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The DVO™ Extended Articulation Humeral Heads for use in hemi-shoulder replacement are indicated for:

1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.
3. Rotator cuff tear arthropathy.
   Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are also indicated for press-fit uncemented use or for use with bone cement. These are sterile, single use devices.

The Extended Articulation Humeral Heads are an addition to the previously cleared modular DVO Total and Hemi Shoulder System. The cobalt chrome alloy, semispherical heads mate with the previously cleared humeral stems through a locking taper. The heads are highly polished. They do not articulate with the previously cleared glenoids as they are intended to be used in hemi-arthroplasty applications only.
The heads are available in four sizes, 44 to 56mm, in 4mm increments, and in heights of 18 and 21 mm.

The provided text is for a 510(k) premarket notification for a medical device called "Extended Articulation Humeral Heads." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on detailed performance studies with acceptance criteria in the way AI/ML devices typically present them.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies, as described in your prompt.

Instead, the submission states:

• Comparison to Predicates: "The DVO Extended Articulation Humeral Heads are similar to the listed predicate devices in intended use for hemi shoulder replacement, indications for use, design, materials of construction (cobalt chrome alloy), methods of sterilization (gamma irradiation), packaging, and manufacturing methods."

This means the device's acceptance is based on its similarity to previously approved devices, not on a new, explicit performance study against pre-defined acceptance criteria as would be typical for a novel diagnostic or AI-powered solution.

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The DVOTM Total and Hemi Shoulder System is intended for use in total or hemi-arthroplasty.

The DVO™ Total and Hemi Sl»vulder System is indicated for:

• 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis:
• Fracture/dislocations of the proximal humerus where the articular surface is severely comminuted, 2. separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
• నే. Other difficult clinical problems where shoulder anthrodesis or resection arthroplasty are not acceptable (c.g., revision of a failed primary component).

Hemi-shoulder replacement is also indicated for:

• 1. Ununited humeral head fractures;
• 2. Avascular necrosis of the humeral head.
• 3. Rotator cuff tear arthropathy.

Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are indicated for press-fit uncemented use or for use with bone cement.

This is a single use device.

This sterile modular total and hemi shoulder system is comprised of a humeral stem, two styles of humeral heads (standard and exentric) and two styles of glenoids (pegged or keeled). The heads mate on the stems through a locking taper. The heads are highly polished and articulate with the glenoids.

The humeral stems are offered in two lengths: standard (110mm with diameters of 6 to 16mm) or long (200 to 220mm in length with diameters of 8 to 14mm). The stems are fluted, except for the 6mm diameter stem. The stems also have fins with suture holes. The head is available in 15 standard sizes (40 to 56mm in heights of 15, 18 and 21 mm) and 10 eccentric sizes (40 to 56mm in heights of 18mm or 21mm).

Materials include titanium humeral stems, cobalt chrome humeral heads and ultrahigh molecular weight polyethylene glenoids.

The provided text describes a 510(k) premarket notification for a medical device, the DVOTM Total and Hemi Shoulder System. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and detailed performance studies.

Therefore, the document does not contain details about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would be typical for an AI/software device or a novel medical device requiring de novo authorization.

Instead, the submission for the DVOTM Total and Hemi Shoulder System primarily relies on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: Similar for total or hemi shoulder replacement.
• Performance Characteristics: Overall comparable.
• Materials of Construction: Titanium alloy, cobalt chrome alloy, and UHMWPE are common in both.
• Methods of Sterilization, Packaging, Manufacturing Methods, and Design: All are similar.
• Technological Characteristics and Dimensional Analysis: These were compared.
• Nonclinical Testing: This is mentioned as evidence, specifically stating that the subject device's "fatigue load carrying capability exceeds the predicate devices." This is the closest thing to a performance metric and a "study" result, but it's a nonclinical bench test, not a clinical study.

Given this context, I cannot provide the requested information in the format of acceptance criteria and a study demonstrating performance because the type of device registration (510(k)) and the provided document do not include such details.

However, I can extract information related to what was presented to establish equivalence:

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

As explained above, specific clinical acceptance criteria and device performance metrics from a human or clinical study are not applicable to this 510(k) submission as presented. The primary "performance" discussed is nonclinical:

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

This information is not provided in the document. The "test set" for the fatigue load capability would refer to the number of devices or components tested during nonclinical bench testing.

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 information is not provided in the document, as it pertains to nonclinical testing, not expert-adjudicated clinical data.

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

This information is not provided. It is not relevant for nonclinical bench testing which does not involve human 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

No, an MRMC comparative effectiveness study was not done. This is a submission for an orthopedic implant, not an AI or imaging diagnostic device.

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

This question is not applicable. This is an orthopedic implant and does not involve an algorithm.

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

For the stated "fatigue load carrying capability," the "ground truth" would be the engineering specifications and test standards (e.g., ISO standards for implant testing) to which the device was subjected. It is not based on expert consensus, pathology, or outcomes data, as those apply to clinical evaluations.

8. The sample size for the training set

This question is not applicable. This is an orthopedic implant, not a software device, and therefore does not have a "training set" in the context of machine learning.

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

This question is not applicable for the reasons stated above.

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For wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability, post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; turnor resection; and spastic deformities. Single use device for cementless use only.

These anatomically contoured plates are offered in two lengths (standard or short), manufactured from either titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM F-2229). The plate contains a single row of screw holes (2.4mm, 2.7mm and 3.2mm in diameter) down its length. The locking screws are 2.4mm in diameter and vary in length from 6mm to 14mm. The 2.7mm and 3.2mm screws were previously cleared. In addition to the screws, the device utilizes a press fit intramedullary fixation for the proximal stem.

This is not an AI/ML device. This is a 510(k) premarket notification for a medical device called "Wrist Fusion Plate". The document does not contain information about acceptance criteria or a study proving the device meets them because it is a traditional medical device, not an AI/ML product. Therefore, it is unable to answer the question as it pertains to AI/ML device testing and evaluation.

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The DVO™ Volar Plate System is intended for volar fixation of fractures and osteotomies involving the distal radius. This single use device is for cementless use only.

This non-sterile volar plate system offers several sizes and styles of volar plates, in either titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM 2229). The three versions include a volar T-plate, a volar intramedullary T-plate and a volar T-plate with translating head. The distal head of the plate contains two rows of fixed angle screw holes that accept 2.7 mm screws. Dorsal and ulnar sheaths are secured into the plate recesses to cover the screw heads. The screws vary in length from 16mm to 26mm. K-wires may also be used for stabilization of bone fragments.

This 510(k) premarket notification describes a medical device, specifically a Volar Plate System for fixing distal radius fractures. However, it does not contain specific acceptance criteria or the details of a study proving the device meets acceptance criteria in the way a clinical performance study would.

In a 510(k) submission, especially for devices like plates and screws that are substantially equivalent to existing predicate devices, the "acceptance criteria" are generally met by demonstrating substantial equivalence in terms of:

• Intended Use: The device is for the same medical purpose.
• Technological Characteristics: The device has similar design, materials, and operating principles.
• Performance: The device performs as safely and effectively as the predicate device(s). This is typically demonstrated through non-clinical testing (e.g., mechanical testing, materials characterization, dimensional analysis, finite element analysis) rather than human clinical trials.

The provided document explicitly states: "The Volar Plate System is similar to the listed predicate devices in intended use, performance characteristics, materials of construction, manufacturing methods and design. This is evidenced by comparison of technological characteristics, dimensional analysis and finite element analysis."

Therefore, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: Specific numerical acceptance criteria for mechanical strength, fatigue life, or other performance aspects are typical for bone fixation devices but are not detailed in this 510(k) summary. These would be found in the full submission, likely in the form of pre-established performance standards or comparison to predicate device data.

Regarding the study proving the device meets acceptance criteria (as requested):

The document describes a bench testing/analysis approach rather than a human clinical study with patients or expert readers.

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

• Test Set Sample Size: Not applicable in the context of human data. For "dimensional analysis and finite element analysis," the "sample" would be the device designs and material properties themselves, for which specific quantification of "sample size" is not provided in this summary.
• Data Provenance: Not applicable for human data. The analysis is based on engineering principles and material science.

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

• Not applicable. Ground truth for non-clinical engineering analysis is based on established scientific principles, material standards (ASTM), and engineering models.

4. Adjudication method for the test set:

• Not applicable. There is no human (e.g., radiologist) adjudication process 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:

• Not applicable. This is not an AI-assisted diagnostic device, nor is it a clinical outcomes study involving human readers.

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

• Not applicable. This is a physical orthopedic implant, not a software algorithm. The "standalone performance" is assessed through engineering tests.

7. The type of ground truth used:

• The "ground truth" for demonstrating substantial equivalence for this device category typically relies on:
  • Engineering Standards: Adherence to ASTM standards (e.g., for materials F-136, F-138, 2229).
  • Biomechanical Equivalence: Finite element analysis and dimensional analysis comparing the device's mechanical behavior to that of predicate devices, ensuring it can withstand typical physiological loads.
  • Predicate Device Performance History: The long-standing safety and effectiveness of the predicate devices establish the "ground truth" for what constitutes acceptable performance in this therapeutic area.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of an AI/machine learning model.

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

• Not applicable for the same reason as above.

In summary: This 510(k) submission seeks clearance based on substantial equivalence to existing, legally marketed predicate devices through bench testing and engineering analysis, not clinical trials with patient data or human interpretation studies. The "acceptance criteria" are intrinsically tied to demonstrating that the new device is as safe and effective as its predicates based on its design, materials, and mechanical performance.

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