Search Results

The Quatro-M Plasma Spray Femoral Component is for press-fit, uncemented use. It is intended to be used for:

• 1 . Noninflammatory degenerative joint disease including osteoarthritis
• ನ Rheumatoid arthritis
• .
  Pri Avascular necrosis
• Correction of functional deformity 4.
• ર . Revision procedures where other treatments or devices have failed
• Treatment of non-unions, femoral neck and trochanteric fractures of the proximal Q. femur with head involvement that are unmanageable using other techniques

The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6AL-4V (ASTM 1472) stem with tapered proximal end and is intended to seat a conventional modular spherical head. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. The distal portion will be a smooth taper anterior-posteriorly and medial – laterally with a grit blasted distal surfaces. The proximal stem will be porous coated with commercially pure titanium plasma spray on all proximal surfaces excluding the articular interface trunion.

The femoral component is made of wrought titanium 6A1-4V (ASTM F1472). The proximal portion of the stem will be porous coated on all surfaces, excluding the ball trunion. The distal portion of the stem will be grit blasted. Sterilization will be 100% ethylene oxide and nitrogen in accordance with AAMI guidelines for sterilization.

This document is a 510(k) summary for a medical device (Quatro-M Femoral Component) and does not contain the information required to answer the questions about acceptance criteria and device performance as it pertains to clinical study data.

A 510(k) summary is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This typically involves comparing design, materials, and intended use, and often relies on bench testing and sometimes animal testing for performance, rather than extensive human clinical trials with specific acceptance criteria in the manner of an AI diagnostic device.

Therefore, I cannot provide the requested information from the given text. The text does not detail:

1. A table of acceptance criteria and reported device performance (in the context of clinical outcomes or diagnostic accuracy).
2. Sample size for a test set or data provenance for a clinical study.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The provided document describes the device, its classification, and its substantial equivalence to a predicate device, along with its indications for use. It's a regulatory approval document, not a clinical study report.

Ask a specific question about this device

The Symmetric Unicompanimental Knee System is for Cemented Use Only and is indicated for restroing efther compartment of a knee that has been damaged by rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, failed osteotomies or hemiarthroplasties.

The Symmetric Unicompartmental Knee System is intended for the resurfacing of one side of the knee joint. The system consists of metallic femoral and tibial components and a polyethylene tibial insert. The FEMORAL COMPONENT is symmetrically designed eliminating the need for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo) and features a central peg, which aids in stabilization. A central strut is provided for rotational stability and added strength. The femoral component will be available in five sizes (1-5) and will be porous coated with Commercial Pure Titanium (CPTi). The TIBIAL COMPONENT is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti-6Al-4V). The tibial tray features a central fin and four pegs on the underside aiding in rotational stabilization. A screw hole is in the center of the tibial tray for optional screw fixation. The tibial tray is designed with locking features permitting the UHMWPE tibial insert to be snapped into place. The tibial tray has 5 sizes (1 - 5) and is porous coated with Commercial Pure Titanium (CPT)). The TIBIAL INSERT is also a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The inserts' articulating geometry is semi-constrained and is captured in the tibial tray by the mating capture features. The insert is available in 5 thicknesses (6, 8, 10, 12, and 14mm) and 5 sizes (1 - 5).

The provided text describes the "Symmetric Unicompartmental Knee System" and its 510(k) summary for FDA clearance. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI or diagnostic accuracy.

The document is a regulatory submission for a medical device (a knee implant) and focuses on describing the device, its components, and its substantial equivalence to previously marketed devices based on design and materials, rather than a diagnostic performance study.

Therefore, I cannot provide the requested information in the format of the table or answer the specific questions about acceptance criteria, sample sizes, ground truth, expert opinions, or MRMC studies because this type of data is not present in the provided text.

The closest relevant information, though not directly addressing your prompt, is:

• "Push-out strength test results on the tibial tray insert are comparable to other legally marketed devices." This implies a mechanical performance test was conducted, and its results were deemed equivalent to competitor devices, but no specifics on acceptance criteria or the study itself are detailed.

Ask a specific question about this device

Ask a specific question about this device

a) General orthopedic uses.
b) Trochanteric reattachment.
c) Fixation of long bone fractures-elbow, shoulder, ankle, patella.
d) Trauma fixation of shoulder, ankle and patella .
e) General spinal uses.
f) Spinal wiring.

This implant consists of a 0.058" diameter cable, 23" in length, 20" length cable and 3" length lead and a cylindrical crimp with a transverse "through hole". The crimp, cable and lead cable are supplied as a single assembled unit. All three are preassembled in the manufacturing process. The cable is manufactured according to the material specifications for ASTM F136-96 in a 7 x 7 x 0.00064 wire construct. The crimp is also manufactured from ASTM F136-96.

A cable passer may be used to pass the free end of the cable around the bone. The free end is then passed through the transverse hole of the crimp in such manner as to have the free end emerge from the center of the crimp. A cable tensioner may be used to achieve a desired cable tension a which time the surgeon uses a crimper/cutter to crimp near the middle of the "through hole" and cuts the free end from the crimp.

The provided text is a 510(k) summary for a medical device called the "Whiteside Biomechanics Low-Profile Titanium Cable System." This document is part of the FDA regulatory process to demonstrate that a new medical device is substantially equivalent to a previously cleared device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way you've described for a diagnostic or AI-powered device.

The 510(k) process for a physical implantable device like a surgical cable ("Bone Fixation Cerclage") typically focuses on demonstrating material equivalence, manufacturing processes, and functional equivalence (e.g., tensile strength, fatigue resistance) to a predicate device, rather than diagnostic performance metrics like sensitivity, specificity, or reader improvement with AI assistance.

Therefore, I cannot provide the requested information from the given text because:

• Acceptance Criteria and Device Performance Table: The document does not define specific performance acceptance criteria for the device (e.g., tensile strength thresholds, fatigue cycles) nor does it report the results of a study against such criteria. The focus is on demonstrating "substantial equivalence" to a predicate device based on similar design, material, and intended use.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (for diagnostic studies): These categories are relevant for studies evaluating the diagnostic performance of software or imaging devices. They are not applicable to the type of regulatory submission presented for a physical surgical cable. The "study" referenced in K993903 is an assessment of the device's characteristics against its predicate, not a clinical trial or performance study as you might expect for a diagnostic AI.
• Training Set Sample Size and Ground Truth: This is also not relevant as there is no AI or diagnostic algorithm being described.

Summary based on the provided document:

The regulatory document (K993903) for the Whiteside Biomechanics Low-Profile Titanium Cable System asserts substantial equivalence to an existing predicate device (Whiteside Biomechanics Low-Profile Cable System K951844).

• Acceptance Criteria: Not explicitly stated in terms of performance metrics. The implicit acceptance criterion is "substantial equivalence" to the predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness.
• Study That Proves the Device Meets Acceptance Criteria: The "study" is the comparison made as part of the 510(k) submission. The document states:
  • "There are no different technological characteristics between the Whiteside Biomechanics Low-Profile Cable System and the Whiteside Biomechanics, Inc. Titanium Low-Profile Cable System."
  • The cable is manufactured according to ASTM F136-96 material specifications.
  • The crimp is also manufactured from ASTM F136-96.

This indicates that the device meets the "acceptance criteria" by being materially and technologically identical (or very similar, without introducing new risks) to a device already cleared by the FDA. There is no mention of a human-in-the-loop study, a standalone algorithm, or diagnostic performance metrics because this is a physical medical implant, not a diagnostic AI system.

Ask a specific question about this device

The system is intended for use anterolateral/anterior, non-pedicle posterior and posterior pedicle.

1.) The device system consisting of pedicle screws, washers, spacers, utilizing the anterolateral/anterior surgical approach is intended for the following uses:
a.) Anterolateral screw fixation to the non-cervical spine,
b.) Anterior screw fixation to the cervical spine.

The anterolateral/anterior system is intended for use in the following indications:
a.) Degenerative disc disease of the lumbar, thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
b.) Spondylolisthesis
c.) Trauma
d.) Spinal Stenosis
e.) Scoliosis
f.) Kyphosis
g.) Tumor
h.) Pseudoarthrosis
i.) Previous failed fusion
2.) The device system consiting of hooks, screws, washers, spacer, when utilized as a non-pedicle posterior system is intended for use in the following:
a.) Hook and sacral/iliac screw fixation to the non-cervical spine.

The non-pedicle posterior system is intended for use in the following indications:
a.) Degenerative disc disease of the lumbar, thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
b.) Spondylolisthesis
c.) Trauma
d.) Spinal Stenosis
e.) Scoliosis
f.) Kyphosis
g.) Tumor
h.) Pseudoarthrosis
i.) Previous failed fusion
3.) The device system of hooks, spacers, sacral/iliac screws and pedicle screws is intended for patients:
a.) Having a severe spondylolisthesis (grades 3 and 4) at the L5-S1 joint:
b.) Who are receiving fusions using autogenous bone graft only:
c.) Who are having the device fixed or attached to the lumbar and sacral spine: and
d.) Who are having the device removed after the development of a solid fusion mass.

The levels of pedicle screws fixation are limited to L3-S1.

A spinal system consisting of screws, hooks, washers, spacer and plates/screws. The pedicle screws are available in four diameters from 5mm to 8mm, and vary in length from 30mm to 55mm. The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm. The anterior washers offer use with 5mm, 6mm, and 7mm screws. The Conical spacers are available in three heights from 7mm to 12mm, increasing in 2.5 increments. The lumbo-sacral rod/plate and screw incorporates lumbo-sacral rod/plates in three lengths from 80mm to 120mm, and bone screws with a 7mm diameter and lengths of 30mm to 45mm, increasing in 5mm increments. There are five laminar hooks and one pedicle hook with the range.

The distal tips of the pedicle screws are fluted to a point beyond the first thread, thus creating a self-tapping screw configuration.

The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm.

The locking mechanism between the rod and screw, as well as the rod and hook, features a three point clamping configuration in order to significantly reduce the risk of rod positioning and migration.

The devices are used to treat a number of spinal conditions.

The devices are manufactured from Titanium Alloy ASTM F1472-93 or Stainless Steel ASTM F138. Only components manufactured from the same material may be used in combination.

The provided text describes the "Whiteside Biomechanics Spinal System," a spinal fixation device, and its indications for use. However, it does not contain any information about acceptance criteria, device performance studies, or data related to AI/algorithm performance.

This document is a 510(k) summary (K991678) for a spinal system, which is a traditional medical device (implants, hardware) cleared through substantial equivalence to a predicate device. It is not an AI/ML medical device submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML, as that information is not present in the provided text.

The document primarily focuses on:

• Device Description: Components (screws, hooks, rods, washers, spacers, plates), their dimensions, and materials.
• Intended Use: Anterolateral/anterior, non-pedicle posterior, and posterior pedicle approaches.
• Indications for Use: Specific spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, scoliosis, kyphosis, tumor, pseudoarthrosis, previous failed fusion) and specific anatomical locations (non-cervical and cervical spine, L5-S1 joint for severe spondylolisthesis).
• Technological Comparison: Stating that it is a subset of, and identical to, the predicate device (The Corin Spinal System, K973425).
• FDA Clearance Letter: Confirming substantial equivalence based on the provided information.

Ask a specific question about this device

This device is intended to be used for :

• femoral noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• rheumatoid arthritis,
• correction of functional deformity,
• revision procedures where other treatments or devices have failed, and
• treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

A bipolar head which is preassembled. Outer head is made from Cobalt Chrome alloy ASTM F75 and sizes range from 38mm to 62mm in 1mm increments. An UHMW polyethylene insert will be pressed into the inner surface of the outer head during the manufacturing process. This polyethylene insert will articulate with an inner femoral head. The inner head diameter will be 22mm for outer head diameters from 38mm to 55mm and 26mm for outer diameters from 56mm to 62mm. The inner head will be pressed into the poly insert in the operating room using a bipolar head assembly device.

The provided text is a 510(k) summary for a medical device called the "Whiteside Biomechanics, Inc. Bipolar Femoral Head." It describes the device, its intended use, and confirms its substantial equivalence to a predicate device.

However, the document is a regulatory submission for a physical medical device (a hip prosthesis component), not an AI/ML-driven software device. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not applicable or present in this type of regulatory document for a physical implant. The 510(k) process for such devices typically focuses on manufacturing, materials, and substantial equivalence to existing devices, rather than the performance metrics and studies you would find for a diagnostic or prognostic AI algorithm.

Therefore, I cannot extract the requested information as it is not contained within the provided input.

Ask a specific question about this device

This device is intended to be used for :

• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• rheumatoid arthritis,
• correction of functional deformity,
• revision procedures where other treatments or devices have failed, and
• treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head is composed of magnesia partially stabilized zirconia (MG-PSZ). The head is generally spherical with a Whiteside Biomechanics, Inc. 12/14 bore machined from distal to proximal. Around the base of the bore a flat will be machined and will be laser-engraved for labeling purposes.

The provided text is a 510(k) summary for the Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head, and it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.

The document primarily covers:

• Device Identification: Classification name, number, common name, proprietary name, and manufacturer details.
• Device Description: Material composition (magnesia partially stabilized zirconia), spherical shape, and bore specifications.
• Intended Use: Five specific indications for use in hip replacement procedures.
• Additional Information: Material composition reiteration, sterilization method (ETO with nitrogen), and labeling for sterilization indicators.
• FDA Communication: A letter from the FDA confirming substantial equivalence to pre-amendment devices, outlining regulatory class (II) and product code (LZO), and specifying a limitation regarding use with titanium alloy hip stems with Whiteside Biomechanics, Inc. 12/14 taper trunnions.
• Indications for Use Form: A summary of the intended uses.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this data is not present in the provided document.

This type of 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria, sample sizes, ground truth establishment, or specific expert involvement for a standalone or MRMC study. Typically, such studies would be included in the full 510(k) submission, not necessarily in the publicly available summary.

Ask a specific question about this device

This device is intended to be used for :

• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• rheumatoid arthritis,
• correction of functional deformity,
• revision procedures where other treatments or devices have failed, and
• treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6Al- 4 V (ASTM 1472) stem with a tapered proximal end and is intended to seat a conventional modular spherical head. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. The distal portion will be a smooth taper anterior-posteriorly and will have step-cut sides medial-laterally. The proximal stem will be porous coated with commercially pure titanium plasma spray on all surfaces excluding the articular interface trunnion.

The provided text is a 510(k) summary for a medical device (Quatroloc Plasma Sprayed Femoral Component) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance against detailed acceptance criteria through a specific study as would be seen in a clinical trial or performance study report.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided document. The document primarily describes the device, its intended use, manufacturer information, and the FDA's decision regarding its clearance based on substantial equivalence.

Ask a specific question about this device

This device is intended to be used for:

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
5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
6. treatment of osteomyelitis
7. endoprosthesis femoral osteotomy
8. use with a polyethylene cup with or without metal backed shell.

The Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head will consist of a generally spherical, partially hollow (trunnion bore) ceramic ball. The implant will have a machined flat on the most distal surface with the trunnion centered and machined proximally into its center. The bore will be a Whiteside Biomechanics 12/14 taper intended to be seated on a trunnion compatible with this taper (see warning label). The head's outer perimeter is intended to articulate with a polyethylene acetabular component of compatible size. Labeling on the femoral head will be printed on a beveled surface machined around the periphery of the trunnion bore or on the top-inside flat of the bore.

This document does not contain information about acceptance criteria or a study proving the device meets those criteria for the Whiteside Biomechanics Zirconia Ceramic Femoral Head.

The provided text is a 510(k) premarket notification letter from the FDA to Whiteside Biomechanics, Inc., and a 510(k) Summary for a zirconia ceramic femoral head. It describes the device, its intended use, classification, and manufacturing information. The letter confirms that the device is substantially equivalent to a predicate device, allowing it to be marketed.

However, it does not include details on:

• A table of acceptance criteria or reported device performance.
• Sample size used for a test set, its provenance, or how ground truth was established for it.
• Number and qualifications of experts, or adjudication methods for a test set.
• Whether a multi-reader multi-case (MRMC) study was done, or any effect sizes of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set or how its ground truth was established.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.

Ask a specific question about this device

This device is intended to be used for:

• noninflammatory degenerative joint disease including 1. osteoarthritis and avascular necrosis
• rheumatoid arthritis, 2.
• correction of functional deformity, 3.
• revision procedures where other treatments or devices have 4. failed,
• 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

This implantable device consists of a generally hemispherical shape titanium shell with six screw holes for optional additional fixation with bone screws. A UHMWPE modular liner is pressed or tapped into the shell. Push out resistance of the polyethylene is attained by the interlocking geometry of the shell. Rotational fixation is obtained by tabs located on the liner that mate with notches on the shell. Toggle fixation is achieved with the nub on the backside The inner surface of the of the liner fitting into the driver hole through the shell. polyethylene articulates with the spherical portion of the femoral component.

The provided document is a 510(k) summary for the Whiteside Biomechanics Micro-Seal Acetabular System. It describes the device, its intended use, and confirms substantial equivalence to pre-amendment devices for market clearance. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document focuses on:

• Device Description: Material, design, and components of the acetabular shell.
• Intended Use: Clinical conditions for which the device is indicated (e.g., osteoarthritis, rheumatoid arthritis, revision procedures).
• Sterilization: Details about the sterilization method (EtO), sterility assurance level (10^-6), and the sterilizer used.
• Regulatory Clearance: The FDA's 510(k) clearance letter, confirming substantial equivalence and the product code.
• Postmarket Surveillance: Mandate for a Section 522(a) postmarket surveillance study for this device, including submission of a protocol and principal investigator's profile.

No information is present in this document regarding:

1. Acceptance criteria for performance (e.g., mechanical strength, wear rates, biocompatibility), or specific quantitative thresholds the device needed to meet.
2. Reported device performance data from a study against any acceptance criteria.
3. Sample size for any test set or the data provenance.
4. Number of experts for ground truth, their qualifications, or adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Training set sample size or how ground truth for training was established.

The document is purely regulatory in nature, indicating FDA clearance based on substantial equivalence, and outlining post-market requirements. It does not provide any technical study results or performance data against specific acceptance criteria.

Ask a specific question about this device