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The First Choice® Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid, degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the distal radioulnar joint and not improved by conservative treatment.

The First Choice Partial Ulnar Head implant is intended for press-fit use.

The First Choice Partial Ulnar Head implant is a onepiece hemi-arthroplasty device intended to replace the articulating surface of the distal ulnar head. It is constructed from cobalt chromium alloy and replaces the ulnar head while retaining the ulnar neck and styloid. The distal head is polished to a mirror finish for articulation within the distal radioulnar joint and the proximal stem has a roughened grit-blasted surface for uncemented press-fit fixation in the ulnar medullary canal. The First Choice Partial Ulnar Head implant is available in 12 sizes.

Here's an analysis of the provided text regarding the "First Choice Partial Ulnar Head Implant" and how it addresses the requested information about acceptance criteria and supporting studies:

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining and meeting new acceptance criteria through a clinical study. Therefore, many of the requested categories related to independent clinical studies with specific performance metrics will not be directly applicable or present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

• Ulnar Head Biomechanics testing.
• DRUJ Stem Bend Strength testing.
  (Specific quantitative acceptance thresholds for these tests are not provided in this summary, but the implicit acceptance criterion is that the results fall within limits demonstrating equivalence to the predicate.) |
  | Clinical Performance: | Clinical Performance: |
  | Not necessary to support substantial equivalence. | Clinical performance data were not necessary to support substantial equivalence. |

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

• Sample Size for Test Set: Not applicable. No clinical test set. The non-clinical tests were conducted on prototypes of the new device and, by inference, compared to design specifications or performance characteristics of the predicate device. The document does not specify the number of units tested.
• Data Provenance: Not applicable. The testing described is non-clinical (biomechanical), likely conducted in a lab setting by the manufacturer, Ascension Orthopedics.

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

• Not applicable. There was no clinical test set requiring expert-established ground truth. The "ground truth" for the non-clinical tests would be the established engineering and biomechanical principles and potentially the performance data of the predicate device.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring 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

• Not applicable. This device is a physical orthopedic implant, not an AI or imaging-based diagnostic tool. Therefore, MRMC studies and AI-assisted reading are irrelevant.

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

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Non-Clinical: The implicit "ground truth" for the non-clinical performance data (Ulnar Head Biomechanics and DRUJ Stem Bend Strength) is the established engineering and biomechanical performance characteristics considered acceptable for the device's function, and, critically, the performance of the predicate device (Ascension® Modular Ulnar Head, K052137). The goal was to prove substantial equivalence, meaning the new device performs at least as well as the legally marketed predicate.
• Clinical: Not applicable, as clinical data was deemed unnecessary for this 510(k) submission.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device that requires a training set.

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

• Not applicable. As noted above, this is not an AI or machine learning device.

Explanation of the Study and Why it Meets "Acceptance Criteria"

The "study" in this context is the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device, not an efficacy or safety study to meet specific, pre-defined acceptance criteria for a novel device.

• Device: First Choice Partial Ulnar Head Implant
• Purpose of the "Study" (Non-Clinical Testing): To demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device (Ascension® Modular Ulnar Head, K052137) in terms of intended use, technological characteristics, and performance (strength and function).
• Acceptance Criteria (Implicit): The primary acceptance criterion for this 510(k) submission is that the First Choice Partial Ulnar Head Implant's performance, as measured by the non-clinical tests, is comparable to, or as safe and effective as, the predicate device. This ensures the new device does not raise new questions of safety or effectiveness.
• Tests Performed:
  • Ulnar Head Biomechanics: Likely assessed mechanical properties related to joint articulation and stress distribution.
  • DRUJ Stem Bend Strength: Assessed the structural integrity and resistance to bending of the stem portion of the implant, which is fixed into the ulna.
• Outcome: The document states, "Performance data demonstrates that the subject device design is substantially equivalent to the predicate in terms of strength and function." This statement is the conclusion that the device has met the implicit acceptance criterion for substantial equivalence based on the non-clinical testing.
• Why Clinical Data Wasn't Needed: For many 510(k) submissions, if the new device is sufficiently similar to a predicate, and non-clinical data can bridge any differences, clinical data is not required by the FDA. This was the case here, as noted: "Clinical performance data were not necessary to support substantial equivalence."

In summary, for medical devices cleared through the 510(k) pathway, the "acceptance criteria" are usually tied to demonstrating substantial equivalence to an already legally marketed device, often through non-clinical testing, rather than through a new clinical trial establishing standalone efficacy and safety metrics.

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The First Choice and First Choice Plus are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain.

The provided text is a 510(k) summary for the First Choice and First Choice Plus TENS units. It does not describe a clinical study focused on meeting acceptance criteria for device performance in a typical sense (e.g., diagnostic accuracy metrics). Instead, it's a submission for demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, or improvement in pain scores from a clinical trial) and reported device performance.

Instead, the "acceptance criteria" are implied by meeting regulatory standards and demonstrating substantial equivalence to a predicate device. The "device performance" is primarily considered in terms of its technological characteristics and safety compared to the predicate.

• First Choice Plus: Identical functionality to predicate, but one pulse rate dial for both channels, plus pulse width adjustment. |
  | Safety Standards Adherence | - Adherence to AAMI/ANSI NS-4 Standard | All required sections were met. |
  | | - Adherence to IEC 60601-1:1990 + a1:1993 + A2: 1995 standards | All units pass. |
  | | - Adherence to IEC 601-1:1988 + a1:1991 + A2:1995 standards | All units pass. |
  | | - Compliance with "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables" Final Rule | All units use "shrouded patient cable connector's". |
  | Intended Use Equivalence | - Same intended use as predicate device | "Used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain." (Same as predicate) |

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

• Test Set Sample Size: Not applicable. The submission does not describe a test set in the context of evaluating diagnostic or clinical performance with a specific sample size. The evaluation is based on non-clinical testing against standards and comparison to a predicate device.
• Data Provenance: Not applicable. No clinical data or patient data is mentioned.

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

• Number of Experts: Not applicable. No "ground truth" for a test set was established by experts in this context. The assessment is regulatory and technical.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

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

• MRMC Study: No. The document explicitly states: "Clinical Testing: Not Applicable as there are no new or innovative aspects that have been introduced." Therefore, no MRMC study, or any clinical study comparing human readers with or without AI assistance, was performed or presented.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no such study was conducted.

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

• Standalone Performance Study: No. This submission is for a TENS unit, which is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here. The evaluation focused on the device's adherence to safety and performance standards and its comparison to the technical specifications of a predicate physical device.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not applicable in the context of diagnostic accuracy or clinical outcomes. The "ground truth" for this submission revolves around:
  • Regulatory Compliance: Meeting established AAMI/ANSI and IEC standards (e.g., electrical safety, mechanical integrity).
  • Technical Specifications: Demonstrating that the device's electrical characteristics and functionality are comparable to the stated specifications of the predicate device.
  • Intended Use: Confirming the device's intended use aligns with that of the predicate.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This document describes a physical medical device, not a machine learning model or algorithm that would require a training set.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Summary of the Study Proving Acceptance Criteria:

The "study" in this context is the non-clinical testing and comparison outlined in section 10.7 ("Non-clinical Testing") and 10.6 ("Technological Comparison to Predicate Devices").

• Non-Clinical Testing: The manufacturer conducted tests to ensure the TENS units met all required sections of the AAMI/ANSI NS-4 Standard and passed the IEC 60601-1 and IEC 601-1 standards. They also ensured the use of "shrouded patient cable connector's" to comply with FDA's Final Rule. This testing demonstrates the device's adherence to established safety and performance standards for TENS units.
• Technological Comparison: The manufacturer compared the functionality and technical characteristics of the First Choice and First Choice Plus devices to the predicate device, FUJI TENS 804SIII (K893874). They identified slight differences (e.g., single dial for pulse rate control) but concluded that these differences did not introduce new questions of safety or effectiveness. The First Choice Plus also added pulse width adjustment, which was also found to be within acceptable parameters relative to the predicate's overall functionality.

The conclusion (Section 10.9) states that "The First Choice and First Choice Plus have the same intended use and similar technical characteristics as the FUJI TENS 804SIII (K893874)... The information supplied in this 510(k) illustrate that the devices do not pose any new questions of safety and effectiveness. The First Choice and First Choice Plus are substantially equivalent to the predicate device(s)." This statement, supported by the non-clinical testing and technological comparison, serves as the "proof" that the device meets the implied acceptance criteria for substantial equivalence necessary for 510(k) clearance.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device