SHORT AND LONG SOFT TISSUE ATTACHMENT

• K Number: K022079
• Device Name: SHORT AND LONG SOFT TISSUE ATTACHMENT
• Manufacturer: BIOMET, INC.
• Date Cleared: 2002-09-24 ( 90 days)
• Product Code: KWT
• Regulation Number: 888.3650
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K913282 , K020045

Intended Use

The indications for the use of the Short and Long Soft Tlssue Attachment Sleeves include:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Correction of functional deformity
5. Treatment of acute fracture of the humeral head unmanageable using other treatment methods
   The sleeves can be used for oncology applications.
   The sleeves are designed for use with the Biomet Mosaic™ Humeral System (K020045), to provide the option for soft tissue stabilization and attachment.
   The Biomet Mosaic™ Humeral System (K020045) is for use with bone cernent.

Device Description

This particular design utilizes a taper junction between the sleeve and the segment component of the Biomet Proximal Humeral Replacement System (K020045). For secure placement, the sleeve has a larger proximal taper junction. Because the soft tissue will naturally be pulling proximally, if the taper junction does move, the soft tissue will only tighten the taper.

There are two sizes that vary only in length and suture hole availability. The short sleeve has 4 suture holes available and the holes are arranged perpendicular to the axis of the segment. The long sleeve has 5 suture holes that are arranged perpendicular to the axis of the segment and 4 suture holes placed parallel to the axis of the segment. Both sleeves have the same outside and inside diameters and inside mating taper.

The sleeves are designed for use in conjunction with the Biomet Modular Proximal Humeral Replacement System (K020045), now called the Mosaic™ Humeral System to provide the option for soft tissue stabilization and attachment to the prosthetic device

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the Short and Long Soft Tissue Attachment Sleeve:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Device must be substantially equivalent to legally marketed predicate devices for its intended use and technology.	The Short and Long Soft Tissue Attachment Sleeve components (materials, design, sizes, and indications) are similar or identical to the predicate devices (LIMA RPS Shoulder (K913282) and Biomet Modular Proximal Humeral Replacement System (K020045), now known as the Mosaic™ Humeral System). The device also uses a taper junction design which, if it moves, is designed to tighten the soft tissue, ensuring secure placement.
Safety (Non-Clinical)	Device must not present new risks compared to legally marketed predicate devices.	Mechanical testing with Engineering Justifications determined that the Short and Long Soft Tissue Attachment Sleeve components presented no new risks and were, therefore, substantially equivalent to the predicate device.
Effectiveness (Non-Clinical)	Device must be effective for its intended use and comparable to predicate devices.	The mechanical testing and engineering justifications implicitly support effectiveness by demonstrating the device's ability to maintain secure placement and function as intended for soft tissue attachment, similarly to the predicate devices.
Indications for Use	Device's indications for use must align with, or be substantially equivalent to, predicate devices.	The stated indications for use are: Non-inflammatory degenerative joint disease (including osteoarthritis and avascular necrosis), rheumatoid arthritis, revision where other devices or treatments have failed, correction of functional deformity, treatment of acute fracture of the humeral head unmanageable using other treatment methods, and oncology applications. The device is specifically designed for use with the Biomet Mosaic™ Humeral System (K020045) for soft tissue stabilization and attachment. These are consistent with the function of similar humeral replacement and soft tissue attachment systems.
Biocompatibility/Material	Materials used should be safe and compatible with the human body. (Implicit, though not explicitly detailed in the provided text for acceptance criteria)	The mention of "materials" being similar or identical to predicate devices implies that the materials are considered biocompatible and safe based on prior approvals of the predicate devices. Specific biocompatibility testing results are not detailed in the provided summary.

Study Information

Based on the provided document, the device approval was based on a demonstration of substantial equivalence to predicate devices, rather than a traditional clinical study with defined acceptance criteria for outcomes like accuracy, sensitivity, or specificity.

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

   • Test Set Sample Size: Not applicable. No clinical test set (patient population) was used for evaluation.
   • Data Provenance: Not applicable. The evaluation was based on non-clinical (mechanical) testing and comparison to existing device specifications.

2. 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. Ground truth from experts in a clinical context was not required as no clinical testing was performed. The "ground truth" here is the established safety and effectiveness of the predicate devices and the engineering principles applied during mechanical testing.

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

   • Not applicable. No test set requiring adjudication was used.

4. 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 medical device (prosthesis component), not an AI-assisted diagnostic or clinical decision support tool. Therefore, an MRMC study is irrelevant.

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

   • Not applicable. This is a physical medical device.

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

   • The "ground truth" for the substantial equivalence determination was based on:
     • Predicate Device Performance: The established safety and effectiveness records of the legally marketed predicate devices (LIMA RPS Shoulder (K913282) and Biomet Modular Proximal Humeral Replacement System (K020045)).
     • Engineering Justifications: Data derived from mechanical testing, interpreted by engineers, to demonstrate that the device's design, materials, and functional characteristics were comparable and did not introduce new risks.

7. The sample size for the training set:

   • Not applicable. There was no "training set" in the context of an algorithm or diagnostic model. The "training" for the device design would implicitly come from the design and manufacturing knowledge for the predicate devices.

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

   • Not applicable, as there was no training set in the typical sense for algorithms. The device's design and manufacturing process would have been informed by established engineering principles and the performance history of similar devices.

Summary of the Study:

The "study" conducted for the Short and Long Soft Tissue Attachment Sleeve was non-clinical mechanical testing combined with engineering justifications. This study aimed to demonstrate substantial equivalence to existing legally marketed predicate devices. The core findings were:

• The device's materials, design, sizes, and indications are "similar or identical" to the predicate devices.
• Mechanical testing and engineering justifications concluded that the device presented "no new risks" compared to the predicate device.
• No clinical testing was performed or provided as a basis for substantial equivalence.

Therefore, the device met the acceptance criteria by successfully demonstrating that it was as safe and effective as the predicate devices through non-clinical means, rather than through a traditional clinical trial establishing efficacy against specific measurable outcomes in patients.

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”