small bones - primary the distal radius in the forearm such as, compression fractures, intra-articular fractures, displaced fractures and surgical reductions.

Normed Distal Radius Reconstruction System consists of a series of titanium plates in various shape and length in left and right curved configurations, which are attached to the bone using 2,7 mm diameter titanium bone screws. The plates are available in 8, 11, and 13 holes with 2.0 mm plate thickness and can be contoured as needed to fit the specific anatomy. The self-tapping 2.7 mm screw diameters will be available in hex-lock screw head designs, in sixteen length 8 through 38 mm long in 2mm intervals. A hand fixation table system is also available for the surgeon to rest the injured hand during the surgery.

It appears there might be a misunderstanding of the provided text. The document is a 510(k) summary for the Normed Distal Radius Reconstruction System, which is a metallic bone fixation appliance.

This type of device is a physical medical implant, not a software algorithm or an AI-powered diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they would apply to the performance of an AI or diagnostic algorithm do not directly apply in the same way.

The 510(k) process for a device like this focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through:

• Design comparison: Showing the new device has similar materials, design, and intended use as a predicate.
• Mechanical testing: Demonstrating that the device meets established engineering standards for strength, fatigue, material biocompatibility, etc.
• Clinical use (if necessary, but often not for 510(k)s): Sometimes, if there are significant differences or new indications, clinical data might be required, but it's not the primary route for most 510(k)s.

The provided document does not contain information about:

• Acceptance criteria for an algorithm's performance (e.g., sensitivity, specificity, AUC).
• A "study" in the sense of an effectiveness trial for an AI model.
• Sample sizes for test or training sets for an algorithm.
• Expert involvement in establishing ground truth for an algorithm.
• MRMC studies, standalone algorithm performance, or different ground truth types for an AI.

To answer your request based on the provided document, I can only state what is present and what is absent:

The document describes a medical device (bone plate and screws) and its intended use, along with the FDA's clearance (510(k)) based on substantial equivalence. It does not pertain to an AI or diagnostic algorithm.

Therefore, most of the fields you requested cannot be filled from the provided text.

Here's an attempt to address your points by clarifying their applicability or lack thereof:

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

   • Applicability: Not applicable in the context of an AI/diagnostic algorithm performance.
   • What's in the document: The document states the device is "substantially equivalent" to predicate devices, implying it meets criteria for safety and effectiveness for its intended use, typically through design and material comparisons, and potentially mechanical testing, though those specific results are not detailed here.

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

   • Applicability: Not applicable. There is no "test set" for an algorithm performance evaluation described.
   • What's in the document: N/A.

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):

   • Applicability: Not applicable. There is no "ground truth" for an algorithm described.
   • What's in the document: N/A.

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

   • Applicability: Not applicable. No test set or adjudication method is described.
   • What's in the document: N/A.

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:

   • Applicability: Not applicable. This is a physical implant, not an AI assistance tool for human readers.
   • What's in the document: N/A.

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

   • Applicability: Not applicable. This is a physical implant, not an algorithm.
   • What's in the document: N/A.

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

   • Applicability: Not applicable. No ground truth is described in this context. Substantial equivalence for this device would rely on established engineering standards and predicate device characteristics rather than "ground truth" in an AI sense.
   • What's in the document: N/A.

8. The sample size for the training set:

   • Applicability: Not applicable. No training set for an algorithm is described.
   • What's in the document: N/A.

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

   • Applicability: Not applicable. No training set or ground truth for it is described.
   • What's in the document: N/A.

In summary, the provided text is about the regulatory clearance (510(k)) of a conventional surgical implant, not an AI or diagnostic algorithm, and thus the specific questions about algorithm performance, test sets, training sets, and expert evaluations are not relevant to this document.

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Normed Mini External Fixator System can be used as a static fixator or dynamically applying distraction or compression to the small bones of finger and toe. The system provides treatment for small bone fractures, including severe open finger and toe fractures, highly comminuted close fractures, monunion and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, figure and toe deformity corrections, burn maintenance, and bone grafting defects and fusion of a joint.

Normed Mini External Fixator System is a unilateral (uni-bar) external fixation frame consists of a series of clamps, rods and half pins. The frame is consists of Adjustable Polyetheretherketon (PEEK) Swivel Clamps, PEEK Simple Swivel Clamps, Stainless Steel Distraction/Compression Rods, PEEK Carbon Fiber Smooth Connecting Rods and Stainless Steel Half Pins. The 4mm rods are designed to provide a connecting element for the clamps and are available in 25,40,50 and 80 mm length. The clamps are manufactured from Polyetheretherketon (PEEK) in one size. The adjustable swivel clamp will be used with stainless steel distraction/compression rods for dynamically applying distraction or compression to the small bones of finger and toe. The simple swivel clamp will be used with Polyetheretherketon PEEK carbon fiber stabilizer rods for static fixator.

The provided text is a 510(k) summary for the Normed Mini External Fixator System. It details the device's components and indications for use, but it does not contain any information about acceptance criteria, study designs, sample sizes, expert involvement, or any performance data comparable to what would be found in a clinical or statistical evaluation.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for test sets.
• Number/qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details.
• Standalone performance study details.
• Type of ground truth used.
• Training set sample size or ground truth establishment.

The document focuses solely on the device description and its substantial equivalence determination based on its intended use and similarity to legally marketed predicate devices, as per the 510(k) pathway. It's a regulatory submission, not a scientific study report.

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Normed Titanium Rondo Fix Fusion Plate and Screw System intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones, patients suffering pain and/or loss of function due to osteoarthritis, post traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, rheumatoid arthritis and tumor resection. The system can be used in both adult and pediatric patients.

Normed Titanium Rondo Fix Fusion Plate and Screw System consists of a series of convex/concave plates in various shape and length which are attached to the bone using screw fixation. The plates are available in 1.0 mm plate thickness and can be contoured as needed to fit the specific anatomy. The self-tapping 2.3 mm screw diameters will be available in two screw head designs, standard cross-lock and square lock.

This document is a 510(k) summary for a medical device. It does not include information about acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.

The document discusses the device name, intended use, classification, and regulatory status (specifically, substantial equivalence to a predicate device). It's a premarket notification, indicating that the device is being cleared for market based on its similarity to existing cleared devices, rather than through a new clinical trial demonstrating specific performance metrics against pre-defined acceptance criteria.

Thus, all sections of your request remain unanswerable from the provided text, as they pertain to performance testing and evaluation, which is not present in this regulatory submission.

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The Normed Titanium Osteotomy Plating System intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes skeleton.

The Normed Titanium Osteotomy Plating System consists of titanium plates in two configurations, wedge and step, which are attached to the bone using screw fixation. The wedge plates are available in six lengths, namely, 3,4,5,6,7and 8 mm with 2.3 mm diameter screws extends from 10 to 28 mm long. The step plates are available in four lengths, namely, 3,4,5 and 6 mm with 3.5 mm diameter screws extends from 10 to 28 mm long. The plates screw holes are threaded and can accept locking screws with threaded and non-threaded screw head.

The provided text is a 510(k) summary for the Normed Titanium Osteotomy Plating System, which is a medical device for bone fixation. It describes the device, its intended use, and states that the FDA found it substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

Specifically, the following information, as requested in the prompt, is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not included. The document only describes the device and its intended use.
2. Sample size used for the test set and the data provenance: No test studies or data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method: Not applicable as no test set or ground truth is discussed.
5. Multi reader multi case (MRMC) comparative effectiveness study: No such study is mentioned. This device is a bone plating system, not an AI or imaging diagnostic device where MRMC studies are typically performed.
6. Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable as no studies or ground truth establishment are discussed.
8. The sample size for the training set: Not applicable as no training sets or algorithms are discussed.
9. How the ground truth for the training set was established: Not applicable.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, often through bench testing and often does not require new clinical studies for Class II devices like this one. The document indicates that the device was deemed "substantially equivalent" to predicate devices, which means its safety and effectiveness are established by its similarity to already-approved devices, rather than through new, extensive clinical studies detailed in this summary.

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The intended use of the Normed Bi-Directional / Multi-Directional Jaw Distractor is identical to the description in the 510 (k) number K952847 in which, the Normed Bi-Directional / Multi-Directional Jaw Distractor is designed for use in bone elongation which takes into account and can reproduce the normal size and shape of the facial skeleton. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Bi-Directional / Multi-Directional Jaw Distractor. This Normed Bi -Directional / Multi-Directional Jaw Distractor device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are, sever open mandibular fractures, highly comminuted closed fractures, nonunion and delayed union, fractures associated with infection, tumor resections, facial deformity corrections, and bone - grafting defects.

The device intended to be introduced by Osteomedics® Inc., is the same identical product described in the 510 (k) number K952847. The manufacturer, product design, product material, manufacturing process, device description, product intend use, labeling 2 quality assurance procedures, sterilization, substantial equivalency information and operational principal is identical to the information available in the 510 (k) number K952847

This document describes a 510(k) submission for an additional distributor of an already cleared device, the "Normed Bi-Directional / Multi-Directional Jaw Distractor." As such, it does not contain the typical information about acceptance criteria and a study to prove performance.

Instead, the submission states that:

• The device intended to be introduced by Osteomedics® Inc., is the same identical product described in the 510(k) number K952847.
• The manufacturer, product design, product material, manufacturing process, device description, product intend use, labeling, quality assurance procedures, sterilization, substantial equivalency information and operational principal is identical to the information available in the 510 (k) number K952847.

Therefore, the performance and acceptance criteria for this specific submission are satisfied by asserting that the device is identical to a previously cleared predicate device (K952847). The original 510(k) (K952847) would have contained the detailed studies and acceptance criteria to demonstrate safety and effectiveness.

Given the provided text, I cannot extract the information required in your request regarding acceptance criteria and studies, as this submission is for a new distributor of an existing device, not a new device requiring new performance studies. The core of this submission is the claim of "substantial equivalence" to a predicate device.

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The intended use of the Normed Transport Distraction Device is described and is identical to the 510 (k) number K990140 in which, the Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Transport Distraction Device. This Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are as follows: - Tumor Resections - Severe trauma which make continuous bone segments no longer possible . - Bone grafting defects . - Sever open mandibular fractures . - Facial deformity corrections

External Mandibular Fixator and/or Distractor

This FDA 510(k) summary does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The document is a notification for an additional distributor (Osteomedics® Inc.) for a device (Normed Bone Transport Distraction Device) that was previously cleared under 510(k) number K990140. It explicitly states that "The manufacturer, product design, product material, manufacturing process, device description, product intend use, labeling', quality assurance procedures, sterilization, substantial equivalency information and operational principal is identical to the information available in the 510 (k) number K990140."

Therefore, none of the requested information can be extracted from the provided text. To obtain this information, one would need to refer to the original 510(k) submission (K990140) for the Normed Bone Transport Distraction Device.

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