(276 days)
The TOSAMA Reusable Applicator is intended to be used to insert a digital (no applicator) menstrual tampon into the vagina.
The TOSAMA Reusable Applicator is a non-sterile, single user, reusable medical device. It is intended to be sold in three different packaging configurations: Applicator with prepackaged tampons (regular, super and super plus absorbency versions) and Applicator with loose tampons of super and regular absorbency. The device is comprised of a tampon holder and pusher made of thermoplastic elastomer and a lipstick-style cap to protect the applicator, which is made of polystyrene. The tampon holder and pusher are connected at the hinged base of the holder, which opens to load a tampon and closes to allow the pusher to eject a tampon. The holder and pusher are designed to stay connected and not separate during use, storage, or cleaning. The TOSAMA Reusable Applicator requires the user to load the applicator with a legally marketed menstrual tampon. The use-life of the subject TOSAMA Reusable Applicator is 2 years. The device requires the user to clean (holder and pusher) and disinfect (lipstick cap) before initial use, before long term storage and at the end of the menstrual cycle, as well as to clean the device after each use. The applicator is available in one size for all sizes of tampon absorbencies (Light, Regular, Super and Super Plus) and accommodates a maximal tampon diameter of 15 mm. The holder inner diameter is 8.2 + 0.25/- 0.10 mm, pusher length is 83.7 ±0.5 mm and total length and diameter of the applicator (without the lipstick cap) is 70.8 ± 1.0 mm and 19.6 ±0.05 mm respectively.
The provided text describes the regulatory clearance of the "TOSAMA Reusable Applicator" (K232060) and includes some information about its testing. However, it does not contain a detailed study report that proves the device meets specific acceptance criteria in the format requested.
The text generally states that "The results of the non-clinical performance data were acceptable and met the established acceptance criteria." but does not provide the specific "acceptance criteria" themselves or the detailed "reported device performance" against those criteria in a table. It also lacks significant details regarding the study design, sample sizes for test sets, data provenance, ground truth establishment, or multi-reader studies as typically found in comprehensive medical device performance reports.
Based on the provided text, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance (General Statement) |
|---|---|
| Non-cytotoxic | The subject device was non-cytotoxic. |
| Non-sensitizing | The subject device was a non-sensitizer. |
| Non-irritating (vaginal) | The subject device was non-irritating. |
| Met applicable design and performance requirements for device weight | Acceptable and met established acceptance criteria. |
| Met applicable design and performance requirements for physical dimensions | Acceptable and met established acceptance criteria. |
| Met applicable design and performance requirements for functional evaluation (e.g., ejection force, plunger pull force, pusher stability, hinge durability, lipstick cap compatibility) | Acceptable and met established acceptance criteria. |
| Met applicable design and performance requirements for use-life testing | Acceptable and met established acceptance criteria. |
| Met reprocessing, cleaning, and disinfecting requirements | Cleaning instructions developed per FDA guidance; validated processes for washing, boiling, and alcohol disinfection. |
Missing specific acceptance values and corresponding performance results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any of the tests (biocompatibility, bench testing, reprocessing).
- Data Provenance: Not specified. It's a regulatory submission from a Slovenian company (Tosama, d.o.o., Domžale, Slovenia). The testing would likely have been conducted by or for this company. Whether the data is retrospective or prospective is not mentioned.
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 type of study (e.g., biocompatibility and functional bench testing for a reusable tampon applicator) would not typically involve human experts establishing "ground truth" in the way an AI diagnostic device would. Instead, the ground truth is based on standardized biochemical assays (for biocompatibility) or engineering measurements against design specifications (for bench testing). Therefore, this question is not directly applicable in the context of this device's testing according to the provided information.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the types of tests described (biocompatibility, bench testing). Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, not for objective laboratory or engineering tests.
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 type of study is specifically relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use AI as an aid. The TOSAMA Reusable Applicator is a physical medical device (tampon applicator), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is not an algorithm or AI. The testing described focuses on the physical and biological safety and performance of the applicator itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Biocompatibility: The ground truth is based on established biological and toxicological standards and test methods (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation) and their defined pass/fail criteria.
- For Bench Testing: The ground truth is established by engineering design specifications and performance requirements (e.g., specific force values for ejection, dimensional tolerances, durability cycles).
- For Reprocessing: The ground truth is based on micro-biological testing (e.g., reduction of bioburden) and visual inspection to ensure cleanliness and disinfection efficacy, validated against pre-defined criteria.
8. The sample size for the training set
- Not applicable. This device is not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).