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1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

For cemented and un-cemented use.

The E-Poly™ Tibial Bearings are provided in five sizes. Each size comes in five thicknesses. (There are five basic styles of the E-Poly™ Bearings which are intended to be unsel with previously cleared Biomet knee products.)

The E-Poly™ UHMWPE tibial bearings are highly-crosslinked to improve wear resistance, and infused with vitamin E to stabilize free-radicals and prevent oxidative degradation.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device met such criteria. This document is a 510(k) summary for the E-Poly™ Tibial Bearings, which focuses on demonstrating substantial equivalence to legally marketed predicate devices for the purpose of market clearance.

Here's what the document does state:

• Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This generally refers to bench testing for mechanical properties, wear resistance, etc., but specific acceptance criteria or detailed results are not provided.
• Clinical Testing: "None provided as a basis for substantial equivalence." This explicitly states that no clinical studies were performed or submitted for this 510(k) application to establish substantial equivalence.

Therefore, I cannot provide the requested information in the table format or answer the specific questions related to acceptance criteria and performance studies because this data is not present in the provided document.

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The InnerVue™ Diagnostic Scope System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.

The InnerVue™ Diagnostic Scope System consists of five (5) main parts: hardware, software, instrumentation and procedural kit(s).

Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface and a storage drawer.

Software: The software enhances the image from the scope to remove fiber optic pixilation without adding distortion. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.

Scope: A rigid fiber optic scope designed for one-time use.

Supplementary Instruments: Supplementary instruments consist of four (4) pieces that can be used interchangeably throughout the procedure. The four components are a cannula, a trocar, and a cannula plug. Both disposable supplementary instruments are available with the system.

Procedural Kits: Supplementary items to assist in the surgical procedure.

The provided text states, "Clinical Testing: None provided as a basis for substantial equivalence." This means that no clinical study was conducted to prove the device meets acceptance criteria specific to its diagnostic or operational performance related to medical outcomes.

Instead, the device's substantial equivalence and performance are based on compliance with electrical safety and general medical equipment standards.

Here's the breakdown of the information requested, based on the provided text:

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

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

Not applicable. No clinical testing with a test set was conducted for substantial equivalence. The performance assessment was based on compliance with electrical and safety standards, not clinical data or patient samples.

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

Not applicable. No clinical testing was performed, so no experts were used to establish ground truth for a test set.

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

Not applicable. No clinical testing was performed.

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. No MRMC study was mentioned or conducted, as the device is not an AI-assisted diagnostic tool and no clinical testing was performed for substantial equivalence.

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

Not applicable. No standalone algorithm performance was assessed as this is a medical device for visualization and illumination, not an AI or algorithm-based diagnostic tool. The performance was assessed against safety and electrical standards.

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

Not applicable. Ground truth in a clinical sense was not established as no clinical testing was performed. The "ground truth" for compliance was the requirements outlined in the specified electrical and medical device safety standards.

8. The sample size for the training set

Not applicable. No training set was used as this device does not involve machine learning or AI that requires a training set.

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

Not applicable. No training set was used.

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Indications for the LactoScrew™ Screw Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, halluxvalgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/ tendon repair.

This device is a screw anchor used to provide a means for attaching soft tissue to bone during healing. The device consists of a screw portion and a head portion. The screw portion engages the bone while the head portion provides a means to drive the anchor in and a means to attach the suture to the anchor. These anchors are comprised of 85% L-Lactide/15% Glycolide and are available in 3.5 mm and 5.5 mm diameter sizes.

The provided text is a 510(k) summary for the Biomet LactoScrew™ Screw Anchor, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a new study with acceptance criteria and performance metrics.

Therefore, the document explicitly states:

• Non-Clinical Testing: "Mechanical testing was performed to establish substantial equivalence to the predicate devices."
• Clinical Testing: "Clinical testing was not used to establish substantial equivalence to predicate devices."

Due to this, the questions regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for a study proving acceptance criteria cannot be answered directly from the provided text.

The 510(k) process for this device relies on demonstrating that its technological characteristics (material and design) are similar to existing, legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "acceptance criteria" here would relate to the successful demonstration of substantial equivalence, primarily through non-clinical mechanical testing, rather than performance against pre-defined clinical metrics.

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Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI bone graft substitute can be combined with autogeneous bone marrow aspirate or autogenous blood. Calcigen™ PSI resorbs and is replaced with bone during the healing process.

Calcigen™ PSI bone graft substitute is a resorbable osteoconductive scaffold composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). The device is available as granules, cubes, or cylinders. Calcigen™ PSI is porous with multidirectional interconnected pores resembling that of cancellous bone.

The provided text describes the 510(k) summary for the Calcigen™ PSI Bone Graft Substitute. Based on the information provided, here's a breakdown of the requested details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This indicates that no clinical studies (and therefore no test set) were conducted with the Calcigen™ PSI device itself for this 510(k) submission. Substantial equivalence was claimed based on comparison to legally marketed predicate devices and non-clinical testing/literature review.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no clinical testing was performed for the Calcigen™ PSI device in this submission, there was no test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing and test set were used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or referenced for this 510(k) submission. The document states "Clinical Testing: None provided as a basis for substantial equivalence."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a bone graft substitute, not an algorithm, and its performance is not assessed in a standalone algorithmic manner.

7. Type of Ground Truth Used

For the Calcigen™ PSI device itself, no specific "ground truth" was established via clinical studies for this 510(k). Instead, the substantial equivalence relied on:

• Comparison of technological characteristics (materials, design, indications) to legally marketed predicate devices.
• Non-clinical laboratory testing and literature review, which would implicitly draw on established scientific understanding and historical data regarding bone graft substitutes.

8. Sample Size for the Training Set

Not applicable. This document pertains to a medical device (bone graft substitute), not an AI/algorithm-based device that would require a 'training set'.

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

Not applicable, as there is no training set for this type of medical device.

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Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.

A surgeon will request a PMI hip stem over a standard line product in order to better fill the patient's natural femoral canal. The most common parameters modified include the expansion of the A-P diameter, the increase of the lateral flare of the device and the posterior bowing of the stem. The resulting device will more closely match the patient's natural anatomy. Since each stem is matched to a particular patient, a specific device description is unavailable. Instead, an envelope has been defined which all devices must fit.

The provided text is a 510(k) premarket notification summary for a medical device, the HA PMI Femoral Hip Stem. It states that no clinical testing was provided for this device. Therefore, a study demonstrating the device meets specific acceptance criteria, as well as information about sample sizes, ground truth establishment, expert qualifications, and adjudication methods, are not available in the provided document.

The primary method used for demonstrating safety and effectiveness for this device was non-clinical testing, specifically "Mechanical testing and engineering analysis has justified the modifications to this device." This device was approved based on substantial equivalence to a legally marketed predicate device (PMI Hip Femoral - 510(k) K923452), meaning it was deemed as safe and effective as a previously cleared device without requiring new clinical trials to prove its performance.

Since no clinical study was cited, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable as no clinical study was conducted.
2. Sample sized used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
6. If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: Not applicable (this is a physical hip stem, not an algorithm).
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Propeller Head Small Cannulated Screw System is indicated for the following conditions:

• Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna . as well as fractures in the patella.
• Fixation of the small bones such as those in the foot, ankle, wrist and elbow. ●
• . Ligament reconstruction
• Arthrodesis of the foot, ankle, wrist and elbow. .
• Small bone osteotomies .
• Osteochondritis dissecans

The Propeller Head Small Cannulated Screw System is a titanium screw that has cutting flutes in the head, which allows it to cut into the bone, thus countersinking itself. The screw is also cannulated to allow insertion over a quide wire. The threads are selfdrilling and self-tapping.

The provided document is a 510(k) summary for a medical device called the "Propeller Head Small Cannulated Screw System." It explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence."

Therefore, the device's acceptance criteria were not based on clinical performance studies, but rather on non-clinical mechanical testing and comparison to a legally marketed predicate device.

Here's a breakdown of the information requested, based on the provided text:

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

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

• Sample size: Not applicable, as no clinical test set was used. Mechanical testing typically involves a set number of screws, but this specific number is not provided in the document.
• Data provenance: Not applicable for clinical data. For mechanical testing, the data would originate from laboratory tests.

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

• Not applicable, as no human-reviewed test set or clinical ground truth was established.

4. Adjudication method for the test set

• Not applicable, as no clinical test set requiring adjudication was used.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a bone screw, not an AI-assisted diagnostic tool that would involve human readers.

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

• Not applicable. This device is a physical bone screw and does not involve any algorithms or AI for standalone performance.

7. The type of ground truth used

• The "ground truth" for the device's performance was established through mechanical testing comparing the device against the performance of predicate devices. There was no clinical ground truth (e.g., pathology, outcomes data) used for this submission.

8. The sample size for the training set

• Not applicable, as no training set was used for an AI or machine learning model.

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

• Not applicable, as no training set was used.

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The Comprehensive Humeral Fracture Stems are indicated for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

The Interlok® finish Comprehensive Humeral Fracture Stems are intended for cemented use and the MacroBond™ coated Comprehensive Humeral Fracture Stems are intended for press-fit or cemented application.

The Comprehensive Humeral Fracture Stems consists of various lengths and can be provided with an Interlok® finish for cement fixation or with a thin layer of plasma spray coating known as MacroBond™ for press-fit. The device is fluted distally which allows for a cement mantle and an increase in anti-rotational stability. The proximal body of the stem incorporates a reverse Morse taper for the Bio-Modular Heads and 4 fins, three of which include suture holes to facilitate multiple attachment sites for the bone. A collar also exists to minimize subsidence.

The provided document is a 510(k) premarket notification for a medical device, the "Comprehensive Humeral Fracture Stems." It outlines the device description, classification, predicate devices, indications for use, and a summary of testing.

Crucially, the document explicitly states:

• "No clinical testing was provided as a basis for substantial equivalence."
• "Non-Clinical Testing: Mechanical Testing and a Finite Element Analysis determined that the Comprehensive Humeral Fracture Stems presented no new risks and were, therefore, substantially equivalent to the predicate devices."

Therefore, based on the provided text, there is no study detailing acceptance criteria and device performance in the context of an AI/algorithm-based system. The regulatory clearance was based on substantial equivalence to predicate devices through non-clinical mechanical testing and finite element analysis, not on clinical performance data or AI model validation.

Because no clinical or AI-related study was performed, I cannot provide information for the following points:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts used to establish ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

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Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis. The device is a single use implant intended for press-fit application.

The Press-Fit Head Resurfacing device is designed to replace the outer surface of the femoral head while preserving as much natural bone as possible. The device retains the diameter of the natural femoral head and articulates aqainst the natural acetabulum (hemi-hip). The device is manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75. It has a highly polished outer surface and a titanium plasma spray coated inner surface. A central post is provided for stabilization. The device is available in diameters of 38mm to 60mm, in one-millimeter increments.

The provided document is a 510(k) premarket notification for a medical device, the "Press-Fit Head Resurfacing Device." It does not present any clinical study data or acceptance criteria related to device performance.

Based on the content of the document, the following observations can be made relevant to your request:

1. Table of acceptance criteria and reported device performance:

   • Not Applicable: The document explicitly states "Non-Clinical and Clinical Testing: None provided." This indicates that no performance data from such studies, nor specific acceptance criteria, are included or were required for this 510(k) submission.

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

   • Not Applicable: As no clinical or non-clinical testing data is provided, there is no test set or associated sample size discussed.

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

   • Not Applicable: No clinical or non-clinical testing was provided, so no ground truth establishment by experts is mentioned.

4. Adjudication method for the test set:

   • Not Applicable: No clinical or non-clinical testing was provided, so 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: This device is a physical implant (a hemi-hip prosthesis), not an AI-powered diagnostic or imaging device. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

   • Not Applicable: This device is a physical implant, not an algorithm.

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

   • Not Applicable: No clinical or non-clinical testing was provided, so no ground truth is discussed.

8. The sample size for the training set:

   • Not Applicable: There is no mention of a training set as no machine learning or AI component is involved.

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

   • Not Applicable: No training set or associated ground truth establishment is mentioned.

Summary of Safety and Effectiveness from the Document:

The document states one "Summary of Safety and Effectiveness." The basis for substantial equivalence is primarily on material and design similarities, not on performance data from primary studies.

"The materials, surface finishes and processing of the Press-Fit Head Resurfacing Device are similar to the predicate device."

This 510(k) submission relies on demonstrating substantial equivalence to already legally marketed devices based on technological characteristics and intended use, rather than presenting novel clinical performance data. The FDA's decision to clear the device (K023188) was based on this substantial equivalence to predicate devices (K021799, K811008, K962514, K811718), and not on a new study demonstrating its performance against specific acceptance criteria.

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The products found in the original 510(k) K950761, and K954417 will use the following Indications for Use:

1. NonInfiammatory degenerative joint disease including osteoarthritis and avascular necrosis,
2. Rheumatoid arthritis,
3. Correction of functional deformity,
4. Revision procedures where other treatments or devices have failed and
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head Involvement, unmanageable using other techniques.
   For Cemented and Non-cemented use

The products found in the original 510(k) K920639, K920640 and K926107 will use the following Indications for Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
2. Rheumatoid arthritis,
3. Correction of functional deformity,
4. Revision procedures where other treatments or devices have failed and
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
   For Cemented use only

The products found in the original 510(k) K921274 will use the following Indications for Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
2. Rheumatoid arthritis,
3. Correction of functional deformity,
4. Revision procedures where other treatments or devices have falled and
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
   For Non-Cemented use only

The products found in the original 510(k) K970501 will use the following Indications for Use:
Intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses.
The device is a single use implant

Biomet's polyethylene components are manufactured from UHMWPE (GUR 1050) resin conforming to ASTM F-648, ISO 5834-1, and ISO 5834-2. This resin is isostatically compression molded under constant temperature and pressure and formed into acetabular components, which are designed to replace the articulating portion of the hip joint.

This document is a 510(k) summary for the Biomet ArCom® Polyethylene Liners and Components. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a novel device. Therefore, a direct answer to the request to describe acceptance criteria and a study proving a device meets these criteria in the context of AI/ML evaluation cannot be fully provided from the given text.

However, I can extract the relevant information from the document that pertains to how the device's equivalence and safety were established.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

1. Table of acceptance criteria and the reported device performance:

This document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, not on setting new acceptance criteria and proving performance against them for a novel device. The "acceptance criteria" here would be demonstrating that the new device is as safe and effective as the predicate devices.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No human "test set" data (clinical data) was used. The evaluation was primarily based on non-clinical (laboratory/mechanical) testing of the material.
• Data Provenance: The non-clinical testing was performed by Biomet, Inc. (Warsaw, IN, USA). This is laboratory/bench testing data, not human patient data.

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 in the context of clinical data was performed, as no clinical studies were submitted. Substantial equivalence relies on comparing the device's technical characteristics and non-clinical performance to legally marketed predicate devices.

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

Not applicable. No clinical test set data requiring adjudication was provided.

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 physical medical implant (hip joint component) and not an AI/ML software. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" in this 510(k) context is the established safety and efficacy of the predicate devices and the conformity of the new device's material and performance to recognized standards and guidelines. For the non-clinical testing, the "ground truth" is based on the performance according to these established standards (ASTM F-648, ISO 5834-1, ISO 5834-2) and the results of the specific physical tests (tensile, impact, physical properties, hip simulator, aging behavior, shelf life).

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. Not an AI/ML algorithm.

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