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The RHS is intended for:

1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
   a. Joint destruction and/or subluxation visible on x-ray
   b. Resistance to conservative treatment
2. Primary replacement after fracture of the radial head
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty
   The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.

The RHS has been designed in order to provide surgeons and patients with a joint prosthesis to restore function and relieve pain of the radial part of the elbow joint. The RHS has an anatomical design, which reproduces the kinematics of the radial joint. The RHS consists of two components: a metal radial stern and a metal-polyethylene radial head.

This is a radial head prosthesis submission, not an AI/ML device, therefore, the requested information about acceptance criteria, study details, and AI/ML specific metrics (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable.

The provided document is a 510(k) Premarket Notification for the "RHS" radial head prosthesis. The purpose of this type of submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not to prove performance against specific acceptance criteria in the manner of an AI/ML diagnostic device study.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

However, based on the general information provided for medical devices, I can extract information relevant to "claims" and "indications for use" as they relate to what a device is designed to do, which can be seen as a form of "acceptance criteria" in a broader sense for a non-AI/ML device.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from Indications for Use and Device Description)

Since this is a prosthesis and not a diagnostic device, "performance" is largely demonstrated through substantial equivalence to predicate devices and the physical properties of the materials, rather than metrics like sensitivity or specificity. "Acceptance criteria" in this context refer to the conditions under which the device is intended to be used and the clinical problems it aims to address.

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

• Not Applicable. This is a 510(k) for a physical implant, not an AI/ML diagnostic device requiring a "test set" in the computational sense. Substantial equivalence is typically demonstrated through comparison of design, materials, manufacturing processes, intended use, and sometimes non-clinical testing (e.g., mechanical testing, biocompatibility) to predicate devices, rather than a clinical study with a "test set" of patient data for performance evaluation against specific metrics.

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. See point 2.

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

• Not Applicable. See point 2.

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 a physical implant, not an AI-assisted diagnostic tool.

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):

• Not Applicable directly for performance evaluation in the AI/ML sense. For a prosthesis, "ground truth" might pertain to established biomechanical principles, material standards (e.g., ASTM, ISO), and historical clinical outcomes of predicate devices that establish the safety and effectiveness of the type of device. Formal "ground truth" to evaluate diagnostic accuracy is not relevant here.

8. The sample size for the training set:

• Not Applicable. See point 2.

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

• Not Applicable. See point 2.

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OSTEOARTHRITIS
RHEUMATOID ARTHRITIS
TRAUMATIC ARTHRITIS
WHERE THE USE OF A MORE CONSERVATIVE PROCEDURE HAS FAILED OR IS UNACCEPTABLE
INTENDED FOR NON-CEMENTED USE SINGLE USE ONLY

The Signal Medical Corporation HHS Acetabular Component is manufactured of ASTM I-136 or F-75. The design is made available in twelve (12) sizes ranging from 48mm to 70mm, in two mm increments. The cup is coated with an F-67 sintered beaded surface for F-136 or F-75 beads for an F-75 cup to enhance bone ingrowth. The device is designed in three models, one with three circumferentially spaced pins or spikes at 120 degree intervals to provide for a primary skeletal fixation and reduce the chance of rotation, one with screw holes and one with both screw holes and spikes. The ultra high molecular weight polyethylene inserts, ASTM F648, are secured to the acetabular shell using a crown-taper fit. They are designed to accept 28mm femoral heads on their inside diameter from 48mm to 70mm and 32mm femoral heads from 54mm to 70mm. This device is intended for single use only.

This document is a 510(k) summary for a medical device (HHS Acetabular Component), not a study report for an AI/ML powered device. As such, it does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details that are typically found in such studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other requested information as it is not present in the provided text.

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The RHS Helmet is a cranial orthosis that applies passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic- shaped heads.

The RHS Helmet is a cranial orthosis that applies passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly. It consists of a polypropylene helmet, three-eighths of an inch thick, that is vacuum formed over a plaster model of a baby's head to produce a helmet. A liner for the helmet is made of plastizote, one-fourth of an inch in thickness. Small holes are bored in the helmet for ventilation, and large holes for the child's ears.

The provided text is a 510(k) summary for the RHS Helmet, a cranial orthosis. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against specific acceptance criteria for a novel device.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable or not detailed in this document.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or provide a table of performance data against such criteria. The basis for clearance is "biocompatibility of the materials and the safety and effectiveness of helmet therapy," which are qualitative statements rather than specific metrics.

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

No specific test set or clinical study data on device performance is provided in this 510(k) summary. The document mentions "Performance Data: Information was provided on the biocompatibility of the materials and the safety and effectiveness of helmet therapy," but does not detail any particular study results or sample sizes.

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

Not applicable. As no specific test set or clinical study is detailed, there's no mention of experts establishing ground truth for performance.

4. Adjudication Method for the Test Set

Not applicable. No test set or clinical study is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. This document does not describe an MRMC study. The focus is on demonstrating substantial equivalence to a predicate device, not on comparative effectiveness against humans or other devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The RHS Helmet is an orthotic device, not an algorithm, so a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to performance studies (e.g., pathology, outcomes data) is not explicitly discussed in this 510(k) summary. The device's effectiveness relies on the established principles of cranial orthosis therapy for nonsynostotic positional plagiocephaly, which is a recognized medical approach. The "effectiveness" mentioned refers to the general understanding of helmet therapy, not a specific ground truth derived from a novel study for this particular device.

8. The Sample Size for the Training Set

Not applicable. This device is a physical orthotic device, not an algorithm or AI model that requires a training set.

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

Not applicable. See #8.

In summary, the provided 510(k) documentation for the RHS Helmet primarily relies on the concept of "substantial equivalence" to a legally marketed predicate device (Clarren Helmet -- 510(k) # 003035). This means that the device's safety and effectiveness are supported by its similarity to an already cleared device, rather than through extensive, independent, novel performance studies with specific acceptance criteria as might be required for a completely new technology or a PMA application. The "Performance Data" mentioned likely refers to general information and existing knowledge about cranial helmet therapy and material biocompatibility, rather than data from a new, comprehensive clinical trial for the RHS Helmet itself.

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