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The Accu-Joint Hemi Implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock, along with the following clinical conditions: Hallux Valgus. Hallux Rigidus, and an unstable or painful MTP ioint. The Accu-Joint Hemi Implant is intended to be used with bone cement.

The metatarsal head and phalangeal base may not be used together at the same joint.

The Accu-Joint Hemi Implant consists of a hemi-arthroplasty metatarsal head or phalangeal base intended to resurface the metatarsophalangeal joint. These components are used for hemi-arthroplasty and are not used together to create a joint. The Accu-Joint Hemi Implant is designed with a threaded shaft for intramedullary insertion. The implant has a driver pocket on the articular surface axially aligned with the threaded shaft. To accommodate a wide range of patient anatomies, various sizes are offered.

The purpose of this submission is to offer a sterile packaged option of the Accu-Joint Hemi Implant.

The provided text is a 510(k) Summary for the Accu-Joint Hemi Implant, focusing on an administrative change regarding the sterility of the device (from non-sterile to sterile packaged). It does not describe a study involving an AI/software device or a comparative effectiveness study with human readers.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies, as these concepts are not applicable to the content of this document.

The document discusses:

• Device: Accu-Joint Hemi Implant (a toe joint prosthesis).
• Purpose of current submission (K240268): To offer a sterile packaged option of the Accu-Joint Hemi Implant, which was previously cleared as non-sterile (under K200951).
• Key finding: The device is substantially equivalent to its predicate (K200951, the non-sterile version of the same implant) because the change in sterility status does not affect its safety and effectiveness.
• Performance Data discussed: This pertains to validation of the sterilization process and sterile packaging, not the performance of an AI algorithm or human readers.
  • Sterilization Validation: Per ISO 11135.
  • Sterile Packaging Validation: Per ISO 11607-2, ASTM D4169, ASTM F188, and ASTM F1929.
  • Mechanical Testing: Screw testing per ASTM F543 and dynamic bending testing were previously performed for the predicate device (K200951) and were not repeated for this submission as the sterilization change does not affect mechanical performance.

In summary, this document is about a medical implant's sterility change, not an AI or software device. Thus, the specific questions posed about AI device acceptance criteria and study methodologies are not applicable here.

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The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock.

Indications include:

• Hallux valgus or Hallux limitus
• Hallux rigidus
• Unstable or painful metatarsallphalangeal (MTP) joint

The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component (four sizes for each component) designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. The implants are made from Cobalt Chrome per ASTM F-1537.

This document is a 510(k) summary for the Montross Extremity Medical Hemi Implant System, a medical device. The document describes the device, its intended use, indications for use, and a summary of nonclinical testing performed to demonstrate substantial equivalence to predicate devices. However, the document does NOT contain information pertaining to AI/ML device performance or studies with acceptance criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods typically associated with such studies.

Therefore, I cannot extract the requested information using the provided text. The device described is a physical implant, not an AI-powered diagnostic or predictive tool, and thus the acceptance criteria and study information requested (e.g., related to multi-reader multi-case studies, standalone algorithm performance, ground truth establishment) are not applicable to this submission.

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The Accu-Joint Hemi Implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Accu-Joint Hemi Implant is intended to be used with bone cement.

The metatarsal head and phalangeal base may not be used together at the same joint.

The Accu-Joint Hemi Implant consists of a hemi-arthroplasty metatarsal head or phalangeal base intended to resurface the metatarsophalangeal joint. These components are used for hemiarthroplasty and are not used together to create a joint Hemi Implant is designed with a threaded shaft for intramedullary insertion. The implant has a driver pocket on the articular surface axially aligned with the threaded shaft. To accommodate a wide range of patient anatomies, various sizes are offered.

The provided text describes a 510(k) premarket notification for a medical device called the "Accu-Joint Hemi Implant," which is a toe joint phalangeal prosthesis. The document details the device's characteristics, indications for use, and performance data from non-clinical testing.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria, as typically understood for an AI/ML-based device validation (which would involve metrics like sensitivity, specificity, F1-scores, ROC curves, etc.). The performance data mentioned refers to mechanical testing (static torsion, driving torque, static pullout, dynamic bending) of the physical implant itself, comparing its physical strength to predicate devices. There is no mention of "acceptance criteria" related to diagnostic or evaluative performance, nor details about a "study" involving a test set, expert ground truth, or MRMC studies.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria for diagnostic performance, test set details, ground truth establishment, expert involvement, and statistical findings of an AI/ML study) is absent from the provided text.

The text focuses on establishing substantial equivalence based on:

• Physical characteristics (materials, insertion method, size, hole)
• Indications for Use
• Mechanical strength testing (demonstrating it's sufficient for intended use and equivalent to predicates)

It's a clearance for a physical orthopedic implant, not an AI/ML diagnostic or assistive device, which explains the lack of the requested AI/ML specific validation information.

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The Vilex CHI (cannulated hemi implant), a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with bone cement. The Vilex cannulated metallic hemi implant is intended for single-use only.

The Vilex CHI System includes one-piece cannulated hemi-arthroplasty implants intended to resurface the metatarsal-phalangeal joint. The CHI system includes an MPJ Base and MPJ Head. These are available in standard and lesser options. These components are used for hemi arthroplasty and are not used together to create a total joint.

It appears you've provided a 510(k) Premarket Notification document for a medical device: the Vilex Cannulated Hemi Implant (CHI).

However, this document describes a joint implant, not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging device. The acceptance criteria and supporting studies described in this document relate to the mechanical performance and biocompatibility of a physical implant, not the performance of an algorithm or the accuracy of a diagnostic reading.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-driven diagnostic or image analysis device (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not present in this document.

The performance data section (VII. Performance Data) for this implant focuses on:

• Engineering analyses: Bending Stress, Shear Stress, Geometric Analysis, Surface Area Analysis. These are tests to ensure the physical implant is strong enough and fits correctly.

It does not contain information relevant to AI/diagnostic device evaluation, such as:

• A table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for a test set of diagnostic images.
• Data provenance for diagnostic images.
• Number of experts for ground truth of diagnostic images or their qualifications.
• Adjudication methods for diagnostic ground truth.
• MRMC studies to show human reader improvement with AI.
• Standalone performance of an algorithm.
• Type of ground truth (e.g., pathology, outcomes data) for diagnostic purposes.
• Training set sample size for an AI model.
• How ground truth for a training set was established for an AI model.

In summary, this document is about a physical orthopedic implant, not an AI or diagnostic software. Therefore, it does not contain the information you are requesting about AI device evaluation methods.

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The Life Spine Metatarsal Hemi Implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone with the following clinical conditions: hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) ioint. The device is a single use implant intended to be used with bone cement.

The Life Spine Metatarsal Hemi Implant is an implant that has a tapered stem and a rounded head. The tapered stem allows for the implant to be fixated into the 1st metatarsal. The rounded head resurfaces the metatarsal head in the metatarso-phalangeal joint.

I apologize, but the provided text is a 510(k) premarket notification for a medical device (Life Spine Metatarsal Hemi Implant) and does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format you've requested for aspects like sample size, ground truth, or expert qualifications for performance evaluation.

The document states that Finite Element Analysis, bench testing (static and dynamic), and engineering rationale were presented to demonstrate substantial equivalence to predicate devices, but it does not detail the specific acceptance criteria for these tests, nor does it present the results of these tests in a tabular format as performance data.

Therefore, I cannot provide the information requested in your numbered list based on the input text. The document focuses on regulatory approval based on demonstrating substantial equivalence, not on a detailed clinical performance study with defined acceptance criteria and study parameters.

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The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint.

The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement.

The Vilex cannulated metallic hemi implant is intended for single use only.

Vilex Cannulated Metallic Hemi Implant is a one-piece device intended to resurface the base of the proximal phalanx. It is similar in design to the predicate devices (BioPro K023684) and MetaSurg (K083469) in terms of articular surface shape and fixation. Implants will be offered in cobalt chrome or titanium, with or without Hydroxyapatite (HA) coated stem and back as an option.

The provided text is a 510(k) summary for a medical device (Vilex Cannulated Metallic Hemi Implant). It describes the device, its indications for use, and a claim of substantial equivalence to predicate devices. However, it does not include the detailed performance study information requested in the prompt.

Specifically, the document states: "Non-Clinical Test Data: Based on the engineering analysis, the Vilex implants are equivalent to predicates in terms of mechanical integrity and resistance to bending torques." This indicates that the primary evidence for this device's acceptance is based on engineering analysis and comparison to existing predicate devices, rather than a clinical study with detailed performance metrics, ground truth establishment, or human reader involvement.

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

Here's a breakdown of what can be extracted and what cannot:

Acceptance Criteria and Device Performance Study for Vilex Cannulated Metallic Hemi Implant

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This device's acceptance is based on an "engineering analysis" and comparison to predicate devices, not a clinical test set with patient data.

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

• Not applicable. No clinical test set requiring expert ground truth establishment is described. The evaluation was an engineering analysis.

4. Adjudication method for the test set:

• Not applicable. No clinical test set requiring adjudication is described.

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. This is a medical implant, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance is relevant.

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

• No. This is a medical implant, not an algorithm.

7. The type of ground truth used:

• Engineering Analysis/Predicate Device Specifications: The "ground truth" for the device's acceptance is based on its engineering properties matching those of previously approved predicate devices, along with comparable indications for use, materials, sizes, and shapes.

8. The sample size for the training set:

• Not applicable. This device's acceptance is based on engineering comparison, not a 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 a machine learning model is involved.

Summary:

The provided 510(k) summary for the Vilex Cannulated Metallic Hemi Implant demonstrates substantial equivalence through an engineering analysis and comparison to predicate devices in terms of mechanical integrity, resistance to bending torques, indications for use, materials, sizes, and shapes. This is a common pathway for medical device clearance, especially for devices similar to existing ones. It does not involve clinical studies with patient data, expert ground truth, or AI-related performance metrics.

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The MetaSurg cannulated titanium hemi implant is indicated for use in the treatment of degenerative arthritis in the 1st metatarsal joint along with the following clinical conditions: Hallux Limitus or Hallux Rigidus, Hallux Valgus and pain or instability in the metatarsophalangeal joint.

The MetaSurg cannulated titanium hemi implant is intended for press fit, uncemented use.

The MetaSurg cannulated titanium hemi implant is intended for single use only.

The MetaSurg cannulated titanium hemi implant is designed to be an anatomical replacement for the base of the phalanax. The implant is offered in 5 sizes ranging from 15 - 23mm in diameter.

The provided document is a 510(k) summary for a medical device called the MetaSurg Cannulated Titanium Hemi Implant. This summary focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific performance metrics such as accuracy, sensitivity, or specificity. Therefore, many of the requested criteria for studies that evaluate device performance (like AI algorithms) are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown based on the information available:

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

The document does not specify "acceptance criteria" in terms of performance metrics typical for AI or diagnostic devices (e.g., accuracy, sensitivity, specificity). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on:

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

Not applicable. This is a 510(k) submission for a physical implant, not a study involving a "test set" of data for performance evaluation in the context of AI or diagnostic accuracy. The substantial equivalence determination is based on device characteristics and intended use.

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

Not applicable. This type of evaluation is not performed for physical implants demonstrating substantial equivalence. The "ground truth" for the predicate devices would have been established through clinical use and regulatory clearance, which is then used as a reference point for the new device.

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

Not applicable. No test set or adjudication method is described for this type of submission.

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 surgical implant, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation in the context of an MRMC study.

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

Not applicable. This is a physical implant, not an algorithm.

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

For the purpose of substantial equivalence, the "ground truth" is effectively the regulatory clearance and established safety and effectiveness of the predicate devices: Vilex hemi implant (K023684) and BioPro hemi implant (K041595). The new device is compared against these already-cleared devices based on their characteristics and intended use. No new clinical 'ground truth' in the sense of diagnostic accuracy is established in this document.

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI model requiring a training set.

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

Not applicable. No training set is involved.

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The Metal Hemi Implant is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.

The Metal Hemi Implant is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adjacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, maintain range of motion and reduce pain without altering the joint biomechanics. The Metal Hemi Implant requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).

This document is a 510(k) premarket notification for a medical device called the "Metal Hemi Implant." 510(k)s are primarily focused on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a comprehensive study proving the device meets specific acceptance criteria in the way a diagnostic AI or interventional device might.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth types) are not applicable or mentioned in this type of submission. This device is a physical implant, not a diagnostic algorithm or imaging device that would typically involve such studies.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

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

Explanation: For a 510(k) for an implantable device like this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a previously legally marketed device (the predicate). The "device performance" is described through its design features, materials, and intended use, which are deemed equivalent to the predicate. There are no quantitative performance metrics (like sensitivity, specificity, or AUC) typically associated with diagnostic algorithms.

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 applicable/Not provided. This is an implantable device, not a diagnostic algorithm tested on a dataset of patient images or readings.
• Data provenance: Not applicable/Not provided.

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)

• Number of experts: Not applicable/Not provided.
• Qualifications of experts: Not applicable/Not provided.

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

• Adjudication method: Not applicable/Not 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

• MRMC study: No, this is not an AI-assisted diagnostic device.
• Effect size: Not applicable.

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

• This is not an algorithm; it is a physical medical implant. Therefore, a standalone performance study in this context is not applicable.

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

• Type of ground truth: For a 510(k) of an implant, the "ground truth" for demonstrating substantial equivalence typically involves engineering testing (e.g., material testing, mechanical load testing, biocompatibility evaluations, sometimes cadaveric studies for range of motion or surgical technique), and clinical experience/literature supporting the safety and effectiveness of the predicate device and the materials used. The document states "The Metal Hemi Implant does not incorporate any new technological characteristics as compared to the predicate device. The Metal Hemi Implant and the predicate devices are made from the same material. The Metal Hemi Implant has the addition of CP Ti plasma spray." This implies that the 'ground truth' for its performance aligns with the established performance of the predicate and the known properties of the materials.

8. The sample size for the training set

• Sample size: Not applicable/Not provided. This is a physical implant, not a machine learning model.

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

• Ground truth establishment: Not applicable/Not provided.

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Indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus and an unstable or painful metatarsophalangeal joint. OsteoMed 1st MPJ Hemi Implants are intended for single use only.

The OsteoMed 1st MPJ Hemi Implant is a one piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to replace the distal base of the proximal phalanx and provide a smooth articular surface for the adjacent first metatarsal head. It is available in several sizes in direct per portion to the anatomic construct of the distal base of the proximal phalanx. Primary fixation is intended via a press fit bone implant interface. The OsteoMed 1* MPJ Hemi Implant is made of cobalt chromium (ASTM F-799) and may also be provided with a titanium plasma coated stem.

This document, K060536, is a 510(k) premarket notification for the OsteoMed 1st MPJ Hemi Implant System, a medical device. It is a submission to the FDA (Food and Drug Administration) for clearance to market the device. The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your request, highlighting what information is available and what is not typically found in a 510(k) summary for this type of device:

Key Takeaway: This 510(k) submission seeks clearance based on substantial equivalence to existing devices, not a clinical study proving new acceptance criteria. Therefore, the requested information about device performance, ground truth, expert review, and sample sizes for a study proving acceptance criteria will largely be absent because such a study was not conducted or required for this type of submission.

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

• Acceptance Criteria: Not explicitly stated as "acceptance criteria" in the context of a performance study with numerical targets. For a 510(k) based on substantial equivalence, the "acceptance criteria" are typically that the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to predicate devices.
• Reported Device Performance: No clinical performance data is reported or provided in this 510(k) summary. The document states, "Due to the similarity of materials and design to the predicate devices, OsteoMed believes that the OsteoMed 1st MPJ Hemi Implant System does not present new safety or effectiveness issues." This indicates reliance on the established safety and effectiveness of the predicate devices.

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

• Not Applicable. No clinical test set or data provenance is mentioned as part of this 510(k) submission. This is typical for Class II devices seeking substantial equivalence through material and design similarity, especially when there are no new technological characteristics.

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. As no clinical test set was used to establish an "acceptance criteria" for a new performance claim, there was no need for experts to establish ground truth in that context. The "ground truth" for this submission is established by the FDA's existing clearances for the predicate devices.

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

• Not Applicable. 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

• Not Applicable. This device is a passive, implantable orthopedic prosthetic (a hemi-implant for a toe joint), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant to this product.

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.)

• Implicit Ground Truth: The "ground truth" in the context of this 510(k) is the established safety and effectiveness of the predicate devices (BioPro Hemi MP Joint (K041555), Kinetikos Medical, K2 Hemi Toe Implant System (K023770), and Fii tira BioMedical Metal Hemi Toe Implant (K971047)) as previously determined by the FDA. Its own safety and effectiveness are inferred by its substantial equivalence to those devices.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. This is a manufactured product, not a machine learning model.

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

• Not Applicable. As there is no training set mentioned, this question is not relevant to the information provided in the 510(k) summary.

Summary of what the K060536 document does provide:

• Predicate Devices: Clearly identifies three predicate devices for comparison.
• Intended Use: The intended use of the OsteoMed 1st MPJ Hemi Implant System is for "treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal joint."
• Materials: Made of cobalt chromium (ASTM F-799) and may also be provided with a titanium plasma coated stem, similar to the materials of predicate devices.
• Design and Operational Principle: Stated to be similar to predicate devices.

For a 510(k) based on substantial equivalence, the "study" demonstrating that the device meets "acceptance criteria" is typically the submission itself, arguing that the device is so similar to existing cleared devices that it inheres their safety and effectiveness profile, without requiring new clinical trials or performance studies.

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