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The UltraConcentrator™ Permeability Hemodialyzer is indicated for use as an ultrafiltrator for the selective removal of undesirable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemodilution such as following cardiopulmonary bypass.

The UltraConcentrator Permeability Hemodialyzer is a device that is used to remove plasma water from dilute blood plamsa proteins, increasing the concentration of plasma proteins and formed cellular elements. The UltraConcentrator is constructed of semi-permeable hollow fibers which divide the device into two compartments. An inner pathway for diluted blood perfusate is defined by the inlet and outlet connectors and flow dispersion headers which are connected through the inner lumen of semi-permeable, hollow fiber membranes. Surrounding the hollow fibers is an enclosed, vented compartment for the collection of ultrafiltrate waste water.

When perfusate fluid passes through the inner diameter of the hollow fibers, water and small dissolved solutes can pass through the semi-permeable membrane walls into the annular ultrafiltrate compartment to then be discarded.

The UltraConcentrator may be used manually or it may be used with the UltraConcentrator Processor, a pneumatically driven device that provides automatic processing of the UltraConcentrator.

The UltraConcentrator Permeability Hemodialyzer is not intended for use with direct patient connection, nor is it intended for use as a dialyzer. Although constructed of highly permeable membrane material, the low total membrane surface area of the UltraConcentrator inherently limits the maximum rate of water removal. Neither an ultrafiltration rate monitor nor a controller is necessary.

The provided document is a 510(k) summary for the UltraConcentrator™ Permeability Hemodialyzer, a conventional hemodialyzer used as an ultrafiltrator. It contains information about the device's specifications, indications for use, contraindications, warnings, and precautions, as well as a comparison to a predicate device.

However, this document does not contain information about acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The 510(k) submission states that "The UltraConcentrator is technologically substantially equivalent to the predicate in every respect," which is the basis for its clearance, rather than proof through a formal study meeting specific acceptance criteria as might be expected for novel devices or software.

Therefore, I cannot fulfill your request for the specific information points regarding acceptance criteria and a study to prove they are met because those details are not present in the provided document.

To be explicit, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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Pro Osteon® 500R Resorbable Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Pro Osteon 500R Resorbable Bone Void Filler is an osteoconductive porous implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes. Pro Osteon 500R has a trabecular structure which resembles the multidirectional interconnected porosity of cancellous bone. It has a median pore diameter of 435 microns. The implant is trabecular calcium carbonate covered by a very thin outer layer of calcium phosphate representing approximately 13% of the total implant structure. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. It is approximately 2 to 10 microns in thickness and overlays the calcium carbonate substructure. Once implanted, the calcium phosphate outer laver will slowly resorb, delaving exposure of the underlying and faster resorbing calcium carbonate. Calcium carbonate resorption will normally occur within six months or less. When Pro Osteon 500R is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the Pro Osteon 500R surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the implant.

Acceptance Criteria and Device Performance for Pro Osteon 500R Resorbable Bone Void Filler

The FDA 510(k) summary for Pro Osteon 500R Resorbable Bone Void Filler does not explicitly state quantitative acceptance criteria to be met by the device. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device (Wright Medical Osteoset™ Bone Void Filler) across several key characteristics. The "reported device performance" is presented in relation to this substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document only mentions "animal testing" using "rabbits" for tibial defects. It does not specify the number of rabbits or the number of defects tested.
• Data Provenance: The study appears to be prospective animal testing conducted specifically for the 510(k) submission. The country of origin is not explicitly stated but is implicitly within the context of FDA submission, suggesting studies relevant to US regulatory standards.

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

• This information is not provided in the summary. The animal study results would likely have been evaluated by veterinary pathologists or other researchers, but details on the number or qualifications of such experts are absent.

4. Adjudication method for the test set:

• This information is not provided. Given the nature of animal studies focusing on biological endpoints like bone formation and resorption, the "adjudication method" as typically described for clinical trials (e.g., 2+1, 3+1 for imaging reads) is unlikely to be applicable in the same way. Evaluation would have likely involved histopathological analysis and quantitative measurements.

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 was not done. This device is a bone void filler (an implantable medical device), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers" and "AI assistance" is not relevant to this submission.

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

• Not applicable. As stated above, this is an implantable medical device for bone repair, not an algorithm.

7. The type of ground truth used:

• For the animal studies, the ground truth would have been established through direct biological observation and measurement (e.g., histopathological assessment of bone ingrowth, direct measurement of resorption from tissue samples or imaging over time, and possibly macroscopic observation of defect repair).

8. The sample size for the training set:

• Not applicable. This summary describes testing for an implantable medical device, not a machine learning algorithm. There is no concept of a "training set" in this context.

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

• Not applicable. As above, there is no training set for this type of device submission.

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The Interpore Inducer Bone Graft Delivery Syringe is indicated for the delivery of allograft, autograft or synthetic bone graft material to an orthopaedic surgical site. In addition, it is designed to facilitate pre-mixing of a bone graft material with I.V. fluids, blood, plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

The Interpore Inducer has a volume of approximately 15 cc.

The INTERPORE Inducer Bone Graft Delivery Syringe is a piston syringe intended for use to deliver allograft, autograft or synthetic bone graft materials to an orthopaedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. The Interpore Inducer has a volume of approximately 15cc.

The Interpore Inducer is a specially designed syringe specifically intended to deliver bone graft materials to a surgical site. It is supplied sterile in double aseptic transfer packaging.

The Interpore Inducer consists of a syringe barrel, syringe top cap, piston and plunger. The distal end of the syringe has a removable top cap which must be aseptically removed in order to load the bone graft material into the syringe. After loading the syringe, the top cap may be reattached to the syringe to constrain the contents of the syringe or to minimize potential contamination of the syringe contents. In addition, the top cap has a male luer-lok connector which may be attached to any standard female luer adapter for fluid transfer.

The piston of the syringe is designed to eject fluids or blood components and bone graft materials into the operative site. It is also designed to be the attachment point for the syringe plunger. The proximal end of the piston also has a female luer-lok connector which may be connected to any standard male luer adapter for delivery of fluids or blood components into the syringe.

The syringe plunger is provided separately and is attached to the proximal end of the syringe piston immediately prior to bone graft expulsion from the syringe into the surgical site.

This 510(k) premarket notification for the Interpore Inducer Bone Graft Delivery Syringe does not contain a study that proves the device meets acceptance criteria. Instead, the document establishes substantial equivalence to existing predicate devices based on product design, material of construction, and function as a piston syringe.

Therefore, I cannot provide the requested information in a table or as answers to points 1-9 because no such study is described or referenced in the provided text.

The core of the submission (pages 1-3) describes the device, its intended use, and comparison to predicate devices, stating: "The product design, material of construction, and function as a piston syringe is substantially equivalent to the FDA cleared predicate devices." This implies that the device is considered safe and effective because it is fundamentally similar to devices already on the market that have established their safety and effectiveness.

The FDA's response (pages 4-5) confirms the finding of substantial equivalence, which allows the device to be marketed without requiring new clinical trials to prove its own efficacy and safety, as its equivalence to already approved devices is sufficient.

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The Odontit Autogenous Bone Collection Device is indicated for use as an aspirator for the removal and collection of blood, autogenous bone chips, or other extraneous fluids from a surgical site. Using a vacuum source, the Odontit aspirator will remove materials (including blood, bone chips and other fluids) from the surgical site and pass them through a stainless steel screen which is designed to capture and collect autogenous bone. At the option of the surgeon, this bone may be removed from the aspirator, washed and cleansed as necessary, and returned to the same patient as an autogenous bone graft.

The capacity for bone collection in the screen is approximately 16 cc.

The Odontit Autogenous Bone Collection Device is a portable suction device intended for use as an aspirator for the removal and collection of blood, autogenous bone, or other extraneous fluids from a surgical site. The device consists of the following components: Body Assembly, Aspirator Tip, Screen Filter, Flex tubing, Rigid tubing and a Plunger.

The provided text describes a 510(k) Premarket Notification for the "Odontit Autogenous Bone Collection Device." 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 specified acceptance criteria. Therefore, the information requested in your prompt related to clinical studies, acceptance criteria, sample sizes, expert ground truth, MRMC studies, and standalone performance is generally not applicable to a 510(k) submission of this nature.

Here's an explanation based on the document:

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

• Not Applicable. The 510(k) process for a device like this focuses on demonstrating "substantial equivalence" to a predicate device, not on meeting specific, pre-defined acceptance criteria from a performance study. Clinical performance metrics (like sensitivity, specificity, accuracy) or detailed engineering performance criteria (beyond basic functional specifications) are not presented in this document.

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

• Not Applicable. No test set or associated data provenance is discussed in this 510(k) summary. The submission is a regulatory filing, not a report of a clinical study.

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. No ground truth establishment by experts is described, as no specific test set or clinical study requiring such a method is mentioned.

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

• Not Applicable. No test set or corresponding adjudication method is discussed.

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. The device is a non-powered, single-patient, portable suction apparatus for collecting bone chips. It is not an AI-assisted diagnostic or interpretative device, so an MRMC study and AI-related effectiveness are entirely irrelevant to this submission.

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, so standalone performance in the context of an algorithm is not relevant.

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

• Not Applicable. As no clinical study results are presented, there is no discussion of ground truth.

8. The sample size for the training set:

• Not Applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not Applicable. As it's not an AI/ML algorithm, there's no training set or ground truth establishment for it.

Summary of the 510(k) Submission:

The provided document is a 510(k) Premarket Notification for the "Odontit Autogenous Bone Collection Device". The core of this submission is demonstrating substantial equivalence to a predicate device, the "KAM Super Sucker™" (K822065).

The claim for substantial equivalence is based on:

• Product design
• Material of construction
• Function as an aspirator

The device's intended use is "as an aspirator for the removal and collection of blood, autogenous bone chips, or other extraneous fluids from a surgical site." It uses a vacuum source to pass materials through a stainless steel screen to capture autogenous bone, which can then be returned to the patient as an autogenous bone graft. The capacity for bone collection in the screen is approximately 16 cc.

The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed devices, allowing it to proceed to market. This type of submission does not typically involve the extensive clinical studies or performance data that would necessitate the reporting of acceptance criteria, sample sizes for test/training sets, or expert-established ground truths.

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The Membrane Tack is a titanium alloy, machined, miniature nail designed to stabilize guided tissue regeneration membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The guided tissue regeneration membranes are intended for use in wrapping bone or cartilage, or in soft tissue defects when bony or soft tissue ingrowth and attachment is required Guided tissue regeneration membranes are also appropriate for augmentation of slight tissue deficiencies. These are medical devices currently cleared by FDA and commercially available for sale in the United States. While not yet classified by FDA, the FDA Dental Advisory Panel has recommended a Class II Classification for guided tissue regeneration devices, both resorbable and non-resorbable.

The IMZ Membrane Tack System consists of components and instruments designed to stabilize guided tissue regeneration membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The Membrane Tack is fabricated of titanium alloy and has a thin low profile head and a barb at the tip for stabilization.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IMZ Membrane Tack System:

Summary of Acceptance Criteria and Device Performance (from the Provided Text):

Detailed Study Information:

1. A table of acceptance criteria and the reported device performance:
   (See table above)

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 explicitly stated. The text only mentions "Pull Force testing of the IMZ Membrane Tack was performed using membrane material tacked into cortical and cancellous bone." The number of samples (tacks, membrane pieces, bone samples) is not provided.
   • Data Provenance: Not explicitly stated. This appears to be a laboratory-based non-clinical test. No information about country of origin or whether it was retrospective/prospective is given.

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):

   • This document describes a non-clinical, physical performance test. Therefore, there were no human "experts" establishing a ground truth in the context of diagnostic interpretation. The "ground truth" was the physical outcome of the pull force test – whether the tack remained in place or the membrane failed first.

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

   • Not applicable. This was a non-clinical physical performance test, not a human reader study requiring 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:

   • Not applicable. This document describes a non-clinical test for a physical medical device (a bone tack), not an AI/software device. No MRMC study was performed or mentioned.

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 or AI.

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

   • The "ground truth" for this non-clinical test was the direct mechanical observation of failure mode during the pull force testing. Specifically, the observation was that the membrane failed before the tack was dislodged, indicating sufficient retentive force of the tack.

8. The sample size for the training set:

   • Not applicable. This is a physical medical device undergoing non-clinical testing, not an AI/machine learning model that requires a training set.

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

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

Conclusion based on the provided text:

The provided 510(k) summary focuses on the non-clinical functional performance of the IMZ Membrane Tack. The only acceptance criterion and corresponding performance mentioned relates to the tack's ability to retain the membrane under pull force. The study conducted was a direct mechanical pull force test. The document lacks details on the specific methodology of this test, such as the number of samples, precise force applied, or detailed quantitative results beyond the qualitative statement of the membrane failing before the tack.

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The INTERPORE Self-Tapping Threaded Implant is indicated for oral reconstruction in the totally edentulous mandible or maxilla, in large edentulous spans, for bilateral and unilateral free-ends and in restoration of single tooth edentulous spaces. It is designed to become an osteointegrated prosthesis allowing the attachment of removable and fixed partial or complete prosthodontic appliances. The external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications.

The INTERPORE Self-Tapping Threaded Implant is a commercially pure titanium, machined, endosseous threaded implant with an external hex configuration on the top of the implant. The outer surface of the implant is externally threaded. The external threads originate at the inferior edge of the machined coronal collar of the implant and continue to the apical end of the implant. The apical end of the implant contains flutes which act as cutting edges to aid installation of the implant during the self-tapping procedure. The inner diameter of the implant is internally threaded with 2.5 mm threads designed for acceptance of a placement screw, a hex cover screw, a healing abutment, and a retaining screw. The latter device affixes the prosthetic appliance to the implant.

The incorporation of the external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications. It is designed to mechanically interface with a female hexagonal configuration on the mating prosthesis such that, when the retaining screw is tightened into place, the crown will not be allowed to rotate.

The provided text is a 510(k) summary for a dental implant, focusing on device description, indications, materials, and comparison to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way described by your request's numbered points (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance).

The section titled "NONCLINICAL TEST CONCLUSIONS" mentions "Static testing was performed on the INTERPORE Threaded Implant and compared with existing mechanical test data for the Branemark 3.75 mm Threaded Implant. Results showed that the INTERPORE Threaded Implant was significantly stronger than the Branemark implant."

This indicates a mechanical comparison, but not a study designed with the elements you've requested.

Therefore, I cannot populate the table or answer the specific questions about clinical study design, ground truth, or expert involvement as the provided text does not contain that information.

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