(365 days)
- Relief of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the clenohumeral joint. 2) Irreducible 3 and 4 part fractures of the proximal humerus. 3) Non-united chronic humeral head fractures or fracture-dislocations. 4) Avascular necrosis of the humeral head. 5) Other difficult clinical management problems, including falled reconstructive procedures, where arthrodesis of resection arthroplasty are not considered acceptable.
The Kirschner Shoulders are all based on the original design concept of the Neer Shoulder. Common design features include Cobalt-Chromium-Molybdenum alloy substrate: smooth. distally tapered stem; grooves in the stem to aid in cement pressurization and provided torsional stability; four proximal fins to provided rotational stability and facilitate positioning insertion; continuous radius of curvature humeral head geometry and; all humeral heads are compatible with all glenoid components. Kirschner II-C Humeral Stems are one piece in that the head and stern are an single component. Modular II-C Humeral Stems are a one piece stem with a modular head attached by a Morse-type taper. Atlas-C Modular Stems are two piece stems composed of a proximal humeral component and a distal stem attached by a screw thread. This component also utilizes a modular humeral head. The Modular Glenoid Metal Backing provides reinforcement to a polyethylene bearing surface. The design is identical to the predicate device.
This 510(k) is for a change from a cobalt alloy plasma spray coating to a titanium alloy coating and a change in the manufacturing location. All other aspects of the device remain the same.
This document is a 510(k) premarket notification for a medical device (Kirschner Shoulders with Titanium Plasma Spray), which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a study or data proving specific acceptance criteria related to device performance in the way requested.
The 510(k) summary describes device modifications (change in plasma spray coating and manufacturing location) and indicates that "All other aspects of the device remain the same." This implies that the performance characteristics, and thus acceptance criteria, are assumed to be identical to the predicate devices. Therefore, a new study to prove updated acceptance criteria is not typically required or presented in such a submission.
Here's a breakdown of why I cannot fulfill your request based on the provided text, and what elements are present:
Why the Request Cannot Be Fully Answered with the Provided Text:
- No Acceptance Criteria or Performance Data: The document presents the device description, indications for use, and potential risks, but it does not explicitly state specific acceptance criteria (e.g., minimum tensile strength, fatigue life, wear rates, clinical success rates, etc.) nor does it provide study results to demonstrate performance against such criteria.
- Focus on Substantial Equivalence: The core of a 510(k) is to prove that a new device is "substantially equivalent" to a legally marketed predicate device. This often means demonstrating that the new device has the same intended use and similar technological characteristics, and does not raise different questions of safety and effectiveness. It doesn't necessarily require new performance studies if the changes are minor and don't affect performance.
- No Clinical Study Details: There is no mention of a clinical study, reader study, or any performance study data that would involve human subjects, readers, ground truth establishment, or sample sizes for testing or training sets.
- Device Type: This device is a shoulder prosthesis, an implantable mechanical device. Performance is typically assessed through mechanical testing (e.g., wear, fatigue, static strength) and sometimes by tracking long-term clinical outcomes, but no such data is present here.
What Information Can Be Extracted/Inferred from the Text (and why it doesn't fit your table):
Since there are no explicit acceptance criteria or performance study results presented, I cannot fill the table or provide the requested details about studies. However, I can explain what the document does convey:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated. For a 510(k) modification, the implied acceptance criterion is that the modified device's performance (e.g., mechanical properties, biocompatibility) is at least equivalent to the predicate device and meets established consensus standards for such implants.
- Reported Device Performance: Not reported directly in terms of specific metrics. The assumption is that its performance remains equivalent to the predicate device due to the limited nature of the changes (coating material and manufacturing location).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No test set or performance data is presented.
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. No human-read or image-based test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert 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:
- Not applicable. This device is a physical implant, not an AI or diagnostic imaging device. No MRMC study or AI component is mentioned.
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):
- Not applicable. No ground truth establishment is described for device performance as typically understood for diagnostic or AI systems. For a physical implant, "ground truth" would relate to its physical properties (e.g., material composition, strength) and clinical outcomes, but no studies proving these are detailed here.
8. The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI or learning-based device.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided text from the 510(k) premarket notification focuses on regulatory approval through substantial equivalence and does not contain the detailed performance study data requested.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.